1. CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
2. SUBCHAPTER A GENERAL
3. PART 1 GENERAL ENFORCEMENT REGULATIONS
4. Subpart A General Provisions
5. § 1.1 General.
6. § 1.3 Definitions.
7. § 1.4 Authority citations.
8. Subpart B General Labeling Requirements
9. § 1.20 Presence of mandatory label information.
10. § 1.21 Failure to reveal material facts.
11. § 1.23 Procedures for requesting variations and exemptions from required label statements.
12. § 1.24 Exemptions from required label statements.
13. C Subpart C [Reserved]
14. Subpart D Electronic Import Entries
15. § 1.70 Scope.
16. § 1.71 Definitions.
17. § 1.72 Data elements that must be submitted in ACE for articles regulated by FDA.
18. § 1.73 Food.
19. § 1.74 Human drugs.
20. § 1.75 Animal drugs and veterinary devices.
21. § 1.76 Medical devices.
22. § 1.77 Radiation-emitting electronic products.
23. § 1.78 Biological products, HCT/Ps, and related drugs and medical devices.
24. § 1.79 Tobacco products.
25. § 1.80 Cosmetics.
26. § 1.81 Rejection of entry filing.
27. Subpart E Imports and Exports
28. § 1.83 Definitions.
29. § 1.90 Notice of sampling.
30. § 1.91 Payment for samples.
31. § 1.94 Hearing on refusal of admission or destruction.
32. § 1.95 Application for authorization to relabel and recondition.
33. § 1.96 Granting of authorization to relabel and recondition.
34. § 1.97 Bonds.
35. § 1.99 Costs chargeable in connection with relabeling and reconditioning inadmissible imports.
36. § 1.101 Notification and recordkeeping.
37. F Subparts F-G [Reserved]
38. Subpart H Registration of Food Facilities
39. 49 General Provisions
40. § 1.225 Who must register under this subpart?
41. § 1.226 Who does not have to register under this subpart?
42. § 1.227 What definitions apply to this subpart?
43. 50 Procedures for Registration of Food Facilities
44. § 1.230 When must you register or renew your registration?
45. § 1.231 How and where do you register or renew your registration?
46. § 1.232 What information is required in the registration?
47. § 1.233 Are there optional items included in the registration form?
48. § 1.234 How and when do you update your facility's registration information?
49. § 1.235 How and when do you cancel your facility's registration information?
50. 51 Additional Provisions
51. § 1.240 What other registration requirements apply?
52. § 1.241 What are the consequences of failing to register, update, renew, or cancel your registration?
53. § 1.242 What does assignment of a registration number mean?
54. § 1.243 Is food registration information available to the public?
55. § 1.245 Waiver request.
56. Subpart I Prior Notice of Imported Food
57. 52 General Provisions
58. § 1.276 What definitions apply to this subpart?
59. § 1.277 What is the scope of this subpart?
60. 53 Requirements To Submit Prior Notice of Imported Food
61. § 1.278 Who is authorized to submit prior notice?
62. § 1.279 When must prior notice be submitted to FDA?
63. § 1.280 How must you submit prior notice?
64. § 1.281 What information must be in a prior notice?
65. § 1.282 What must you do if information changes after you have received confirmation of a prior notice from FDA?
66. 54 Consequences
67. § 1.283 What happens to food that is imported or offered for import without adequate prior notice?
68. § 1.284 What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?
69. § 1.285 What happens to food that is imported or offered for import from unregistered facilities that are required to register under subpart H of this part?
70. Subpart J Establishment, Maintenance, and Availability of Records
71. 55 General Provisions
72. § 1.326 Who is subject to this subpart?
73. § 1.327 Who is excluded from all or part of the regulations in this subpart?
74. § 1.328 What definitions apply to this subpart?
75. § 1.329 Do other statutory provisions and regulations apply?
76. § 1.330 Can existing records satisfy the requirements of this subpart?
77. 56 Requirements for Nontransporters To Establish and Maintain Records To Identify the Nontransporter and Transporter Immediate Previous Sources of Food
78. § 1.337 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food?
79. 57 Requirements for Nontransporters To Establish and Maintain Records To Identify the Nontransporter and Transporter Immediate Subsequent Recipients of Food
80. § 1.345 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?
81. 58 Requirements for Transporters To Establish and Maintain Records
82. § 1.352 What information must transporters establish and maintain?
83. 59 General Requirements
84. § 1.360 What are the record retention requirements?
85. § 1.361 What are the record availability requirements?
86. § 1.362 What records are excluded from this subpart?
87. § 1.363 What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?
88. 60 Compliance Dates
89. § 1.368 What are the compliance dates for this subpart?
90. Subpart K Administrative Detention of Food for Human or Animal Consumption
91. 61 General Provisions
92. § 1.377 What definitions apply to this subpart?
93. § 1.378 What criteria does FDA use to order a detention?
94. § 1.379 How long may FDA detain an article of food?
95. § 1.380 Where and under what conditions must the detained article of food be held?
96. § 1.381 May a detained article of food be delivered to another entity or transferred to another location?
97. § 1.382 What labeling or marking requirements apply to a detained article of food?
98. § 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food?
99. § 1.384 When does a detention order terminate?
100. 62 How Does FDA Order a Detention?
101. § 1.391 Who approves a detention order?
102. § 1.392 Who receives a copy of the detention order?
103. § 1.393 What information must FDA include in the detention order?
104. 63 What Is the Appeal Process for a Detention Order?
105. § 1.401 Who is entitled to appeal?
106. § 1.402 What are the requirements for submitting an appeal?
107. § 1.403 What requirements apply to an informal hearing?
108. § 1.404 Who serves as the presiding officer for an appeal and for an informal hearing?
109. § 1.405 When does FDA have to issue a decision on an appeal?
110. § 1.406 How will FDA handle classified information in an informal hearing?
111. Subpart L Foreign Supplier Verification Programs for Food Importers
112. § 1.500 What definitions apply to this subpart?
113. § 1.501 To what foods do the requirements in this subpart apply?
114. § 1.502 What foreign supplier verification program (FSVP) must I have?
115. § 1.503 Who must develop my FSVP and perform FSVP activities?
116. § 1.504 What hazard analysis must I conduct?
117. § 1.505 What evaluation for foreign supplier approval and verification must I conduct?
118. § 1.506 What foreign supplier verification and related activities must I conduct?
119. § 1.507 What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation?
120. § 1.508 What corrective actions must I take under my FSVP?
121. § 1.509 How must the importer be identified at entry?
122. § 1.510 How must I maintain records of my FSVP?
123. § 1.511 What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?
124. § 1.512 What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers?
125. § 1.513 What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system?
126. § 1.514 What are some consequences of failing to comply with the requirements of this subpart?
127. Subpart M Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
128. § 1.600 What definitions apply to this subpart?
129. § 1.601 Who is subject to this subpart?
130. 64 Recognition of Accreditation Bodies Under This Subpart
131. § 1.610 Who is eligible to seek recognition?
132. § 1.611 What legal authority must an accreditation body have to qualify for recognition?
133. § 1.612 What competency and capacity must an accreditation body have to qualify for recognition?
134. § 1.613 What protections against conflicts of interest must an accreditation body have to qualify for recognition?
135. § 1.614 What quality assurance procedures must an accreditation body have to qualify for recognition?
136. § 1.615 What records procedures must an accreditation body have to qualify for recognition?
137. 65 Requirements for Accreditation Bodies That Have Been Recognized Under This Subpart
138. § 1.620 How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?
139. § 1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?
140. § 1.622 How must a recognized accreditation body monitor its own performance?
141. § 1.623 What reports and notifications must a recognized accreditation body submit to FDA?
142. § 1.624 How must a recognized accreditation body protect against conflicts of interest?
143. § 1.625 What records requirements must an accreditation body that has been recognized meet?
144. 66 Procedures for Recognition of Accreditation Bodies Under This Subpart
145. § 1.630 How do I apply to FDA for recognition or renewal of recognition?
146. § 1.631 How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?
147. § 1.632 What is the duration of recognition?
148. § 1.633 How will FDA monitor recognized accreditation bodies?
149. § 1.634 When will FDA revoke recognition?
150. § 1.635 What if I want to voluntarily relinquish recognition or do not want to renew recognition?
151. § 1.636 How do I request reinstatement of recognition?
152. 67 Accreditation of Third-Party Certification Bodies Under This Subpart
153. § 1.640 Who is eligible to seek accreditation?
154. § 1.641 What legal authority must a third-party certification body have to qualify for accreditation?
155. § 1.642 What competency and capacity must a third-party certification body have to qualify for accreditation?
156. § 1.643 What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?
157. § 1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation?
158. § 1.645 What records procedures must a third-party certification body have to qualify for accreditation?
159. 68 Requirements for Third-Party Certification Bodies That Have Been Accredited Under This Subpart
160. § 1.650 How must an accredited third-party certification body ensure its audit agents are competent and objective?
161. § 1.651 How must an accredited third-party certification body conduct a food safety audit of an eligible entity?
162. § 1.652 What must an accredited third-party certification body include in food safety audit reports?
163. § 1.653 What must an accredited third-party certification body do when issuing food or facility certifications?
164. § 1.654 When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?
165. § 1.655 How must an accredited third-party certification body monitor its own performance?
166. § 1.656 What reports and notifications must an accredited third-party certification body submit?
167. § 1.657 How must an accredited third-party certification body protect against conflicts of interest?
168. § 1.658 What records requirements must a third-party certification body that has been accredited meet?
169. 69 Procedures for Accreditation of Third-Party Certification Bodies Under This Subpart
170. § 1.660 Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application?
171. § 1.661 What is the duration of accreditation by a recognized accreditation body?
172. § 1.662 How will FDA monitor accredited third-party certification bodies?
173. § 1.663 How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?
174. § 1.664 When would FDA withdraw accreditation?
175. § 1.665 What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?
176. § 1.666 How do I request reaccreditation?
177. 70 Additional Procedures for Direct Accreditation of Third-Party Certification Bodies Under This Subpart
178. § 1.670 How do I apply to FDA for direct accreditation or renewal of direct accreditation?
179. § 1.671 How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application?
180. § 1.672 What is the duration of direct accreditation?
181. 71 Requirements for Eligible Entities Under This Subpart
182. § 1.680 How and when will FDA monitor eligible entities?
183. § 1.681 How frequently must eligible entities be recertified?
184. 72 General Requirements of This Subpart
185. § 1.690 How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?
186. § 1.691 How do I request reconsideration of a denial by FDA of an application or a waiver request?
187. § 1.692 How do I request internal agency review of a denial of an application or waiver request upon reconsideration?
188. § 1.693 How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?
189. § 1.694 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
190. § 1.695 Are the records obtained by FDA under this subpart subject to public disclosure?
191. 73 Requirements for User Fees Under This Subpart
192. § 1.700 Who is subject to a user fee under this subpart?
193. § 1.705 What user fees are established under this subpart?
194. § 1.710 How will FDA notify the public about the fee schedule?
195. § 1.715 When must a user fee required by this subpart be submitted?
196. § 1.720 Are user fees under this subpart refundable?
197. § 1.725 What are the consequences of not paying a user fee under this subpart on time?
198. N Subpart N [Reserved]
199. Subpart O Sanitary Transportation of Human and Animal Food
200. 74 General Provisions
201. § 1.900 Who is subject to this subpart?
202. § 1.902 How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act?
203. § 1.904 What definitions apply to this subpart?
204. 75 Vehicles and Transportation Equipment
205. § 1.906 What requirements apply to vehicles and transportation equipment?
206. 76 Transportation Operations
207. § 1.908 What requirements apply to transportation operations?
208. 77 Training
209. § 1.910 What training requirements apply to carriers engaged in transportation operations?
210. 78 Records
211. § 1.912 What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations?
212. 79 Waivers
213. § 1.914 Under what circumstances will we waive a requirement of this subpart?
214. § 1.916 When will we consider whether to waive a requirement of this subpart?
215. § 1.918 What must be included in the Statement of Grounds in a petition requesting a waiver?
216. § 1.920 What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available?
217. § 1.922 Who will respond to a petition requesting a waiver?
218. § 1.924 What process applies to a petition requesting a waiver?
219. § 1.926 Under what circumstances may we deny a petition requesting a waiver?
220. § 1.928 What process will we follow when waiving a requirement of this subpart on our own initiative?
221. § 1.930 When will a waiver that we grant become effective?
222. § 1.932 Under what circumstances may we modify or revoke a waiver?
223. § 1.934 What procedures apply if we determine that a waiver should be modified or revoked?
224. P Subpart P [Reserved]
225. Subpart Q Administrative Detention of Drugs Intended for Human or Animal Use
226. § 1.980 Administrative detention of drugs.
227. Subpart R Laboratory Accreditation for Analyses of Foods
228. 80 General Provisions
229. § 1.1101 What documents are incorporated by reference in this subpart
230. § 1.1102 What definitions apply to this subpart?
231. § 1.1103 Who is subject to this subpart?
232. 81 General Requirements
233. § 1.1107 When must food testing be conducted under this subpart?
234. § 1.1108 When and how will FDA issue a directed food laboratory order?
235. § 1.1109 How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?
236. § 1.1110 What are the general requirements for submitting information to FDA under this subpart?
237. 82 FDA Recognition of Accreditation Bodies
238. § 1.1113 What are the eligibility requirements for a recognized accreditation body?
239. § 1.1114 How does an accreditation body apply to FDA for recognition or renewal of recognition?
240. § 1.1115 How will FDA evaluate applications for recognition and renewal of recognition?
241. § 1.1116 What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?
242. § 1.1117 How may an accreditation body request reinstatement of recognition?
243. 83 Requirements for Recognized Accreditation Bodies
244. § 1.1119 What are the conflict of interest requirements for a recognized accreditation body?
245. § 1.1120 How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
246. § 1.1121 When must a recognized accreditation body require corrective action, suspend a LAAF-accredited laboratory, or reduce the scope of or withdraw the LAAF-accreditation of a laboratory?
247. § 1.1122 What procedures must a recognized accreditation body provide for appeals of decisions to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation?
248. § 1.1123 What reports, notifications, and documentation must a recognized accreditation body submit to FDA?
249. § 1.1124 What are the records requirements for a recognized accreditation body?
250. § 1.1125 What are the internal audit requirements for a recognized accreditation body?
251. 84 FDA Oversight of Recognized Accreditation Bodies
252. § 1.1130 How will FDA oversee recognized accreditation bodies?
253. § 1.1131 When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?
254. 85 LAAF-Accreditation of Laboratories
255. § 1.1138 What are the eligibility requirements for a LAAF-accredited laboratory?
256. § 1.1139 How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?
257. § 1.1140 What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?
258. § 1.1141 What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?
259. § 1.1142 How does a laboratory request reinstatement of LAAF-accreditation?
260. 86 Requirements for LAAF-Accredited Laboratories
261. § 1.1147 What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?
262. § 1.1149 What oversight standards apply to sampling?
263. § 1.1150 What are the requirements for analysis of samples by a LAAF-accredited laboratory?
264. § 1.1151 What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?
265. § 1.1152 What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?
266. § 1.1153 What are the requirements for submitting abridged analytical reports?
267. § 1.1154 What other records requirements must a LAAF-accredited laboratory meet?
268. 87 FDA Oversight of LAAF-Accredited Laboratories
269. § 1.1159 How will FDA oversee LAAF-accredited laboratories?
270. § 1.1160 How will FDA review test results and analytical reports?
271. § 1.1161 When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports?
272. § 1.1162 What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?
273. 88 Requesting FDA Reconsideration or Regulatory Hearings of FDA Decisions Under This Subpart
274. § 1.1171 How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?
275. § 1.1173 How does an accreditation body or laboratory request a regulatory hearing on FDA's decision to revoke the accreditation body's recognition or disqualify a LAAF-accredited laboratory?
276. § 1.1174 How does an owner or consignee request a regulatory hearing on a directed food laboratory order?
277. 89 Electronic Records and Public Disclosure Requirements
278. § 1.1199 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
279. § 1.1200 Are the records obtained by FDA under this subpart subject to public disclosure?
280. Subpart S Additional Traceability Records for Certain Foods
281. 90 General Provisions
282. § 1.1300 Who is subject to this subpart?
283. § 1.1305 What foods and persons are exempt from this subpart?
284. § 1.1310 What definitions apply to this subpart?
285. 91 Traceability Plan
286. § 1.1315 What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?
287. § 1.1320 When must I assign traceability lot codes to foods on the Food Traceability List?
288. 92 Records of Critical Tracking Events
289. § 1.1325 What records must I keep and provide when I harvest or cool a raw agricultural commodity on the Food Traceability List?
290. § 1.1330 What records must I keep when I am performing the initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List?
291. § 1.1335 What records must I keep when I am the first land-based receiver of a food on the Food Traceability List that was obtained from a fishing vessel?
292. § 1.1340 What records must I keep and provide when I ship a food on the Food Traceability List?
293. § 1.1345 What records must I keep when I receive a food on the Food Traceability List?
294. § 1.1350 What records must I keep when I transform a food on the Food Traceability List?
295. 93 Procedures for Modified Requirements and Exemptions
296. § 1.1360 Under what circumstances will FDA modify the requirements in this subpart that apply to a food or type of entity or exempt a food or type of entity from the requirements of this subpart?
297. § 1.1365 When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?
298. § 1.1370 What must be included in a petition requesting modified requirements or an exemption from the requirements?
299. § 1.1375 What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available?
300. § 1.1380 What process applies to a petition requesting modified requirements or an exemption?
301. § 1.1385 What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?
302. § 1.1390 When will modified requirements that we adopt or an exemption that we grant become effective?
303. § 1.1395 Under what circumstances may FDA revise or revoke modified requirements or an exemption?
304. § 1.1400 What procedures apply if FDA tentatively determines that modified requirements or an exemption should be revised or revoked?
305. 94 Waivers
306. § 1.1405 Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?
307. § 1.1410 When will FDA consider whether to waive a requirement of this subpart?
308. § 1.1415 How may I request a waiver for an individual entity?
309. § 1.1420 What process applies to a request for a waiver for an individual entity?
310. § 1.1425 What must be included in a petition requesting a waiver for a type of entity?
311. § 1.1430 What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available?
312. § 1.1435 What process applies to a petition requesting a waiver for a type of entity?
313. § 1.1440 What process will FDA follow when waiving a requirement of this subpart on our own initiative?
314. § 1.1445 Under what circumstances may FDA modify or revoke a waiver?
315. § 1.1450 What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?
316. 95 Records Maintenance and Availability
317. § 1.1455 How must records required by this subpart be maintained and made available?
318. 96 Consequences of Failure To Comply
319. § 1.1460 What consequences could result from failing to comply with the requirements of this subpart?
320. 97 Updating the Food Traceability List
321. § 1.1465 How will FDA update the Food Traceability List?
322. PART 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
323. Subpart A General Provisions
324. § 2.5 Imminent hazard to the public health.
325. § 2.10 Examination and investigation samples.
326. § 2.19 [Reserved]
327. Subpart B Human and Animal Foods
328. § 2.25 Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food.
329. § 2.35 Use of secondhand containers for the shipment or storage of food and animal feed.
330. C Subparts C-E [Reserved]
331. Subpart F Caustic Poisons
332. § 2.110 Definition of ammonia under Federal Caustic Poison Act.
333. Subpart G Provisions Applicable to Specific Products Subject to the Federal Food, Drug, and Cosmetic Act
334. § 2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.
335. PART 3 PRODUCT JURISDICTION
336. Subpart A Assignment of Agency Component for Review of Premarket Applications
337. § 3.1 Purpose.
338. § 3.2 Definitions.
339. § 3.3 Scope.
340. § 3.4 Designated agency component.
341. § 3.5 Procedures for identifying the designated agency component.
342. § 3.6 Product jurisdiction officer.
343. § 3.7 Request for designation.
344. § 3.8 Letter of designation.
345. § 3.9 Effect of letter of designation.
346. § 3.10 Stay of review time.
347. B Subpart B [Reserved]
348. PART 4 REGULATION OF COMBINATION PRODUCTS
349. Subpart A Current Good Manufacturing Practice Requirements for Combination Products
350. § 4.1 What is the scope of this subpart?
351. § 4.2 How does FDA define key terms and phrases in this subpart?
352. § 4.3 What current good manufacturing practice requirements apply to my combination product?
353. § 4.4 How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?
354. Subpart B Postmarketing Safety Reporting for Combination Products
355. § 4.100 What is the scope of this subpart?
356. § 4.101 How does the FDA define key terms and phrases in this subpart?
357. § 4.102 What reports must you submit to FDA for your combination product or constituent part?
358. § 4.103 What information must you share with other constituent part applicants for the combination product?
359. § 4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part?
360. § 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
361. PART 5 ORGANIZATION
362. A Subparts A-L [Reserved]
363. Subpart M Organization
364. § 5.1100 Agency Organization Information.
365. PART 7 ENFORCEMENT POLICY
366. Subpart A General Provisions
367. § 7.1 Scope.
368. § 7.3 Definitions.
369. § 7.12 Guaranty.
370. § 7.13 Suggested forms of guaranty.
371. B Subpart B [Reserved]
372. Subpart C Recalls (Including Product Corrections)—Guidance on Policy, Procedures, and Industry Responsibilities
373. § 7.40 Recall policy.
374. § 7.41 Health hazard evaluation and recall classification.
375. § 7.42 Recall strategy.
376. § 7.45 Food and Drug Administration-requested recall.
377. § 7.46 Firm-initiated recall.
378. § 7.49 Recall communications.
379. § 7.50 Public notification of recall.
380. § 7.53 Recall status reports.
381. § 7.55 Termination of a recall.
382. § 7.59 General industry guidance.
383. D Subpart D [Reserved]
384. Subpart E Criminal Violations
385. § 7.84 Opportunity for presentation of views before report of criminal violation.
386. § 7.85 Conduct of a presentation of views before report of criminal violation.
387. § 7.87 Records related to opportunities for presentation of views conducted before report of criminal violation.
388. PART 10 ADMINISTRATIVE PRACTICES AND PROCEDURES
389. Subpart A General Provisions
390. § 10.1 Scope.
391. § 10.3 Definitions.
392. § 10.10 Summaries of administrative practices and procedures.
393. § 10.19 Waiver, suspension, or modification of procedural requirements.
394. Subpart B General Administrative Procedures
395. § 10.20 Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.
396. § 10.25 Initiation of administrative proceedings.
397. § 10.30 Citizen petition.
398. § 10.31 Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications.
399. § 10.33 Administrative reconsideration of action.
400. § 10.35 Administrative stay of action.
401. § 10.40 Promulgation of regulations for the efficient enforcement of the law.
402. § 10.45 Court review of final administrative action; exhaustion of administrative remedies.
403. § 10.50 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
404. § 10.55 Separation of functions; ex parte communications.
405. § 10.60 Referral by court.
406. § 10.65 Meetings and correspondence.
407. § 10.70 Documentation of significant decisions in administrative file.
408. § 10.75 Internal agency review of decisions.
409. § 10.80 Dissemination of draft Federal Register notices and regulations.
410. § 10.85 Advisory opinions.
411. § 10.90 Food and Drug Administration regulations, recommendations, and agreements.
412. § 10.95 Participation in outside standard-setting activities.
413. § 10.100 Public calendar.
414. § 10.105 Representation by an organization.
415. § 10.110 Settlement proposals.
416. § 10.115 Good guidance practices.
417. Subpart C Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures
418. § 10.200 Scope.
419. § 10.203 Definitions.
420. § 10.204 General.
421. § 10.205 Electronic media coverage of public administrative proceedings.
422. § 10.206 Procedures for electronic media coverage of agency public administrative proceedings.
423. PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
424. Subpart A General Provisions
425. § 11.1 Scope.
426. § 11.2 Implementation.
427. § 11.3 Definitions.
428. Subpart B Electronic Records
429. § 11.10 Controls for closed systems.
430. § 11.30 Controls for open systems.
431. § 11.50 Signature manifestations.
432. § 11.70 Signature/record linking.
433. Subpart C Electronic Signatures
434. § 11.100 General requirements.
435. § 11.200 Electronic signature components and controls.
436. § 11.300 Controls for identification codes/passwords.
437. PART 12 FORMAL EVIDENTIARY PUBLIC HEARING
438. Subpart A General Provisions
439. § 12.1 Scope.
440. Subpart B Initiation of Proceedings
441. § 12.20 Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.
442. § 12.21 Initiation of a hearing involving the issuance, amendment, or revocation of an order.
443. § 12.22 Filing objections and requests for a hearing on a regulation or order.
444. § 12.23 Notice of filing of objections.
445. § 12.24 Ruling on objections and requests for hearing.
446. § 12.26 Modification or revocation of regulation or order.
447. § 12.28 Denial of hearing in whole or in part.
448. § 12.30 Judicial review after waiver of hearing on a regulation.
449. § 12.32 Request for alternative form of hearing.
450. § 12.35 Notice of hearing; stay of action.
451. § 12.37 Effective date of a regulation.
452. § 12.38 Effective date of an order.
453. Subpart C Appearance and Participation
454. § 12.40 Appearance.
455. § 12.45 Notice of participation.
456. § 12.50 Advice on public participation in hearings.
457. Subpart D Presiding Officer
458. § 12.60 Presiding officer.
459. § 12.62 Commencement of functions.
460. § 12.70 Authority of presiding officer.
461. § 12.75 Disqualification of presiding officer.
462. § 12.78 Unavailability of presiding officer.
463. Subpart E Hearing Procedures
464. § 12.80 Filing and service of submissions.
465. § 12.82 Petition to participate in forma pauperis.
466. § 12.83 Advisory opinions.
467. § 12.85 Disclosure of data and information by the participants.
468. § 12.87 Purpose; oral and written testimony; burden of proof.
469. § 12.89 Participation of nonparties.
470. § 12.90 Conduct at oral hearings or conferences.
471. § 12.91 Time and place of prehearing conference.
472. § 12.92 Prehearing conference procedure.
473. § 12.93 Summary decisions.
474. § 12.94 Receipt of evidence.
475. § 12.95 Official notice.
476. § 12.96 Briefs and arguments.
477. § 12.97 Interlocutory appeal from ruling of presiding officer.
478. § 12.98 Official transcript.
479. § 12.99 Motions.
480. Subpart F Administrative Record
481. § 12.100 Administrative record of a hearing.
482. § 12.105 Examination of record.
483. Subpart G Initial and Final Decisions
484. § 12.120 Initial decision.
485. § 12.125 Appeal from or review of initial decision.
486. § 12.130 Decision by Commissioner on appeal or review of initial decision.
487. § 12.139 Reconsideration and stay of action.
488. Subpart H Judicial Review
489. § 12.140 Review by the courts.
490. § 12.159 Copies of petitions for judicial review.
491. PART 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
492. Subpart A General Provisions
493. § 13.1 Scope.
494. § 13.5 Notice of a hearing before a Board.
495. § 13.10 Members of a Board.
496. § 13.15 Separation of functions; ex parte communications; administrative support.
497. Subpart B Hearing Procedures
498. § 13.20 Submissions to a Board.
499. § 13.25 Disclosure of data and information by the participants.
500. § 13.30 Proceedings of a Board.
501. Subpart C Records of a Hearing Before a Board
502. § 13.40 Administrative record of a Board.
503. § 13.45 Examination of administrative record.
504. § 13.50 Record for administrative decision.
505. PART 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
506. Subpart A General Provisions
507. § 14.1 Scope.
508. § 14.5 Purpose of proceedings before an advisory committee.
509. § 14.7 Administrative remedies.
510. § 14.10 Applicability to Congress.
511. § 14.15 Committees working under a contract with FDA.
512. Subpart B Meeting Procedures
513. § 14.20 Notice of hearing before an advisory committee.
514. § 14.22 Meetings of an advisory committee.
515. § 14.25 Portions of advisory committee meetings.
516. § 14.27 Determination to close portions of advisory committee meetings.
517. § 14.29 Conduct of a hearing before an advisory committee.
518. § 14.30 Chairperson of an advisory committee.
519. § 14.31 Consultation by an advisory committee with other persons.
520. § 14.33 Compilation of materials for members of an advisory committee.
521. § 14.35 Written submissions to an advisory committee.
522. § 14.39 Additional rules for a particular advisory committee.
523. Subpart C Establishment of Advisory Committees
524. § 14.40 Establishment and renewal of advisory committees.
525. § 14.55 Termination of advisory committees.
526. Subpart D Records of Meetings and Hearings Before Advisory Committees
527. § 14.60 Minutes and reports of advisory committee meetings.
528. § 14.61 Transcripts of advisory committee meetings.
529. § 14.65 Public inquiries and requests for advisory committee records.
530. § 14.70 Administrative record of a public hearing before an advisory committee.
531. § 14.75 Examination of administrative record and other advisory committee records.
532. Subpart E Members of Advisory Committees
533. § 14.80 Qualifications for members of standing policy and technical advisory committees.
534. § 14.82 Nominations of voting members of standing advisory committees.
535. § 14.84 Nominations and selection of nonvoting members of standing technical advisory committees.
536. § 14.86 Rights and responsibilities of nonvoting members of advisory committees.
537. § 14.90 Ad hoc advisory committee members.
538. § 14.95 Compensation of advisory committee members.
539. Subpart F Standing Advisory Committees
540. § 14.100 List of standing advisory committees.
541. Subpart G Technical Electronic Products Radiation Safety Standards Committee
542. § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).
543. § 14.122 Functions of TEPRSSC.
544. § 14.125 Procedures of TEPRSSC.
545. § 14.127 Membership of TEPRSSC.
546. § 14.130 Conduct of TEPRSSC meeting; availability of TEPRSSC records.
547. Subpart H Color Additive Advisory Committees
548. § 14.140 Establishment of a color additive advisory committee.
549. § 14.142 Functions of a color additive advisory committee.
550. § 14.145 Procedures of a color additive advisory committee.
551. § 14.147 Membership of a color additive advisory committee.
552. § 14.155 Fees and compensation pertaining to a color additive advisory committee.
553. Subpart I Advisory Committees for Human Prescription Drugs
554. § 14.160 Establishment of standing technical advisory committees for human prescription drugs.
555. § 14.171 Utilization of an advisory committee on the initiative of FDA.
556. § 14.172 Utilization of an advisory committee at the request of an interested person.
557. § 14.174 Advice and recommendations in writing.
558. PART 15 PUBLIC HEARING BEFORE THE COMMISSIONER
559. Subpart A General Provisions
560. § 15.1 Scope.
561. Subpart B Procedures for Public Hearing Before the Commissioner
562. § 15.20 Notice of a public hearing before the Commissioner.
563. § 15.21 Notice of participation; schedule for hearing.
564. § 15.25 Written submissions.
565. § 15.30 Conduct of a public hearing before the Commissioner.
566. Subpart C Records of a Public Hearing Before the Commissioner
567. § 15.40 Administrative record.
568. § 15.45 Examination of administrative record.
569. PART 16 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
570. Subpart A General Provisions
571. § 16.1 Scope.
572. § 16.5 Inapplicability and limited applicability.
573. Subpart B Initiation of Proceedings
574. § 16.22 Initiation of regulatory hearing.
575. § 16.24 Regulatory hearing required by the act or a regulation.
576. § 16.26 Denial of hearing and summary decision.
577. Subpart C Commissioner and Presiding Officer
578. § 16.40 Commissioner.
579. § 16.42 Presiding officer.
580. § 16.44 Communication to presiding officer and Commissioner.
581. Subpart D Procedures for Regulatory Hearing
582. § 16.60 Hearing procedure.
583. § 16.62 Right to counsel.
584. Subpart E Administrative Record and Decision
585. § 16.80 Administrative record of a regulatory hearing.
586. § 16.85 Examination of administrative record.
587. § 16.95 Administrative decision and record for decision.
588. Subpart F Reconsideration and Stay
589. § 16.119 Reconsideration and stay of action.
590. Subpart G Judicial Review
591. § 16.120 Judicial review.
592. PART 17 CIVIL MONEY PENALTIES HEARINGS
593. § 17.1 Scope.
594. § 17.2 Maximum penalty amounts.
595. § 17.3 Definitions.
596. § 17.5 Complaint.
597. § 17.7 Service of complaint.
598. § 17.9 Answer.
599. § 17.11 Default upon failure to file an answer.
600. § 17.13 Notice of hearing.
601. § 17.15 Parties to the hearing.
602. § 17.17 Summary decisions.
603. § 17.18 Interlocutory appeal from ruling of presiding officer.
604. § 17.19 Authority of the presiding officer.
605. § 17.20 Ex parte contacts.
606. § 17.21 Prehearing conferences.
607. § 17.23 Discovery.
608. § 17.25 Exchange of witness lists, witness statements, and exhibits.
609. § 17.27 Hearing subpoenas.
610. § 17.28 Protective order.
611. § 17.29 Fees.
612. § 17.30 Computation of time.
613. § 17.31 Form, filing, and service of papers.
614. § 17.32 Motions.
615. § 17.33 The hearing and burden of proof.
616. § 17.34 Determining the amount of penalties and assessments.
617. § 17.35 Sanctions.
618. § 17.37 Witnesses.
619. § 17.39 Evidence.
620. § 17.41 The administrative record.
621. § 17.43 Posthearing briefs.
622. § 17.45 Initial decision.
623. § 17.47 Appeals.
624. § 17.48 Harmless error.
625. § 17.51 Judicial review.
626. § 17.54 Deposit in the Treasury of the United States.
627. PART 19 STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
628. Subpart A General Provisions
629. § 19.1 Scope.
630. § 19.5 Reference to Department regulations.
631. § 19.6 Code of ethics for government service.
632. § 19.10 Food and Drug Administration Conflict of Interest Review Board.
633. Subpart B Reporting of Violations
634. § 19.21 Duty to report violations.
635. Subpart C Disqualification Conditions
636. § 19.45 Temporary disqualification of former employees.
637. § 19.55 Permanent disqualification of former employees.
638. PART 20 PUBLIC INFORMATION
639. Subpart A Official Testimony and Information
640. § 20.1 Testimony by Food and Drug Administration employees.
641. § 20.2 Production of records by Food and Drug Administration employees.
642. § 20.3 Certification and authentication of Food and Drug Administration records.
643. Subpart B General Policy
644. § 20.20 Policy on disclosure of Food and Drug Administration records.
645. § 20.21 Uniform access to records.
646. § 20.22 Partial disclosure of records.
647. § 20.23 Request for existing records.
648. § 20.24 Preparation of new records.
649. § 20.25 Retroactive application of regulations.
650. § 20.26 Electronic availability and indexes of certain records.
651. § 20.27 Submission of records marked as confidential.
652. § 20.28 Food and Drug Administration determinations of confidentiality.
653. § 20.29 Prohibition on withdrawal of records from Food and Drug Administration files.
654. § 20.30 Food and Drug Administration Division of Freedom of Information.
655. § 20.31 Retention schedule of requests for Food and Drug Administration records.
656. § 20.32 Disclosure of Food and Drug Administration employee names.
657. § 20.33 Form or format of response.
658. § 20.34 Search for records.
659. Subpart C Procedures and Fees
660. § 20.40 Filing a request for records.
661. § 20.41 Time limitations.
662. § 20.42 Aggregation of certain requests.
663. § 20.43 Multitrack processing.
664. § 20.44 Expedited processing.
665. § 20.45 Fees to be charged.
666. § 20.46 Waiver or reduction of fees.
667. § 20.47 Situations in which confidentiality is uncertain.
668. § 20.48 Judicial review of proposed disclosure.
669. § 20.49 Denial of a request for records.
670. § 20.50 Nonspecific and overly burdensome requests.
671. § 20.51 Referral to primary source of records.
672. § 20.52 Availability of records at National Technical Information Service.
673. § 20.53 Use of private contractor for copying.
674. § 20.54 Request for review without copying.
675. § 20.55 Indexing trade secrets and confidential commercial or financial information.
676. Subpart D Exemptions
677. § 20.60 Applicability of exemptions.
678. § 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
679. § 20.62 Inter- or intra-agency memoranda or letters.
680. § 20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.
681. § 20.64 Records or information compiled for law enforcement purposes.
682. § 20.65 National defense and foreign policy.
683. § 20.66 Internal personnel rules and practices.
684. § 20.67 Records exempted by other statutes.
685. Subpart E Limitations on Exemptions
686. § 20.80 Applicability of limitations on exemptions.
687. § 20.81 Data and information previously disclosed to the public.
688. § 20.82 Discretionary disclosure by the Commissioner.
689. § 20.83 Disclosure required by court order.
690. § 20.84 Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees.
691. § 20.85 Disclosure to other Federal Government departments and agencies.
692. § 20.86 Disclosure in administrative or court proceedings.
693. § 20.87 Disclosure to Congress.
694. § 20.88 Communications with State and local government officials.
695. § 20.89 Communications with foreign government officials.
696. § 20.90 Disclosure to contractors.
697. § 20.91 Use of data or information for administrative or court enforcement action.
698. Subpart F Availability of Specific Categories of Records
699. § 20.100 Applicability; cross-reference to other regulations.
700. § 20.101 Administrative enforcement records.
701. § 20.102 Court enforcement records.
702. § 20.103 Correspondence.
703. § 20.104 Summaries of oral discussions.
704. § 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration.
705. § 20.106 Studies and reports prepared by or with funds provided by the Food and Drug Administration.
706. § 20.107 Food and Drug Administration manuals.
707. § 20.108 Agreements between the Food and Drug Administration and other departments, agencies, and organizations.
708. § 20.109 Data and information obtained by contract.
709. § 20.110 Data and information about Food and Drug Administration employees.
710. § 20.111 Data and information submitted voluntarily to the Food and Drug Administration.
711. § 20.112 Voluntary drug experience reports submitted by physicians and hospitals.
712. § 20.113 Voluntary product defect reports.
713. § 20.114 Data and information submitted pursuant to cooperative quality assurance agreements.
714. § 20.115 Product codes for manufacturing or sales dates.
715. § 20.116 Drug and device registration and listing information.
716. § 20.117 New drug information.
717. § 20.118 Advisory committee records.
718. § 20.119 Lists of names and addresses.
719. § 20.120 Records available in Food and Drug Administration Public Reading Rooms.
720. PART 21 PROTECTION OF PRIVACY
721. Subpart A General Provisions
722. § 21.1 Scope.
723. § 21.3 Definitions.
724. § 21.10 Policy concerning records about individuals.
725. Subpart B Food and Drug Administration Privacy Act Record Systems
726. § 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record Systems.
727. § 21.21 Changes in systems and new systems.
728. Subpart C Requirements for Specific Categories of Records
729. § 21.30 Records of contractors.
730. § 21.31 Records stored by the National Archives and Records Administration.
731. § 21.32 Personnel records.
732. § 21.33 Medical records.
733. Subpart D Procedures for Notification of and Access to Records in Privacy Act Record Systems
734. § 21.40 Procedures for submitting requests for notification and access.
735. § 21.41 Processing of requests.
736. § 21.42 Responses to requests.
737. § 21.43 Access to requested records.
738. § 21.44 Verification of identity.
739. § 21.45 Fees.
740. Subpart E Procedures for Requests for Amendment of Records
741. § 21.50 Procedures for submitting requests for amendment of records.
742. § 21.51 Responses to requests for amendment of records.
743. § 21.52 Administrative appeals of refusals to amend records.
744. § 21.53 Notation and disclosure of disputed records.
745. § 21.54 Amended or disputed records received from other agencies.
746. Subpart F Exemptions
747. § 21.60 Policy.
748. § 21.61 Exempt systems.
749. § 21.65 Access to records in exempt systems.
750. Subpart G Disclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject Individual
751. § 21.70 Disclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required.
752. § 21.71 Disclosure of records in Privacy Act Record Systems; accounting required.
753. § 21.72 Individual consent to disclosure of records to other persons.
754. § 21.73 Accuracy, completeness, timeliness, and relevance of records disclosed from Privacy Act Record Systems.
755. § 21.74 Providing notice that a record is disputed.
756. § 21.75 Rights of legal guardians.
757. PART 25 ENVIRONMENTAL IMPACT CONSIDERATIONS
758. Subpart A General Provisions
759. § 25.1 Purpose.
760. § 25.5 Terminology.
761. § 25.10 Policies and NEPA planning.
762. Subpart B Agency Actions Requiring Environmental Consideration
763. § 25.15 General procedures.
764. § 25.16 Public health and safety emergencies.
765. § 25.20 Actions requiring preparation of an environmental assessment.
766. § 25.21 Extraordinary circumstances.
767. § 25.22 Actions requiring the preparation of an environmental impact statement.
768. Subpart C Categorical Exclusions
769. § 25.30 General.
770. § 25.31 Human drugs and biologics.
771. § 25.32 Foods, food additives, and color additives.
772. § 25.33 Animal drugs.
773. § 25.34 Devices and electronic products.
774. § 25.35 Tobacco product applications.
775. Subpart D Preparation of Environmental Documents
776. § 25.40 Environmental assessments.
777. § 25.41 Findings of no significant impact.
778. § 25.42 Environmental impact statements.
779. § 25.43 Records of decision.
780. § 25.44 Lead and cooperating agencies.
781. § 25.45 Responsible agency official.
782. Subpart E Public Participation and Notification of Environmental Documents
783. § 25.50 General information.
784. § 25.51 Environmental assessments and findings of no significant impact.
785. § 25.52 Environmental impact statements.
786. Subpart F Other Requirements
787. § 25.60 Environmental effects abroad of major agency actions.
788. PART 50 PROTECTION OF HUMAN SUBJECTS
789. Subpart A General Provisions
790. § 50.1 Scope.
791. § 50.3 Definitions.
792. Subpart B Informed Consent of Human Subjects
793. § 50.20 General requirements for informed consent.
794. § 50.22 Exception from informed consent requirements for minimal risk clinical investigations.
795. § 50.23 Exception from general requirements.
796. § 50.24 Exception from informed consent requirements for emergency research.
797. § 50.25 Elements of informed consent.
798. § 50.27 Documentation of informed consent.
799. C Subpart C [Reserved]
800. Subpart D Additional Safeguards for Children in Clinical Investigations
801. § 50.50 IRB duties.
802. § 50.51 Clinical investigations not involving greater than minimal risk.
803. § 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
804. § 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
805. § 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
806. § 50.55 Requirements for permission by parents or guardians and for assent by children.
807. § 50.56 Wards.
808. PART 54 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
809. § 54.1 Purpose.
810. § 54.2 Definitions.
811. § 54.3 Scope.
812. § 54.4 Certification and disclosure requirements.
813. § 54.5 Agency evaluation of financial interests.
814. § 54.6 Recordkeeping and record retention.
815. PART 56 INSTITUTIONAL REVIEW BOARDS
816. Subpart A General Provisions
817. § 56.101 Scope.
818. § 56.102 Definitions.
819. § 56.103 Circumstances in which IRB review is required.
820. § 56.104 Exemptions from IRB requirement.
821. § 56.105 Waiver of IRB requirement.
822. Subpart B Organization and Personnel
823. § 56.106 Registration.
824. § 56.107 IRB membership.
825. Subpart C IRB Functions and Operations
826. § 56.108 IRB functions and operations.
827. § 56.109 IRB review of research.
828. § 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
829. § 56.111 Criteria for IRB approval of research.
830. § 56.112 Review by institution.
831. § 56.113 Suspension or termination of IRB approval of research.
832. § 56.114 Cooperative research.
833. Subpart D Records and Reports
834. § 56.115 IRB records.
835. Subpart E Administrative Actions for Noncompliance
836. § 56.120 Lesser administrative actions.
837. § 56.121 Disqualification of an IRB or an institution.
838. § 56.122 Public disclosure of information regarding revocation.
839. § 56.123 Reinstatement of an IRB or an institution.
840. § 56.124 Actions alternative or additional to disqualification.
841. PART 58 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
842. Subpart A General Provisions
843. § 58.1 Scope.
844. § 58.3 Definitions.
845. § 58.10 Applicability to studies performed under grants and contracts.
846. § 58.15 Inspection of a testing facility.
847. Subpart B Organization and Personnel
848. § 58.29 Personnel.
849. § 58.31 Testing facility management.
850. § 58.33 Study director.
851. § 58.35 Quality assurance unit.
852. Subpart C Facilities
853. § 58.41 General.
854. § 58.43 Animal care facilities.
855. § 58.45 Animal supply facilities.
856. § 58.47 Facilities for handling test and control articles.
857. § 58.49 Laboratory operation areas.
858. § 58.51 Specimen and data storage facilities.
859. Subpart D Equipment
860. § 58.61 Equipment design.
861. § 58.63 Maintenance and calibration of equipment.
862. Subpart E Testing Facilities Operation
863. § 58.81 Standard operating procedures.
864. § 58.83 Reagents and solutions.
865. § 58.90 Animal care.
866. Subpart F Test and Control Articles
867. § 58.105 Test and control article characterization.
868. § 58.107 Test and control article handling.
869. § 58.113 Mixtures of articles with carriers.
870. Subpart G Protocol for and Conduct of a Nonclinical Laboratory Study
871. § 58.120 Protocol.
872. § 58.130 Conduct of a nonclinical laboratory study.
873. H Subparts H-I [Reserved]
874. Subpart J Records and Reports
875. § 58.185 Reporting of nonclinical laboratory study results.
876. § 58.190 Storage and retrieval of records and data.
877. § 58.195 Retention of records.
878. Subpart K Disqualification of Testing Facilities
879. § 58.200 Purpose.
880. § 58.202 Grounds for disqualification.
881. § 58.204 Notice of and opportunity for hearing on proposed disqualification.
882. § 58.206 Final order on disqualification.
883. § 58.210 Actions upon disqualification.
884. § 58.213 Public disclosure of information regarding disqualification.
885. § 58.215 Alternative or additional actions to disqualification.
886. § 58.217 Suspension or termination of a testing facility by a sponsor.
887. § 58.219 Reinstatement of a disqualified testing facility.
888. PART 60 PATENT TERM RESTORATION
889. Subpart A General Provisions
890. § 60.1 Scope.
891. § 60.2 Purpose.
892. § 60.3 Definitions.
893. Subpart B Eligibility Assistance
894. § 60.10 FDA assistance on eligibility.
895. Subpart C Regulatory Review Period Determinations
896. § 60.20 FDA action on regulatory review period determinations.
897. § 60.22 Regulatory review period determinations.
898. § 60.24 Revision of regulatory review period determinations.
899. § 60.26 Final action on regulatory review period determinations.
900. § 60.28 Time frame for determining regulatory review periods.
901. Subpart D Due Diligence Petitions
902. § 60.30 Filing, format, and content of petitions.
903. § 60.32 Applicant response to petition.
904. § 60.34 FDA action on petitions.
905. § 60.36 Standard of due diligence.
906. Subpart E Due Diligence Hearings
907. § 60.40 Request for hearing.
908. § 60.42 Notice of hearing.
909. § 60.44 Hearing procedures.
910. § 60.46 Administrative decision.
911. PART 70 COLOR ADDITIVES
912. Subpart A General Provisions
913. § 70.3 Definitions.
914. § 70.5 General restrictions on use of color additives.
915. § 70.10 Color additives in standardized foods and new drugs.
916. § 70.11 Related substances.
917. § 70.19 Fees for listing.
918. Subpart B Packaging and Labeling
919. § 70.20 Packaging requirements for straight colors (other than hair dyes).
920. § 70.25 Labeling requirements for color additives (other than hair dyes).
921. Subpart C Safety Evaluation
922. § 70.40 Safety factors to be considered.
923. § 70.42 Criteria for evaluating the safety of color additives.
924. § 70.45 Allocation of color additives.
925. § 70.50 Application of the cancer clause of section 721 of the act.
926. § 70.51 Advisory committee on the applicability of the anticancer clause.
927. § 70.55 Request for scientific studies.
928. PART 71 COLOR ADDITIVE PETITIONS
929. Subpart A General Provisions
930. § 71.1 Petitions.
931. § 71.2 Notice of filing of petition.
932. § 71.4 Samples; additional information.
933. § 71.6 Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice.
934. § 71.15 Confidentiality of data and information in color additive petitions.
935. § 71.18 Petition for exemption from certification.
936. Subpart B Administrative Action on Petitions
937. § 71.20 Publication of regulation.
938. § 71.22 Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued.
939. § 71.25 Condition for certification.
940. § 71.26 Revocation of exemption from certification.
941. § 71.27 Listing and exemption from certification on the Commissioner's initiative.
942. § 71.30 Procedure for filing objections to regulations.
943. § 71.37 Exemption of color additives for investigational use.
944. PART 73 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
945. Subpart A Foods
946. § 73.1 Diluents in color additive mixtures for food use exempt from certification.
947. § 73.30 Annatto extract.
948. § 73.32 Antarctic krill meal.
949. § 73.35 Astaxanthin.
950. § 73.37 Astaxanthin dimethyldisuccinate.
951. § 73.39 xxx
952. § 73.40 Dehydrated beets (beet powder).
953. § 73.50 Ultramarine blue.
954. § 73.69 Butterfly pea flower extract.
955. § 73.70 Calcium carbonate.
956. § 73.75 Canthaxanthin.
957. § 73.80 Calcium phosphate.
958. § 73.85 Caramel.
959. § 73.90 β-Apo-8′-carotenal.
960. § 73.95 β-Carotene.
961. § 73.100 Cochineal extract; carmine.
962. § 73.125 Sodium copper chlorophyllin.
963. § 73.140 Toasted partially defatted cooked cottonseed flour.
964. § 73.160 Ferrous gluconate.
965. § 73.165 Ferrous lactate.
966. § 73.167 Galdieria extract blue.
967. § 73.168 Gardenia (genipin) blue.
968. § 73.169 Grape color extract.
969. § 73.170 Grape skin extract (enocianina).
970. § 73.185 Haematococcus algae meal.
971. § 73.200 Synthetic iron oxide.
972. § 73.225 Jagua (genipin-glycine) blue.
973. § 73.250 Fruit juice.
974. § 73.260 Vegetable juice.
975. § 73.275 Dried algae meal.
976. § 73.295 Tagetes (Aztec marigold) meal and extract.
977. § 73.297 Myoglobin.
978. § 73.300 Carrot oil.
979. § 73.315 Corn endosperm oil.
980. § 73.340 Paprika.
981. § 73.345 Paprika oleoresin.
982. § 73.350 Mica-based pearlescent pigments.
983. § 73.352 Paracoccus pigment.
984. § 73.355 Phaffia yeast.
985. § 73.450 Riboflavin.
986. § 73.500 Saffron.
987. § 73.520 Soy leghemoglobin.
988. § 73.530 Spirulina extract.
989. § 73.575 Titanium dioxide.
990. § 73.585 Tomato lycopene extract; tomato lycopene concentrate.
991. § 73.600 Turmeric.
992. § 73.615 Turmeric oleoresin.
993. Subpart B Drugs
994. § 73.1001 Diluents in color additive mixtures for drug use exempt from certification.
995. § 73.1010 Alumina (dried aluminum hydroxide).
996. § 73.1015 Chromium-cobalt-aluminum oxide.
997. § 73.1025 Ferric ammonium citrate.
998. § 73.1030 Annatto extract.
999. § 73.1070 Calcium carbonate.
1000. § 73.1075 Canthaxanthin.
1001. § 73.1085 Caramel.
1002. § 73.1095 β-Carotene.
1003. § 73.1100 Cochineal extract; carmine.
1004. § 73.1125 Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).
1005. § 73.1150 Dihydroxyacetone.
1006. § 73.1162 Bismuth oxychloride.
1007. § 73.1200 Synthetic iron oxide.
1008. § 73.1298 Ferric ammonium ferrocyanide.
1009. § 73.1299 Ferric ferrocyanide.
1010. § 73.1326 Chromium hydroxide green.
1011. § 73.1327 Chromium oxide greens.
1012. § 73.1329 Guanine.
1013. § 73.1350 Mica-based pearlescent pigments.
1014. § 73.1375 Pyrogallol.
1015. § 73.1400 Pyrophyllite.
1016. § 73.1410 Logwood extract.
1017. § 73.1496 Mica.
1018. § 73.1530 Spirulina extract.
1019. § 73.1550 Talc.
1020. § 73.1575 Titanium dioxide.
1021. § 73.1645 Aluminum powder.
1022. § 73.1646 Bronze powder.
1023. § 73.1647 Copper powder.
1024. § 73.1991 Zinc oxide.
1025. Subpart C Cosmetics
1026. § 73.2030 Annatto.
1027. § 73.2085 Caramel.
1028. § 73.2087 Carmine.
1029. § 73.2095 β-Carotene.
1030. § 73.2110 Bismuth citrate.
1031. § 73.2120 Disodium EDTA-copper.
1032. § 73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex).
1033. § 73.2150 Dihydroxyacetone.
1034. § 73.2162 Bismuth oxychloride.
1035. § 73.2180 Guaiazulene.
1036. § 73.2190 Henna.
1037. § 73.2250 Iron oxides.
1038. § 73.2298 Ferric ammonium ferrocyanide.
1039. § 73.2299 Ferric ferrocyanide.
1040. § 73.2326 Chromium hydroxide green.
1041. § 73.2327 Chromium oxide greens.
1042. § 73.2329 Guanine.
1043. § 73.2400 Pyrophyllite.
1044. § 73.2496 Mica.
1045. § 73.2500 Silver.
1046. § 73.2550 Silver nitrate.
1047. § 73.2575 Titanium dioxide.
1048. § 73.2645 Aluminum powder.
1049. § 73.2646 Bronze powder.
1050. § 73.2647 Copper powder.
1051. § 73.2725 Ultramarines.
1052. § 73.2775 Manganese violet.
1053. § 73.2991 Zinc oxide.
1054. § 73.2995 Luminescent zinc sulfide.
1055. Subpart D Medical Devices
1056. § 73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers.
1057. § 73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.
1058. § 73.3106 1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone copolymers.
1059. § 73.3107 Carbazole violet.
1060. § 73.3110 Chlorophyllin-copper complex, oil soluble.
1061. § 73.3110a Chromium-cobalt-aluminum oxide.
1062. § 73.3111 Chromium oxide greens.
1063. § 73.3112 C.I. Vat Orange 1.
1064. § 73.3115 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol.
1065. § 73.3117 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone.
1066. § 73.3118 N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.
1067. § 73.3119 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.
1068. § 73.3120 16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione.
1069. § 73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers.
1070. § 73.3122 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.
1071. § 73.3123 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one.
1072. § 73.3124 Phthalocyanine green.
1073. § 73.3125 Iron oxides.
1074. § 73.3126 Titanium dioxide.
1075. § 73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products.
1076. § 73.3128 Mica-based pearlescent pigments.
1077. § 73.3129 Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate.
1078. PART 74 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
1079. Subpart A Foods
1080. § 74.101 FD&C Blue No. 1.
1081. § 74.102 FD&C Blue No. 2.
1082. § 74.203 FD&C Green No. 3.
1083. § 74.302 Citrus Red No. 2.
1084. § 74.303 FD&C Red No. 3.
1085. § 74.340 FD&C Red No. 40.
1086. § 74.705 FD&C Yellow No. 5.
1087. § 74.706 FD&C Yellow No. 6.
1088. Subpart B Drugs
1089. § 74.1101 FD&C Blue No. 1
1090. § 74.1102 FD&C Blue No. 2.
1091. § 74.1104 D&C Blue No. 4.
1092. § 74.1109 D&C Blue No. 9.
1093. § 74.1203 FD&C Green No. 3.
1094. § 74.1205 D&C Green No. 5.
1095. § 74.1206 D&C Green No. 6.
1096. § 74.1208 D&C Green No. 8.
1097. § 74.1254 D&C Orange No. 4.
1098. § 74.1255 D&C Orange No. 5.
1099. § 74.1260 D&C Orange No. 10.
1100. § 74.1261 D&C Orange No. 11.
1101. § 74.1303 FD&C Red No. 3.
1102. § 74.1304 FD&C Red No. 4.
1103. § 74.1306 D&C Red No. 6.
1104. § 74.1307 D&C Red No. 7.
1105. § 74.1317 D&C Red No. 17.
1106. § 74.1321 D&C Red No. 21.
1107. § 74.1322 D&C Red No. 22.
1108. § 74.1327 D&C Red No. 27.
1109. § 74.1328 D&C Red No. 28.
1110. § 74.1330 D&C Red No. 30.
1111. § 74.1331 D&C Red No. 31.
1112. § 74.1333 D&C Red No. 33.
1113. § 74.1334 D&C Red No. 34.
1114. § 74.1336 D&C Red No. 36.
1115. § 74.1339 D&C Red No. 39.
1116. § 74.1340 FD&C Red No. 40.
1117. § 74.1602 D&C Violet No. 2.
1118. § 74.1705 FD&C Yellow No. 5.
1119. § 74.1706 FD&C Yellow No. 6.
1120. § 74.1707 D&C Yellow No. 7.
1121. § 74.1707a Ext. D&C Yellow No. 7.
1122. § 74.1708 D&C Yellow No. 8.
1123. § 74.1710 D&C Yellow No. 10.
1124. § 74.1711 D&C Yellow No. 11.
1125. Subpart C Cosmetics
1126. § 74.2052 D&C Black No. 2.
1127. § 74.2053 D&C Black No. 3.
1128. § 74.2101 FD&C Blue No. 1.
1129. § 74.2104 D&C Blue No. 4.
1130. § 74.2151 D&C Brown No. 1.
1131. § 74.2203 FD&C Green No. 3.
1132. § 74.2205 D&C Green No. 5.
1133. § 74.2206 D&C Green No. 6.
1134. § 74.2208 D&C Green No. 8.
1135. § 74.2254 D&C Orange No. 4.
1136. § 74.2255 D&C Orange No. 5.
1137. § 74.2260 D&C Orange No. 10.
1138. § 74.2261 D&C Orange No. 11.
1139. § 74.2304 FD&C Red No. 4.
1140. § 74.2306 D&C Red No. 6.
1141. § 74.2307 D&C Red No. 7
1142. § 74.2317 D&C Red No. 17.
1143. § 74.2321 D&C Red No. 21.
1144. § 74.2322 D&C Red No. 22.
1145. § 74.2327 D&C Red No. 27.
1146. § 74.2328 D&C Red No. 28.
1147. § 74.2330 D&C Red No. 30.
1148. § 74.2331 D&C Red No. 31.
1149. § 74.2333 D&C Red No. 33.
1150. § 74.2334 D&C Red No. 34.
1151. § 74.2336 D&C Red No. 36.
1152. § 74.2340 FD&C Red No. 40.
1153. § 74.2602 D&C Violet No. 2.
1154. § 74.2602a Ext. D&C Violet No. 2.
1155. § 74.2705 FD&C Yellow No. 5.
1156. § 74.2706 FD&C Yellow No. 6.
1157. § 74.2707 D&C Yellow No. 7.
1158. § 74.2707a Ext. D&C Yellow No. 7.
1159. § 74.2708 D&C Yellow No. 8.
1160. § 74.2710 D&C Yellow No. 10.
1161. § 74.2711 D&C Yellow No. 11.
1162. Subpart D Medical Devices
1163. § 74.3045 [Phthalocyaninato(2-)] copper.
1164. § 74.3054 D&C Black No. 4.
1165. § 74.3102 FD&C Blue No. 2.
1166. § 74.3106 D&C Blue No. 6.
1167. § 74.3206 D&C Green No. 6.
1168. § 74.3230 D&C Red No. 17.
1169. § 74.3602 D&C Violet No. 2.
1170. § 74.3708 D&C Yellow No. 8.
1171. § 74.3710 D&C Yellow No. 10.
1172. PART 80 COLOR ADDITIVE CERTIFICATION
1173. Subpart A General Provisions
1174. § 80.10 Fees for certification services.
1175. Subpart B Certification Procedures
1176. § 80.21 Request for certification.
1177. § 80.22 Samples to accompany requests for certification.
1178. § 80.31 Certification.
1179. § 80.32 Limitations of certificates.
1180. § 80.34 Authority to refuse certification service.
1181. § 80.35 Color additive mixtures; certification and exemption from certification.
1182. § 80.37 Treatment of batch pending certification.
1183. § 80.38 Treatment of batch after certification.
1184. § 80.39 Records of distribution.
1185. PART 81 GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
1186. § 81.1 Provisional lists of color additives.
1187. § 81.10 Termination of provisional listings of color additives.
1188. § 81.30 Cancellation of certificates.
1189. PART 82 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
1190. Subpart A General Provisions
1191. § 82.3 Definitions.
1192. § 82.5 General specifications for straight colors.
1193. § 82.6 Certifiable mixtures.
1194. Subpart B Foods, Drugs, and Cosmetics
1195. § 82.50 General.
1196. § 82.51 Lakes (FD&C).
1197. § 82.101 FD&C Blue No. 1.
1198. § 82.102 FD&C Blue No. 2.
1199. § 82.203 FD&C Green No. 3.
1200. § 82.304 FD&C Red No. 4.
1201. § 82.705 FD&C Yellow No. 5.
1202. § 82.706 FD&C Yellow No. 6.
1203. Subpart C Drugs and Cosmetics
1204. § 82.1050 General.
1205. § 82.1051 Lakes (D&C).
1206. § 82.1104 D&C Blue No. 4.
1207. § 82.1205 D&C Green No. 5.
1208. § 82.1206 D&C Green No. 6.
1209. § 82.1254 D&C Orange No. 4.
1210. § 82.1255 D&C Orange No. 5.
1211. § 82.1260 D&C Orange No. 10.
1212. § 82.1261 D&C Orange No. 11.
1213. § 82.1306 D&C Red No. 6.
1214. § 82.1307 D&C Red No. 7.
1215. § 82.1317 D&C Red No. 17.
1216. § 82.1321 D&C Red No. 21.
1217. § 82.1322 D&C Red No. 22.
1218. § 82.1327 D&C Red No. 27.
1219. § 82.1328 D&C Red No. 28.
1220. § 82.1330 D&C Red No. 30.
1221. § 82.1331 D&C Red No. 31.
1222. § 82.1333 D&C Red No. 33.
1223. § 82.1334 D&C Red No. 34.
1224. § 82.1336 D&C Red No. 36.
1225. § 82.1602 D&C Violet No. 2.
1226. § 82.1707 D&C Yellow No. 7.
1227. § 82.1708 D&C Yellow No. 8.
1228. § 82.1710 D&C Yellow No. 10.
1229. Subpart D Externally Applied Drugs and Cosmetics
1230. § 82.2050 General.
1231. § 82.2051 Lakes (Ext. D&C).
1232. § 82.2707a Ext. D&C Yellow No. 7.
1233. 83-98 PARTS 83-98 [RESERVED]
1234. PART 99 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
1235. Subpart A General Information
1236. § 99.1 Scope.
1237. § 99.3 Definitions.
1238. Subpart B Information To Be Disseminated
1239. § 99.101 Information that may be disseminated.
1240. § 99.103 Mandatory statements and information.
1241. § 99.105 Recipients of information.
1242. Subpart C Manufacturer's Submissions, Requests, and Applications
1243. § 99.201 Manufacturer's submission to the agency.
1244. § 99.203 Request to extend the time for completing planned studies.
1245. § 99.205 Application for exemption from the requirement to file a supplemental application.
1246. Subpart D FDA Action on Submissions, Requests, and Applications
1247. § 99.301 Agency action on a submission.
1248. § 99.303 Extension of time for completing planned studies.
1249. § 99.305 Exemption from the requirement to file a supplemental application.
1250. Subpart E Corrective Actions and Cessation of Dissemination
1251. § 99.401 Corrective actions and cessation of dissemination of information.
1252. § 99.403 Termination of approvals of applications for exemption.
1253. § 99.405 Applicability of labeling, adulteration, and misbranding authority.
1254. Subpart F Recordkeeping and Reports
1255. § 99.501 Recordkeeping and reports.
1256. CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) (Parts 100 to 169)
1257. SUBCHAPTER B FOOD FOR HUMAN CONSUMPTION
1258. PART 100 GENERAL
1259. Subpart A State and Local Requirements
1260. § 100.1 Petitions requesting exemption from preemption for State or local requirements.
1261. § 100.2 State enforcement of Federal regulations.
1262. B Subparts B-E [Reserved]
1263. Subpart F Misbranding for Reasons Other Than Labeling
1264. § 100.100 Misleading containers.
1265. Subpart G Specific Administrative Rulings and Decisions
1266. § 100.155 Salt and iodized salt.
1267. PART 101 FOOD LABELING
1268. Subpart A General Provisions
1269. § 101.1 Principal display panel of package form food.
1270. § 101.2 Information panel of package form food.
1271. § 101.3 Identity labeling of food in packaged form.
1272. § 101.4 Food; designation of ingredients.
1273. § 101.5 Food; name and place of business of manufacturer, packer, or distributor.
1274. § 101.7 Declaration of net quantity of contents.
1275. § 101.8 Vending machines.
1276. § 101.9 Nutrition labeling of food.
1277. § 101.10 Nutrition labeling of restaurant foods whose labels or labeling bear nutrient content claims or health claims.
1278. § 101.11 Nutrition labeling of standard menu items in covered establishments.
1279. § 101.12 Reference amounts customarily consumed per eating occasion.
1280. § 101.13 Nutrient content claims—general principles.
1281. § 101.14 Health claims: general requirements.
1282. § 101.15 Food; prominence of required statements.
1283. § 101.17 Food labeling warning, notice, and safe handling statements.
1284. § 101.18 Misbranding of food.
1285. Subpart B Specific Food Labeling Requirements
1286. § 101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives.
1287. § 101.30 Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice.
1288. Subpart C Specific Nutrition Labeling Requirements and Guidelines
1289. § 101.36 Nutrition labeling of dietary supplements.
1290. § 101.42 Nutrition labeling of raw fruit, vegetables, and fish.
1291. § 101.43 Substantial compliance of food retailers with the guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish.
1292. § 101.44 What are the 20 most frequently consumed raw fruits, vegetables, and fish in the United States?
1293. § 101.45 Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish.
1294. Subpart D Specific Requirements for Nutrient Content Claims
1295. § 101.54 Nutrient content claims for “good source,” “high,” “more,” and “high potency.”
1296. § 101.56 Nutrient content claims for “light” or “lite.”
1297. § 101.60 Nutrient content claims for the calorie content of foods.
1298. § 101.61 Nutrient content claims for the sodium content of foods.
1299. § 101.62 Nutrient content claims for fat, fatty acid, and cholesterol content of foods.
1300. § 101.65 Implied nutrient content claims and related label statements.
1301. § 101.67 Use of nutrient content claims for butter.
1302. § 101.69 Petitions for nutrient content claims.
1303. Subpart E Specific Requirements for Health Claims
1304. § 101.70 Petitions for health claims.
1305. § 101.71 Health claims: claims not authorized.
1306. § 101.72 Health claims: calcium, vitamin D, and osteoporosis.
1307. § 101.73 Health claims: dietary lipids and cancer.
1308. § 101.74 Health claims: sodium and hypertension.
1309. § 101.75 Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease.
1310. § 101.76 Health claims: fiber-containing grain products, fruits, and vegetables and cancer.
1311. § 101.77 Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease.
1312. § 101.78 Health claims: fruits and vegetables and cancer.
1313. § 101.79 Health claims: Folate and neural tube defects.
1314. § 101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries.
1315. § 101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD).
1316. § 101.82 Health claims: Soy protein and risk of coronary heart disease (CHD).
1317. § 101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD).
1318. Subpart F Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims
1319. § 101.91 Gluten-free labeling of food.
1320. § 101.93 Certain types of statements for dietary supplements.
1321. § 101.95 “Fresh,” “freshly frozen,” “fresh frozen,” “frozen fresh.”
1322. Subpart G Exemptions From Food Labeling Requirements
1323. § 101.100 Food; exemptions from labeling.
1324. § 101.108 Temporary exemptions for purposes of conducting authorized food labeling experiments.
1325. 0
1326. Appendix B to Part 101 Graphic Enhancements Used by the FDA
1327. Appendix C to Part 101 Nutrition Facts for Raw Fruits and Vegetables
1328. Appendix D to Part 101 Nutrition Facts for Cooked Fish
1329. PART 102 COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
1330. Subpart A General Provisions
1331. § 102.5 General principles.
1332. § 102.19 Petitions.
1333. Subpart B Requirements for Specific Nonstandardized Foods
1334. § 102.22 Protein hydrolysates.
1335. § 102.23 Peanut spreads.
1336. § 102.26 Frozen “heat and serve” dinners.
1337. § 102.28 Foods packaged for use in the preparation of “main dishes” or “dinners.”
1338. § 102.33 Beverages that contain fruit or vegetable juice.
1339. § 102.37 Mixtures of edible fat or oil and olive oil.
1340. § 102.39 Onion rings made from diced onion.
1341. § 102.41 Potato chips made from dried potatoes.
1342. § 102.45 Fish sticks or portions made from minced fish.
1343. § 102.46 Pacific whiting.
1344. § 102.47 Bonito.
1345. § 102.49 Fried clams made from minced clams.
1346. § 102.50 Crabmeat.
1347. § 102.54 Seafood cocktails.
1348. § 102.55 Nonstandardized breaded composite shrimp units.
1349. § 102.57 Greenland turbot (Reinhardtius hippoglossoides).
1350. PART 104 NUTRITIONAL QUALITY GUIDELINES FOR FOODS
1351. Subpart A General Provisions
1352. § 104.5 General principles.
1353. Subpart B Fortification Policy
1354. § 104.20 Statement of purpose.
1355. Subpart C Specific Nutritional Quality Guidelines
1356. § 104.47 Frozen “heat and serve” dinner.
1357. PART 105 FOODS FOR SPECIAL DIETARY USE
1358. Subpart A General Provisions
1359. § 105.3 Definitions and interpretations.
1360. Subpart B Label Statements
1361. § 105.62 Hypoallergenic foods.
1362. § 105.65 Infant foods.
1363. § 105.66 Label statements relating to usefulness in reducing or maintaining body weight.
1364. C Subpart C [Reserved]
1365. Subpart D Standards of Identity [Reserved]
1366. PART 106 INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS
1367. Subpart A General Provisions
1368. § 106.1 Status and applicability of the regulations in part 106.
1369. § 106.3 Definitions.
1370. Subpart B Current Good Manufacturing Practice
1371. § 106.5 Current good manufacturing practice.
1372. § 106.6 Production and in-process control system.
1373. § 106.10 Controls to prevent adulteration by workers.
1374. § 106.20 Controls to prevent adulteration caused by facilities.
1375. § 106.30 Controls to prevent adulteration caused by equipment or utensils.
1376. § 106.35 Controls to prevent adulteration due to automatic (mechanical or electronic) equipment.
1377. § 106.40 Controls to prevent adulteration caused by ingredients, containers, and closures.
1378. § 106.50 Controls to prevent adulteration during manufacturing.
1379. § 106.55 Controls to prevent adulteration from microorganisms.
1380. § 106.60 Controls to prevent adulteration during packaging and labeling of infant formula.
1381. § 106.70 Controls on the release of finished infant formula.
1382. § 106.80 Traceability.
1383. § 106.90 Audits of current good manufacturing practice.
1384. Subpart C Quality Control Procedures
1385. § 106.91 General quality control.
1386. § 106.92 Audits of quality control procedures.
1387. Subpart D Conduct of Audits
1388. § 106.94 Audit plans and procedures.
1389. Subpart E Quality Factors for Infant Formulas
1390. § 106.96 Requirements for quality factors for infant formulas.
1391. Subpart F Records and Reports
1392. § 106.100 Records.
1393. Subpart G Registration, Submission, and Notification Requirements
1394. § 106.110 New infant formula registration.
1395. § 106.120 New infant formula submission.
1396. § 106.121 Quality factor assurances for infant formulas.
1397. § 106.130 Verification submission.
1398. § 106.140 Submission concerning a change in infant formula that may adulterate the product.
1399. § 106.150 Notification of an adulterated or misbranded infant formula.
1400. § 106.160 Incorporation by reference.
1401. PART 107 INFANT FORMULA
1402. Subpart A General Provisions
1403. § 107.1 Status and applicability of the regulations in part 107.
1404. § 107.3 Definitions.
1405. Subpart B Labeling
1406. § 107.10 Nutrient information.
1407. § 107.20 Directions for use.
1408. § 107.30 Exemptions.
1409. Subpart C Exempt Infant Formulas
1410. § 107.50 Terms and conditions.
1411. Subpart D Nutrient Requirements
1412. § 107.100 Nutrient specifications.
1413. Subpart E Infant Formula Recalls
1414. § 107.200 Food and Drug Administration-required recall.
1415. § 107.210 Firm-initiated product removals.
1416. § 107.220 Scope and effect of infant formula recalls.
1417. § 107.230 Elements of an infant formula recall.
1418. § 107.240 Notification requirements.
1419. § 107.250 Termination of an infant formula recall.
1420. § 107.260 Revision of an infant formula recall.
1421. § 107.270 Compliance with this subpart.
1422. § 107.280 Records retention.
1423. PART 108 EMERGENCY PERMIT CONTROL
1424. Subpart A General Provisions
1425. § 108.3 Definitions.
1426. § 108.5 Determination of the need for a permit.
1427. § 108.6 Revocation of determination of need for permit.
1428. § 108.7 Issuance or denial of permit.
1429. § 108.10 Suspension and reinstatement of permit.
1430. § 108.12 Manufacturing, processing, or packing without a permit, or in violation of a permit.
1431. § 108.19 Establishment of requirements for exemption from section 404 of the act.
1432. Subpart B Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit
1433. § 108.25 Acidified foods.
1434. § 108.35 Thermal processing of low-acid foods packaged in hermetically sealed containers.
1435. PART 109 UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL
1436. Subpart A General Provisions
1437. § 109.3 Definitions and interpretations.
1438. § 109.4 Establishment of tolerances, regulatory limits, and action levels.
1439. § 109.6 Added poisonous or deleterious substances.
1440. § 109.7 Unavoidability.
1441. § 109.15 Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.
1442. § 109.16 Ornamental and decorative ceramicware.
1443. Subpart B Tolerances for Unavoidable Poisonous or Deleterious Substances
1444. § 109.30 Tolerances for polychlorinated biphenyls (PCB's).
1445. Subpart C Regulatory Limits for Added Poisonous or Deleterious Substances [Reserved]
1446. Subpart D Naturally Occurring Poisonous or Deleterious Substances [Reserved]
1447. PART 110 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
1448. Subpart A General Provisions
1449. § 110.3 Definitions.
1450. § 110.5 Current good manufacturing practice.
1451. § 110.10 Personnel.
1452. § 110.19 Exclusions.
1453. Subpart B Buildings and Facilities
1454. § 110.20 Plant and grounds.
1455. § 110.35 Sanitary operations.
1456. § 110.37 Sanitary facilities and controls.
1457. Subpart C Equipment
1458. § 110.40 Equipment and utensils.
1459. D Subpart D [Reserved]
1460. Subpart E Production and Process Controls
1461. § 110.80 Processes and controls.
1462. § 110.93 Warehousing and distribution.
1463. F Subpart F [Reserved]
1464. Subpart G Defect Action Levels
1465. § 110.110 Natural or unavoidable defects in food for human use that present no health hazard.
1466. PART 111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
1467. Subpart A General Provisions
1468. § 111.1 Who is subject to this part?
1469. § 111.3 What definitions apply to this part?
1470. § 111.5 Do other statutory provisions and regulations apply?
1471. Subpart B Personnel
1472. § 111.8 What are the requirements under this subpart B for written procedures?
1473. § 111.10 What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?
1474. § 111.12 What personnel qualification requirements apply?
1475. § 111.13 What supervisor requirements apply?
1476. § 111.14 Under this subpart B, what records must you make and keep?
1477. Subpart C Physical Plant and Grounds
1478. § 111.15 What sanitation requirements apply to your physical plant and grounds?
1479. § 111.16 What are the requirements under this subpart C for written procedures?
1480. § 111.20 What design and construction requirements apply to your physical plant?
1481. § 111.23 Under this subpart C, what records must you make and keep?
1482. Subpart D Equipment and Utensils
1483. § 111.25 What are the requirements under this subpart D for written procedures?
1484. § 111.27 What requirements apply to the equipment and utensils that you use?
1485. § 111.30 What requirements apply to automated, mechanical, or electronic equipment?
1486. § 111.35 Under this subpart D, what records must you make and keep?
1487. Subpart E Requirement to Establish a Production and Process Control System
1488. § 111.55 What are the requirements to implement a production and process control system?
1489. § 111.60 What are the design requirements for the production and process control system?
1490. § 111.65 What are the requirements for quality control operations?
1491. § 111.70 What specifications must you establish?
1492. § 111.73 What is your responsibility for determining whether established specifications are met?
1493. § 111.75 What must you do to determine whether specifications are met?
1494. § 111.77 What must you do if established specifications are not met?
1495. § 111.80 What representative samples must you collect?
1496. § 111.83 What are the requirements for reserve samples?
1497. § 111.87 Who conducts a material review and makes a disposition decision?
1498. § 111.90 What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with § 111.70 is not met?
1499. § 111.95 Under this subpart E, what records must you make and keep?
1500. Subpart F Production and Process Control System: Requirements for Quality Control
1501. § 111.103 What are the requirements under this subpart F for written procedures?
1502. § 111.105 What must quality control personnel do?
1503. § 111.110 What quality control operations are required for laboratory operations associated with the production and process control system?
1504. § 111.113 What quality control operations are required for a material review and disposition decision?
1505. § 111.117 What quality control operations are required for equipment, instruments, and controls?
1506. § 111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
1507. § 111.123 What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?
1508. § 111.127 What quality control operations are required for packaging and labeling operations?
1509. § 111.130 What quality control operations are required for returned dietary supplements?
1510. § 111.135 What quality control operations are required for product complaints?
1511. § 111.140 Under this subpart F, what records must you make and keep?
1512. Subpart G Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement
1513. § 111.153 What are the requirements under this subpart G for written procedures?
1514. § 111.155 What requirements apply to components of dietary supplements?
1515. § 111.160 What requirements apply to packaging and labels received?
1516. § 111.165 What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier)?
1517. § 111.170 What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement?
1518. § 111.180 Under this subpart G, what records must you make and keep?
1519. Subpart H Production and Process Control System: Requirements for the Master Manufacturing Record
1520. § 111.205 What is the requirement to establish a master manufacturing record?
1521. § 111.210 What must the master manufacturing record include?
1522. Subpart I Production and Process Control System: Requirements for the Batch Production Record
1523. § 111.255 What is the requirement to establish a batch production record?
1524. § 111.260 What must the batch record include?
1525. Subpart J Production and Process Control System: Requirements for Laboratory Operations
1526. § 111.303 What are the requirements under this subpart J for written procedures?
1527. § 111.310 What are the requirements for the laboratory facilities that you use?
1528. § 111.315 What are the requirements for laboratory control processes?
1529. § 111.320 What requirements apply to laboratory methods for testing and examination?
1530. § 111.325 Under this subpart J, what records must you make and keep?
1531. Subpart K Production and Process Control System: Requirements for Manufacturing Operations
1532. § 111.353 What are the requirements under this subpart K for written procedures?
1533. § 111.355 What are the design requirements for manufacturing operations?
1534. § 111.360 What are the requirements for sanitation?
1535. § 111.365 What precautions must you take to prevent contamination?
1536. § 111.370 What requirements apply to rejected dietary supplements?
1537. § 111.375 Under this subpart K, what records must you make and keep?
1538. Subpart L Production and Process Control System: Requirements for Packaging and Labeling Operations
1539. § 111.403 What are the requirements under this subpart L for written procedures?
1540. § 111.410 What requirements apply to packaging and labels?
1541. § 111.415 What requirements apply to filling, assembling, packaging, labeling, and related operations?
1542. § 111.420 What requirements apply to repackaging and relabeling?
1543. § 111.425 What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?
1544. § 111.430 Under this subpart L, what records must you make and keep?
1545. Subpart M Holding and Distributing
1546. § 111.453 What are the requirements under this subpart for M written procedures?
1547. § 111.455 What requirements apply to holding components, dietary supplements, packaging, and labels?
1548. § 111.460 What requirements apply to holding in-process material?
1549. § 111.465 What requirements apply to holding reserve samples of dietary supplements?
1550. § 111.470 What requirements apply to distributing dietary supplements?
1551. § 111.475 Under this subpart M, what records must you make and keep?
1552. Subpart N Returned Dietary Supplements
1553. § 111.503 What are the requirements under this subpart N for written procedures?
1554. § 111.510 What requirements apply when a returned dietary supplement is received?
1555. § 111.515 When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?
1556. § 111.520 When may a returned dietary supplement be salvaged?
1557. § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?
1558. § 111.530 When must an investigation be conducted of your manufacturing processes and other batches?
1559. § 111.535 Under this subpart N, what records must you make and keep?
1560. Subpart O Product Complaints
1561. § 111.553 What are the requirements under this subpart O for written procedures?
1562. § 111.560 What requirements apply to the review and investigation of a product complaint?
1563. § 111.570 Under this subpart O, what records must you make and keep?
1564. Subpart P Records and Recordkeeping
1565. § 111.605 What requirements apply to the records that you make and keep?
1566. § 111.610 What records must be made available to FDA?
1567. PART 112 STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
1568. Subpart A General Provisions
1569. § 112.1 What food is covered by this part?
1570. § 112.2 What produce is not covered by this part?
1571. § 112.3 What definitions apply to this part?
1572. § 112.4 Which farms are subject to the requirements of this part?
1573. § 112.5 Which farms are eligible for a qualified exemption and associated modified requirements based on average monetary value of all food sold and direct farm marketing?
1574. § 112.6 What modified requirements apply to me if my farm is eligible for a qualified exemption in accordance with § 112.5?
1575. § 112.7 What records must I establish and keep if my farm is eligible for a qualified exemption in accordance with § 112.5?
1576. Subpart B General Requirements
1577. § 112.11 What general requirements apply to persons who are subject to this part?
1578. § 112.12 Are there any alternatives to the requirements established in this part?
1579. Subpart C Personnel Qualifications and Training
1580. § 112.21 What requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces?
1581. § 112.22 What minimum requirements apply for training personnel who conduct a covered activity?
1582. § 112.23 What requirements apply regarding supervisors?
1583. § 112.30 Under this subpart, what requirements apply regarding records?
1584. Subpart D Health and Hygiene
1585. § 112.31 What measures must I take to prevent ill or infected persons from contaminating covered produce with microorganisms of public health significance?
1586. § 112.32 What hygienic practices must personnel use?
1587. § 112.33 What measures must I take to prevent visitors from contaminating covered produce and food contact surfaces with microorganisms of public health significance?
1588. Subpart E Agricultural Water
1589. § 112.40 What requirements of this subpart apply to my covered farm?
1590. § 112.41 What requirements apply to the quality of my agricultural water?
1591. § 112.42 What requirements apply to inspecting and maintaining my agricultural water systems?
1592. § 112.43 What requirements apply to assessing agricultural water used in growing covered produce (other than sprouts)?
1593. § 112.44 What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce?
1594. § 112.45 What measures must I take for agricultural water to reduce the potential for contamination of covered produce or food contact surfaces with known or reasonably foreseeable hazards?
1595. § 112.46 What requirements apply to treating agricultural water?
1596. § 112.47 Who must perform the tests required under this subpart?
1597. §§ 112.48-112.49 [Reserved]
1598. § 112.50 Under this subpart, what requirements apply regarding records?
1599. Subpart F Biological Soil Amendments of Animal Origin and Human Waste
1600. § 112.51 What requirements apply for determining the status of a biological soil amendment of animal origin?
1601. § 112.52 How must I handle, convey, and store biological soil amendments of animal origin?
1602. § 112.53 What prohibitions apply regarding use of human waste?
1603. § 112.54 What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce?
1604. § 112.55 What microbial standards apply to the treatment processes in § 112.54?
1605. § 112.56 What application requirements and minimum application intervals apply to biological soil amendments of animal origin?
1606. § 112.60 Under this subpart, what requirements apply regarding records?
1607. G Subpart G-H [Reserved]
1608. Subpart I Domesticated and Wild Animals
1609. § 112.81 How do the requirements of this subpart apply to areas where covered activities take place?
1610. § 112.83 What requirements apply regarding grazing animals, working animals, and animal intrusion?
1611. § 112.84 Does this regulation require covered farms to take actions that would constitute a “taking” of threatened or endangered species; to take measures to exclude animals from outdoor growing areas; or to destroy animal habitat or otherwise clear farm borders around outdoor growing areas or drainages?
1612. J Subpart J [Reserved]
1613. Subpart K Growing, Harvesting, Packing, and Holding Activities
1614. § 112.111 What measures must I take if I grow, harvest, pack or hold both covered and excluded produce?
1615. § 112.112 What measures must I take immediately prior to and during harvest activities?
1616. § 112.113 How must I handle harvested covered produce during covered activities?
1617. § 112.114 What requirements apply to dropped covered produce?
1618. § 112.115 What measures must I take when packaging covered produce?
1619. § 112.116 What measures must I take when using food-packing (including food packaging) material?
1620. Subpart L Equipment, Tools, Buildings, and Sanitation
1621. § 112.121 What equipment and tools are subject to the requirements of this subpart?
1622. § 112.122 What buildings are subject to the requirements of this subpart?
1623. § 112.123 What general requirements apply regarding equipment and tools subject to this subpart?
1624. § 112.124 What requirements apply to instruments and controls used to measure, regulate, or record?
1625. § 112.125 What requirements apply to equipment that is subject to this subpart used in the transport of covered produce?
1626. § 112.126 What requirements apply to my buildings?
1627. § 112.127 What requirements apply regarding domesticated animals in and around a fully-enclosed building?
1628. § 112.128 What requirements apply regarding pest control in buildings?
1629. § 112.129 What requirements apply to toilet facilities?
1630. § 112.130 What requirements apply for hand-washing facilities?
1631. § 112.131 What must I do to control and dispose of sewage?
1632. § 112.132 What must I do to control and dispose of trash, litter, and waste in areas used for covered activities?
1633. § 112.133 What requirements apply to plumbing?
1634. § 112.134 What must I do to control animal excreta and litter from domesticated animals that are under my control?
1635. § 112.140 Under this subpart, what requirements apply regarding records?
1636. Subpart M Sprouts
1637. § 112.141 What commodities are subject to this subpart?
1638. § 112.142 What requirements apply to seeds or beans used to grow sprouts?
1639. § 112.143 What measures must I take for growing, harvesting, packing, and holding sprouts?
1640. § 112.144 What testing must I do during growing, harvesting, packing, and holding sprouts?
1641. § 112.145 What requirements apply to testing the environment for Listeria species or L. monocytogenes?
1642. § 112.146 What actions must I take if the growing, harvesting, packing, or holding environment tests positive for Listeria species or L. monocytogenes?
1643. § 112.147 What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens?
1644. § 112.148 What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen?
1645. § 112.150 Under this subpart, what requirements apply regarding records?
1646. Subpart N Analytical Methods
1647. § 112.151 What methods must I use to test the quality of water to satisfy the requirements of subpart E of this part?
1648. § 112.152 What methods must I use to test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes to satisfy the requirements of § 112.144(a)?
1649. § 112.153 What methods must I use to test spent sprout irrigation water (or sprouts) from each production batch of sprouts for pathogens to satisfy the requirements of § 112.144(b) and (c)?
1650. Subpart O Records
1651. § 112.161 What general requirements apply to records required under this part?
1652. § 112.162 Where must I store records?
1653. § 112.163 May I use existing records to satisfy the requirements of this part?
1654. § 112.164 How long must I keep records?
1655. § 112.165 What formats are acceptable for the records I keep?
1656. § 112.166 What requirements apply for making records available and accessible to FDA?
1657. § 112.167 Can records that I provide to FDA be disclosed to persons outside of FDA?
1658. Subpart P Variances
1659. § 112.171 Who may request a variance from the requirements of this part?
1660. § 112.172 How may a State, tribe, or foreign country request a variance from one or more requirements of this part?
1661. § 112.173 What must be included in the Statement of Grounds in a petition requesting a variance?
1662. § 112.174 What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?
1663. § 112.175 Who responds to a petition requesting a variance?
1664. § 112.176 What process applies to a petition requesting a variance?
1665. § 112.177 Can an approved variance apply to any person other than those identified in the petition requesting that variance?
1666. § 112.178 Under what circumstances may FDA deny a petition requesting a variance?
1667. § 112.179 When does a variance approved by FDA become effective?
1668. § 112.180 Under what circumstances may FDA modify or revoke an approved variance?
1669. § 112.181 What procedures apply if FDA determines that an approved variance should be modified or revoked?
1670. § 112.182 What are the permissible types of variances that may be granted?
1671. Subpart Q Compliance and Enforcement
1672. § 112.192 What is the applicability and status of this part?
1673. § 112.193 What are the provisions for coordination of education and enforcement?
1674. Subpart R Withdrawal of Qualified Exemption
1675. § 112.201 Under what circumstances can FDA withdraw a qualified exemption in accordance with the requirements of § 112.5?
1676. § 112.202 What procedure will FDA use to withdraw an exemption?
1677. § 112.203 What information must FDA include in an order to withdraw a qualified exemption?
1678. § 112.204 What must I do if I receive an order to withdraw a qualified exemption applicable to my farm?
1679. § 112.205 Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm?
1680. § 112.206 What is the procedure for submitting an appeal?
1681. § 112.207 What is the procedure for requesting an informal hearing?
1682. § 112.208 What requirements are applicable to an informal hearing?
1683. § 112.209 Who is the presiding officer for an appeal and for an informal hearing?
1684. § 112.210 What is the timeframe for issuing a decision on an appeal?
1685. § 112.211 When is an order to withdraw a qualified exemption applicable to a farm revoked?
1686. § 112.213 If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption?
1687. PART 113 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
1688. Subpart A General Provisions
1689. § 113.3 Definitions.
1690. § 113.5 Current good manufacturing practice.
1691. § 113.10 Personnel.
1692. B Subpart B [Reserved]
1693. Subpart C Equipment
1694. § 113.40 Equipment and procedures.
1695. Subpart D Control of Components, Food Product Containers, Closures, and In-Process Materials
1696. § 113.60 Containers.
1697. Subpart E Production and Process Controls
1698. § 113.81 Product preparation.
1699. § 113.83 Establishing scheduled processes.
1700. § 113.87 Operations in the thermal processing room.
1701. § 113.89 Deviations in processing, venting, or control of critical factors.
1702. Subpart F Records and Reports
1703. § 113.100 Processing and production records.
1704. PART 114 ACIDIFIED FOODS
1705. Subpart A General Provisions
1706. § 114.3 Definitions.
1707. § 114.5 Current good manufacturing practice.
1708. § 114.10 Personnel.
1709. B Subparts B-D [Reserved]
1710. Subpart E Production and Process Controls
1711. § 114.80 Processes and controls.
1712. § 114.83 Establishing scheduled processes.
1713. § 114.89 Deviations from scheduled processes.
1714. § 114.90 Methodology.
1715. Subpart F Records and Reports
1716. § 114.100 Records.
1717. PART 115 SHELL EGGS
1718. § 115.50 Refrigeration of shell eggs held for retail distribution.
1719. PART 117 CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
1720. Subpart A General Provisions
1721. § 117.1 Applicability and status.
1722. § 117.3 Definitions.
1723. § 117.4 Qualifications of individuals who manufacture, process, pack, or hold food.
1724. § 117.5 Exemptions.
1725. § 117.7 Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food.
1726. § 117.8 Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities.
1727. § 117.9 Records required for this subpart.
1728. Subpart B Current Good Manufacturing Practice
1729. § 117.10 Personnel.
1730. § 117.20 Plant and grounds.
1731. § 117.35 Sanitary operations.
1732. § 117.37 Sanitary facilities and controls.
1733. § 117.40 Equipment and utensils.
1734. § 117.80 Processes and controls.
1735. § 117.93 Warehousing and distribution.
1736. § 117.95 Holding and distribution of human food by-products for use as animal food.
1737. § 117.110 Defect action levels.
1738. Subpart C Hazard Analysis and Risk-Based Preventive Controls
1739. § 117.126 Food safety plan.
1740. § 117.130 Hazard analysis.
1741. § 117.135 Preventive controls.
1742. § 117.136 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
1743. § 117.137 Provision of assurances required under § 117.136(a)(2), (3), and (4).
1744. § 117.139 Recall plan.
1745. § 117.140 Preventive control management components.
1746. § 117.145 Monitoring.
1747. § 117.150 Corrective actions and corrections.
1748. § 117.155 Verification.
1749. § 117.160 Validation.
1750. § 117.165 Verification of implementation and effectiveness.
1751. § 117.170 Reanalysis.
1752. § 117.180 Requirements applicable to a preventive controls qualified individual and a qualified auditor.
1753. § 117.190 Implementation records required for this subpart.
1754. Subpart D Modified Requirements
1755. § 117.201 Modified requirements that apply to a qualified facility.
1756. § 117.206 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food.
1757. Subpart E Withdrawal of a Qualified Facility Exemption
1758. § 117.251 Circumstances that may lead FDA to withdraw a qualified facility exemption.
1759. § 117.254 Issuance of an order to withdraw a qualified facility exemption.
1760. § 117.257 Contents of an order to withdraw a qualified facility exemption.
1761. § 117.260 Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
1762. § 117.264 Procedure for submitting an appeal.
1763. § 117.267 Procedure for requesting an informal hearing.
1764. § 117.270 Requirements applicable to an informal hearing.
1765. § 117.274 Presiding officer for an appeal and for an informal hearing.
1766. § 117.277 Timeframe for issuing a decision on an appeal.
1767. § 117.280 Revocation of an order to withdraw a qualified facility exemption.
1768. § 117.284 Final agency action.
1769. § 117.287 Reinstatement of a qualified facility exemption that was withdrawn.
1770. Subpart F Requirements Applying to Records That Must Be Established and Maintained
1771. § 117.301 Records subject to the requirements of this subpart.
1772. § 117.305 General requirements applying to records.
1773. § 117.310 Additional requirements applying to the food safety plan.
1774. § 117.315 Requirements for record retention.
1775. § 117.320 Requirements for official review.
1776. § 117.325 Public disclosure.
1777. § 117.330 Use of existing records.
1778. § 117.335 Special requirements applicable to a written assurance.
1779. Subpart G Supply-Chain Program
1780. § 117.405 Requirement to establish and implement a supply-chain program.
1781. § 117.410 General requirements applicable to a supply-chain program.
1782. § 117.415 Responsibilities of the receiving facility.
1783. § 117.420 Using approved suppliers.
1784. § 117.425 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
1785. § 117.430 Conducting supplier verification activities for raw materials and other ingredients.
1786. § 117.435 Onsite audit.
1787. § 117.475 Records documenting the supply-chain program.
1788. PART 118 PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS
1789. § 118.1 Persons covered by the requirements in this part.
1790. § 118.3 Definitions.
1791. § 118.4 Salmonella Enteritidis (SE) prevention measures.
1792. § 118.5 Environmental testing for Salmonella Enteritidis (SE).
1793. § 118.6 Egg testing for Salmonella Enteritidis (SE).
1794. § 118.7 Sampling methodology for Salmonella Enteritidis (SE).
1795. § 118.8 Testing methodology for Salmonella Enteritidis (SE).
1796. § 118.9 Administration of the Salmonella Enteritidis (SE) prevention plan.
1797. § 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
1798. § 118.11 Registration requirements for shell egg producers covered by the requirements of this part.
1799. § 118.12 Enforcement and compliance.
1800. PART 119 DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK
1801. § 119.1 Dietary supplements containing ephedrine alkaloids.
1802. PART 120 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
1803. Subpart A General Provisions
1804. § 120.1 Applicability.
1805. § 120.3 Definitions.
1806. § 120.5 Current good manufacturing practice.
1807. § 120.6 Sanitation standard operating procedures.
1808. § 120.7 Hazard analysis.
1809. § 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
1810. § 120.9 Legal basis.
1811. § 120.10 Corrective actions.
1812. § 120.11 Verification and validation.
1813. § 120.12 Records.
1814. § 120.13 Training.
1815. § 120.14 Application of requirements to imported products.
1816. Subpart B Pathogen Reduction
1817. § 120.20 General.
1818. § 120.24 Process controls.
1819. § 120.25 Process verification for certain processors.
1820. PART 121 MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION
1821. Subpart A General Provisions
1822. § 121.1 Applicability.
1823. § 121.3 Definitions.
1824. § 121.4 Qualifications of individuals who perform activities under subpart C of this part.
1825. § 121.5 Exemptions.
1826. Subpart B Reserved
1827. Subpart C Food Defense Measures
1828. § 121.126 Food defense plan.
1829. § 121.130 Vulnerability assessment to identify significant vulnerabilities and actionable process steps.
1830. § 121.135 Mitigation strategies for actionable process steps.
1831. § 121.138 Mitigation strategies management components.
1832. § 121.140 Food defense monitoring.
1833. § 121.145 Food defense corrective actions.
1834. § 121.150 Food defense verification.
1835. § 121.157 Reanalysis.
1836. Subpart D Requirements Applying to Records That Must Be Established and Maintained
1837. § 121.301 Records subject to the requirements of this subpart.
1838. § 121.305 General requirements applying to records.
1839. § 121.310 Additional requirements applying to the food defense plan.
1840. § 121.315 Requirements for record retention.
1841. § 121.320 Requirements for official review.
1842. § 121.325 Public disclosure.
1843. § 121.330 Use of existing records.
1844. Subpart E Compliance
1845. § 121.401 Compliance.
1846. PART 123 FISH AND FISHERY PRODUCTS
1847. Subpart A General Provisions
1848. § 123.3 Definitions.
1849. § 123.5 Current good manufacturing practice.
1850. § 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
1851. § 123.7 Corrective actions.
1852. § 123.8 Verification.
1853. § 123.9 Records.
1854. § 123.10 Training.
1855. § 123.11 Sanitation control procedures.
1856. § 123.12 Special requirements for imported products.
1857. Subpart B Smoked and Smoke-Flavored Fishery Products
1858. § 123.15 General.
1859. § 123.16 Process controls.
1860. Subpart C Raw Molluscan Shellfish
1861. § 123.20 General.
1862. § 123.28 Source controls.
1863. PART 129 PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
1864. Subpart A General Provisions
1865. § 129.1 Current good manufacturing practice.
1866. § 129.3 Definitions.
1867. Subpart B Buildings and Facilities
1868. § 129.20 Plant construction and design.
1869. § 129.35 Sanitary facilities.
1870. § 129.37 Sanitary operations.
1871. Subpart C Equipment
1872. § 129.40 Equipment and procedures.
1873. D Subpart D [Reserved]
1874. Subpart E Production and Process Controls
1875. § 129.80 Processes and controls.
1876. PART 130 FOOD STANDARDS: GENERAL
1877. Subpart A General Provisions
1878. § 130.3 Definitions and interpretations.
1879. § 130.5 Procedure for establishing a food standard.
1880. § 130.6 Review of Codex Alimentarius food standards.
1881. § 130.8 Conformity to definitions and standards of identity.
1882. § 130.9 Sulfites in standardized food.
1883. § 130.10 Requirements for foods named by use of a nutrient content claim and a standardized term.
1884. § 130.11 Label designations of ingredients for standardized foods.
1885. § 130.12 General methods for water capacity and fill of containers.
1886. § 130.14 General statements of substandard quality and substandard fill of container.
1887. § 130.17 Temporary permits for interstate shipment of experimental packs of food varying from the requirements of definitions and standards of identity.
1888. Subpart B Food Additives in Standardized Foods
1889. § 130.20 Food additives proposed for use in foods for which definitions and standards of identity are established.
1890. Subpart C XXX
1891. PART 131 MILK AND CREAM
1892. Subpart A General Provisions
1893. § 131.1 xxx
1894. § 131.3 Definitions.
1895. § 131.25 Whipped cream products containing flavoring or sweetening.
1896. Subpart B Requirements for Specific Standardized Milk and Cream
1897. § 131.110 Milk.
1898. § 131.111 Acidified milk.
1899. § 131.112 Cultured milk.
1900. § 131.115 Concentrated milk.
1901. § 131.120 Sweetened condensed milk.
1902. § 131.125 Nonfat dry milk.
1903. § 131.127 Nonfat dry milk fortified with vitamins A and D.
1904. § 131.130 Evaporated milk.
1905. § 131.147 Dry whole milk.
1906. § 131.149 Dry cream.
1907. § 131.150 Heavy cream.
1908. § 131.155 Light cream.
1909. § 131.157 Light whipping cream.
1910. § 131.160 Sour cream.
1911. § 131.162 Acidified sour cream.
1912. § 131.170 Eggnog.
1913. § 131.180 Half-and-half.
1914. § 131.200 Yogurt.
1915. PART 133 CHEESES AND RELATED CHEESE PRODUCTS
1916. Subpart A General Provisions
1917. § 133.3 Definitions.
1918. § 133.5 Methods of analysis.
1919. § 133.10 Notice to manufacturers, packers, and distributors of pasteurized blended cheese, pasteurized process cheese, cheese food, cheese spread, and related foods.
1920. Subpart B Requirements for Specific Standardized Cheese and Related Products
1921. § 133.102 Asiago fresh and asiago soft cheese.
1922. § 133.103 Asiago medium cheese.
1923. § 133.104 Asiago old cheese.
1924. § 133.106 Blue cheese.
1925. § 133.108 Brick cheese.
1926. § 133.109 Brick cheese for manufacturing.
1927. § 133.111 Caciocavallo siciliano cheese.
1928. § 133.113 Cheddar cheese.
1929. § 133.114 Cheddar cheese for manufacturing.
1930. § 133.116 Low sodium cheddar cheese.
1931. § 133.118 Colby cheese.
1932. § 133.119 Colby cheese for manufacturing.
1933. § 133.121 Low sodium colby cheese.
1934. § 133.123 Cold-pack and club cheese.
1935. § 133.124 Cold-pack cheese food.
1936. § 133.125 Cold-pack cheese food with fruits, vegetables, or meats.
1937. § 133.127 Cook cheese, koch kaese.
1938. § 133.128 Cottage cheese.
1939. § 133.129 Dry curd cottage cheese.
1940. § 133.133 Cream cheese.
1941. § 133.134 Cream cheese with other foods.
1942. § 133.136 Washed curd and soaked curd cheese.
1943. § 133.137 Washed curd cheese for manufacturing.
1944. § 133.138 Edam cheese.
1945. § 133.140 Gammelost cheese.
1946. § 133.141 Gorgonzola cheese.
1947. § 133.142 Gouda cheese.
1948. § 133.144 Granular and stirred curd cheese.
1949. § 133.145 Granular cheese for manufacturing.
1950. § 133.146 Grated cheeses.
1951. § 133.147 Grated American cheese food.
1952. § 133.148 Hard grating cheeses.
1953. § 133.149 Gruyere cheese.
1954. § 133.150 Hard cheeses.
1955. § 133.152 Limburger cheese.
1956. § 133.153 Monterey cheese and monterey jack cheese.
1957. § 133.154 High-moisture jack cheese.
1958. § 133.155 Mozzarella cheese and scamorza cheese.
1959. § 133.156 Low-moisture mozzarella and scamorza cheese.
1960. § 133.157 Part-skim mozzarella and scamorza cheese.
1961. § 133.158 Low-moisture part-skim mozzarella and scamorza cheese.
1962. § 133.160 Muenster and munster cheese.
1963. § 133.161 Muenster and munster cheese for manufacturing.
1964. § 133.162 Neufchatel cheese.
1965. § 133.164 Nuworld cheese.
1966. § 133.165 Parmesan and reggiano cheese.
1967. § 133.167 Pasteurized blended cheese.
1968. § 133.168 Pasteurized blended cheese with fruits, vegetables, or meats.
1969. § 133.169 Pasteurized process cheese.
1970. § 133.170 Pasteurized process cheese with fruits, vegetables, or meats.
1971. § 133.171 Pasteurized process pimento cheese.
1972. § 133.173 Pasteurized process cheese food.
1973. § 133.174 Pasteurized process cheese food with fruits, vegetables, or meats.
1974. § 133.175 Pasteurized cheese spread.
1975. § 133.176 Pasteurized cheese spread with fruits, vegetables, or meats.
1976. § 133.178 Pasteurized neufchatel cheese spread with other foods.
1977. § 133.179 Pasteurized process cheese spread.
1978. § 133.180 Pasteurized process cheese spread with fruits, vegetables, or meats.
1979. § 133.181 Provolone cheese.
1980. § 133.182 Soft ripened cheeses.
1981. § 133.183 Romano cheese.
1982. § 133.184 Roquefort cheese, sheep's milk blue-mold, and blue-mold cheese from sheep's milk.
1983. § 133.185 Samsoe cheese.
1984. § 133.186 Sap sago cheese.
1985. § 133.187 Semisoft cheeses.
1986. § 133.188 Semisoft part-skim cheeses.
1987. § 133.189 Skim milk cheese for manufacturing.
1988. § 133.190 Spiced cheeses.
1989. § 133.191 Part-skim spiced cheeses.
1990. § 133.193 Spiced, flavored standardized cheeses.
1991. § 133.195 Swiss and emmentaler cheese.
1992. § 133.196 Swiss cheese for manufacturing.
1993. PART 135 FROZEN DESSERTS
1994. Subpart A General Provisions
1995. § 135.3 Definitions.
1996. Subpart B Requirements for Specific Standardized Frozen Desserts
1997. § 135.110 Ice cream and frozen custard.
1998. § 135.115 Goat's milk ice cream.
1999. § 135.130 Mellorine.
2000. § 135.140 Sherbet.
2001. § 135.160 Water ices.
2002. PART 136 BAKERY PRODUCTS
2003. Subpart A General Provisions
2004. § 136.3 Definitions.
2005. Subpart B Requirements for Specific Standardized Bakery Products
2006. § 136.110 Bread, rolls, and buns.
2007. § 136.115 Enriched bread, rolls, and buns.
2008. § 136.130 Milk bread, rolls, and buns.
2009. § 136.160 Raisin bread, rolls, and buns.
2010. § 136.180 Whole wheat bread, rolls, and buns.
2011. PART 137 CEREAL FLOURS AND RELATED PRODUCTS
2012. Subpart A XXX
2013. Subpart B Requirements for Specific Standardized Cereal Flours and Related Products
2014. § 137.105 Flour.
2015. § 137.155 Bromated flour.
2016. § 137.160 Enriched bromated flour.
2017. § 137.165 Enriched flour.
2018. § 137.170 Instantized flours.
2019. § 137.175 Phosphated flour.
2020. § 137.180 Self-rising flour.
2021. § 137.185 Enriched self-rising flour.
2022. § 137.190 Cracked wheat.
2023. § 137.195 Crushed wheat.
2024. § 137.200 Whole wheat flour.
2025. § 137.205 Bromated whole wheat flour.
2026. § 137.211 White corn flour.
2027. § 137.215 Yellow corn flour.
2028. § 137.220 Durum flour.
2029. § 137.225 Whole durum flour.
2030. § 137.250 White corn meal.
2031. § 137.255 Bolted white corn meal.
2032. § 137.260 Enriched corn meals.
2033. § 137.265 Degerminated white corn meal.
2034. § 137.270 Self-rising white corn meal.
2035. § 137.275 Yellow corn meal.
2036. § 137.280 Bolted yellow corn meal.
2037. § 137.285 Degerminated yellow corn meal.
2038. § 137.290 Self-rising yellow corn meal.
2039. § 137.300 Farina.
2040. § 137.305 Enriched farina.
2041. § 137.320 Semolina.
2042. § 137.350 Enriched rice.
2043. PART 139 MACARONI AND NOODLE PRODUCTS
2044. Subpart A XXX
2045. Subpart B Requirements for Specific Standardized Macaroni and Noodle Products
2046. § 139.110 Macaroni products.
2047. § 139.115 Enriched macaroni products.
2048. § 139.117 Enriched macaroni products with fortified protein.
2049. § 139.120 Milk macaroni products.
2050. § 139.121 Nonfat milk macaroni products.
2051. § 139.122 Enriched nonfat milk macaroni products.
2052. § 139.125 Vegetable macaroni products.
2053. § 139.135 Enriched vegetable macaroni products.
2054. § 139.138 Whole wheat macaroni products.
2055. § 139.140 Wheat and soy macaroni products.
2056. § 139.150 Noodle products.
2057. § 139.155 Enriched noodle products.
2058. § 139.160 Vegetable noodle products.
2059. § 139.165 Enriched vegetable noodle products.
2060. § 139.180 Wheat and soy noodle products.
2061. PART 145 CANNED FRUITS
2062. Subpart A General Provisions
2063. § 145.3 Definitions.
2064. Subpart B Requirements for Specific Standardized Canned Fruits
2065. § 145.110 Canned applesauce.
2066. § 145.115 Canned apricots.
2067. § 145.120 Canned berries.
2068. § 145.125 Canned cherries.
2069. § 145.130 Canned figs.
2070. § 145.135 Canned fruit cocktail.
2071. § 145.145 Canned grapefruit.
2072. § 145.170 Canned peaches.
2073. § 145.175 Canned pears.
2074. § 145.180 Canned pineapple.
2075. § 145.185 Canned plums.
2076. § 145.190 Canned prunes.
2077. PART 146 CANNED FRUIT JUICES
2078. Subpart A General Provisions
2079. § 146.3 Definitions.
2080. Subpart B Requirements for Specific Standardized Canned Fruit Juices and Beverages
2081. § 146.114 Lemon juice.
2082. § 146.120 Frozen concentrate for lemonade.
2083. § 146.121 Frozen concentrate for artificially sweetened lemonade.
2084. § 146.126 Frozen concentrate for colored lemonade.
2085. § 146.132 Grapefruit juice.
2086. § 146.135 Orange juice.
2087. § 146.137 Frozen orange juice.
2088. § 146.140 Pasteurized orange juice.
2089. § 146.141 Canned orange juice.
2090. § 146.145 Orange juice from concentrate.
2091. § 146.146 Frozen concentrated orange juice.
2092. § 146.148 Reduced acid frozen concentrated orange juice.
2093. § 146.150 Canned concentrated orange juice.
2094. § 146.151 Orange juice for manufacturing.
2095. § 146.152 Orange juice with preservative.
2096. § 146.153 Concentrated orange juice for manufacturing.
2097. § 146.154 Concentrated orange juice with preservative.
2098. § 146.185 Pineapple juice.
2099. § 146.187 Canned prune juice.
2100. PART 150 FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
2101. Subpart A XXX
2102. Subpart B Requirements for Specific Standardized Fruit Butters, Jellies, Preserves, and Related Products
2103. § 150.110 Fruit butter.
2104. § 150.140 Fruit jelly.
2105. § 150.160 Fruit preserves and jams.
2106. PART 155 CANNED VEGETABLES
2107. Subpart A General Provisions
2108. § 155.1 xxx
2109. § 155.3 Definitions.
2110. Subpart B Requirements for Specific Standardized Canned Vegetables
2111. § 155.120 Canned green beans and canned wax beans.
2112. § 155.130 Canned corn.
2113. § 155.170 Canned peas.
2114. § 155.190 Canned tomatoes.
2115. § 155.191 Tomato concentrates.
2116. § 155.194 Catsup.
2117. § 155.200 Certain other canned vegetables.
2118. § 155.201 Canned mushrooms.
2119. PART 156 VEGETABLE JUICES
2120. Subpart A General Provisions
2121. § 156.3 Definitions.
2122. Subpart B Requirements for Specific Standardized Vegetable Juices
2123. § 156.145 Tomato juice.
2124. PART 158 FROZEN VEGETABLES
2125. Subpart A General Provisions
2126. § 158.3 Definitions.
2127. Subpart B Requirements for Specific Standardized Frozen Vegetables
2128. § 158.170 Frozen peas.
2129. PART 160 EGGS AND EGG PRODUCTS
2130. A Subpart A [Reserved]
2131. Subpart B Requirements for Specific Standardized Eggs and Egg Products
2132. § 160.100 Eggs.
2133. § 160.105 Dried eggs.
2134. § 160.110 Frozen eggs.
2135. § 160.115 Liquid eggs.
2136. § 160.140 Egg whites.
2137. § 160.145 Dried egg whites.
2138. § 160.150 Frozen egg whites.
2139. § 160.180 Egg yolks.
2140. § 160.185 Dried egg yolks.
2141. § 160.190 Frozen egg yolks.
2142. PART 161 FISH AND SHELLFISH
2143. Subpart A General Provisions
2144. § 161.1 xxx
2145. § 161.30 Declaration of quantity of contents on labels for canned oysters.
2146. Subpart B Requirements for Specific Standardized Fish and Shellfish
2147. § 161.130 Oysters.
2148. § 161.136 Olympia oysters.
2149. § 161.145 Canned oysters.
2150. § 161.170 Canned Pacific salmon.
2151. § 161.173 Canned wet pack shrimp in transparent or nontransparent containers.
2152. § 161.175 Frozen raw breaded shrimp.
2153. § 161.176 Frozen raw lightly breaded shrimp.
2154. § 161.190 Canned tuna.
2155. PART 163 CACAO PRODUCTS
2156. Subpart A General Provisions
2157. § 163.5 Methods of analysis.
2158. Subpart B Requirements for Specific Standardized Cacao Products
2159. § 163.110 Cacao nibs.
2160. § 163.111 Chocolate liquor.
2161. § 163.112 Breakfast cocoa.
2162. § 163.113 Cocoa.
2163. § 163.114 Lowfat cocoa.
2164. § 163.117 Cocoa with dioctyl sodium sulfosuccinate for manufacturing.
2165. § 163.123 Sweet chocolate.
2166. § 163.124 White chocolate.
2167. § 163.130 Milk chocolate.
2168. § 163.135 Buttermilk chocolate.
2169. § 163.140 Skim milk chocolate.
2170. § 163.145 Mixed dairy product chocolates.
2171. § 163.150 Sweet cocoa and vegetable fat coating.
2172. § 163.153 Sweet chocolate and vegetable fat coating.
2173. § 163.155 Milk chocolate and vegetable fat coating.
2174. PART 164 TREE NUT AND PEANUT PRODUCTS
2175. A Subpart A [Reserved]
2176. Subpart B Requirements for Specific Standardized Tree Nut and Peanut Products
2177. § 164.110 Mixed nuts.
2178. § 164.120 Shelled nuts in rigid or semirigid containers.
2179. § 164.150 Peanut butter.
2180. PART 165 BEVERAGES
2181. Subpart A General Provisions
2182. § 165.3 Definitions.
2183. Subpart B Requirements for Specific Standardized Beverages
2184. § 165.110 Bottled water.
2185. PART 166 MARGARINE
2186. Subpart A General Provisions
2187. § 166.40 Labeling of margarine.
2188. Subpart B Requirements for Specific Standardized Margarine
2189. § 166.110 Margarine.
2190. PART 168 SWEETENERS AND TABLE SIRUPS
2191. A Subpart A [Reserved]
2192. Subpart B Requirements for Specific Standardized Sweeteners and Table Sirups
2193. § 168.110 Dextrose anhydrous.
2194. § 168.111 Dextrose monohydrate.
2195. § 168.120 Glucose sirup.
2196. § 168.121 Dried glucose sirup.
2197. § 168.122 Lactose.
2198. § 168.130 Cane sirup.
2199. § 168.140 Maple sirup.
2200. § 168.160 Sorghum sirup.
2201. § 168.180 Table sirup.
2202. PART 169 FOOD DRESSINGS AND FLAVORINGS
2203. Subpart A General Provisions
2204. § 169.3 Definitions.
2205. Subpart B Requirements for Specific Standardized Food Dressings and Flavorings
2206. § 169.140 Mayonnaise.
2207. § 169.150 Salad dressing.
2208. § 169.175 Vanilla extract.
2209. § 169.176 Concentrated vanilla extract.
2210. § 169.177 Vanilla flavoring.
2211. § 169.178 Concentrated vanilla flavoring.
2212. § 169.179 Vanilla powder.
2213. § 169.180 Vanilla-vanillin extract.
2214. § 169.181 Vanilla-vanillin flavoring.
2215. § 169.182 Vanilla-vanillin powder.
2216. CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
2217. SUBCHAPTER B FOOD FOR HUMAN CONSUMPTION (CONTINUED)
2218. PART 170 FOOD ADDITIVES
2219. Subpart A General Provisions
2220. § 170.3 Definitions.
2221. § 170.6 Opinion letters on food additive status.
2222. § 170.10 Food additives in standardized foods.
2223. § 170.15 Adoption of regulation on initiative of Commissioner.
2224. § 170.17 Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.
2225. § 170.18 Tolerances for related food additives.
2226. § 170.19 Pesticide chemicals in processed foods.
2227. Subpart B Food Additive Safety
2228. § 170.20 General principles for evaluating the safety of food additives.
2229. § 170.22 Safety factors to be considered.
2230. § 170.30 Eligibility for classification as generally recognized as safe (GRAS).
2231. § 170.35 Affirmation of generally recognized as safe (GRAS) status.
2232. § 170.38 Determination of food additive status.
2233. § 170.39 Threshold of regulation for substances used in food-contact articles.
2234. Subpart C Specific Administrative Rulings and Decisions
2235. § 170.45 Fluorine-containing compounds.
2236. § 170.50 Glycine (aminoacetic acid) in food for human consumption.
2237. § 170.60 Nitrites and/or nitrates in curing premixes.
2238. Subpart D Premarket Notifications
2239. § 170.100 Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA).
2240. § 170.101 Information in a premarket notification for a food contact substance (FCN).
2241. § 170.102 Confidentiality of information related to premarket notification for a food contact substance (FCN).
2242. § 170.103 Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).
2243. § 170.104 Action on a premarket notification for a food contact substance (FCN).
2244. § 170.105 The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective.
2245. § 170.106 Notification for a food contact substance formulation (NFCSF).
2246. Subpart E Generally Recognized as Safe (GRAS) Notice
2247. § 170.203 Definitions.
2248. § 170.205 Opportunity to submit a GRAS notice.
2249. § 170.210 How to send your GRAS notice to FDA.
2250. § 170.215 Incorporation into a GRAS notice.
2251. § 170.220 General requirements applicable to a GRAS notice.
2252. § 170.225 Part 1 of a GRAS notice: Signed statements and certification.
2253. § 170.230 Part 2 of a GRAS notice: Identity, method of manufacture, specifications, and physical or technical effect.
2254. § 170.235 Part 3 of a GRAS notice: Dietary exposure.
2255. § 170.240 Part 4 of a GRAS notice: Self-limiting levels of use.
2256. § 170.245 Part 5 of a GRAS notice: Experience based on common use in food before 1958.
2257. § 170.250 Part 6 of a GRAS notice: Narrative.
2258. § 170.255 Part 7 of a GRAS notice: List of supporting data and information in your GRAS notice.
2259. § 170.260 Steps you may take before FDA responds to your GRAS notice.
2260. § 170.265 What FDA will do with a GRAS notice.
2261. § 170.270 Procedures that apply when the intended conditions of use of a notified substance include use in a product or products subject to regulation by the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture.
2262. § 170.275 Public disclosure of a GRAS notice.
2263. § 170.280 Submission of a supplement.
2264. § 170.285 Disposition of pending GRAS affirmation petitions.
2265. PART 171 FOOD ADDITIVE PETITIONS
2266. Subpart A General Provisions
2267. § 171.1 Petitions.
2268. § 171.6 Amendment of petition.
2269. § 171.7 Withdrawal of petition without prejudice.
2270. § 171.8 Threshold of regulation for substances used in food-contact articles.
2271. Subpart B Administrative Actions on Applications
2272. § 171.100 Regulation based on petition.
2273. § 171.102 Effective date of regulation.
2274. § 171.110 Procedure for objections and hearings.
2275. § 171.130 Procedure for amending and repealing tolerances or exemptions from tolerances.
2276. PART 172 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
2277. Subpart A General Provisions
2278. § 172.5 General provisions for direct food additives.
2279. Subpart B Food Preservatives
2280. § 172.105 Anoxomer.
2281. § 172.110 BHA.
2282. § 172.115 BHT.
2283. § 172.120 Calcium disodium EDTA.
2284. § 172.130 Dehydroacetic acid.
2285. § 172.133 Dimethyl dicarbonate.
2286. § 172.135 Disodium EDTA.
2287. § 172.140 Ethoxyquin.
2288. § 172.145 Heptylparaben.
2289. § 172.150 4-Hydroxymethyl-2,6-di-tert-butylphenol.
2290. § 172.155 Natamycin (pimaricin).
2291. § 172.160 Potassium nitrate.
2292. § 172.165 Quaternary ammonium chloride combination.
2293. § 172.167 Silver nitrate and hydrogen peroxide solution.
2294. § 172.170 Sodium nitrate.
2295. § 172.175 Sodium nitrite.
2296. § 172.177 Sodium nitrite used in processing smoked chub.
2297. § 172.180 Stannous chloride.
2298. § 172.185 TBHQ.
2299. § 172.190 THBP.
2300. Subpart C Coatings, Films and Related Substances
2301. § 172.210 Coatings on fresh citrus fruit.
2302. § 172.215 Coumarone-indene resin.
2303. § 172.225 Methyl and ethyl esters of fatty acids produced from edible fats and oils.
2304. § 172.230 Microcapsules for flavoring substances.
2305. § 172.235 Morpholine.
2306. § 172.250 Petroleum naphtha.
2307. § 172.255 Polyacrylamide.
2308. § 172.260 Oxidized polyethylene.
2309. § 172.270 Sulfated butyl oleate.
2310. § 172.275 Synthetic paraffin and succinic derivatives.
2311. § 172.280 Terpene resin.
2312. Subpart D Special Dietary and Nutritional Additives
2313. § 172.310 Aluminum nicotinate.
2314. § 172.315 Nicotinamide-ascorbic acid complex.
2315. § 172.320 Amino acids.
2316. § 172.325 Bakers yeast protein.
2317. § 172.330 Calcium pantothenate, calcium chloride double salt.
2318. § 172.335 D-Pantothenamide.
2319. § 172.340 Fish protein isolate.
2320. § 172.345 Folic acid (folacin).
2321. § 172.350 Fumaric acid and salts of fumaric acid.
2322. § 172.365 Kelp.
2323. § 172.370 Iron-choline citrate complex.
2324. § 172.372 N-Acetyl-L-methionine.
2325. § 172.375 Potassium iodide.
2326. § 172.379 Vitamin D2.
2327. § 172.380 Vitamin D3.
2328. § 172.381 Vitamin D2 bakers yeast.
2329. § 172.382 Vitamin D2 mushroom powder.
2330. § 172.383 Vitamin D2 inactive bakers yeast.
2331. § 172.385 Whole fish protein concentrate.
2332. § 172.395 Xylitol.
2333. § 172.399 Zinc methionine sulfate.
2334. Subpart E Anticaking Agents
2335. § 172.410 Calcium silicate.
2336. § 172.430 Iron ammonium citrate.
2337. § 172.480 Silicon dioxide.
2338. § 172.490 Yellow prussiate of soda.
2339. Subpart F Flavoring Agents and Related Substances
2340. § 172.510 Natural flavoring substances and natural substances used in conjunction with flavors.
2341. § 172.515 Synthetic flavoring substances and adjuvants.
2342. § 172.520 Cocoa with dioctyl sodium sulfosuccinate for manufacturing.
2343. § 172.530 Disodium guanylate.
2344. § 172.535 Disodium inosinate.
2345. § 172.540 DL-Alanine.
2346. § 172.560 Modified hop extract.
2347. § 172.575 Quinine.
2348. § 172.580 Safrole-free extract of sassafras.
2349. § 172.585 Sugar beet extract flavor base.
2350. § 172.590 Yeast-malt sprout extract.
2351. Subpart G Gums, Chewing Gum Bases and Related Substances
2352. § 172.610 Arabinogalactan.
2353. § 172.615 Chewing gum base.
2354. § 172.620 Carrageenan.
2355. § 172.623 Carrageenan with polysorbate 80.
2356. § 172.626 Salts of carrageenan.
2357. § 172.655 Furcelleran.
2358. § 172.660 Salts of furcelleran.
2359. § 172.665 Gellan gum.
2360. § 172.695 Xanthan gum.
2361. Subpart H Other Specific Usage Additives
2362. § 172.710 Adjuvants for pesticide use dilutions.
2363. § 172.712 1,3-Butylene glycol.
2364. § 172.715 Calcium lignosulfonate.
2365. § 172.720 Calcium lactobionate.
2366. § 172.723 Epoxidized soybean oil.
2367. § 172.725 Gibberellic acid and its potassium salt.
2368. § 172.730 Potassium bromate.
2369. § 172.735 Glycerol ester of rosin.
2370. § 172.736 Glycerides and polyglycides of hydrogenated vegetable oils.
2371. § 172.755 Stearyl monoglyceridyl citrate.
2372. § 172.765 Succistearin (stearoyl propylene glycol hydrogen succinate).
2373. § 172.770 Ethylene oxide polymer.
2374. § 172.775 Methacrylic acid-divinylbenzene copolymer.
2375. § 172.780 Acacia (gum arabic).
2376. § 172.785 Listeria-specific bacteriophage preparation.
2377. Subpart I Multipurpose Additives
2378. § 172.800 Acesulfame potassium.
2379. § 172.802 Acetone peroxides.
2380. § 172.803 Advantame.
2381. § 172.804 Aspartame.
2382. § 172.806 Azodicarbonamide.
2383. § 172.808 Copolymer condensates of ethylene oxide and propylene oxide.
2384. § 172.809 Curdlan.
2385. § 172.810 Dioctyl sodium sulfosuccinate.
2386. § 172.811 Glyceryl tristearate.
2387. § 172.812 Glycine.
2388. § 172.814 Hydroxylated lecithin.
2389. § 172.816 Methyl glucoside-coconut oil ester.
2390. § 172.818 Oxystearin.
2391. § 172.820 Polyethylene glycol (mean molecular weight 200-9,500).
2392. § 172.822 Sodium lauryl sulfate.
2393. § 172.824 Sodium mono- and dimethyl naphthalene sulfonates.
2394. § 172.826 Sodium stearyl fumarate.
2395. § 172.828 Acetylated monoglycerides.
2396. § 172.829 Neotame.
2397. § 172.830 Succinylated monoglycerides.
2398. § 172.831 Sucralose.
2399. § 172.832 Monoglyceride citrate.
2400. § 172.833 Sucrose acetate isobutyrate (SAIB).
2401. § 172.834 Ethoxylated mono- and diglycerides.
2402. § 172.836 Polysorbate 60.
2403. § 172.838 Polysorbate 65.
2404. § 172.840 Polysorbate 80.
2405. § 172.841 Polydextrose.
2406. § 172.842 Sorbitan monostearate.
2407. § 172.844 Calcium stearoyl-2-lactylate.
2408. § 172.846 Sodium stearoyl lactylate.
2409. § 172.848 Lactylic esters of fatty acids.
2410. § 172.850 Lactylated fatty acid esters of glycerol and propylene glycol.
2411. § 172.852 Glyceryl-lacto esters of fatty acids.
2412. § 172.854 Polyglycerol esters of fatty acids.
2413. § 172.856 Propylene glycol mono- and diesters of fats and fatty acids.
2414. § 172.858 Propylene glycol alginate.
2415. § 172.859 Sucrose fatty acid esters.
2416. § 172.860 Fatty acids.
2417. § 172.861 Cocoa butter substitute from coconut oil, palm kernel oil, or both oils.
2418. § 172.862 Oleic acid derived from tall oil fatty acids.
2419. § 172.863 Salts of fatty acids.
2420. § 172.864 Synthetic fatty alcohols.
2421. § 172.866 Synthetic glycerin produced by the hydrogenolysis of carbohydrates.
2422. § 172.867 Olestra.
2423. § 172.868 Ethyl cellulose.
2424. § 172.869 Sucrose oligoesters.
2425. § 172.870 Hydroxypropyl cellulose.
2426. § 172.872 Methyl ethyl cellulose.
2427. § 172.874 Hydroxypropyl methylcellulose.
2428. § 172.876 Castor oil.
2429. § 172.878 White mineral oil.
2430. § 172.880 Petrolatum.
2431. § 172.882 Synthetic isoparaffinic petroleum hydrocarbons.
2432. § 172.884 Odorless light petroleum hydrocarbons.
2433. § 172.886 Petroleum wax.
2434. § 172.888 Synthetic petroleum wax.
2435. § 172.890 Rice bran wax.
2436. § 172.892 Food starch-modified.
2437. § 172.894 Modified cottonseed products intended for human consumption.
2438. § 172.896 Dried yeasts.
2439. § 172.898 Bakers yeast glycan.
2440. PART 173 SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
2441. Subpart A Polymer Substances and Polymer Adjuvants for Food Treatment
2442. § 173.5 Acrylate-acrylamide resins.
2443. § 173.10 Modified polyacrylamide resin.
2444. § 173.20 Ion-exchange membranes.
2445. § 173.21 Perfluorinated ion exchange membranes.
2446. § 173.25 Ion-exchange resins.
2447. § 173.40 Molecular sieve resins.
2448. § 173.45 Polymaleic acid and its sodium salt.
2449. § 173.50 Polyvinylpolypyrrolidone.
2450. § 173.55 Polyvinylpyrrolidone.
2451. § 173.60 Dimethylamine-epichlorohydrin copolymer.
2452. § 173.65 Divinylbenzene copolymer.
2453. § 173.70 Chloromethylated aminated styrene-divinylbenzene resin.
2454. § 173.73 Sodium polyacrylate.
2455. § 173.75 Sorbitan monooleate.
2456. Subpart B Enzyme Preparations and Microorganisms
2457. § 173.110 Amyloglucosidase derived from Rhizopus niveus.
2458. § 173.115 Alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis.
2459. § 173.120 Carbohydrase and cellulase derived from Aspergillus niger.
2460. § 173.130 Carbohydrase derived from Rhizopus oryzae.
2461. § 173.135 Catalase derived from Micrococcus lysodeikticus.
2462. § 173.140 Esterase-lipase derived from Mucor miehei.
2463. § 173.145 Alpha-Galactosidase derived from Mortierella vinaceae var. raffinoseutilizer.
2464. § 173.150 Milk-clotting enzymes, microbial.
2465. § 173.160 Candida guilliermondii.
2466. § 173.165 Candida lipolytica.
2467. § 173.170 Aminoglycoside 3′-phosphotransferase II.
2468. Subpart C Solvents, Lubricants, Release Agents and Related Substances
2469. § 173.210 Acetone.
2470. § 173.220 1,3-Butylene glycol.
2471. § 173.228 Ethyl acetate.
2472. § 173.230 Ethylene dichloride.
2473. § 173.240 Isopropyl alcohol.
2474. § 173.250 Methyl alcohol residues.
2475. § 173.255 Methylene chloride.
2476. § 173.270 Hexane.
2477. § 173.275 Hydrogenated sperm oil.
2478. § 173.280 Solvent extraction process for citric acid.
2479. § 173.290 Trichloroethylene.
2480. Subpart D Specific Usage Additives
2481. § 173.300 Chlorine dioxide.
2482. § 173.310 Boiler water additives.
2483. § 173.315 Chemicals used in washing or to assist in the peeling of fruits and vegetables.
2484. § 173.320 Chemicals for controlling microorganisms in cane-sugar and beet-sugar mills.
2485. § 173.322 Chemicals used in delinting cottonseed.
2486. § 173.325 Acidified sodium chlorite solutions.
2487. § 173.340 Defoaming agents.
2488. § 173.342 Chlorofluorocarbon 113 and perfluorohexane.
2489. § 173.345 Chloropentafluoroethane.
2490. § 173.350 Combustion product gas.
2491. § 173.355 Dichlorodifluoromethane.
2492. § 173.356 Hydrogen peroxide.
2493. § 173.357 Materials used as fixing agents in the immobilization of enzyme preparations.
2494. § 173.360 Octafluorocyclobutane.
2495. § 173.368 Ozone.
2496. § 173.370 Peroxyacids.
2497. § 173.375 Cetylpyridinium chloride.
2498. § 173.385 Sodium methyl sulfate.
2499. § 173.395 Trifluoromethane sulfonic acid.
2500. § 173.400 Dimethyldialkylammonium chloride.
2501. § 173.405 Sodium dodecylbenzenesulfonate.
2502. PART 174 INDIRECT FOOD ADDITIVES: GENERAL
2503. § 174.5 General provisions applicable to indirect food additives.
2504. § 174.6 Threshold of regulation for substances used in food-contact articles.
2505. PART 175 INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
2506. A Subpart A [Reserved]
2507. Subpart B Substances for Use Only as Components of Adhesives
2508. § 175.105 Adhesives.
2509. § 175.125 Pressure-sensitive adhesives.
2510. Subpart C Substances for Use as Components of Coatings
2511. § 175.210 Acrylate ester copolymer coating.
2512. § 175.230 Hot-melt strippable food coatings.
2513. § 175.250 Paraffin (synthetic).
2514. § 175.260 Partial phosphoric acid esters of polyester resins.
2515. § 175.270 Poly(vinyl fluoride) resins.
2516. § 175.300 Resinous and polymeric coatings.
2517. § 175.320 Resinous and polymeric coatings for polyolefin films.
2518. § 175.350 Vinyl acetate/crotonic acid copolymer.
2519. § 175.360 Vinylidene chloride copolymer coatings for nylon film.
2520. § 175.365 Vinylidene chloride copolymer coatings for polycarbonate film.
2521. § 175.380 Xylene-formaldehyde resins condensed with 4,4′-isopropylidenediphenol-epichlorohydrin epoxy resins.
2522. § 175.390 Zinc-silicon dioxide matrix coatings.
2523. PART 176 INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
2524. A Subpart A [Reserved]
2525. Subpart B Substances for Use Only as Components of Paper and Paperboard
2526. § 176.110 Acrylamide-acrylic acid resins.
2527. § 176.120 Alkyl ketene dimers.
2528. § 176.130 Anti-offset substances.
2529. § 176.150 Chelating agents used in the manufacture of paper and paperboard.
2530. § 176.160 Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine.
2531. § 176.170 Components of paper and paperboard in contact with aqueous and fatty foods.
2532. § 176.180 Components of paper and paperboard in contact with dry food.
2533. § 176.200 Defoaming agents used in coatings.
2534. § 176.210 Defoaming agents used in the manufacture of paper and paperboard.
2535. § 176.230 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione.
2536. § 176.250 Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane.
2537. § 176.260 Pulp from reclaimed fiber.
2538. § 176.300 Slimicides.
2539. § 176.320 Sodium nitrate-urea complex.
2540. § 176.350 Tamarind seed kernel powder.
2541. PART 177 INDIRECT FOOD ADDITIVES: POLYMERS
2542. A Subpart A [Reserved]
2543. Subpart B Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces
2544. § 177.1010 Acrylic and modified acrylic plastics, semirigid and rigid.
2545. § 177.1020 Acrylonitrile/butadiene/styrene co-polymer.
2546. § 177.1030 Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer.
2547. § 177.1040 Acrylonitrile/styrene copoly-mer.
2548. § 177.1050 Acrylonitrile/styrene copoly-mer modified with butadiene/styrene elastomer.
2549. § 177.1060 n-Alkylglutarimide/acrylic copolymers.
2550. § 177.1200 Cellophane.
2551. § 177.1210 Closures with sealing gaskets for food containers.
2552. § 177.1211 Cross-linked polyacrylate copolymers.
2553. § 177.1240 1,4-Cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate copolymer.
2554. § 177.1310 Ethylene-acrylic acid copolymers.
2555. § 177.1312 Ethylene-carbon monoxide copolymers.
2556. § 177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers.
2557. § 177.1320 Ethylene-ethyl acrylate copolymers.
2558. § 177.1330 Ionomeric resins.
2559. § 177.1340 Ethylene-methyl acrylate copolymer resins.
2560. § 177.1345 Ethylene/1,3-phenylene oxyethylene isophthalate/ terephthalate copolymer.
2561. § 177.1350 Ethylene-vinyl acetate copolymers.
2562. § 177.1360 Ethylene-vinyl acetate-vinyl alcohol copolymers.
2563. § 177.1380 Fluorocarbon resins.
2564. § 177.1390 Laminate structures for use at temperatures of 250 °F and above.
2565. § 177.1395 Laminate structures for use at temperatures between 120 °F and 250 °F.
2566. § 177.1400 Hydroxyethyl cellulose film, water-insoluble.
2567. § 177.1420 Isobutylene polymers.
2568. § 177.1430 Isobutylene-butene copolymers.
2569. § 177.1440 4,4′-Isopropylidenediphenol-epichlorohydrin resins minimum molecular weight 10,000.
2570. § 177.1460 Melamine-formaldehyde resins in molded articles.
2571. § 177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate copolymers.
2572. § 177.1500 Nylon resins.
2573. § 177.1520 Olefin polymers.
2574. § 177.1550 Perfluorocarbon resins.
2575. § 177.1555 Polyarylate resins.
2576. § 177.1556 Polyaryletherketone resins.
2577. § 177.1560 Polyarylsulfone resins.
2578. § 177.1570 Poly-1-butene resins and butene/ethylene copolymers.
2579. § 177.1580 Polycarbonate resins.
2580. § 177.1585 Polyestercarbonate resins.
2581. § 177.1590 Polyester elastomers.
2582. § 177.1595 Polyetherimide resin.
2583. § 177.1600 Polyethylene resins, carboxyl modified.
2584. § 177.1610 Polyethylene, chlorinated.
2585. § 177.1615 Polyethylene, fluorinated.
2586. § 177.1620 Polyethylene, oxidized.
2587. § 177.1630 Polyethylene phthalate polymers.
2588. § 177.1632 Poly(phenyleneterephthalamide) resins.
2589. § 177.1635 Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene).
2590. § 177.1637 Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins.
2591. § 177.1640 Polystyrene and rubber-modified polystyrene.
2592. § 177.1650 Polysulfide polymer-polyepoxy resins.
2593. § 177.1655 Polysulfone resins.
2594. § 177.1660 Poly (tetramethylene terephthalate).
2595. § 177.1670 Polyvinyl alcohol film.
2596. § 177.1680 Polyurethane resins.
2597. § 177.1810 Styrene block polymers.
2598. § 177.1820 Styrene-maleic anhydride copolymers.
2599. § 177.1830 Styrene-methyl methacrylate copolymers.
2600. § 177.1850 Textryls.
2601. § 177.1900 Urea-formaldehyde resins in molded articles.
2602. § 177.1950 Vinyl chloride-ethylene copolymers.
2603. § 177.1960 Vinyl chloride-hexene-1 copolymers.
2604. § 177.1970 Vinyl chloride-lauryl vinyl ether copolymers.
2605. § 177.1980 Vinyl chloride-propylene copolymers.
2606. § 177.1990 Vinylidene chloride/methyl acrylate copolymers.
2607. § 177.2000 Vinylidene chloride/methyl acrylate/methyl methacrylate polymers.
2608. Subpart C Substances for Use Only as Components of Articles Intended for Repeated Use
2609. § 177.2210 Ethylene polymer, chlorosulfonated.
2610. § 177.2250 Filters, microporous polymeric.
2611. § 177.2260 Filters, resin-bonded.
2612. § 177.2280 4,4′-Isopropylidenediphenolepichlorohydrin thermosetting epoxy resins.
2613. § 177.2355 Mineral reinforced nylon resins.
2614. § 177.2400 Perfluorocarbon cured elastomers.
2615. § 177.2410 Phenolic resins in molded articles.
2616. § 177.2415 Poly(aryletherketone) resins.
2617. § 177.2420 Polyester resins, cross-linked.
2618. § 177.2430 Polyether resins, chlorinated.
2619. § 177.2440 Polyethersulfone resins.
2620. § 177.2450 Polyamide-imide resins.
2621. § 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins.
2622. § 177.2465 Polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers.
2623. § 177.2470 Polyoxymethylene copolymer.
2624. § 177.2480 Polyoxymethylene homopolymer.
2625. § 177.2490 Polyphenylene sulfide resins.
2626. § 177.2500 Polyphenylene sulfone resins.
2627. § 177.2510 Polyvinylidene fluoride resins.
2628. § 177.2550 Reverse osmosis membranes.
2629. § 177.2600 Rubber articles intended for repeated use.
2630. § 177.2710 Styrene-divinylbenzene resins, cross-linked.
2631. § 177.2800 Textiles and textile fibers.
2632. § 177.2910 Ultra-filtration membranes.
2633. PART 178 INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
2634. A Subpart A [Reserved]
2635. Subpart B Substances Utilized To Control the Growth of Microorganisms
2636. § 178.1005 Hydrogen peroxide solution.
2637. § 178.1010 Sanitizing solutions.
2638. Subpart C Antioxidants and Stabilizers
2639. § 178.2010 Antioxidants and/or stabilizers for polymers.
2640. § 178.2550 4-Hydroxymethyl-2,6-di-tert-butylphenol.
2641. § 178.2650 Organotin stabilizers in vinyl chloride plastics.
2642. Subpart D Certain Adjuvants and Production Aids
2643. § 178.3010 Adjuvant substances used in the manufacture of foamed plastics.
2644. § 178.3120 Animal glue.
2645. § 178.3125 Anticorrosive agents.
2646. § 178.3130 Antistatic and/or antifogging agents in food-packaging materials.
2647. § 178.3280 Castor oil, hydrogenated.
2648. § 178.3290 Chromic chloride complexes.
2649. § 178.3295 Clarifying agents for polymers.
2650. § 178.3297 Colorants for polymers.
2651. § 178.3300 Corrosion inhibitors used for steel or tinplate.
2652. § 178.3400 Emulsifiers and/or surface-active agents.
2653. § 178.3450 Esters of stearic and palmitic acids.
2654. § 178.3480 Fatty alcohols, synthetic.
2655. § 178.3500 Glycerin, synthetic.
2656. § 178.3505 Glyceryl tri-(12-acetoxystearate).
2657. § 178.3520 Industrial starch-modified.
2658. § 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic.
2659. § 178.3570 Lubricants with incidental food contact.
2660. § 178.3600 Methyl glucoside-coconut oil ester.
2661. § 178.3610 α-Methylstyrene-vinyltoluene resins, hydrogenated.
2662. § 178.3620 Mineral oil.
2663. § 178.3650 Odorless light petroleum hydrocarbons.
2664. § 178.3690 Pentaerythritol adipate-stearate.
2665. § 178.3700 Petrolatum.
2666. § 178.3710 Petroleum wax.
2667. § 178.3720 Petroleum wax, synthetic.
2668. § 178.3725 Pigment dispersants.
2669. § 178.3730 Piperonyl butoxide and pyrethrins as components of bags.
2670. § 178.3740 Plasticizers in polymeric substances.
2671. § 178.3750 Polyethylene glycol (mean molecular weight 200-9,500).
2672. § 178.3760 Polyethylene glycol (400) monolaurate.
2673. § 178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids.
2674. § 178.3780 Polyhydric alcohol esters of long chain monobasic acids.
2675. § 178.3790 Polymer modifiers in semirigid and rigid vinyl chloride plastics.
2676. § 178.3800 Preservatives for wood.
2677. § 178.3850 Reinforced wax.
2678. § 178.3860 Release agents.
2679. § 178.3870 Rosins and rosin derivatives.
2680. § 178.3900 Sodium pentachlorophenate.
2681. § 178.3910 Surface lubricants used in the manufacture of metallic articles.
2682. § 178.3930 Terpene resins.
2683. § 178.3940 Tetraethylene glycol di-(2-ethylhexoate).
2684. § 178.3950 Tetrahydrofuran.
2685. PART 179 IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD
2686. A Subpart A [Reserved]
2687. Subpart B Radiation and Radiation Sources
2688. § 179.21 Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing.
2689. § 179.25 General provisions for food irradiation.
2690. § 179.26 Ionizing radiation for the treatment of food.
2691. § 179.30 Radiofrequency radiation for the heating of food, including microwave frequencies.
2692. § 179.39 Ultraviolet radiation for the processing and treatment of food.
2693. § 179.41 Pulsed light for the treatment of food.
2694. § 179.43 Carbon dioxide laser for etching food.
2695. Subpart C Packaging Materials for Irradiated Foods
2696. § 179.45 Packaging materials for use during the irradiation of prepackaged foods.
2697. PART 180 FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
2698. Subpart A General Provisions
2699. § 180.1 General.
2700. Subpart B Specific Requirements for Certain Food Additives
2701. § 180.22 Acrylonitrile copolymers.
2702. § 180.25 Mannitol.
2703. § 180.37 Saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin.
2704. PART 181 PRIOR-SANCTIONED FOOD INGREDIENTS
2705. Subpart A General Provisions
2706. § 181.1 General.
2707. § 181.5 Prior sanctions.
2708. Subpart B Specific Prior-Sanctioned Food Ingredients
2709. § 181.22 Certain substances employed in the manufacture of food-packaging materials.
2710. § 181.23 Antimycotics.
2711. § 181.24 Antioxidants.
2712. § 181.25 Driers.
2713. § 181.26 Drying oils as components of finished resins.
2714. § 181.27 Plasticizers.
2715. § 181.28 Release agents.
2716. § 181.29 Stabilizers.
2717. § 181.30 Substances used in the manufacture of paper and paperboard products used in food packaging.
2718. § 181.32 Acrylonitrile copolymers and resins.
2719. § 181.33 Sodium nitrate and potassium nitrate.
2720. § 181.34 Sodium nitrite and potassium nitrite.
2721. PART 182 SUBSTANCES GENERALLY RECOGNIZED AS SAFE
2722. Subpart A General Provisions
2723. § 182.1 Substances that are generally recognized as safe.
2724. § 182.10 Spices and other natural seasonings and flavorings.
2725. § 182.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).
2726. § 182.40 Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings.
2727. § 182.50 Certain other spices, seasonings, essential oils, oleoresins, and natural extracts.
2728. § 182.60 Synthetic flavoring substances and adjuvants.
2729. § 182.70 Substances migrating from cotton and cotton fabrics used in dry food packaging.
2730. § 182.90 Substances migrating to food from paper and paperboard products.
2731. § 182.99 Adjuvants for pesticide chemicals.
2732. Subpart B Multiple Purpose GRAS Food Substances
2733. § 182.1045 Glutamic acid.
2734. § 182.1047 Glutamic acid hydrochloride.
2735. § 182.1057 Hydrochloric acid.
2736. § 182.1073 Phosphoric acid.
2737. § 182.1087 Sodium acid pyrophosphate.
2738. § 182.1125 Aluminum sulfate.
2739. § 182.1127 Aluminum ammonium sulfate.
2740. § 182.1129 Aluminum potassium sulfate.
2741. § 182.1131 Aluminum sodium sulfate.
2742. § 182.1180 Caffeine.
2743. § 182.1217 Calcium phosphate.
2744. § 182.1235 Caramel.
2745. § 182.1320 Glycerin.
2746. § 182.1480 Methylcellulose.
2747. § 182.1500 Monoammonium glutamate.
2748. § 182.1516 Monopotassium glutamate.
2749. § 182.1711 Silica aerogel.
2750. § 182.1745 Sodium carboxymethylcellulose.
2751. § 182.1748 Sodium caseinate.
2752. § 182.1778 Sodium phosphate.
2753. § 182.1781 Sodium aluminum phosphate.
2754. § 182.1810 Sodium tripolyphosphate.
2755. Subpart C Anticaking Agents
2756. § 182.2122 Aluminum calcium silicate.
2757. § 182.2227 Calcium silicate.
2758. § 182.2437 Magnesium silicate.
2759. § 182.2727 Sodium aluminosilicate.
2760. § 182.2729 Sodium calcium aluminosilicate, hydrated.
2761. § 182.2906 Tricalcium silicate.
2762. Subpart D Chemical Preservatives
2763. § 182.3013 Ascorbic acid.
2764. § 182.3041 Erythorbic acid.
2765. § 182.3089 Sorbic acid.
2766. § 182.3109 Thiodipropionic acid.
2767. § 182.3149 Ascorbyl palmitate.
2768. § 182.3169 Butylated hydroxyanisole.
2769. § 182.3173 Butylated hydroxytoluene.
2770. § 182.3189 Calcium ascorbate.
2771. § 182.3225 Calcium sorbate.
2772. § 182.3280 Dilauryl thiodipropionate.
2773. § 182.3616 Potassium bisulfite.
2774. § 182.3637 Potassium metabisulfite.
2775. § 182.3640 Potassium sorbate.
2776. § 182.3731 Sodium ascorbate.
2777. § 182.3739 Sodium bisulfite.
2778. § 182.3766 Sodium metabisulfite.
2779. § 182.3795 Sodium sorbate.
2780. § 182.3798 Sodium sulfite.
2781. § 182.3862 Sulfur dioxide.
2782. § 182.3890 Tocopherols.
2783. Subpart E Emulsifying Agents [Reserved]
2784. Subpart F Dietary Supplements [Reserved]
2785. Subpart G Sequestrants 1
2786. § 182.6085 Sodium acid phosphate.
2787. § 182.6197 Calcium diacetate.
2788. § 182.6203 Calcium hexametaphosphate.
2789. § 182.6215 Monobasic calcium phosphate.
2790. § 182.6285 Dipotassium phosphate.
2791. § 182.6290 Disodium phosphate.
2792. § 182.6757 Sodium gluconate.
2793. § 182.6760 Sodium hexametaphosphate.
2794. § 182.6769 Sodium metaphosphate.
2795. § 182.6778 Sodium phosphate.
2796. § 182.6787 Sodium pyrophosphate.
2797. § 182.6789 Tetra sodium pyrophosphate.
2798. § 182.6810 Sodium tripolyphosphate.
2799. Subpart H Stabilizers
2800. § 182.7255 Chondrus extract.
2801. Subpart I Nutrients
2802. § 182.8013 Ascorbic acid.
2803. § 182.8159 Biotin.
2804. § 182.8217 Calcium phosphate.
2805. § 182.8223 Calcium pyrophosphate.
2806. § 182.8250 Choline bitartrate.
2807. § 182.8252 Choline chloride.
2808. § 182.8778 Sodium phosphate.
2809. § 182.8890 Tocopherols.
2810. § 182.8892 α-Tocopherol acetate.
2811. § 182.8985 Zinc chloride.
2812. § 182.8988 Zinc gluconate.
2813. § 182.8991 Zinc oxide.
2814. § 182.8994 Zinc stearate.
2815. § 182.8997 Zinc sulfate.
2816. PART 184 DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
2817. Subpart A General Provisions
2818. § 184.1 Substances added directly to human food affirmed as generally recognized as safe (GRAS).
2819. Subpart B Listing of Specific Substances Affirmed as GRAS
2820. § 184.1005 Acetic acid.
2821. § 184.1007 Aconitic acid.
2822. § 184.1009 Adipic acid.
2823. § 184.1011 Alginic acid.
2824. § 184.1012 α-Amylase enzyme preparation from Bacillus stearothermophilus.
2825. § 184.1021 Benzoic acid.
2826. § 184.1024 Bromelain.
2827. § 184.1025 Caprylic acid.
2828. § 184.1027 Mixed carbohydrase and protease enzyme product.
2829. § 184.1033 Citric acid.
2830. § 184.1034 Catalase (bovine liver).
2831. § 184.1061 Lactic acid.
2832. § 184.1063 Enzyme-modified lecithin.
2833. § 184.1065 Linoleic acid.
2834. § 184.1069 Malic acid.
2835. § 184.1077 Potassium acid tartrate.
2836. § 184.1081 Propionic acid.
2837. § 184.1090 Stearic acid.
2838. § 184.1091 Succinic acid.
2839. § 184.1095 Sulfuric acid.
2840. § 184.1097 Tannic acid.
2841. § 184.1099 Tartaric acid.
2842. § 184.1101 Diacetyl tartaric acid esters of mono- and diglycerides.
2843. § 184.1115 Agar-agar.
2844. § 184.1120 Brown algae.
2845. § 184.1121 Red algae.
2846. § 184.1133 Ammonium alginate.
2847. § 184.1135 Ammonium bicarbonate.
2848. § 184.1137 Ammonium carbonate.
2849. § 184.1138 Ammonium chloride.
2850. § 184.1139 Ammonium hydroxide.
2851. § 184.1140 Ammonium citrate, dibasic.
2852. § 184.1141a Ammonium phosphate, monobasic.
2853. § 184.1141b Ammonium phosphate, dibasic.
2854. § 184.1143 Ammonium sulfate.
2855. § 184.1148 Bacterially-derived carbohydrase enzyme preparation.
2856. § 184.1150 Bacterially-derived protease enzyme preparation.
2857. § 184.1155 Bentonite.
2858. § 184.1157 Benzoyl peroxide.
2859. § 184.1165 n-Butane and iso-butane.
2860. § 184.1185 Calcium acetate.
2861. § 184.1187 Calcium alginate.
2862. § 184.1191 Calcium carbonate.
2863. § 184.1193 Calcium chloride.
2864. § 184.1195 Calcium citrate.
2865. § 184.1199 Calcium gluconate.
2866. § 184.1201 Calcium glycerophosphate.
2867. § 184.1205 Calcium hydroxide.
2868. § 184.1206 Calcium iodate.
2869. § 184.1207 Calcium lactate.
2870. § 184.1210 Calcium oxide.
2871. § 184.1212 Calcium pantothenate.
2872. § 184.1221 Calcium propionate.
2873. § 184.1229 Calcium stearate.
2874. § 184.1230 Calcium sulfate.
2875. § 184.1240 Carbon dioxide.
2876. § 184.1245 Beta-carotene.
2877. § 184.1250 Cellulase enzyme preparation derived from Trichoderma longibrachiatum.
2878. § 184.1257 Clove and its derivatives.
2879. § 184.1259 Cocoa butter substitute.
2880. § 184.1260 Copper gluconate.
2881. § 184.1261 Copper sulfate.
2882. § 184.1262 Corn silk and corn silk extract.
2883. § 184.1265 Cuprous iodide.
2884. § 184.1271 L-Cysteine.
2885. § 184.1272 L-Cysteine monohydrochloride.
2886. § 184.1277 Dextrin.
2887. § 184.1278 Diacetyl.
2888. § 184.1282 Dill and its derivatives.
2889. § 184.1287 Enzyme-modified fats.
2890. § 184.1293 Ethyl alcohol.
2891. § 184.1295 Ethyl formate.
2892. § 184.1296 Ferric ammonium citrate.
2893. § 184.1297 Ferric chloride.
2894. § 184.1298 Ferric citrate.
2895. § 184.1301 Ferric phosphate.
2896. § 184.1304 Ferric pyrophosphate.
2897. § 184.1307 Ferric sulfate.
2898. § 184.1307a Ferrous ascorbate.
2899. § 184.1307b Ferrous carbonate.
2900. § 184.1307c Ferrous citrate.
2901. § 184.1307d Ferrous fumarate.
2902. § 184.1308 Ferrous gluconate.
2903. § 184.1311 Ferrous lactate.
2904. § 184.1315 Ferrous sulfate.
2905. § 184.1316 Ficin.
2906. § 184.1317 Garlic and its derivatives.
2907. § 184.1318 Glucono delta-lactone.
2908. § 184.1321 Corn gluten.
2909. § 184.1322 Wheat gluten.
2910. § 184.1323 Glyceryl monooleate.
2911. § 184.1324 Glyceryl monostearate.
2912. § 184.1328 Glyceryl behenate.
2913. § 184.1329 Glyceryl palmitostearate.
2914. § 184.1330 Acacia (gum arabic).
2915. § 184.1333 Gum ghatti.
2916. § 184.1339 Guar gum.
2917. § 184.1343 Locust (carob) bean gum.
2918. § 184.1349 Karaya gum (sterculia gum).
2919. § 184.1351 Gum tragacanth.
2920. § 184.1355 Helium.
2921. § 184.1366 Hydrogen peroxide.
2922. § 184.1370 Inositol.
2923. § 184.1372 Insoluble glucose isomerase enzyme preparations.
2924. § 184.1375 Iron, elemental.
2925. § 184.1386 Isopropyl citrate.
2926. § 184.1387 Lactase enzyme preparation from Candida pseudotropicalis.
2927. § 184.1388 Lactase enzyme preparation from Kluyveromyces lactis.
2928. § 184.1400 Lecithin.
2929. § 184.1408 Licorice and licorice derivatives.
2930. § 184.1409 Ground limestone.
2931. § 184.1415 Animal lipase.
2932. § 184.1420 Lipase enzyme preparation derived from Rhizopus niveus.
2933. § 184.1425 Magnesium carbonate.
2934. § 184.1426 Magnesium chloride.
2935. § 184.1428 Magnesium hydroxide.
2936. § 184.1431 Magnesium oxide.
2937. § 184.1434 Magnesium phosphate.
2938. § 184.1440 Magnesium stearate.
2939. § 184.1443 Magnesium sulfate.
2940. § 184.1443a Malt.
2941. § 184.1444 Maltodextrin.
2942. § 184.1445 Malt syrup (malt extract).
2943. § 184.1446 Manganese chloride.
2944. § 184.1449 Manganese citrate.
2945. § 184.1452 Manganese gluconate.
2946. § 184.1461 Manganese sulfate.
2947. § 184.1472 Menhaden oil.
2948. § 184.1490 Methylparaben.
2949. § 184.1498 Microparticulated protein product.
2950. § 184.1505 Mono- and diglycerides.
2951. § 184.1521 Monosodium phosphate derivatives of mono- and diglycerides.
2952. § 184.1530 Niacin.
2953. § 184.1535 Niacinamide.
2954. § 184.1537 Nickel.
2955. § 184.1538 Nisin preparation.
2956. § 184.1540 Nitrogen.
2957. § 184.1545 Nitrous oxide.
2958. § 184.1553 Peptones.
2959. § 184.1555 Rapeseed oil.
2960. § 184.1560 Ox bile extract.
2961. § 184.1563 Ozone.
2962. § 184.1583 Pancreatin.
2963. § 184.1585 Papain.
2964. § 184.1588 Pectins.
2965. § 184.1595 Pepsin.
2966. § 184.1610 Potassium alginate.
2967. § 184.1613 Potassium bicarbonate.
2968. § 184.1619 Potassium carbonate.
2969. § 184.1622 Potassium chloride.
2970. § 184.1625 Potassium citrate.
2971. § 184.1631 Potassium hydroxide.
2972. § 184.1634 Potassium iodide.
2973. § 184.1635 Potassium iodate.
2974. § 184.1639 Potassium lactate.
2975. § 184.1643 Potassium sulfate.
2976. § 184.1655 Propane.
2977. § 184.1660 Propyl gallate.
2978. § 184.1666 Propylene glycol.
2979. § 184.1670 Propylparaben.
2980. § 184.1676 Pyridoxine hydrochloride.
2981. § 184.1685 Rennet (animal-derived) and chymosin preparation (fermentation-derived).
2982. § 184.1695 Riboflavin.
2983. § 184.1697 Riboflavin-5′-phosphate (sodium).
2984. § 184.1698 Rue.
2985. § 184.1699 Oil of rue.
2986. § 184.1702 Sheanut oil.
2987. § 184.1721 Sodium acetate.
2988. § 184.1724 Sodium alginate.
2989. § 184.1733 Sodium benzoate.
2990. § 184.1736 Sodium bicarbonate.
2991. § 184.1742 Sodium carbonate.
2992. § 184.1751 Sodium citrate.
2993. § 184.1754 Sodium diacetate.
2994. § 184.1763 Sodium hydroxide.
2995. § 184.1764 Sodium hypophosphite.
2996. § 184.1768 Sodium lactate.
2997. § 184.1769a Sodium metasilicate.
2998. § 184.1784 Sodium propionate.
2999. § 184.1792 Sodium sesquicarbonate.
3000. § 184.1801 Sodium tartrate.
3001. § 184.1804 Sodium potassium tartrate.
3002. § 184.1807 Sodium thiosulfate.
3003. § 184.1835 Sorbitol.
3004. § 184.1845 Stannous chloride (anhydrous and dihydrated).
3005. § 184.1848 Starter distillate.
3006. § 184.1851 Stearyl citrate.
3007. § 184.1854 Sucrose.
3008. § 184.1857 Corn sugar.
3009. § 184.1859 Invert sugar.
3010. § 184.1865 Corn syrup.
3011. § 184.1866 High fructose corn syrup.
3012. § 184.1875 Thiamine hydrochloride.
3013. § 184.1878 Thiamine mononitrate.
3014. § 184.1890 α-Tocopherols.
3015. § 184.1901 Triacetin.
3016. § 184.1903 Tributyrin.
3017. § 184.1911 Triethyl citrate.
3018. § 184.1914 Trypsin.
3019. § 184.1923 Urea.
3020. § 184.1924 Urease enzyme preparation from Lactobacillus fermentum.
3021. § 184.1930 Vitamin A.
3022. § 184.1945 Vitamin B12.
3023. § 184.1950 Vitamin D.
3024. § 184.1973 Beeswax (yellow and white).
3025. § 184.1976 Candelilla wax.
3026. § 184.1978 Carnauba wax.
3027. § 184.1979 Whey.
3028. § 184.1979a Reduced lactose whey.
3029. § 184.1979b Reduced minerals whey.
3030. § 184.1979c Whey protein concentrate.
3031. § 184.1983 Bakers yeast extract.
3032. § 184.1984 Zein.
3033. § 184.1985 Aminopeptidase enzyme preparation derived from lactococcus lactis.
3034. PART 186 INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
3035. Subpart A General Provisions
3036. § 186.1 Substances added indirectly to human food affirmed as generally recognized as safe (GRAS).
3037. Subpart B Listing of Specific Substances Affirmed as GRAS
3038. § 186.1093 Sulfamic acid.
3039. § 186.1256 Clay (kaolin).
3040. § 186.1275 Dextrans.
3041. § 186.1300 Ferric oxide.
3042. § 186.1316 Formic acid.
3043. § 186.1374 Iron oxides.
3044. § 186.1555 Japan wax.
3045. § 186.1557 Tall oil.
3046. § 186.1673 Pulp.
3047. § 186.1750 Sodium chlorite.
3048. § 186.1756 Sodium formate.
3049. § 186.1770 Sodium oleate.
3050. § 186.1771 Sodium palmitate.
3051. § 186.1797 Sodium sulfate.
3052. § 186.1839 Sorbose.
3053. PART 189 SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
3054. Subpart A General Provisions
3055. § 189.1 Substances prohibited from use in human food.
3056. Subpart B Prohibited Cattle Materials
3057. § 189.5 Prohibited cattle materials.
3058. Subpart C Substances Generally Prohibited From Direct Addition or Use as Human Food
3059. § 189.110 Calamus and its derivatives.
3060. § 189.113 Cinnamyl anthranilate.
3061. § 189.120 Cobaltous salts and its derivatives.
3062. § 189.130 Coumarin.
3063. § 189.135 Cyclamate and its derivatives.
3064. § 189.140 Diethylpyrocarbonate (DEPC).
3065. § 189.145 Dulcin.
3066. § 189.155 Monochloroacetic acid.
3067. § 189.165 Nordihydroguaiaretic acid (NDGA).
3068. § 189.175 P-4000.
3069. § 189.180 Safrole.
3070. § 189.190 Thiourea.
3071. § 189.191 Chlorofluorocarbon propellants.
3072. Subpart D Substances Prohibited From Indirect Addition to Human Food Through Food-Contact Surfaces
3073. § 189.220 Flectol H.
3074. § 189.240 Lead solders.
3075. § 189.250 Mercaptoimidazoline and 2-mercaptoimidazoline.
3076. § 189.280 4,4′-Methylenebis (2-chloroanaline).
3077. § 189.300 Hydrogenated 4,4′-isopropylidene-diphenolphosphite ester resins.
3078. § 189.301 Tin-coated lead foil capsules for wine bottles.
3079. PART 190 DIETARY SUPPLEMENTS
3080. A Subpart A [Reserved]
3081. Subpart B New Dietary Ingredient Notification
3082. § 190.6 Requirement for premarket notification.
3083. 191-199 PARTS 191-199 [RESERVED]
3084. CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
3085. SUBCHAPTER C DRUGS: GENERAL
3086. PART 200 GENERAL
3087. Subpart A General Provisions
3088. § 200.5 Mailing of important information about drugs.
3089. § 200.7 Supplying pharmacists with indications and dosage information.
3090. § 200.10 Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers.
3091. § 200.11 Use of octadecylamine in steam lines of drug establishments.
3092. § 200.15 Definition of term “insulin.”
3093. B Subpart B [Reserved]
3094. Subpart C Requirements for Specific Classes of Drugs
3095. § 200.50 Ophthalmic preparations and dispensers.
3096. § 200.51 Aqueous-based drug products for oral inhalation.
3097. D Subpart D [Reserved]
3098. Subpart E Prescription Drug Consumer Price Listing
3099. § 200.200 Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers.
3100. PART 201 LABELING
3101. Subpart A General Labeling Provisions
3102. § 201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
3103. § 201.2 Drugs and devices; National Drug Code numbers.
3104. § 201.5 Drugs; adequate directions for use.
3105. § 201.6 Drugs; misleading statements.
3106. § 201.10 Drugs; statement of ingredients.
3107. § 201.15 Drugs; prominence of required label statements.
3108. § 201.16 Drugs; Spanish-language version of certain required statements.
3109. § 201.17 Drugs; location of expiration date.
3110. § 201.18 Drugs; significance of control numbers.
3111. § 201.19 Drugs; use of term “infant”.
3112. § 201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
3113. § 201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
3114. § 201.22 Prescription drugs containing sulfites; required warning statements.
3115. § 201.23 Required pediatric studies.
3116. § 201.24 Labeling for systemic antibacterial drug products.
3117. § 201.25 Bar code label requirements.
3118. § 201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.
3119. Subpart B Labeling Requirements for Prescription Drugs and/or Insulin
3120. § 201.50 Statement of identity.
3121. § 201.51 Declaration of net quantity of contents.
3122. § 201.55 Statement of dosage.
3123. § 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
3124. § 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1).
3125. § 201.58 Waiver of labeling requirements.
3126. Subpart C Labeling Requirements for Over-the-Counter Drugs
3127. § 201.60 Principal display panel.
3128. § 201.61 Statement of identity.
3129. § 201.62 Declaration of net quantity of contents.
3130. § 201.63 Pregnancy/breast-feeding warning.
3131. § 201.64 Sodium labeling.
3132. § 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
3133. § 201.67 Labeling requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU).
3134. § 201.70 Calcium labeling.
3135. § 201.71 Magnesium labeling.
3136. § 201.72 Potassium labeling.
3137. § 201.80 Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1).
3138. Subpart D Exemptions From Adequate Directions for Use
3139. § 201.100 Prescription drugs for human use.
3140. § 201.105 Veterinary drugs.
3141. § 201.115 New drugs or new animal drugs.
3142. § 201.116 Drugs having commonly known directions.
3143. § 201.117 Inactive ingredients.
3144. § 201.119 In vitro diagnostic products.
3145. § 201.120 Prescription chemicals and other prescription components.
3146. § 201.122 Drugs for processing, repacking, or manufacturing.
3147. § 201.125 Drugs for use in teaching, law enforcement, research, and analysis.
3148. § 201.127 Drugs; expiration of exemptions.
3149. § 201.128 Meaning of “intended uses”.
3150. § 201.129 Drugs; exemption for radioactive drugs for research use.
3151. § 201.130 Exemption from adequate directions for use for a nonprescription drug product with an additional condition for nonprescription use (ACNU).
3152. Subpart E Other Exemptions
3153. § 201.150 Drugs; processing, labeling, or repacking.
3154. § 201.161 Medical gases.
3155. Subpart F Labeling Claims for Drugs in Drug Efficacy Study
3156. § 201.200 Disclosure of drug efficacy study evaluations in labeling and advertising.
3157. Subpart G Specific Labeling Requirements for Specific Drug Products
3158. § 201.300 Notice to manufacturers, packers, and distributors of glandular preparations.
3159. § 201.301 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
3160. § 201.302 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
3161. § 201.303 Labeling of drug preparations containing significant proportions of wintergreen oil.
3162. § 201.304 Tannic acid and barium enema preparations.
3163. § 201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
3164. § 201.306 Potassium salt preparations intended for oral ingestion by man.
3165. § 201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
3166. § 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale.
3167. § 201.309 Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
3168. § 201.310 Phenindione; labeling of drug preparations intended for use by man.
3169. § 201.311 [Reserved]
3170. § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products.
3171. § 201.313 Estradiol labeling.
3172. § 201.314 Labeling of drug preparations containing salicylates.
3173. § 201.315 Over-the-counter drugs for minor sore throats; suggested warning.
3174. § 201.316 Drugs with thyroid hormone activity for human use; required warning.
3175. § 201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
3176. § 201.319 Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil tragacanth, and xanthan gum) as active ingredients; required warnings and directions.
3177. § 201.320 Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
3178. § 201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition.
3179. § 201.325 Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.
3180. § 201.326 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.
3181. § 201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
3182. § 201.328 Labeling of medical gas containers.
3183. Appendix A to Part 201 Examples of Graphic Enhancements Used by FDA
3184. PART 202 PRESCRIPTION DRUG ADVERTISING
3185. § 202.1 Prescription-drug advertisements.
3186. PART 203 PRESCRIPTION DRUG MARKETING
3187. Subpart A General Provisions
3188. § 203.1 Scope.
3189. § 203.2 Purpose.
3190. § 203.3 Definitions.
3191. Subpart B Reimportation
3192. § 203.10 Restrictions on reimportation.
3193. § 203.11 Applications for reimportation to provide emergency medical care.
3194. § 203.12 An appeal from an adverse decision by the district office.
3195. Subpart C Sales Restrictions
3196. § 203.20 Sales restrictions.
3197. § 203.22 Exclusions.
3198. § 203.23 Returns.
3199. Subpart D Samples
3200. § 203.30 Sample distribution by mail or common carrier.
3201. § 203.31 Sample distribution by means other than mail or common carrier (direct delivery by a representative or detailer).
3202. § 203.32 Drug sample storage and handling requirements.
3203. § 203.33 Drug sample forms.
3204. § 203.34 Policies and procedures; administrative systems.
3205. § 203.35 Standing requests.
3206. § 203.36 Fulfillment houses, shipping and mailing services, comarketing agreements, and third-party recordkeeping.
3207. § 203.37 Investigation and notification requirements.
3208. § 203.38 Sample lot or control numbers; labeling of sample units.
3209. § 203.39 Donation of drug samples to charitable institutions.
3210. Subpart E Wholesale Distribution
3211. § 203.50 Requirements for wholesale distribution of prescription drugs.
3212. Subpart F Request and Receipt Forms, Reports, and Records
3213. § 203.60 Request and receipt forms, reports, and records.
3214. Subpart G Rewards
3215. § 203.70 Application for a reward.
3216. PART 205 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS
3217. § 205.1 Scope.
3218. § 205.2 Purpose.
3219. § 205.3 Definitions.
3220. § 205.4 Wholesale drug distributor licensing requirement.
3221. § 205.5 Minimum required information for licensure.
3222. § 205.6 Minimum qualifications.
3223. § 205.7 Personnel.
3224. § 205.8 Violations and penalties.
3225. § 205.50 Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.
3226. PART 206 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE
3227. § 206.1 Scope.
3228. § 206.3 Definitions.
3229. § 206.7 Exemptions.
3230. § 206.10 Code imprint required.
3231. PART 207 REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, AND THE NATIONAL DRUG CODE
3232. Subpart A General
3233. § 207.1 What definitions and interpretations of terms apply to this part?
3234. § 207.3 Bulk drug substance.
3235. § 207.5 What is the purpose of this part?
3236. § 207.9 Who does this part cover?
3237. § 207.13 Who is exempt from the registration and listing requirements?
3238. Subpart B Registration
3239. § 207.17 Who must register?
3240. § 207.21 When must initial registration information be provided?
3241. § 207.25 What information is required for registration?
3242. § 207.29 What are the requirements for reviewing and updating registration information?
3243. Subpart C National Drug Code
3244. § 207.33 What is the National Drug Code (NDC), how is it assigned, and what are its requirements?
3245. § 207.35 What changes require a new NDC?
3246. § 207.37 What restrictions pertain to the use of the NDC?
3247. Subpart D Listing
3248. § 207.41 Who must list drugs and what drugs must they list?
3249. § 207.45 When, after initial registration of an establishment, must drug listing information be submitted?
3250. § 207.49 What listing information must a registrant submit for a drug it manufactures?
3251. § 207.53 What listing information must a registrant submit for a drug that it repacks or relabels?
3252. § 207.54 What listing information must a registrant submit for a drug that it salvages?
3253. § 207.55 What additional drug listing information may FDA require?
3254. § 207.57 What information must registrants submit when updating listing information and when?
3255. Subpart E Electronic Format for Registration and Listing
3256. § 207.61 How is registration and listing information provided to FDA?
3257. § 207.65 How can a waiver of the electronic submission requirement be obtained?
3258. Subpart F Miscellaneous
3259. § 207.69 What are the requirements for an official contact and a United States agent?
3260. § 207.77 What legal status is conferred by registration and listing?
3261. § 207.81 What registration and listing information will FDA make available for public disclosure?
3262. PART 208 MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
3263. Subpart A General Provisions
3264. § 208.1 Scope and purpose.
3265. § 208.3 Definitions.
3266. Subpart B General Requirements for a Medication Guide
3267. § 208.20 Content and format of a Medication Guide.
3268. § 208.24 Distributing and dispensing a Medication Guide.
3269. § 208.26 Exemptions and deferrals.
3270. PART 209 REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT
3271. Subpart A General Provisions
3272. § 209.1 Scope and purpose.
3273. § 209.2 Definitions.
3274. Subpart B Requirements
3275. § 209.10 Content and format of the side effects statement.
3276. § 209.11 Dispensing and distributing the side effects statement.
3277. PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
3278. § 210.1 Status of current good manufacturing practice regulations.
3279. § 210.2 Applicability of current good manufacturing practice regulations.
3280. § 210.3 Definitions.
3281. PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
3282. Subpart A General Provisions
3283. § 211.1 Scope.
3284. § 211.3 Definitions.
3285. Subpart B Organization and Personnel
3286. § 211.22 Responsibilities of quality control unit.
3287. § 211.25 Personnel qualifications.
3288. § 211.28 Personnel responsibilities.
3289. § 211.34 Consultants.
3290. Subpart C Buildings and Facilities
3291. § 211.42 Design and construction features.
3292. § 211.44 Lighting.
3293. § 211.46 Ventilation, air filtration, air heating and cooling.
3294. § 211.48 Plumbing.
3295. § 211.50 Sewage and refuse.
3296. § 211.52 Washing and toilet facilities.
3297. § 211.56 Sanitation.
3298. § 211.58 Maintenance.
3299. Subpart D Equipment
3300. § 211.63 Equipment design, size, and location.
3301. § 211.65 Equipment construction.
3302. § 211.67 Equipment cleaning and maintenance.
3303. § 211.68 Automatic, mechanical, and electronic equipment.
3304. § 211.72 Filters.
3305. Subpart E Control of Components and Drug Product Containers and Closures
3306. § 211.80 General requirements.
3307. § 211.82 Receipt and storage of untested components, drug product containers, and closures.
3308. § 211.84 Testing and approval or rejection of components, drug product containers, and closures.
3309. § 211.86 Use of approved components, drug product containers, and closures.
3310. § 211.87 Retesting of approved components, drug product containers, and closures.
3311. § 211.89 Rejected components, drug product containers, and closures.
3312. § 211.94 Drug product containers and closures.
3313. Subpart F Production and Process Controls
3314. § 211.100 Written procedures; deviations.
3315. § 211.101 Charge-in of components.
3316. § 211.103 Calculation of yield.
3317. § 211.105 Equipment identification.
3318. § 211.110 Sampling and testing of in-process materials and drug products.
3319. § 211.111 Time limitations on production.
3320. § 211.113 Control of microbiological contamination.
3321. § 211.115 Reprocessing.
3322. Subpart G Packaging and Labeling Control
3323. § 211.122 Materials examination and usage criteria.
3324. § 211.125 Labeling issuance.
3325. § 211.130 Packaging and labeling operations.
3326. § 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
3327. § 211.134 Drug product inspection.
3328. § 211.137 Expiration dating.
3329. Subpart H Holding and Distribution
3330. § 211.142 Warehousing procedures.
3331. § 211.150 Distribution procedures.
3332. Subpart I Laboratory Controls
3333. § 211.160 General requirements.
3334. § 211.165 Testing and release for distribution.
3335. § 211.166 Stability testing.
3336. § 211.167 Special testing requirements.
3337. § 211.170 Reserve samples.
3338. § 211.173 Laboratory animals.
3339. § 211.176 Penicillin contamination.
3340. Subpart J Records and Reports
3341. § 211.180 General requirements.
3342. § 211.182 Equipment cleaning and use log.
3343. § 211.184 Component, drug product container, closure, and labeling records.
3344. § 211.186 Master production and control records.
3345. § 211.188 Batch production and control records.
3346. § 211.192 Production record review.
3347. § 211.194 Laboratory records.
3348. § 211.196 Distribution records.
3349. § 211.198 Complaint files.
3350. Subpart K Returned and Salvaged Drug Products
3351. § 211.204 Returned drug products.
3352. § 211.208 Drug product salvaging.
3353. PART 212 CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
3354. Subpart A General Provisions
3355. § 212.1 What are the meanings of the technical terms used in these regulations?
3356. § 212.2 What is current good manufacturing practice for PET drugs?
3357. § 212.5 To what drugs do the regulations in this part apply?
3358. Subpart B Personnel and Resources
3359. § 212.10 What personnel and resources must I have?
3360. Subpart C Quality Assurance
3361. § 212.20 What activities must I perform to ensure drug quality?
3362. Subpart D Facilities and Equipment
3363. § 212.30 What requirements must my facilities and equipment meet?
3364. Subpart E Control of Components, Containers, and Closures
3365. § 212.40 How must I control the components I use to produce PET drugs and the containers and closures I package them in?
3366. Subpart F Production and Process Controls
3367. § 212.50 What production and process controls must I have?
3368. Subpart G Laboratory Controls
3369. § 212.60 What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?
3370. § 212.61 What must I do to ensure the stability of my PET drug products through expiry?
3371. Subpart H Finished Drug Product Controls and Acceptance
3372. § 212.70 What controls and acceptance criteria must I have for my finished PET drug products?
3373. § 212.71 What actions must I take if a batch of PET drug product does not conform to specifications?
3374. Subpart I Packaging and Labeling
3375. § 212.80 What are the requirements associated with labeling and packaging PET drug products?
3376. Subpart J Distribution
3377. § 212.90 What actions must I take to control the distribution of PET drug products?
3378. Subpart K Complaint Handling
3379. § 212.100 What do I do if I receive a complaint about a PET drug product produced at my facility?
3380. Subpart L Records
3381. § 212.110 How must I maintain records of my production of PET drugs?
3382. PART 213 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES
3383. Subpart A General Provisions
3384. § 213.1 Scope.
3385. § 213.3 Definitions.
3386. Subpart B Organization and Personnel
3387. § 213.22 Responsibilities of quality unit.
3388. § 213.25 Personnel qualifications and responsibilities.
3389. § 213.34 Consultants.
3390. Subpart C Buildings and Facilities
3391. § 213.42 Design and construction features.
3392. Subpart D Equipment
3393. § 213.63 Equipment design, size, and location.
3394. § 213.65 Equipment construction.
3395. § 213.67 Equipment maintenance and cleaning.
3396. § 213.68 Automatic, mechanical, and electronic equipment.
3397. Subpart E Control of Incoming Designated Medical Gas, Components, and Medical Gas Containers and Closures
3398. § 213.80 General requirements.
3399. § 213.82 Receipt and storage of incoming designated medical gases.
3400. § 213.84 Testing and approval or rejection of components, containers, and closures.
3401. § 213.89 Rejected components, incoming designated medical gases, and medical gas containers and closures.
3402. § 213.94 Medical gas containers and closures.
3403. Subpart F Production and Process Controls
3404. § 213.100 Written procedures; deviations.
3405. § 213.101 Charge-in of components and incoming designated medical gases.
3406. § 213.110 Sampling and testing of in-process materials.
3407. Subpart G Packaging and Labeling Control
3408. § 213.122 Materials examination and usage criteria.
3409. § 213.125 Labeling issuance.
3410. § 213.130 Packaging and labeling operations.
3411. Subpart H Holding and Distribution
3412. § 213.150 Warehousing and distribution procedures.
3413. Subpart I Laboratory Controls
3414. § 213.160 General requirements.
3415. § 213.165 Testing and release for distribution.
3416. § 213.166 Stability testing and expiration dating for medical gases marketed under applications submitted under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act.
3417. Subpart J Records
3418. § 213.180 General requirements.
3419. § 213.182 Equipment cleaning and use log.
3420. § 213.184 Records for components, medical gas containers and closures, and labeling.
3421. § 213.186 Master production and control records.
3422. § 213.189 Batch production and control records.
3423. § 213.192 Production record review.
3424. § 213.194 Laboratory records.
3425. § 213.196 Distribution records.
3426. § 213.198 Complaint files.
3427. Subpart K Returned and Salvaged Medical Gases
3428. § 213.204 Returned medical gases.
3429. § 213.208 Salvaging of medical gases.
3430. PART 216 HUMAN DRUG COMPOUNDING
3431. Subpart A General Provisions [Reserved]
3432. Subpart B Compounded Drug Products
3433. § 216.23 Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act.
3434. § 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.
3435. PART 225 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
3436. Subpart A General Provisions
3437. § 225.1 Current good manufacturing practice.
3438. § 225.10 Personnel.
3439. Subpart B Construction and Maintenance of Facilities and Equipment
3440. § 225.20 Buildings.
3441. § 225.30 Equipment.
3442. § 225.35 Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.
3443. Subpart C Product Quality Control
3444. § 225.42 Components.
3445. § 225.58 Laboratory controls.
3446. § 225.65 Equipment cleanout procedures.
3447. Subpart D Packaging and Labeling
3448. § 225.80 Labeling.
3449. Subpart E Records and Reports
3450. § 225.102 Master record file and production records.
3451. § 225.110 Distribution records.
3452. § 225.115 Complaint files.
3453. Subpart F Facilities and Equipment
3454. § 225.120 Buildings and grounds.
3455. § 225.130 Equipment.
3456. § 225.135 Work and storage areas.
3457. Subpart G Product Quality Assurance
3458. § 225.142 Components.
3459. § 225.158 Laboratory assays.
3460. § 225.165 Equipment cleanout procedures.
3461. Subpart H Labeling
3462. § 225.180 Labeling.
3463. Subpart I Records
3464. § 225.202 Formula, production, and distribution records.
3465. PART 226 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
3466. Subpart A General Provisions
3467. § 226.1 Current good manufacturing practice.
3468. § 226.10 Personnel.
3469. Subpart B Construction and Maintenance of Facilities and Equipment
3470. § 226.20 Buildings.
3471. § 226.30 Equipment.
3472. Subpart C Product Quality Control
3473. § 226.40 Production and control procedures.
3474. § 226.42 Components.
3475. § 226.58 Laboratory controls.
3476. Subpart D Packaging and Labeling
3477. § 226.80 Packaging and labeling.
3478. Subpart E Records and Reports
3479. § 226.102 Master-formula and batch-production records.
3480. § 226.110 Distribution records.
3481. § 226.115 Complaint files.
3482. PART 230 CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES
3483. Subpart A General Provisions
3484. § 230.1 Scope of this part.
3485. § 230.2 Purpose.
3486. § 230.3 Definitions.
3487. Subpart B Certification of Designated Medical Gases
3488. § 230.50 General requirements for all submission types.
3489. § 230.65 Withdrawal by the applicant of a certification request before it is deemed granted.
3490. § 230.70 Supplements and other changes to a granted certification.
3491. § 230.72 Change in ownership of a granted certification.
3492. § 230.80 Annual report.
3493. § 230.100 FDA review of submissions.
3494. § 230.105 When a submission is deemed granted.
3495. § 230.150 Withdrawal or revocation of approval of an application.
3496. Subpart C Postmarketing Quality and Safety Reporting
3497. § 230.205 Field alert reports.
3498. § 230.210 General reporting requirements for designated medical gas adverse events.
3499. § 230.220 Human designated medical gas ICSR requirements.
3500. § 230.230 Animal designated medical gas adverse event reporting requirements.
3501. PART 250 SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
3502. Subpart A Drugs Regarded as Misbranded
3503. § 250.11 Thyroid-containing drug preparations intended for treatment of obesity in humans.
3504. § 250.12 Stramonium preparations labeled with directions for use in self-medication regarded as misbranded.
3505. Subpart B New Drug or Prescription Status of Specific Drugs
3506. § 250.100 Amyl nitrite inhalant as a prescription drug for human use.
3507. § 250.101 Amphetamine and methamphetamine inhalers regarded as prescription drugs.
3508. § 250.102 Drug preparations intended for human use containing certain “coronary vasodilators”.
3509. §§ 250.103-250.104 [Reserved]
3510. § 250.105 Gelsemium-containing preparations regarded as prescription drugs.
3511. §§ 250.106-250.107 [Reserved]
3512. § 250.108 Potassium permanganate preparations as prescription drugs.
3513. Subpart C Requirements for Drugs and Foods
3514. § 250.201 Preparations for the treatment of pernicious anemia.
3515. Subpart D Requirements for Drugs and Cosmetics
3516. § 250.250 Hexachlorophene, as a component of drug and cosmetic products.
3517. PART 251 SECTION 804 IMPORTATION PROGRAM
3518. Subpart A General Provisions
3519. § 251.1 Scope of the part.
3520. § 251.2 Definitions.
3521. Subpart B Section 804 Importation Program Proposals and Pre-Import Requests
3522. § 251.3 SIP proposal submission requirements.
3523. § 251.4 Review and authorization of importation program proposals.
3524. § 251.5 Pre-Import Request.
3525. § 251.6 Termination of authorized importation programs.
3526. § 251.7 Suspension and revocation of authorized importation programs.
3527. § 251.8 Modification or extension of authorized importation programs.
3528. Subpart C Certain Requirements for Section 804 Importation Programs
3529. § 251.9 Registration of Foreign Sellers.
3530. § 251.10 Reviewing and updating registration information for Foreign Sellers.
3531. § 251.11 Official contact and U.S. agent for Foreign Sellers.
3532. § 251.12 Importer responsibilities.
3533. § 251.13 Labeling of eligible prescription drugs.
3534. § 251.14 Supply chain security requirements for eligible prescription drugs.
3535. § 251.15 Qualifying laboratory requirements.
3536. § 251.16 Laboratory testing requirements.
3537. § 251.17 Importation requirements.
3538. § 251.18 Post-importation requirements.
3539. § 251.19 Reports to FDA.
3540. § 251.20 Severability.
3541. § 251.21 Consequences for violations.
3542. PART 290 CONTROLLED DRUGS
3543. Subpart A General Provisions
3544. § 290.1 Controlled substances.
3545. § 290.2 Exemption from prescription requirements.
3546. § 290.5 Drugs; statement of required warning.
3547. § 290.6 Spanish-language version of required warning.
3548. § 290.10 Definition of emergency situation.
3549. B Subpart B [Reserved]
3550. Subpart C Requirements for Specific Controlled Drugs [Reserved]
3551. PART 299 DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
3552. Subpart A General Provisions
3553. § 299.3 Definitions and interpretations.
3554. § 299.4 Established names for drugs.
3555. § 299.5 Drugs; compendial name.
3556. CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
3557. SUBCHAPTER D DRUGS FOR HUMAN USE
3558. PART 300 GENERAL
3559. A Subpart A [Reserved]
3560. Subpart B Combination Drugs
3561. § 300.50 Fixed-combination prescription drugs for humans.
3562. Subpart C Substances Generally Prohibited From Drugs
3563. § 300.100 Chlorofluorocarbon propellants.
3564. Subpart D Annual Summary Reporting Requirements.
3565. § 300.200 Annual summary requirements under the Right to Try Act.
3566. PART 310 NEW DRUGS
3567. Subpart A General Provisions
3568. § 310.3 Definitions and interpretations.
3569. § 310.4 Biologics; products subject to license control.
3570. § 310.6 Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products.
3571. Subpart B Specific Administrative Rulings and Decisions
3572. § 310.100 New drug status opinions; statement of policy.
3573. § 310.103 New drug substances intended for hypersensitivity testing.
3574. Subpart C New Drugs Exempted From Prescription-Dispensing Requirements
3575. § 310.200 Prescription-exemption procedure.
3576. § 310.201 Exemption for certain drugs limited by new-drug applications to prescription sale.
3577. Subpart D Records and Reports
3578. § 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
3579. § 310.306 Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.
3580. Subpart E Requirements for Specific New Drugs or Devices
3581. § 310.501 Patient package inserts for oral contraceptives.
3582. § 310.502 Certain drugs accorded new drug status through rulemaking procedures.
3583. § 310.503 Requirements regarding certain radioactive drugs.
3584. § 310.509 Parenteral drug products in plastic containers.
3585. § 310.515 Patient package inserts for estrogens.
3586. § 310.517 Labeling for oral hypoglycemic drugs of the sulfonylurea class.
3587. § 310.518 Drug products containing iron or iron salts.
3588. § 310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives.
3589. § 310.527 Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.
3590. § 310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
3591. § 310.529 Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
3592. § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
3593. § 310.531 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
3594. § 310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
3595. § 310.533 Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.
3596. § 310.534 Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
3597. § 310.536 Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.
3598. § 310.537 Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.
3599. § 310.538 Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
3600. § 310.540 Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
3601. § 310.541 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.
3602. § 310.542 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
3603. § 310.543 Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
3604. § 310.544 Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
3605. § 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
3606. § 310.546 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.
3607. § 310.547 Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
3608. § 310.548 Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.
3609. PART 312 INVESTIGATIONAL NEW DRUG APPLICATION
3610. Subpart A General Provisions
3611. § 312.1 Scope.
3612. § 312.2 Applicability.
3613. § 312.3 Definitions and interpretations.
3614. § 312.6 Labeling of an investigational new drug.
3615. § 312.7 Promotion of investigational drugs.
3616. § 312.8 Charging for investigational drugs under an IND.
3617. § 312.10 Waivers.
3618. Subpart B Investigational New Drug Application (IND)
3619. § 312.20 Requirement for an IND.
3620. § 312.21 Phases of an investigation.
3621. § 312.22 General principles of the IND submission.
3622. § 312.23 IND content and format.
3623. § 312.30 Protocol amendments.
3624. § 312.31 Information amendments.
3625. § 312.32 IND safety reporting.
3626. § 312.33 Annual reports.
3627. § 312.38 Withdrawal of an IND.
3628. Subpart C Administrative Actions
3629. § 312.40 General requirements for use of an investigational new drug in a clinical investigation.
3630. § 312.41 Comment and advice on an IND.
3631. § 312.42 Clinical holds and requests for modification.
3632. § 312.44 Termination.
3633. § 312.45 Inactive status.
3634. § 312.47 Meetings.
3635. § 312.48 Dispute resolution.
3636. Subpart D Responsibilities of Sponsors and Investigators
3637. § 312.50 General responsibilities of sponsors.
3638. § 312.52 Transfer of obligations to a contract research organization.
3639. § 312.53 Selecting investigators and monitors.
3640. § 312.54 Emergency research under § 50.24 of this chapter.
3641. § 312.55 Informing investigators.
3642. § 312.56 Review of ongoing investigations.
3643. § 312.57 Recordkeeping and record retention.
3644. § 312.58 Inspection of sponsor's records and reports.
3645. § 312.59 Disposition of unused supply of investigational drug.
3646. § 312.60 General responsibilities of investigators.
3647. § 312.61 Control of the investigational drug.
3648. § 312.62 Investigator recordkeeping and record retention.
3649. § 312.64 Investigator reports.
3650. § 312.66 Assurance of IRB review.
3651. § 312.68 Inspection of investigator's records and reports.
3652. § 312.69 Handling of controlled substances.
3653. § 312.70 Disqualification of a clinical investigator.
3654. Subpart E Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
3655. § 312.80 Purpose.
3656. § 312.81 Scope.
3657. § 312.82 Early consultation.
3658. § 312.83 Treatment protocols.
3659. § 312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
3660. § 312.85 Phase 4 studies.
3661. § 312.86 Focused FDA regulatory research.
3662. § 312.87 Active monitoring of conduct and evaluation of clinical trials.
3663. § 312.88 Safeguards for patient safety.
3664. Subpart F Miscellaneous
3665. § 312.110 Import and export requirements.
3666. § 312.120 Foreign clinical studies not conducted under an IND.
3667. § 312.130 Availability for public disclosure of data and information in an IND.
3668. § 312.140 Address for correspondence.
3669. § 312.145 Guidance documents.
3670. Subpart G Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
3671. § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests.
3672. H Subpart H [Reserved]
3673. Subpart I Expanded Access to Investigational Drugs for Treatment Use
3674. § 312.300 General.
3675. § 312.305 Requirements for all expanded access uses.
3676. § 312.310 Individual patients, including for emergency use.
3677. § 312.315 Intermediate-size patient populations.
3678. § 312.320 Treatment IND or treatment protocol.
3679. PART 314 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
3680. Subpart A General Provisions
3681. § 314.1 Scope of this part.
3682. § 314.2 Purpose.
3683. § 314.3 Definitions.
3684. Subpart B Applications
3685. § 314.50 Content and format of an NDA.
3686. § 314.52 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
3687. § 314.53 Submission of patent information.
3688. § 314.54 Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug.
3689. § 314.55 Pediatric use information.
3690. § 314.56 Nonprescription drug product with an additional condition for nonprescription use (ACNU).
3691. § 314.60 Amendments to an unapproved NDA, supplement, or resubmission.
3692. § 314.65 Withdrawal by the applicant of an unapproved application.
3693. § 314.70 Supplements and other changes to an approved NDA.
3694. § 314.71 Procedures for submission of a supplement to an approved application.
3695. § 314.72 Change in ownership of an application.
3696. § 314.80 Postmarketing reporting of adverse drug experiences.
3697. § 314.81 Other postmarketing reports.
3698. § 314.90 Waivers.
3699. Subpart C Abbreviated Applications
3700. § 314.92 Drug products for which abbreviated applications may be submitted.
3701. § 314.93 Petition to request a change from a listed drug.
3702. § 314.94 Content and format of an ANDA.
3703. § 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
3704. § 314.96 Amendments to an unapproved ANDA.
3705. § 314.97 Supplements and other changes to an approved ANDA.
3706. § 314.98 Postmarketing reports.
3707. § 314.99 Other responsibilities of an applicant of an ANDA.
3708. Subpart D FDA Action on Applications and Abbreviated Applications
3709. § 314.100 Timeframes for reviewing applications and abbreviated applications.
3710. § 314.101 Filing an NDA and receiving an ANDA.
3711. § 314.102 Communications between FDA and applicants.
3712. § 314.103 Dispute resolution.
3713. § 314.104 Drugs with potential for abuse.
3714. § 314.105 Approval of an NDA and an ANDA.
3715. § 314.106 Foreign data.
3716. § 314.107 Date of approval of a 505(b)(2) application or ANDA.
3717. § 314.108 New drug product exclusivity.
3718. § 314.110 Complete response letter to the applicant.
3719. § 314.120 [Reserved]
3720. § 314.122 Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed.
3721. § 314.125 Refusal to approve an NDA.
3722. § 314.126 Adequate and well-controlled studies.
3723. § 314.127 Refusal to approve an ANDA.
3724. § 314.150 Withdrawal of approval of an application or abbreviated application.
3725. § 314.151 Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
3726. § 314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug.
3727. § 314.153 Suspension of approval of an abbreviated new drug application.
3728. § 314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
3729. § 314.161 Determination of reasons for voluntary withdrawal of a listed drug.
3730. § 314.162 Removal of a drug product from the list.
3731. § 314.170 Adulteration and misbranding of an approved drug.
3732. Subpart E Hearing Procedures for New Drugs
3733. § 314.200 Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.
3734. § 314.201 Procedure for hearings.
3735. § 314.235 Judicial review.
3736. F Subpart F [Reserved]
3737. Subpart G Miscellaneous Provisions
3738. § 314.410 Imports and exports of new drugs.
3739. § 314.420 Drug master files.
3740. § 314.430 Availability for public disclosure of data and information in an application or abbreviated application.
3741. § 314.440 Addresses for applications and abbreviated applications.
3742. § 314.445 Guidance documents.
3743. Subpart H Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
3744. § 314.500 Scope.
3745. § 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
3746. § 314.520 Approval with restrictions to assure safe use.
3747. § 314.530 Withdrawal procedures.
3748. § 314.540 Postmarketing safety reporting.
3749. § 314.550 Promotional materials.
3750. § 314.560 Termination of requirements.
3751. Subpart I Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
3752. § 314.600 Scope.
3753. § 314.610 Approval based on evidence of effectiveness from studies in animals.
3754. § 314.620 Withdrawal procedures.
3755. § 314.630 Postmarketing safety reporting.
3756. § 314.640 Promotional materials.
3757. § 314.650 Termination of requirements.
3758. PART 315 DIAGNOSTIC RADIOPHARMACEUTICALS
3759. § 315.1 Scope.
3760. § 315.2 Definition.
3761. § 315.3 General factors relevant to safety and effectiveness.
3762. § 315.4 Indications.
3763. § 315.5 Evaluation of effectiveness.
3764. § 315.6 Evaluation of safety.
3765. PART 316 ORPHAN DRUGS
3766. Subpart A General Provisions
3767. § 316.1 Scope of this part.
3768. § 316.2 Purpose.
3769. § 316.3 Definitions.
3770. § 316.4 Address for submissions.
3771. Subpart B Written Recommendations for Investigations of Orphan Drugs
3772. § 316.10 Content and format of a request for written recommendations.
3773. § 316.12 Providing written recommendations.
3774. § 316.14 Refusal to provide written recommendations.
3775. Subpart C Designation of an Orphan Drug
3776. § 316.20 Content and format of a request for orphan-drug designation.
3777. § 316.21 Verification of orphan-drug status.
3778. § 316.22 Permanent-resident agent for foreign sponsor.
3779. § 316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
3780. § 316.24 Deficiency letters and granting orphan-drug designation.
3781. § 316.25 Refusal to grant orphan-drug designation.
3782. § 316.26 Amendment to orphan-drug designation.
3783. § 316.27 Change in ownership of orphan-drug designation.
3784. § 316.28 Publication of orphan-drug designations.
3785. § 316.29 Revocation of orphan-drug designation.
3786. § 316.30 Annual reports of holder of orphan-drug designation.
3787. Subpart D Orphan-drug Exclusive Approval
3788. § 316.31 Scope of orphan-drug exclusive approval.
3789. § 316.34 FDA recognition of exclusive approval.
3790. § 316.36 Insufficient quantities of orphan drugs.
3791. Subpart E Open Protocols for Investigations
3792. § 316.40 Treatment use of a designated orphan drug.
3793. Subpart F Availability of Information
3794. § 316.50 Guidance documents.
3795. § 316.52 Availability for public disclosure of data and information in requests and applications.
3796. PART 317 QUALIFYING PATHOGENS
3797. § 317.1 [Reserved]
3798. § 317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health.
3799. PART 320 BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
3800. Subpart A General Provisions
3801. § 320.1 Definitions.
3802. Subpart B Procedures for Determining the Bioavailability or Bioequivalence of Drug Products
3803. § 320.21 Requirements for submission of bioavailability and bioequivalence data.
3804. § 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
3805. § 320.23 Basis for measuring in vivo bioavailability or demonstrating bioequivalence.
3806. § 320.24 Types of evidence to measure bioavailability or establish bioequivalence.
3807. § 320.25 Guidelines for the conduct of an in vivo bioavailability study.
3808. § 320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.
3809. § 320.27 Guidelines on the design of a multiple-dose in vivo bioavailability study.
3810. § 320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence.
3811. § 320.29 Analytical methods for an in vivo bioavailability or bioequivalence study.
3812. § 320.30 Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.
3813. § 320.31 Applicability of requirements regarding an “Investigational New Drug Application.”
3814. § 320.32 Procedures for establishing or amending a bioequivalence requirement.
3815. § 320.33 Criteria and evidence to assess actual or potential bioequivalence problems.
3816. § 320.34 Requirements for batch testing and certification by the Food and Drug Administration.
3817. § 320.35 Requirements for in vitro testing of each batch.
3818. § 320.36 Requirements for maintenance of records of bioequivalence testing.
3819. § 320.38 Retention of bioavailability samples.
3820. § 320.63 Retention of bioequivalence samples.
3821. PART 328 OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
3822. Subpart A General Provisions
3823. § 328.1 Scope.
3824. § 328.3 Definitions.
3825. Subpart B Ingredients
3826. § 328.10 Alcohol.
3827. Subpart C Labeling
3828. § 328.50 Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol.
3829. PART 329 NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
3830. § 329.100 Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act.
3831. PART 330 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
3832. Subpart A General Provisions
3833. § 330.1 General conditions for general recognition as safe, effective and not misbranded.
3834. § 330.2 Pregnancy-nursing warning.
3835. § 330.3 Imprinting of solid oral dosage form drug products.
3836. § 330.5 Drug categories.
3837. Subpart B Administrative Procedures
3838. § 330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
3839. § 330.11 NDA deviations from applicable monograph.
3840. § 330.12 Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).
3841. § 330.13 Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.
3842. § 330.14 Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.
3843. § 330.15 Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.
3844. PART 331 ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
3845. Subpart A General Provisions
3846. § 331.1 Scope.
3847. Subpart B Active Ingredients
3848. § 331.10 Antacid active ingredients.
3849. § 331.11 Listing of specific active ingredients.
3850. § 331.15 Combination with nonantacid active ingredients.
3851. Subpart C Testing Procedures
3852. § 331.20 Determination of percent contribution of active ingredients.
3853. § 331.21 Test modifications.
3854. Subpart D Labeling
3855. § 331.30 Labeling of antacid products.
3856. § 331.80 Professional labeling.
3857. PART 332 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3858. Subpart A General Provisions
3859. § 332.1 Scope.
3860. § 332.3 Definitions.
3861. Subpart B Active Ingredients
3862. § 332.10 Antiflatulent active ingredients.
3863. § 332.15 Combination with non-antiflatulent active ingredients.
3864. Subpart C Labeling
3865. § 332.30 Labeling of antiflatulent drug products.
3866. § 332.31 Professional labeling.
3867. PART 333 TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3868. A Subpart A [Reserved]
3869. Subpart B First Aid Antibiotic Drug Products
3870. § 333.101 Scope.
3871. § 333.103 Definitions.
3872. § 333.110 First aid antibiotic active ingredients.
3873. § 333.120 Permitted combinations of active ingredients.
3874. § 333.150 Labeling of first aid antibiotic drug products.
3875. § 333.160 Labeling of permitted combinations of active ingredients.
3876. Subpart C Topical Antifungal Drug Products
3877. § 333.201 Scope.
3878. § 333.203 Definitions.
3879. § 333.210 Antifungal active ingredients.
3880. § 333.250 Labeling of antifungal drug products.
3881. § 333.280 Professional labeling.
3882. Subpart D Topical Acne Drug Products
3883. § 333.301 Scope.
3884. § 333.303 Definitions.
3885. § 333.310 Acne active ingredients.
3886. § 333.320 Permitted combinations of active ingredients.
3887. § 333.350 Labeling of acne drug products.
3888. PART 335 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3889. Subpart A General Provisions
3890. § 335.1 Scope.
3891. § 335.3 Definitions.
3892. Subpart B Active Ingredients
3893. § 335.10 Antidiarrheal active ingredients.
3894. Subpart C Labeling
3895. § 335.50 Labeling of antidiarrheal drug products.
3896. PART 336 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3897. Subpart A General Provisions
3898. § 336.1 Scope.
3899. § 336.3 Definition.
3900. Subpart B Active Ingredients
3901. § 336.10 Antiemetic active ingredients.
3902. Subpart C Labeling
3903. § 336.50 Labeling of antiemetic drug products.
3904. § 336.80 Professional labeling.
3905. PART 338 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3906. Subpart A General Provisions
3907. § 338.1 Scope.
3908. § 338.3 Definition.
3909. Subpart B Active Ingredients
3910. § 338.10 Nighttime sleep-aid active ingredients.
3911. Subpart C Labeling
3912. § 338.50 Labeling of nighttime sleep-aid drug products.
3913. PART 340 STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3914. Subpart A General Provisions
3915. § 340.1 Scope.
3916. § 340.3 Definition.
3917. Subpart B Active Ingredient
3918. § 340.10 Stimulant active ingredient.
3919. Subpart C Labeling
3920. § 340.50 Labeling of stimulant drug products.
3921. PART 341 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3922. Subpart A General Provisions
3923. § 341.1 Scope.
3924. § 341.3 Definitions.
3925. Subpart B Active Ingredients
3926. § 341.12 Antihistamine active ingredients.
3927. § 341.14 Antitussive active ingredients.
3928. § 341.16 Bronchodilator active ingredients.
3929. § 341.18 Expectorant active ingredient.
3930. § 341.20 Nasal decongestant active ingredients.
3931. § 341.40 Permitted combinations of active ingredients.
3932. Subpart C Labeling
3933. § 341.70 Labeling of OTC drug products containing ingredients that are used for treating concurrent symptoms (in either a single-ingredient or combination drug product).
3934. § 341.72 Labeling of antihistamine drug products.
3935. § 341.74 Labeling of antitussive drug products.
3936. § 341.76 Labeling of bronchodilator drug products.
3937. § 341.78 Labeling of expectorant drug products.
3938. § 341.80 Labeling of nasal decongestant drug products.
3939. § 341.85 Labeling of permitted combinations of active ingredients.
3940. § 341.90 Professional labeling.
3941. PART 343 INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3942. Subpart A General Provisions
3943. § 343.1 Scope.
3944. § 343.3 Definitions.
3945. Subpart B Active Ingredients
3946. § 343.10 [Reserved]
3947. § 343.12 Cardiovascular active ingredients.
3948. § 343.13 Rheumatologic active ingredients.
3949. § 343.20 [Reserved]
3950. § 343.22 Permitted combinations of active ingredients for cardiovascular-rheumatologic use.
3951. Subpart C Labeling
3952. §§ 343.50-343.60 [Reserved]
3953. § 343.80 Professional labeling.
3954. Subpart D Testing Procedures
3955. § 343.90 Dissolution and drug release testing.
3956. PART 344 TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3957. Subpart A General Provisions
3958. § 344.1 Scope.
3959. § 344.3 Definitions.
3960. Subpart B Active Ingredients
3961. § 344.10 Earwax removal aid active ingredient.
3962. § 344.12 Ear drying aid active ingredient.
3963. Subpart C Labeling
3964. § 344.50 Labeling of earwax removal aid drug products.
3965. § 344.52 Labeling of ear drying aid drug products.
3966. PART 346 ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3967. Subpart A General Provisions
3968. § 346.1 Scope.
3969. § 346.3 Definitions.
3970. Subpart B Active Ingredients
3971. § 346.10 Local anesthetic active ingredients.
3972. § 346.12 Vasoconstrictor active ingredients.
3973. § 346.14 Protectant active ingredients.
3974. § 346.16 Analgesic, anesthetic, and antipruritic active ingredients.
3975. § 346.18 Astringent active ingredients.
3976. § 346.20 Keratolytic active ingredients.
3977. § 346.22 Permitted combinations of anorectal active ingredients.
3978. Subpart C Labeling
3979. § 346.50 Labeling of anorectal drug products.
3980. § 346.52 Labeling of permitted combinations of anorectal active ingredients.
3981. PART 347 SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3982. Subpart A General Provisions
3983. § 347.1 Scope.
3984. § 347.3 Definitions.
3985. Subpart B Active Ingredients
3986. § 347.10 Skin protectant active ingredients.
3987. § 347.12 Astringent active ingredients.
3988. § 347.20 Permitted combinations of active ingredients.
3989. Subpart C Labeling
3990. § 347.50 Labeling of skin protectant drug products.
3991. § 347.52 Labeling of astringent drug products.
3992. § 347.60 Labeling of permitted combinations of active ingredients.
3993. PART 348 EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3994. Subpart A General Provisions
3995. § 348.1 Scope.
3996. § 348.3 Definitions.
3997. Subpart B Active Ingredients
3998. § 348.10 Analgesic, anesthetic, and antipruritic active ingredients.
3999. Subpart C Labeling
4000. § 348.50 Labeling of external analgesic drug products.
4001. PART 349 OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
4002. Subpart A General Provisions
4003. § 349.1 Scope.
4004. § 349.3 Definitions.
4005. Subpart B Active Ingredients
4006. § 349.10 Ophthalmic astringent.
4007. § 349.12 Ophthalmic demulcents.
4008. § 349.14 Ophthalmic emollients.
4009. § 349.16 Ophthalmic hypertonicity agent.
4010. § 349.18 Ophthalmic vasoconstrictors.
4011. § 349.20 Eyewashes.
4012. § 349.30 Permitted combinations of active ingredients.
4013. Subpart C Labeling
4014. § 349.50 Labeling of ophthalmic drug products.
4015. § 349.55 Labeling of ophthalmic astringent drug products.
4016. § 349.60 Labeling of ophthalmic demulcent drug products.
4017. § 349.65 Labeling of ophthalmic emollient drug products.
4018. § 349.70 Labeling of ophthalmic hypertonicity drug products.
4019. § 349.75 Labeling of ophthalmic vasoconstrictor drug products.
4020. § 349.78 Labeling of eyewash drug products.
4021. § 349.79 Labeling of permitted combinations of active ingredients.
4022. § 349.80 Professional labeling.
4023. PART 350 ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
4024. Subpart A General Provisions
4025. § 350.1 Scope.
4026. § 350.3 Definition.
4027. Subpart B Active Ingredients
4028. § 350.10 Antiperspirant active ingredients.
4029. Subpart C Labeling
4030. § 350.50 Labeling of antiperspirant drug products.
4031. Subpart D Guidelines for Effectiveness Testing
4032. § 350.60 Guidelines for effectiveness testing of antiperspirant drug products.
4033. PART 352 SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
4034. Subpart A General Provisions
4035. § 352.1 Scope.
4036. § 352.3 Definitions.
4037. Subpart B Active Ingredients
4038. § 352.10 Sunscreen active ingredients.
4039. § 352.20 Permitted combinations of active ingredients.
4040. Subpart C Labeling
4041. § 352.50 Principal display panel of all sunscreen drug products.
4042. § 352.52 Labeling of sunscreen drug products.
4043. § 352.60 Labeling of permitted combinations of active ingredients.
4044. Subpart D Testing Procedures
4045. § 352.70 Standard sunscreen.
4046. § 352.71 Light source (solar simulator).
4047. § 352.72 General testing procedures.
4048. § 352.73 Determination of SPF value.
4049. § 352.76 Determination if a product is water resistant or very water resistant.
4050. § 352.77 Test modifications.
4051. PART 355 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
4052. Subpart A General Provisions
4053. § 355.1 Scope.
4054. § 355.3 Definitions.
4055. Subpart B Active Ingredients
4056. § 355.10 Anticaries active ingredients.
4057. § 355.20 Packaging conditions.
4058. Subpart C Labeling
4059. § 355.50 Labeling of anticaries drug products.
4060. § 355.55 Principal display panel of all fluoride rinse drug products.
4061. § 355.60 Professional labeling.
4062. Subpart D Testing Procedures
4063. § 355.70 Testing procedures for fluoride dentifrice drug products.
4064. PART 357 MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
4065. A Subpart A [Reserved]
4066. Subpart B Anthelmintic Drug Products
4067. § 357.101 Scope.
4068. § 357.103 Definition.
4069. § 357.110 Anthelmintic active ingredient.
4070. § 357.150 Labeling of anthelmintic drug products.
4071. § 357.152 Package inserts for anthelmintic drug products.
4072. § 357.180 Professional labeling.
4073. Subpart C Cholecystokinetic Drug Products
4074. § 357.201 Scope.
4075. § 357.203 Definition.
4076. § 357.210 Cholecystokinetic active ingredients.
4077. § 357.250 Labeling of cholecystokinetic drug products.
4078. § 357.280 Professional labeling.
4079. D Subparts D-H [Reserved]
4080. Subpart I Deodorant Drug Products for Internal Use
4081. § 357.801 Scope.
4082. § 357.803 Definitions.
4083. § 357.810 Active ingredients for deodorant drug products for internal use.
4084. § 357.850 Labeling of deodorant drug products for internal use.
4085. PART 358 MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
4086. A Subpart A [Reserved]
4087. Subpart B Wart Remover Drug Products
4088. § 358.101 Scope.
4089. § 358.103 Definitions.
4090. § 358.110 Wart remover active ingredients.
4091. § 358.150 Labeling of wart remover drug products.
4092. C Subpart C [Reserved]
4093. Subpart D Ingrown Toenail Relief Drug Products
4094. § 358.301 Scope.
4095. § 358.303 Definitions.
4096. § 358.310 Ingrown toenail relief active ingredient.
4097. § 358.350 Labeling of ingrown toenail relief drug products.
4098. E Subpart E [Reserved]
4099. Subpart F Corn and Callus Remover Drug Products
4100. § 358.501 Scope.
4101. § 358.503 Definitions.
4102. § 358.510 Corn and callus remover active ingredients.
4103. § 358.550 Labeling of corn and callus remover drug products.
4104. Subpart G Pediculicide Drug Products
4105. § 358.601 Scope.
4106. § 358.603 Definition.
4107. § 358.610 Pediculicide active ingredients.
4108. § 358.650 Labeling of pediculicide drug products.
4109. Subpart H Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis
4110. § 358.701 Scope.
4111. § 358.703 Definitions.
4112. § 358.710 Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis.
4113. § 358.720 Permitted combinations of active ingredients.
4114. § 358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis.
4115. § 358.760 Labeling of permitted combinations of active ingredients for the control of dandruff.
4116. PART 361 PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
4117. § 361.1 Radioactive drugs for certain research uses.
4118. PART 369 INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
4119. Subpart A Definitions and Interpretations
4120. § 369.1 Purpose of issuance.
4121. § 369.2 Definitions.
4122. § 369.3 Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C).
4123. § 369.4 Warnings suggested for drugs by formal or informal statements of policy.
4124. § 369.6 [Reserved]
4125. § 369.7 Warnings required by official compendia.
4126. § 369.8 Warning statements in relation to conditions for use.
4127. § 369.9 General warnings re accidental ingestion by children.
4128. § 369.10 Conspicuousness of warning statements.
4129. Subpart B Warning and Caution Statements for Drugs
4130. § 369.20 Drugs; recommended warning and caution statements.
4131. § 369.21 Drugs; warning and caution statements required by regulations.
4132. 370-499 PARTS 370-499 [RESERVED]
4133. CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
4134. SUBCHAPTER E ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
4135. PART 500 GENERAL
4136. A Subpart A [Reserved]
4137. Subpart B Specific Administrative Rulings and Decisions
4138. § 500.23 Thermally processed low-acid foods packaged in hermetically sealed containers.
4139. § 500.24 Emergency permit control.
4140. § 500.25 Anthelmintic drugs for use in animals.
4141. § 500.26 Timed-release dosage form drugs.
4142. § 500.27 Methylene blue-containing drugs for use in animals.
4143. § 500.29 Gentian violet for use in animal feed.
4144. § 500.30 Gentian violet for animal drug use.
4145. § 500.45 Use of polychlorinated biphenyls (PCB's) in the production, handling, and storage of animal feed.
4146. § 500.46 Hexachlorophene in animal drugs.
4147. § 500.50 Propylene glycol in or on cat food.
4148. Subpart C Animal Drug Labeling Requirements
4149. § 500.51 Labeling of animal drugs; misbranding.
4150. § 500.52 Use of terms such as “tonic”, “tone”, “toner”, or “conditioner” in the labeling of preparations intended for use in or on animals.
4151. § 500.55 Exemption from certain drug-labeling requirements.
4152. Subpart D Requirements for Specific Animal Drugs
4153. § 500.65 Epinephrine injection 1:1,000 in 10-milliliter containers for emergency treatment of anaphylactoid shock in cattle, horses, sheep, and swine.
4154. Subpart E Regulation of Carcinogenic Compounds Used in Food-Producing Animals
4155. § 500.80 Scope of this subpart.
4156. § 500.82 Definitions.
4157. § 500.84 Conditions for approval of the sponsored compound.
4158. § 500.86 Marker residue and target tissue.
4159. § 500.88 Regulatory method.
4160. § 500.90 Waiver of requirements.
4161. § 500.92 Implementation.
4162. Subpart F Methods for Detection of Residues of Carcinogenic Compounds Used in Food-Producing Animals
4163. § 500.1410 N-methyl-2-pyrrolidone.
4164. PART 501 ANIMAL FOOD LABELING
4165. Subpart A General Provisions
4166. § 501.1 Principal display panel of package form animal food.
4167. § 501.2 Information panel of package for animal food.
4168. § 501.3 Identity labeling of animal food in package form.
4169. § 501.4 Animal food; designation of ingredients.
4170. § 501.5 Animal food; name and place of business of manufacturer, packer, or distributor.
4171. § 501.8 Labeling of animal food with number of servings.
4172. § 501.15 Animal food; prominence of required statements.
4173. § 501.17 Animal food labeling warning statements.
4174. § 501.18 Misbranding of animal food.
4175. Subpart B Specific Animal Food Labeling Requirements
4176. § 501.22 Animal foods; labeling of spices, flavorings, colorings, and chemical preservatives.
4177. C Subparts C-E [Reserved]
4178. Subpart F Exemptions From Animal Food Labeling Requirements
4179. § 501.100 Animal food; exemptions from labeling.
4180. § 501.103 Petitions requesting exemptions from or special requirements for label declaration of ingredients.
4181. § 501.105 Declaration of net quantity of contents when exempt.
4182. § 501.110 Animal feed labeling; collective names for feed ingredients.
4183. PART 502 COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS
4184. § 502.5 General principles.
4185. § 502.19 Petitions.
4186. PART 507 CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
4187. Subpart A General Provisions
4188. § 507.1 Applicability and status.
4189. § 507.3 Definitions.
4190. § 507.4 Qualifications of individuals who manufacture, process, pack, or hold animal food.
4191. § 507.5 Exemptions.
4192. § 507.7 Requirements that apply to a qualified facility.
4193. § 507.10 Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food.
4194. § 507.12 Applicability of this part to the holding and distribution of human food by-products for use as animal food.
4195. Subpart B Current Good Manufacturing Practice
4196. § 507.14 Personnel.
4197. § 507.17 Plant and grounds.
4198. § 507.19 Sanitation.
4199. § 507.20 Water supply and plumbing.
4200. § 507.22 Equipment and utensils.
4201. § 507.25 Plant operations.
4202. § 507.27 Holding and distribution.
4203. § 507.28 Holding and distribution of human food by-products for use as animal food.
4204. Subpart C Hazard Analysis and Risk-Based Preventive Controls
4205. § 507.31 Food safety plan.
4206. § 507.33 Hazard analysis.
4207. § 507.34 Preventive controls.
4208. § 507.36 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
4209. § 507.37 Provision of assurances required under § 507.36(a)(2), (3), and (4).
4210. § 507.38 Recall plan.
4211. § 507.39 Preventive control management components.
4212. § 507.40 Monitoring.
4213. § 507.42 Corrective actions and corrections.
4214. § 507.45 Verification.
4215. § 507.47 Validation.
4216. § 507.49 Verification of implementation and effectiveness.
4217. § 507.50 Reanalysis.
4218. § 507.51 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food.
4219. § 507.53 Requirements applicable to a preventive controls qualified individual and a qualified auditor.
4220. § 507.55 Implementation records required for this subpart.
4221. Subpart D Withdrawal of a Qualified Facility Exemption
4222. § 507.60 Circumstances that may lead FDA to withdraw a qualified facility exemption.
4223. § 507.62 Issuance of an order to withdraw a qualified facility exemption.
4224. § 507.65 Contents of an order to withdraw a qualified facility exemption.
4225. § 507.67 Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
4226. § 507.69 Procedure for submitting an appeal.
4227. § 507.71 Procedure for requesting an informal hearing.
4228. § 507.73 Requirements applicable to an informal hearing.
4229. § 507.75 Presiding officer for an appeal and for an informal hearing.
4230. § 507.77 Timeframe for issuing a decision on an appeal.
4231. § 507.80 Revocation of an order to withdraw a qualified facility exemption.
4232. § 507.83 Final agency action.
4233. § 507.85 Reinstatement of a qualified facility exemption that was withdrawn.
4234. Subpart E Supply-Chain Program
4235. § 507.105 Requirement to establish and implement a supply-chain program.
4236. § 507.110 General requirements applicable to a supply-chain program.
4237. § 507.115 Responsibilities of the receiving facility.
4238. § 507.120 Using approved suppliers.
4239. § 507.125 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
4240. § 507.130 Conducting supplier verification activities for raw materials and other ingredients.
4241. § 507.135 Onsite audit.
4242. § 507.175 Records documenting the supply-chain program.
4243. Subpart F Requirements Applying to Records That Must Be Established and Maintained
4244. § 507.200 Records subject to the requirements of this subpart.
4245. § 507.202 General requirements applying to records.
4246. § 507.206 Additional requirements applying to the food safety plan.
4247. § 507.208 Requirements for record retention.
4248. § 507.212 Use of existing records.
4249. § 507.215 Special requirements applicable to a written assurance.
4250. PART 509 UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL
4251. Subpart A General Provisions
4252. § 509.3 Definitions and interpretations.
4253. § 509.4 Establishment of tolerances, regulatory limits, and action levels.
4254. § 509.5 Petitions.
4255. § 509.6 Added poisonous or deleterious substances.
4256. § 509.7 Unavoidability.
4257. § 509.15 Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.
4258. Subpart B Tolerances for Unavoidable Poisonous or Deleterious Substances
4259. § 509.30 Temporary tolerances for polychlorinated biphenyls (PCB's).
4260. Subpart C Regulatory Limits for Added Poisonous or Deleterious Substances [Reserved]
4261. Subpart D Naturally Occurring Poisonous or Deleterious Substances [Reserved]
4262. PART 510 NEW ANIMAL DRUGS
4263. Subpart A General Provisions
4264. § 510.3 Definitions and interpretations.
4265. § 510.4 Biologics; products subject to license control.
4266. § 510.7 Consignees of new animal drugs for use in the manufacture of animal feed.
4267. § 510.95 [Reserved]
4268. Subpart B Specific Administrative Rulings and Decisions
4269. § 510.105 Labeling of drugs for use in milk-producing animals.
4270. § 510.106 Labeling of antibiotic and antibiotic-containing drugs intended for use in milk-producing animals.
4271. § 510.110 Antibiotics used in food-producing animals.
4272. § 510.112 Antibiotics used in veterinary medicine and for nonmedical purposes; required data.
4273. Subpart C Import Tolerances for Residues of Unapproved New Animal Drugs in Food
4274. § 510.201 Scope.
4275. § 510.202 Definitions.
4276. § 510.203 Initiation of a proceeding to establish or amend an import tolerance.
4277. § 510.205 Content and administration of a request.
4278. § 510.206 Review of information supporting actions to establish or amend an import tolerance.
4279. § 510.207 Disclosure of information submitted in a request.
4280. § 510.209 Establishment, denial, or amendment of an import tolerance.
4281. § 510.210 Revocation of an import tolerance.
4282. § 510.212 Administrative reconsideration of action.
4283. § 510.213 Administrative stay of action.
4284. Subpart D Records and Reports
4285. § 510.301 Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect.
4286. § 510.305 Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs.
4287. Subpart E Requirements for Specific New Animal Drugs
4288. § 510.410 Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling requirements.
4289. § 510.440 Injectable iron preparations.
4290. § 510.455 Requirements for free-choice medicated feeds.
4291. F Subpart F [Reserved]
4292. Subpart G Sponsors of Approved Applications
4293. § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
4294. PART 511 NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
4295. § 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act.
4296. § 511.3 Definitions.
4297. PART 514 NEW ANIMAL DRUG APPLICATIONS
4298. Subpart A General Provisions
4299. § 514.1 Applications.
4300. § 514.3 Definitions.
4301. § 514.4 Substantial evidence.
4302. § 514.5 Presubmission conferences.
4303. § 514.6 Amended applications.
4304. § 514.7 Withdrawal of applications without prejudice.
4305. § 514.8 Supplements and other changes to an approved application.
4306. § 514.11 Confidentiality of data and information in a new animal drug application file.
4307. § 514.12 Confidentiality of data and information in an investigational new animal drug notice.
4308. § 514.15 Untrue statements in applications.
4309. Subpart B Administrative Actions on Applications
4310. § 514.80 Records and reports concerning experience with approved new animal drugs.
4311. § 514.87 Annual reports for antimicrobial animal drug sales and distribution.
4312. § 514.100 Evaluation and comment on applications.
4313. § 514.105 Approval of applications.
4314. § 514.106 Approval of supplemental applications.
4315. § 514.110 Reasons for refusing to file applications.
4316. § 514.111 Refusal to approve an application.
4317. § 514.115 Withdrawal of approval of applications.
4318. § 514.116 Notice of withdrawal of approval of application.
4319. § 514.117 Adequate and well-controlled studies.
4320. § 514.120 Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.
4321. § 514.121 Service of notices and orders.
4322. Subpart C Hearing Procedures
4323. § 514.200 Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing.
4324. § 514.201 Procedures for hearings.
4325. D Subparts D-E [Reserved]
4326. Subpart F Judicial Review
4327. § 514.235 Judicial review.
4328. PART 515 MEDICATED FEED MILL LICENSE
4329. Subpart A Applications
4330. § 515.10 Medicated feed mill license applications.
4331. § 515.11 Supplemental medicated feed mill license applications.
4332. Subpart B Administrative Actions on Licenses
4333. § 515.20 Approval of medicated feed mill license applications.
4334. § 515.21 Refusal to approve a medicated feed mill license application.
4335. § 515.22 Suspension and/or revocation of approval of a medicated feed mill license.
4336. § 515.23 Voluntary revocation of medicated feed mill license.
4337. § 515.24 Notice of revocation of a medicated feed mill license.
4338. § 515.25 Revocation of order refusing to approve a medicated feed mill license application or suspending or revoking a license.
4339. § 515.26 Services of notices and orders.
4340. Subpart C Hearing Procedures
4341. § 515.30 Contents of notice of opportunity for a hearing.
4342. § 515.31 Procedures for hearings.
4343. Subpart D Judicial Review
4344. § 515.40 Judicial review.
4345. PART 516 NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
4346. Subpart A General Provisions
4347. § 516.1 Scope.
4348. § 516.2 Purpose.
4349. § 516.3 Definitions.
4350. Subpart B Designation of a Minor Use or Minor Species New Animal Drug
4351. § 516.11 Scope of this subpart.
4352. § 516.12 Purpose.
4353. § 516.13 Definitions.
4354. § 516.14 Submission of requests for designation.
4355. § 516.16 Eligibility to request designation.
4356. § 516.20 Content and format of a request for MUMS-drug designation.
4357. § 516.21 Documentation of minor use status.
4358. § 516.22 Permanent-resident U.S. agent for foreign sponsor.
4359. § 516.23 Timing of requests for MUMS-drug designation.
4360. § 516.24 Granting MUMS-drug designation.
4361. § 516.25 Refusal to grant MUMS-drug designation.
4362. § 516.26 Amendment to MUMS-drug designation.
4363. § 516.27 Change in sponsorship.
4364. § 516.28 Publication of MUMS-drug designations.
4365. § 516.29 Termination of MUMS-drug designation.
4366. § 516.30 Annual reports for a MUMS-designated drug.
4367. § 516.31 Scope of MUMS-drug exclusive marketing rights.
4368. § 516.34 FDA recognition of exclusive marketing rights.
4369. § 516.36 Insufficient quantities of MUMS-designated drugs.
4370. § 516.52 Availability for public disclosure of data and information in requests.
4371. Subpart C Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
4372. § 516.111 Scope of this subpart.
4373. § 516.115 Definitions.
4374. § 516.117 Submission of correspondence under this subpart.
4375. § 516.119 Permanent-resident U.S. agent for foreign requestors and holders.
4376. § 516.121 Meetings.
4377. § 516.123 Informal conferences regarding agency administrative actions.
4378. § 516.125 Investigational use of minor species new animal drugs to support indexing.
4379. § 516.129 Content and format of a request for determination of eligibility for indexing.
4380. § 516.131 Refuse to file a request for determination of eligibility for indexing.
4381. § 516.133 Denying a request for determination of eligibility for indexing.
4382. § 516.135 Granting a request for determination of eligibility for indexing.
4383. § 516.137 Notification of decision regarding eligibility for indexing.
4384. § 516.141 Qualified expert panels.
4385. § 516.143 Written report.
4386. § 516.145 Content and format of a request for addition to the index.
4387. § 516.147 Refuse to file a request for addition to the index.
4388. § 516.149 Denying a request for addition to the index.
4389. § 516.151 Granting a request for addition to the index.
4390. § 516.153 Notification of decision regarding index listing.
4391. § 516.155 Labeling of indexed drugs.
4392. § 516.157 Publication of the index and content of an index listing.
4393. § 516.161 Modifications to indexed drugs.
4394. § 516.163 Change in ownership of an index file.
4395. § 516.165 Records and reports.
4396. § 516.167 Removal from the index.
4397. § 516.171 Confidentiality of data and information in an index file.
4398. D Subpart D [Reserved]
4399. Subpart E Conditionally Approved New Animal Drugs For Minor Use and Minor Species
4400. § 516.498 Crofelemer.
4401. § 516.570 Doramectin.
4402. § 516.900 Fluralaner.
4403. § 516.1012 Fuzapladib.
4404. § 516.1287 Lotilaner, moxidectin, praziquantel, and pyrantel.
4405. § 516.1449 Molidustat oral suspension.
4406. § 516.1760 Phenobarbital.
4407. § 516.1780 Pimobendan.
4408. § 516.2106 Sirolimus.
4409. § 516.2475 Torsemide.
4410. PART 520 ORAL DOSAGE FORM NEW ANIMAL DRUGS
4411. § 520.23 Acepromazine.
4412. § 520.28 Acetazolamide.
4413. § 520.35 Afoxolaner, moxidectin, and pyrantel.
4414. § 520.38 Albendazole oral dosage forms.
4415. § 520.38a Albendazole suspension.
4416. § 520.38b Albendazole paste.
4417. § 520.43 Afoxolaner.
4418. § 520.48 Altrenogest.
4419. § 520.62 Aminopentamide.
4420. § 520.82 Aminopropazine oral dosage forms.
4421. § 520.82a Aminopropazine.
4422. § 520.82b Aminopropazine and neomycin.
4423. § 520.88 Amoxicillin oral dosage forms.
4424. § 520.88a Amoxicillin trihydrate film-coated tablets.
4425. § 520.88b Amoxicillin trihydrate for oral suspension.
4426. § 520.88c Amoxicillin trihydrate oral suspension.
4427. § 520.88d Amoxicillin trihydrate soluble powder.
4428. § 520.88e Amoxicillin trihydrate boluses.
4429. § 520.88f Amoxicillin trihydrate tablets.
4430. § 520.88g Amoxicillin and clavulanate potassium tablets.
4431. § 520.88h Amoxicillin trihydrate and clavulanate potassium for oral suspension.
4432. § 520.90 Ampicillin oral dosage forms.
4433. § 520.90a Ampicillin tablets.
4434. § 520.90b Ampicillin capsules.
4435. § 520.90c Ampicillin boluses.
4436. § 520.100 Amprolium.
4437. § 520.110 Apramycin sulfate soluble powder.
4438. § 520.136 Atinvicitinib tablets.
4439. § 520.154 Bacitracin oral dosage forms.
4440. § 520.154a Bacitracin methylenedisalicylate.
4441. § 520.154b Bacitracin methylenedisalicylate and streptomycin sulfate powder.
4442. § 520.154c Bacitracin zinc soluble powder.
4443. § 520.170 Bexagliflozin.
4444. § 520.222 Bunamidine hydrochloride.
4445. § 520.246 Butorphanol tablets.
4446. § 520.260 n-Butyl chloride.
4447. § 520.292 Capromorelin.
4448. § 520.301 Caramiphen ethanedisulfonate and ammonium chloride tablets.
4449. § 520.302 Carnidazole tablets.
4450. § 520.304 Carprofen.
4451. § 520.314 Cefadroxil.
4452. § 520.370 Cefpodoxime tablets.
4453. § 520.376 Cephalexin.
4454. § 520.390 Chloramphenicol oral dosage forms.
4455. § 520.390a Chloramphenicol tablets.
4456. § 520.390b Chloramphenicol capsules.
4457. § 520.390c Chloramphenicol palmitate oral suspension.
4458. § 520.434 Chlorphenesin carbamate tablets.
4459. § 520.441 Chlortetracycline powder.
4460. § 520.443 Chlortetracycline tablets and boluses.
4461. § 520.445 Chlortetracycline and sulfamethazine powder.
4462. § 520.446 Clindamycin capsules and tablets.
4463. § 520.447 Clindamycin solution.
4464. § 520.452 Clenbuterol syrup.
4465. § 520.455 Clomipramine.
4466. § 520.462 Clorsulon drench.
4467. § 520.522 Cyclosporine.
4468. § 520.530 Cythioate oral liquid.
4469. § 520.531 Cythioate tablets.
4470. § 520.534 Decoquinate.
4471. § 520.538 Deracoxib.
4472. § 520.540 Dexamethasone oral dosage forms.
4473. § 520.540a Dexamethasone powder.
4474. § 520.540b Dexamethasone tablets and boluses.
4475. § 520.540c Dexamethasone chewable tablets.
4476. § 520.563 Diatrizoate.
4477. § 520.580 Dichlorophene and toluene.
4478. § 520.581 Dichlorophene tablets.
4479. § 520.596 Dichlorvos powder.
4480. § 520.598 Dichlorvos tablets.
4481. § 520.600 Dichlorvos capsules and pellets.
4482. § 520.602 Dichlorvos gel.
4483. § 520.606 Diclazuril.
4484. § 520.608 Dicloxacillin.
4485. § 520.620 Diethylcarbamazine oral dosage forms.
4486. § 520.622 Diethylcarbamazine citrate oral dosage forms.
4487. § 520.622a Diethylcarbamazine citrate tablets.
4488. § 520.622b Diethylcarbamazine citrate syrup.
4489. § 520.622c Diethylcarbamazine citrate chewable tablets.
4490. § 520.623 Diethylcarbamazine and oxibendazole chewable tablets.
4491. § 520.666 Dirlotapide.
4492. § 520.763 Dithiazanine oral dosage forms.
4493. § 520.763a Dithiazanine tablets.
4494. § 520.763b Dithiazanine powder.
4495. § 520.763c Dithiazanine iodide and piperazine citrate suspension.
4496. § 520.766 Domperidone.
4497. § 520.784 Doxylamine.
4498. § 520.812 Enrofloxacin.
4499. § 520.816 Epsiprantel.
4500. § 520.823 Erythromycin.
4501. § 520.852 Estriol.
4502. § 520.863 Ethylisobutrazine.
4503. § 520.903 Febantel oral dosage forms.
4504. § 520.903a Febantel paste.
4505. § 520.903b Febantel suspension.
4506. § 520.903c Febantel and praziquantel paste.
4507. § 520.903d Febantel tablets.
4508. § 520.905 Fenbendazole oral dosage forms.
4509. § 520.905a Fenbendazole suspension.
4510. § 520.905b Fenbendazole granules.
4511. § 520.905c Fenbendazole paste.
4512. § 520.905d Fenbendazole powder.
4513. § 520.928 Firocoxib tablets.
4514. § 520.929 Firocoxib solution.
4515. § 520.930 Firocoxib paste.
4516. § 520.955 Florfenicol.
4517. § 520.960 Flumethasone.
4518. § 520.970 Flunixin.
4519. § 520.980 Fluoxetine.
4520. § 520.998 Fluralaner chewable tablets.
4521. § 520.999 Fluralaner oral solution.
4522. § 520.1010 Furosemide.
4523. § 520.1044 Gentamicin sulfate oral dosage forms.
4524. § 520.1044a Gentamicin sulfate oral solution.
4525. § 520.1044b Gentamicin sulfate pig pump oral solution.
4526. § 520.1044c Gentamicin sulfate powder.
4527. § 520.1060 Glucose and glycine.
4528. § 520.1084 Grapiprant.
4529. § 520.1100 Griseofulvin.
4530. § 520.1120 Haloxon oral dosage forms.
4531. § 520.1120a Haloxon drench.
4532. § 520.1120b Haloxon boluses.
4533. § 520.1136 Ilunocitinib.
4534. § 520.1150 Imepitoin.
4535. § 520.1156 Imidacloprid.
4536. § 520.1157 Iodinated casein.
4537. § 520.1158 Iodochlorhydroxyquin.
4538. § 520.1189 Itraconazole.
4539. § 520.1192 Ivermectin paste.
4540. § 520.1193 Ivermectin tablets and chewables.
4541. § 520.1194 Ivermectin meal.
4542. § 520.1195 Ivermectin liquid.
4543. § 520.1196 Ivermectin and pyrantel tablets.
4544. § 520.1197 Ivermectin sustained-release bolus.
4545. § 520.1198 Ivermectin and praziquantel paste.
4546. § 520.1199 Ivermectin, pyrantel, and praziquantel tablets.
4547. § 520.1200 Ivermectin, fenbendazole, and praziquantel tablets.
4548. § 520.1204 Kanamycin, bismuth subcarbonate, activated attapulgite.
4549. § 520.1242 Levamisole.
4550. § 520.1242a Levamisole powder.
4551. § 520.1242b Levamisol boluses or oblets.
4552. § 520.1242c Levamisol and piperazine.
4553. § 520.1242d Levamisole resinate.
4554. § 520.1242e Levamisole hydrochloride effervescent tablets.
4555. § 520.1242f Levamisol gel.
4556. § 520.1242g Levamisole resinate and famphur paste.
4557. § 520.1248 Levothyroxine.
4558. § 520.1263 Lincomycin.
4559. § 520.1263a Lincomycin tablets and syrup.
4560. § 520.1263b Lincomycin hydrochloride soluble powder.
4561. § 520.1265 Lincomycin and spectinomycin powder.
4562. § 520.1284 Liothyronine.
4563. § 520.1286 Lotilaner.
4564. § 520.1287 Lotilaner, moxidectin, praziquantel, and pyrantel.
4565. § 520.1288 Lufenuron tablets.
4566. § 520.1289 Lufenuron suspension.
4567. § 520.1310 Marbofloxacin.
4568. § 520.1315 Maropitant.
4569. § 520.1320 Mebendazole.
4570. § 520.1326 Mebendazole and trichlorfon oral dosage forms.
4571. § 520.1326a Mebendazole and trichlorfon powder.
4572. § 520.1326b Mebendazole and trichlorfon paste.
4573. § 520.1330 Meclofenamic acid granules.
4574. § 520.1331 Meclofenamic acid tablets.
4575. § 520.1341 Megestrol.
4576. § 520.1367 Meloxicam.
4577. § 520.1375 Methimazole tablets.
4578. § 520.1376 Methimazole solution.
4579. § 520.1380 Methocarbamol.
4580. § 520.1408 Methylprednisolone.
4581. § 520.1409 Methylprednisolone and aspirin.
4582. § 520.1422 Metoserpate hydrochloride.
4583. § 520.1425 Metronidazole.
4584. § 520.1430 Mibolerone.
4585. § 520.1441 Milbemycin.
4586. § 520.1443 Milbemycin oxime and lufenuron.
4587. § 520.1445 Milbemycin oxime and praziquantel.
4588. § 520.1447 Milbemycin oxime, lufenuron, and praziquantel tablets.
4589. § 520.1450 Morantel tartrate oral dosage forms.
4590. § 520.1450a Morantel tartrate bolus.
4591. § 520.1450b Morantel tartrate cartridge.
4592. § 520.1450c Morantel tartrate sustained-release trilaminate cylinder/sheet.
4593. § 520.1451 Moxidectin tablets.
4594. § 520.1452 Moxidectin gel.
4595. § 520.1453 Moxidectin and praziquantel gel.
4596. § 520.1454 Moxidectin solution.
4597. § 520.1468 Naproxen.
4598. § 520.1484 Neomycin.
4599. § 520.1510 Nitenpyram.
4600. § 520.1604 Oclacitinib.
4601. § 520.1615 Omeprazole.
4602. § 520.1616 Orbifloxacin tablets.
4603. § 520.1618 Orbifloxacin suspension.
4604. § 520.1628 Oxfendazole powder and pellets.
4605. § 520.1629 Oxfendazole paste.
4606. § 520.1630 Oxfendazole suspension.
4607. § 520.1631 Oxfendazole and trichlorfon paste.
4608. § 520.1638 Oxibendazole.
4609. § 520.1660 Oxytetracycline.
4610. § 520.1660a [Reserved]
4611. § 520.1660b Oxytetracycline capsules.
4612. § 520.1660c Oxytetracycline tablets.
4613. § 520.1660d Oxytetracycline powder.
4614. § 520.1664 Oxytetracycline and carbomycin.
4615. § 520.1696 Penicillin.
4616. § 520.1696a Penicillin G powder.
4617. § 520.1696c Penicillin V tablets.
4618. § 520.1705 Pergolide.
4619. § 520.1720 Phenylbutazone oral dosage forms.
4620. § 520.1720a Phenylbutazone tablets and boluses.
4621. § 520.1720b Phenylbutazone granules.
4622. § 520.1720c Phenylbutazone paste.
4623. § 520.1720d Phenylbutazone gel.
4624. § 520.1720e Phenylbutazone powder.
4625. § 520.1760 Phenylpropanolamine.
4626. § 520.1780 Pimobendan tablets.
4627. § 520.1782 Pimobendan solution.
4628. § 520.1802 Piperazine-carbon disulfide complex oral dosage forms.
4629. § 520.1802a Piperazine-carbon disulfide complex suspension.
4630. § 520.1802b Piperazine-carbon disulfide complex boluses.
4631. § 520.1802c Piperazine-carbon disulfide complex with phenothiazine suspension.
4632. § 520.1803 Piperazine citrate capsules.
4633. § 520.1805 Piperazine phosphate with thenium closylate tablets.
4634. § 520.1806 Piperazine suspension.
4635. § 520.1840 Poloxalene.
4636. § 520.1855 Ponazuril.
4637. § 520.1858 Potassium bromide chewable tablets.
4638. § 520.1860 Pradofloxacin.
4639. § 520.1870 Praziquantel tablets.
4640. § 520.1871 Praziquantel and pyrantel.
4641. § 520.1872 Praziquantel, pyrantel pamoate, and febantel tablets.
4642. § 520.1880 Prednisolone.
4643. § 520.1892 Pregabalin.
4644. § 520.1900 Primidone.
4645. § 520.1920 Prochlorperazine and isopropamide.
4646. § 520.1921 Prochlorperazine, isopropamide, and neomycin.
4647. § 520.1962 Promazine.
4648. § 520.2002 Propiopromazine.
4649. § 520.2041 Pyrantel pamoate chewable tablets.
4650. § 520.2042 Pyrantel pamoate tablets.
4651. § 520.2043 Pyrantel pamoate suspension.
4652. § 520.2044 Pyrantel pamoate paste.
4653. § 520.2045 Pyrantel tartrate powder.
4654. § 520.2046 Pyrantel tartrate pellets.
4655. § 520.2075 Robenacoxib.
4656. § 520.2086 Sarolaner.
4657. § 520.2090 Sarolaner, moxidectin, and pyrantel.
4658. § 520.2098 Selegiline.
4659. § 520.2100 Selenium and vitamin E.
4660. § 520.2123 Spectinomycin oral dosage forms.
4661. § 520.2123a Spectinomycin tablets.
4662. § 520.2123b Spectinomycin powder.
4663. § 520.2123c Spectinomycin solution.
4664. § 520.2130 Spinosad.
4665. § 520.2134 Spinosad and milbemycin.
4666. § 520.2138 Spironolactone and benazepril.
4667. § 520.2150 Stanozolol.
4668. § 520.2158 Streptomycin.
4669. § 520.2184 Sulfachloropyrazine.
4670. § 520.2200 Sulfachlorpyridazine.
4671. § 520.2215 Sulfadiazine/pyrimethamine suspension.
4672. § 520.2218 Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder.
4673. § 520.2220 Sulfadimethoxine oral dosage forms.
4674. § 520.2220a Sulfadimethoxine oral solution and soluble powder.
4675. § 520.2220b Sulfadimethoxine suspension.
4676. § 520.2220c Sulfadimethoxine tablet.
4677. § 520.2220d Sulfadimethoxine bolus.
4678. § 520.2220e Sulfadimethoxine extended-release bolus.
4679. § 520.2220f Sulfadimethoxine and ormetoprim tablet.
4680. § 520.2240 Sulfaethoxypyridazine.
4681. § 520.2240a Sulfaethoxypyridazine solution.
4682. § 520.2240b Sulfaethoxypyridazine tablets.
4683. § 520.2260 Sulfamethazine oral dosage forms.
4684. § 520.2260a Sulfamethazine oblets and boluses.
4685. § 520.2260b Sulfamethazine sustained-release boluses.
4686. § 520.2260c Sulfamethazine sustained-release tablets.
4687. § 520.2261 Sulfamethazine sodium oral dosage forms.
4688. § 520.2261a Sulfamethazine solution.
4689. § 520.2261b Sulfamethazine powder.
4690. § 520.2280 Sulfamethizole and methenamine.
4691. § 520.2325 Sulfaquinoxaline oral dosage forms.
4692. § 520.2325a Sulfaquinoxaline powder and solution.
4693. § 520.2325b Sulfaquinoxaline drench.
4694. § 520.2330 Sulfisoxazole tablets.
4695. § 520.2335 Telmisartan.
4696. § 520.2340 Tepoxalin.
4697. § 520.2345 Tetracycline.
4698. § 520.2345a Tetracycline capsules.
4699. § 520.2345b Tetracycline tablets.
4700. § 520.2345c Tetracycline boluses.
4701. § 520.2345d Tetracycline powder.
4702. § 520.2345e Tetracycline solution.
4703. § 520.2345f Tetracycline phosphate complex and sodium novobiocin capsules.
4704. § 520.2345g Tetracycline hydrochloride and sodium novobiocin tablets.
4705. § 520.2345h Tetracycline hydrochloride, sodium novobiocin, and prednisolone tablets.
4706. § 520.2362 Thenium closylate.
4707. § 520.2382 Thiabendazole and triclorfon.
4708. § 520.2455 Tiamulin.
4709. § 520.2471 Tilmicosin.
4710. § 520.2473 Tioxidazole oral dosage forms.
4711. § 520.2473a Tioxidazole granules.
4712. § 520.2473b Tioxidazole paste.
4713. § 520.2475 Toceranib.
4714. § 520.2520 Trichlorfon oral dosage forms.
4715. § 520.2520a Trichlorfon and atropine.
4716. § 520.2520b Trichlorfon boluses.
4717. § 520.2520c Trichlorfon granules.
4718. § 520.2520d Trichlorfon, phenothiazine, and piperazine.
4719. § 520.2582 Triflupromazine.
4720. § 520.2598 Trilostane.
4721. § 520.2604 Trimeprazine and prednisolone tablets.
4722. § 520.2605 Trimeprazine and prednisolone capsules.
4723. § 520.2610 Trimethoprim and sulfadiazine tablets.
4724. § 520.2611 Trimethoprim and sulfadiazine paste.
4725. § 520.2612 Trimethoprim and sulfadiazine suspension.
4726. § 520.2613 Trimethoprim and sulfadiazine powder.
4727. § 520.2640 Tylosin.
4728. § 520.2645 Tylvalosin.
4729. § 520.2654 Velagliflozin.
4730. § 520.2700 Verdinexor tablets.
4731. PART 522 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
4732. § 522.23 Acepromazine.
4733. § 522.52 Alfaxalone.
4734. § 522.56 Amikacin.
4735. § 522.62 Aminopentamide.
4736. § 522.82 Aminopropazine.
4737. § 522.88 Amoxicillin.
4738. § 522.90 Ampicillin injectable dosage forms.
4739. § 522.90a Ampicillin trihydrate suspension.
4740. § 522.90b Ampicillin trihydrate powder for injection.
4741. § 522.90c Ampicillin sodium.
4742. § 522.144 Arsenamide.
4743. § 522.147 Atipamezole.
4744. § 522.150 Azaperone.
4745. § 522.158 Bedinvetmab.
4746. § 522.161 Betamethasone.
4747. § 522.163 Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension.
4748. § 522.167 Betamethasone sodium phosphate and betamethasone acetate.
4749. § 522.204 Boldenone.
4750. § 522.224 Bupivacaine.
4751. § 522.230 Buprenorphine.
4752. § 522.234 Butamisole.
4753. § 522.246 Butorphanol.
4754. § 522.275 N-Butylscopolammonium.
4755. § 522.304 Carprofen.
4756. § 522.311 Cefovecin.
4757. § 522.313 Ceftiofur injectable dosage forms.
4758. § 522.313a Ceftiofur crystalline free acid.
4759. § 522.313b Ceftiofur hydrochloride.
4760. § 522.313c Ceftiofur sodium.
4761. § 522.380 Chloral hydrate, pentobarbital, and magnesium sulfate.
4762. § 522.390 Chloramphenicol.
4763. § 522.454 Clodronate.
4764. § 522.460 Cloprostenol.
4765. § 522.468 Colistimethate sodium powder for injection.
4766. § 522.480 Corticotropin.
4767. § 522.500 Cosyntropin injection.
4768. § 522.522 Danofloxacin.
4769. § 522.533 Deslorelin.
4770. § 522.535 Desoxycorticosterone.
4771. § 522.536 Detomidine.
4772. § 522.540 Dexamethasone solution.
4773. § 522.558 Dexmedetomidine.
4774. § 522.563 Diatrizoate.
4775. § 522.650 Dihydrostreptomycin sulfate injection.
4776. § 522.690 Dinoprost.
4777. § 522.723 Diprenorphine.
4778. § 522.770 Doramectin.
4779. § 522.772 Doramectin and levamisole.
4780. § 522.784 Doxylamine.
4781. § 522.800 Droperidol and fentanyl.
4782. § 522.810 Embutramide, chloroquine, and lidocaine solution.
4783. § 522.812 Enrofloxacin.
4784. § 522.814 Eprinomectin.
4785. § 522.820 Erythromycin.
4786. § 522.840 Estradiol.
4787. § 522.850 Estradiol valerate and norgestomet in combination.
4788. § 522.863 Ethylisobutrazine.
4789. § 522.883 Etorphine.
4790. § 522.914 Fenprostalene.
4791. § 522.930 Firocoxib.
4792. § 522.955 Florfenicol.
4793. § 522.956 Florfenicol and flunixin.
4794. § 522.960 Flumethasone injectable dosage forms.
4795. § 522.960a Flumethasone suspension.
4796. § 522.960b Flumethasone acetate solution.
4797. § 522.960c Flumethasone solution.
4798. § 522.970 Flunixin.
4799. § 522.995 Fluprostenol.
4800. § 522.998 Fluralaner.
4801. § 522.1002 Follicle stimulating hormone.
4802. § 522.1008 Frunevetmab.
4803. § 522.1010 Furosemide.
4804. § 522.1014 Gamithromycin.
4805. § 522.1020 Gelatin.
4806. § 522.1044 Gentamicin.
4807. § 522.1055 Gleptoferron.
4808. § 522.1066 Glycopyrrolate.
4809. § 522.1077 Gonadorelin.
4810. § 522.1079 Serum gonadotropin and chorionic gonadotropin.
4811. § 522.1081 Chorionic gonadotropin.
4812. § 522.1083 Gonadotropin releasing factor analog-diphtheria toxoid conjugate.
4813. § 522.1085 Guaifenesin powder for injection.
4814. § 522.1086 Guaifenesin solution.
4815. § 522.1125 Hemoglobin glutamer-200 (bovine).
4816. § 522.1145 Hyaluronate.
4817. § 522.1155 Imidocarb powder for injection.
4818. § 522.1156 Imidocarb solution.
4819. § 522.1160 Insulin.
4820. § 522.1182 Iron injection.
4821. § 522.1185 Isoflupredone.
4822. § 522.1192 Ivermectin.
4823. § 522.1193 Ivermectin and clorsulon.
4824. § 522.1204 Kanamycin.
4825. § 522.1222 Ketamine.
4826. § 522.1223 Ketamine, promazine, and aminopentamide.
4827. § 522.1225 Ketoprofen.
4828. § 522.1242 Levamisole.
4829. § 522.1260 Lincomycin.
4830. § 522.1289 Lufenuron.
4831. § 522.1290 Luprostiol.
4832. § 522.1315 Maropitant.
4833. § 522.1335 Medetomidine.
4834. § 522.1338 Medetomidine and vatinoxan.
4835. § 522.1350 Melatonin implant.
4836. § 522.1362 Melarsomine powder for injection.
4837. § 522.1367 Meloxicam.
4838. § 522.1372 Mepivacaine.
4839. § 522.1380 Methocarbamol.
4840. § 522.1410 Methylprednisolone.
4841. § 522.1450 Moxidectin solution.
4842. § 522.1451 Moxidectin microspheres for injection.
4843. § 522.1452 Nalorphine.
4844. § 522.1465 Naltrexone.
4845. § 522.1468 Naproxen for injection.
4846. § 522.1484 Neomycin.
4847. § 522.1503 Neostigmine.
4848. § 522.1610 Oleate sodium.
4849. § 522.1660 Oxytetracycline injectable dosage forms.
4850. § 522.1660a Oxytetracycline solution, 200 milligrams/milliliter.
4851. § 522.1660b Oxytetracycline solution, 300 milligrams/milliliter.
4852. § 522.1662 Oxytetracycline.
4853. § 522.1663 Oxytetracycline hydrochloride with lidocaine injection.
4854. § 522.1664 Oxytetracycline and flunixin.
4855. § 522.1680 Oxytocin.
4856. § 522.1684 Pegbovigrastim.
4857. § 522.1696 Penicillin G procaine injectable dosage forms.
4858. § 522.1696a Penicillin G benzathine and penicillin G procaine suspension.
4859. § 522.1696b Penicillin G procaine aqueous suspension.
4860. § 522.1696c Penicillin G procaine in oil.
4861. § 522.1698 Pentazocine.
4862. § 522.1700 Pentobarbital and phenytoin.
4863. § 522.1703 Pentobarbital.
4864. § 522.1704 Pentosan polysulfate sodium.
4865. § 522.1720 Phenylbutazone.
4866. § 522.1820 Pituitary luteinizing hormone powder for injection.
4867. § 522.1850 Polysulfated glycosaminoglycan.
4868. § 522.1860 Pradofloxacin.
4869. § 522.1862 Pralidoxime powder for injection.
4870. § 522.1870 Praziquantel.
4871. § 522.1881 Prednisolone acetate.
4872. § 522.1883 Prednisolone sodium phosphate.
4873. § 522.1884 Prednisolone sodium succinate.
4874. § 522.1890 Prednisone suspension.
4875. § 522.1920 Prochlorperazine and isopropamide.
4876. § 522.1940 Progesterone and estradiol benzoate.
4877. § 522.1962 Promazine.
4878. § 522.2002 Propiopromazine.
4879. § 522.2005 Propofol.
4880. § 522.2012 Prostalene.
4881. § 522.2063 Pyrilamine.
4882. § 522.2065 Rabacfosadine.
4883. § 522.2075 Robenacoxib.
4884. § 522.2076 Romifidine.
4885. § 522.2092 Secobarbital and dibucaine.
4886. § 522.2100 Selenium and vitamin E.
4887. § 522.2112 Sometribove zinc suspension.
4888. § 522.2120 Spectinomycin hydrochloride.
4889. § 522.2121 Spectinomycin sulfate.
4890. § 522.2150 Stanozolol.
4891. § 522.2220 Sulfadimethoxine.
4892. § 522.2240 Sulfaethoxypyridazine.
4893. § 522.2260 Sulfamethazine.
4894. § 522.2340 Sulfomyxin.
4895. § 522.2343 Testosterone propionate and estradiol benzoate.
4896. § 522.2404 Thialbarbitone sodium for injection.
4897. § 522.2424 Thiamylal.
4898. § 522.2444 Thiopental injectable dosage forms.
4899. § 522.2444a Thiopental powder for injection.
4900. § 522.2444b Thiopental and pentobarbital powder for injection.
4901. § 522.2450 Tigilanol.
4902. § 522.2460 Tildipirosin.
4903. § 522.2470 Tiletamine and zolazepam.
4904. § 522.2471 Tilmicosin.
4905. § 522.2473 Tiludronate.
4906. § 522.2474 Tolazoline.
4907. § 522.2476 Trenbolone acetate.
4908. § 522.2477 Trenbolone acetate and estradiol.
4909. § 522.2478 Trenbolone acetate and estradiol benzoate.
4910. § 522.2483 Triamcinolone.
4911. § 522.2582 Triflupromazine.
4912. § 522.2610 Trimethoprim and sulfadiazine.
4913. § 522.2615 Tripelennamine.
4914. § 522.2630 Tulathromycin.
4915. § 522.2632 Tulathromycin and ketoprofen.
4916. § 522.2640 Tylosin.
4917. § 522.2662 Xylazine.
4918. § 522.2670 Yohimbine.
4919. § 522.2680 Zeranol.
4920. § 522.2690 Zinc gluconate.
4921. § 522.2694 Zinc, copper, manganese, and selenium.
4922. PART 524 OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
4923. § 524.86 Amitraz.
4924. § 524.154 Bacitracin, neomycin, and polymyxin B ophthalmic ointment.
4925. § 524.155 Bacitracin, neomycin, polymyxin B, and hydrocortisone ophthalmic ointment.
4926. § 524.230 Buprenorphine.
4927. § 524.390 Chloramphenicol ophthalmic ointment.
4928. § 524.402 Chlorhexidine.
4929. § 524.450 Clotrimazole.
4930. § 524.463 Copper naphthenate.
4931. § 524.575 Cyclosporine ophthalmic ointment.
4932. § 524.590 Diclofenac.
4933. § 524.660 Dimethyl sulfoxide.
4934. § 524.770 Doramectin.
4935. § 524.775 Emodepside and praziquantel.
4936. § 524.802 Enrofloxacin and silver sulfadiazine otic emulsion.
4937. § 524.814 Eprinomectin.
4938. § 524.815 Eprinomectin and praziquantel.
4939. § 524.838 Esafoxolaner, eprinomectin, and praziquantel.
4940. § 524.900 Famphur.
4941. § 524.920 Fenthion.
4942. § 524.955 Florfenicol, terbinafine, and betamethasone acetate otic gel.
4943. § 524.957 Florfenicol, terbinafine, and mometasone otic solution.
4944. § 524.960 Flumethasone, neomycin, and polymyxin B ophthalmic solution.
4945. § 524.970 Flunixin.
4946. 1 Fluocinolone Topical and Otic Dosage Forms
4947. § 524.981 [Reserved]
4948. § 524.981a Fluocinolone cream.
4949. § 524.981b Fluocinolone solution.
4950. § 524.981c Fluocinolone and neomycin cream.
4951. § 524.981d Fluocinolone and dimethyl sulfoxide solution.
4952. § 524.981e Fluocinolone and dimethyl sulfoxide otic solution.
4953. § 524.998 Fluralaner.
4954. § 524.1001 Fluralaner and moxidectin.
4955. § 524.1005 Furazolidone powder.
4956. § 524.1044 Gentamicin ophthalmic and topical dosage forms.
4957. § 524.1044a Gentamicin ophthalmic solution.
4958. § 524.1044b Gentamicin and betamethasone otic solution.
4959. § 524.1044c Gentamicin ophthalmic ointment.
4960. § 524.1044d Gentamicin and betamethasone ointment.
4961. § 524.1044e Gentamicin spray.
4962. § 524.1044f Gentamicin and betamethasone spray.
4963. § 524.1044g Gentamicin, betamethasone, and clotrimazole ointment.
4964. § 524.1044h Gentamicin, mometasone, and clotrimazole otic suspension.
4965. § 524.1044i Gentamicin and betamethasone ophthalmic solution.
4966. § 524.1132 Hydrocortisone, miconazole, and gentamicin otic suspension.
4967. § 524.1140 Imidacloprid and ivermectin.
4968. § 524.1144j Gentamicin, posaconazole, and mometasone furoate otic suspension.
4969. § 524.1146 Imidacloprid and moxidectin.
4970. § 524.1193 Ivermectin topical solution.
4971. § 524.1195 Ivermectin otic suspension.
4972. § 524.1200 Kanamycin ophthalmic and topical dosage forms.
4973. § 524.1200a Kanamycin ophthalmic ointment.
4974. § 524.1200b Kanamycin ophthalmic solution.
4975. § 524.1204 Kanamycin, amphomycin, and hydrocortisone ointment.
4976. § 524.1240 Levamisole.
4977. § 524.1312 Marbofloxacin, terbinafine, and dexamethasone otic suspension.
4978. § 524.1376 2-Mercaptobenzothiazole solution.
4979. § 524.1443 Miconazole.
4980. § 524.1445 Miconazole, polymixin B, and prednisolone suspension.
4981. § 524.1446 Milbemycin otic solution.
4982. § 524.1448 Mirtazapine transdermal ointment.
4983. § 524.1450 Moxidectin.
4984. § 524.1465 Mupirocin.
4985. § 524.1484 Neomycin ophthalmic and topical dosage forms.
4986. § 524.1484b Neomycin, isoflupredone, and tetracaine powder.
4987. § 524.1484c Neomycin, isoflupredone, and tetracaine ointment.
4988. § 524.1484d Neomycin, hydrocortisone, and tetracaine otic ointment.
4989. § 524.1484e Neomycin and polymyxin B ophthalmic solution.
4990. § 524.1484f Neomycin, prednisolone, and tetracaine otic suspension.
4991. § 524.1484g Neomycin, thiabendazole, and dexamethasone solution.
4992. § 524.1484h Neomycin, penicillin, polymyxin B, and hydrocortisone suspension.
4993. § 524.1484i Neomycin and hydrocortisone ointment.
4994. § 524.1484k Neomycin and prednisolone suspension.
4995. § 524.1580 Nitrofurazone topical dosage forms.
4996. § 524.1580a Nitrofurazone ointment.
4997. § 524.1580b Nitrofurazone soluble powder.
4998. § 524.1600 Nystatin ophthalmic and topical dosage forms.
4999. § 524.1600a Nystatin, neomycin, thiostrepton, and triamcinolone ointment.
5000. § 524.1600b Nystatin, neomycin, thiostrepton, and triamcinolone ophthalmic ointment.
5001. § 524.1610 Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension.
5002. § 524.1662 Oxytetracycline ophthalmic and topical dosage forms.
5003. § 524.1662a Oxytetracycline and hydrocortisone spray.
5004. § 524.1662b Oxytetracycline and polymyxin B ophthalmic ointment.
5005. § 524.1742 Phosmet emulsifiable liquid.
5006. § 524.1982 Proparacaine ophthalmic solution.
5007. § 524.2080 Ropinirole.
5008. § 524.2098 Selamectin.
5009. § 524.2099 Selamectin and sarolaner.
5010. § 524.2101 Selenium disulfide suspension.
5011. § 524.2338 Terbinafine and betamethasone acetate.
5012. § 524.2350 Tolnaftate cream.
5013. § 524.2482 Triamcinolone spray.
5014. § 524.2620 Liquid crystalline trypsin, Peru balsam, castor oil.
5015. PART 526 INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
5016. § 526.88 Amoxicillin.
5017. § 526.313 Ceftiofur.
5018. § 526.363 Cephapirin benzathine.
5019. § 526.365 Cephapirin sodium.
5020. § 526.464 Cloxacillin benzathine.
5021. § 526.465 Cloxacillin sodium.
5022. § 526.820 Erythromycin.
5023. § 526.1130 Hetacillin.
5024. § 526.1590 Novobiocin.
5025. § 526.1696 Penicillin G procaine.
5026. § 526.1697 Penicillin G procaine and dihydrostreptomycin.
5027. § 526.1698 Penicillin G procaine and novobiocin.
5028. § 526.1810 Pirlimycin.
5029. PART 528 INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS
5030. § 528.1080 Bc2371 recombinant deoxyribonucleic acid construct.
5031. § 528.1092 opAFP-GHc2 recombinant deoxyribonucleic acid construct.
5032. § 528.2000 Deletion of exon 7 of CD163 gene in domestic pigs.
5033. § 528.2001 pPL657 recombinant deoxyribonucleic acid construct.
5034. § 528.2010 Human lysosomal acid lipase recombinant deoxyribonucleic acid construct.
5035. PART 529 CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
5036. § 529.56 Amikacin.
5037. § 529.382 Chloramine-T.
5038. § 529.400 Chlorhexidine tablets and suspension.
5039. § 529.443 Ciclesonide.
5040. § 529.536 Detomidine.
5041. § 529.539 Dexmedetomidine.
5042. § 529.778 Doxycycline.
5043. § 529.1004 Formalin.
5044. § 529.1044 Gentamicin in certain other dosage forms.
5045. § 529.1044a Gentamicin solution for infusion.
5046. § 529.1044b Gentamicin solution for dipping eggs.
5047. § 529.1115 Halothane.
5048. § 529.1150 Hydrogen peroxide.
5049. § 529.1186 Isoflurane.
5050. § 529.1350 Meloxicam.
5051. § 529.1660 Oxytetracycline.
5052. § 529.1940 Progesterone intravaginal inserts.
5053. § 529.2110 Sevoflurane.
5054. § 529.2464 Ticarcillin.
5055. § 529.2503 Tricaine methanesulfonate.
5056. § 529.2620 Triptorelin.
5057. PART 530 EXTRALABEL DRUG USE IN ANIMALS
5058. Subpart A General Provisions
5059. § 530.1 Scope.
5060. § 530.2 Purpose.
5061. § 530.3 Definitions.
5062. § 530.4 Advertising and promotion.
5063. § 530.5 Veterinary records.
5064. Subpart B Rules and Provisions for Extralabel Uses of Drugs in Animals
5065. § 530.10 Provision permitting extralabel use of animal drugs.
5066. § 530.11 Limitations.
5067. § 530.12 Labeling.
5068. § 530.13 Extralabel use from compounding of approved new animal and approved human drugs.
5069. Subpart C Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals
5070. § 530.20 Conditions for permitted extralabel animal and human drug use in food-producing animals.
5071. § 530.21 Prohibitions for food-producing animals.
5072. § 530.22 Safe levels and analytical methods for food-producing animals.
5073. § 530.23 Procedure for setting and announcing safe levels.
5074. § 530.24 Procedure for announcing analytical methods for drug residue quantification.
5075. § 530.25 Orders prohibiting extralabel uses for drugs in food-producing animals.
5076. Subpart D Extralabel Use of Human and Animal Drugs in Animals Not Intended for Human Consumption
5077. § 530.30 Extralabel drug use in nonfood animals.
5078. Subpart E Safe Levels for Extralabel Use of Drugs in Animals and Drugs Prohibited From Extralabel Use in Animals
5079. § 530.40 Safe levels and availability of analytical methods.
5080. § 530.41 Drugs prohibited for extralabel use in animals.
5081. PART 556 TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
5082. Subpart A General Provisions
5083. § 556.1 Scope.
5084. § 556.3 Definitions.
5085. § 556.5 General considerations.
5086. Subpart B Specific Tolerances for Residues of Approved and Conditionally Approved New Animal Drugs
5087. § 556.34 Albendazole.
5088. § 556.36 Altrenogest.
5089. § 556.38 Amoxicillin.
5090. § 556.40 Ampicillin.
5091. § 556.50 Amprolium.
5092. § 556.52 Apramycin.
5093. § 556.60 Avilamycin.
5094. § 556.68 Azaperone.
5095. § 556.70 Bacitracin.
5096. § 556.75 Bambermycins.
5097. § 556.100 Carbadox.
5098. § 556.110 Carbomycin.
5099. § 556.113 Ceftiofur.
5100. § 556.115 Cephapirin.
5101. § 556.118 Chloramine-T.
5102. § 556.120 Chlorhexidine.
5103. § 556.150 Chlortetracycline.
5104. § 556.160 Clopidol.
5105. § 556.163 Clorsulon.
5106. § 556.165 Cloxacillin.
5107. § 556.167 Colistimethate.
5108. § 556.168 Coumaphos.
5109. § 556.169 Danofloxacin.
5110. § 556.170 Decoquinate.
5111. § 556.180 Dichlorvos.
5112. § 556.185 Diclazuril.
5113. § 556.200 Dihydrostreptomycin.
5114. § 556.222 Doramectin.
5115. § 556.224 Efrotomycin.
5116. § 556.226 Enrofloxacin.
5117. § 556.227 Eprinomectin.
5118. § 556.230 Erythromycin.
5119. § 556.240 Estradiol and related esters.
5120. § 556.260 Ethopabate.
5121. § 556.273 Famphur.
5122. § 556.275 Fenbendazole.
5123. § 556.277 Fenprostalene.
5124. § 556.280 Fenthion.
5125. § 556.283 Florfenicol.
5126. § 556.286 Flunixin.
5127. § 556.290 Fluralaner.
5128. § 556.292 Gamithromycin.
5129. § 556.300 Gentamicin.
5130. § 556.304 Gonadotropin.
5131. § 556.308 Halofuginone.
5132. § 556.310 Haloxon.
5133. § 556.316 Hetacillin.
5134. § 556.330 Hygromycin B.
5135. § 556.344 Ivermectin.
5136. § 556.345 Ketoprofen.
5137. § 556.346 Laidlomycin.
5138. § 556.347 Lasalocid.
5139. § 556.350 Levamisole.
5140. § 556.360 Lincomycin.
5141. § 556.370 Lubabegron.
5142. § 556.375 Maduramicin.
5143. § 556.380 Melengestrol.
5144. § 556.410 Metoserpate.
5145. § 556.420 Monensin.
5146. § 556.425 Morantel.
5147. § 556.426 Moxidectin.
5148. § 556.428 Narasin.
5149. § 556.430 Neomycin.
5150. § 556.445 Nicarbazin.
5151. § 556.460 Novobiocin.
5152. § 556.470 Nystatin.
5153. § 556.490 Ormetoprim.
5154. § 556.495 Oxfendazole.
5155. § 556.500 Oxytetracycline.
5156. § 556.510 Penicillin.
5157. § 556.515 Pirlimycin.
5158. § 556.517 Poloxalene.
5159. § 556.530 Pradofloxacin.
5160. § 556.540 Progesterone.
5161. § 556.560 Pyrantel.
5162. § 556.570 Ractopamine.
5163. § 556.580 Robenidine.
5164. § 556.592 Salinomycin.
5165. § 556.597 Semduramicin.
5166. § 556.600 Spectinomycin.
5167. § 556.610 Streptomycin.
5168. § 556.625 Sulfachloropyrazine.
5169. § 556.630 Sulfachlorpyridazine.
5170. § 556.640 Sulfadimethoxine.
5171. § 556.650 Sulfaethoxypyridazine.
5172. § 556.660 Sulfamerazine.
5173. § 556.670 Sulfamethazine.
5174. § 556.685 Sulfaquinoxaline.
5175. § 556.700 Sulfomyxin.
5176. § 556.710 Testosterone.
5177. § 556.720 Tetracycline.
5178. § 556.732 Tiamulin.
5179. § 556.733 Tildipirosin.
5180. § 556.735 Tilmicosin.
5181. § 556.739 Trenbolone.
5182. § 556.741 Tripelennamine.
5183. § 556.745 Tulathromycin.
5184. § 556.746 Tylosin.
5185. § 556.748 Tylvalosin.
5186. § 556.750 Virginiamycin.
5187. § 556.760 Zeranol.
5188. § 556.765 Zilpaterol.
5189. § 556.770 Zoalene.
5190. PART 558 NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
5191. Subpart A General Provisions
5192. § 558.3 Definitions and general considerations applicable to this part.
5193. § 558.4 Requirement of a medicated feed mill license.
5194. § 558.5 Requirements for liquid medicated feed.
5195. § 558.6 Veterinary feed directive drugs.
5196. Subpart B Specific New Animal Drugs for Use in Animal Feeds
5197. § 558.55 Amprolium.
5198. § 558.58 Amprolium and ethopabate.
5199. § 558.59 Apramycin.
5200. § 558.68 Avilamycin.
5201. § 558.76 Bacitracin methylenedisalicylate.
5202. § 558.78 Bacitracin zinc.
5203. § 558.95 Bambermycins.
5204. § 558.115 Carbadox.
5205. § 558.128 Chlortetracycline.
5206. § 558.140 Chlortetracycline and sulfamethazine.
5207. § 558.175 Clopidol.
5208. § 558.185 Coumaphos.
5209. § 558.195 Decoquinate.
5210. § 558.198 Dichlorvos.
5211. § 558.205 Diclazuril.
5212. § 558.235 Efrotomycin.
5213. § 558.248 Erythromycin.
5214. § 558.254 Famphur.
5215. § 558.258 Fenbendazole.
5216. § 558.261 Florfenicol.
5217. § 558.265 Halofuginone.
5218. § 558.274 Hygromycin B.
5219. § 558.295 Iodinated casein.
5220. § 558.300 Ivermectin.
5221. § 558.305 Laidlomycin propionate potassium.
5222. § 558.311 Lasalocid.
5223. § 558.325 Lincomycin.
5224. § 558.330 Lubabegron.
5225. § 558.340 Maduramicin.
5226. § 558.342 Melengestrol.
5227. § 558.348 Mibolerone.
5228. § 558.355 Monensin.
5229. § 558.360 Morantel.
5230. § 558.363 Narasin.
5231. § 558.364 Narasin and nicarbazin.
5232. § 558.365 Neomycin sulfate.
5233. § 558.366 Nicarbazin.
5234. § 558.415 Novobiocin.
5235. § 558.430 Nystatin.
5236. § 558.450 Oxytetracycline.
5237. § 558.455 Oxytetracycline and neomycin.
5238. § 558.464 Poloxalene.
5239. § 558.470 Polyoxyethylene.
5240. § 558.485 Pyrantel.
5241. § 558.500 Ractopamine.
5242. § 558.515 Robenidine.
5243. § 558.550 Salinomycin.
5244. § 558.555 Semduramicin.
5245. § 558.575 Sulfadimethoxine and ormetoprim.
5246. § 558.582 Sulfamerazine.
5247. § 558.586 Sulfaquinoxaline.
5248. § 558.612 Tiamulin.
5249. § 558.618 Tilmicosin.
5250. § 558.625 Tylosin.
5251. § 558.630 Tylosin and sulfamethazine.
5252. § 558.633 Tylvalosin.
5253. § 558.635 Virginiamycin.
5254. § 558.665 Zilpaterol.
5255. § 558.680 Zoalene.
5256. 564 PART 564 [RESERVED]
5257. PART 570 FOOD ADDITIVES
5258. Subpart A General Provisions
5259. § 570.3 Definitions.
5260. § 570.6 Opinion letters on food additive status.
5261. § 570.13 Indirect food additives resulting from packaging materials prior sanctioned for animal feed and pet food.
5262. § 570.14 Indirect food additives resulting from packaging materials for animal feed and pet food.
5263. § 570.15 Adoption of regulation on initiative of Commissioner.
5264. § 570.17 Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.
5265. § 570.18 Tolerances for related food additives.
5266. § 570.19 Pesticide chemicals in processed foods.
5267. Subpart B Food Additive Safety
5268. § 570.20 General principles for evaluating the safety of food additives.
5269. § 570.30 Eligibility for classification as generally recognized as safe (GRAS).
5270. § 570.35 Affirmation of generally recognized as safe (GRAS) status.
5271. § 570.38 Determination of food additive status.
5272. C Subparts C-D [Reserved]
5273. Subpart E Generally Recognized as Safe (GRAS) Notice
5274. § 570.203 Definitions.
5275. § 570.205 Opportunity to submit a GRAS notice.
5276. § 570.210 How to send your GRAS notice to FDA.
5277. § 570.215 Incorporation into a GRAS notice.
5278. § 570.220 General requirements applicable to a GRAS notice.
5279. § 570.225 Part 1 of a GRAS notice: Signed statements and certification.
5280. § 570.230 Part 2 of a GRAS notice: Identity, method of manufacture, specifications, and physical or technical effect.
5281. § 570.235 Part 3 of a GRAS notice: Target animal and human exposures.
5282. § 570.240 Part 4 of a GRAS notice: Self-limiting levels of use.
5283. § 570.245 Part 5 of a GRAS notice: Experience based on common use in food before 1958.
5284. § 570.250 Part 6 of a GRAS notice: Narrative.
5285. § 570.255 Part 7 of a GRAS notice: List of supporting data and information in your GRAS notice.
5286. § 570.260 Steps you may take before FDA responds to your GRAS notice.
5287. § 570.265 What FDA will do with a GRAS notice.
5288. § 570.275 Public disclosure of a GRAS notice.
5289. § 570.280 Submission of a supplement.
5290. PART 571 FOOD ADDITIVE PETITIONS
5291. Subpart A General Provisions
5292. § 571.1 Petitions.
5293. § 571.6 Amendment of petition.
5294. § 571.7 Withdrawal of petition without prejudice.
5295. Subpart B Administrative Actions on Applications
5296. § 571.100 Regulation based on petition.
5297. § 571.102 Effective date of regulation.
5298. § 571.110 Procedure for objections and hearings.
5299. § 571.115 Application of the cancer clause of section 409 of the act.
5300. § 571.130 Procedure for amending and repealing tolerances or exemptions from tolerances.
5301. PART 573 FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS
5302. A Subpart A [Reserved]
5303. Subpart B Food Additive Listing
5304. § 573.120 Acrylamide-acrylic acid resin.
5305. § 573.130 Aminoglycoside 3′-phospho- transferase II.
5306. § 573.140 Ammoniated cottonseed meal.
5307. § 573.160 Ammoniated rice hulls.
5308. § 573.170 Ammonium formate.
5309. § 573.180 Anhydrous ammonia.
5310. § 573.200 Condensed animal protein hydrolysate.
5311. § 573.210 Benzoic acid.
5312. § 573.220 Feed-grade biuret.
5313. § 573.225 1,3-Butylene glycol.
5314. § 573.230 Calcium formate.
5315. § 573.240 Calcium periodate.
5316. § 573.260 Calcium silicate.
5317. § 573.280 Feed-grade calcium stearate and sodium stearate.
5318. § 573.300 Choline xanthate.
5319. § 573.302 Chromium DL-methionine chelate.
5320. § 573.304 Chromium propionate.
5321. § 573.310 Crambe meal, heat toasted.
5322. § 573.320 Diammonium phosphate.
5323. § 573.340 Diatomaceous earth.
5324. § 573.360 Disodium EDTA.
5325. § 573.380 Ethoxyquin in animal feeds.
5326. § 573.400 Ethoxyquin in certain dehydrated forage crops.
5327. § 573.420 Ethyl cellulose.
5328. § 573.440 Ethylene dichloride.
5329. § 573.450 Fermented ammoniated condensed whey.
5330. § 573.460 Formaldehyde.
5331. § 573.480 Formic acid.
5332. § 573.485 Fumonisin esterase.
5333. § 573.490 Gamma-linolenic acid safflower meal.
5334. § 573.492 Gamma-linolenic acid safflower oil.
5335. § 573.496 Guanidinoacetic acid.
5336. § 573.500 Condensed, extracted glutamic acid fermentation product.
5337. § 573.520 Hemicellulose extract.
5338. § 573.530 Hydrogenated corn syrup.
5339. § 573.540 Hydrolyzed leather meal.
5340. § 573.550 25-hydroxyvitamin D3.
5341. § 573.560 Iron ammonium citrate.
5342. § 573.580 Iron-choline citrate complex.
5343. § 573.587 Komagataella pastoris dried yeast.
5344. § 573.600 Lignin sulfonates.
5345. § 573.615 Marine microalgae.
5346. § 573.620 Menadione dimethylpyrimidinol bisulfite.
5347. § 573.625 Menadione nicotinamide bisulfite.
5348. § 573.637 Methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12-octadecadienoic acids).
5349. § 573.640 Methyl esters of higher fatty acids.
5350. § 573.660 Methyl glucoside-coconut oil ester.
5351. § 573.680 Mineral oil.
5352. § 573.685 Natamycin.
5353. § 573.696 Feed grade sodium formate.
5354. § 573.700 Sodium nitrite.
5355. § 573.720 Petrolatum.
5356. § 573.740 Odorless light petroleum hydrocarbons.
5357. § 573.760 Poloxalene.
5358. § 573.780 Polyethylene.
5359. § 573.800 Polyethylene glycol (400) mono- and dioleate.
5360. § 573.820 Polyoxyethylene glycol (400) mono- and dioleates.
5361. § 573.840 Polysorbate 60.
5362. § 573.860 Polysorbate 80.
5363. § 573.870 Poly(2-vinylpyridine-co-styrene).
5364. § 573.880 Normal propyl alcohol.
5365. § 573.900 Pyrophyllite.
5366. § 573.914 Salts of volatile fatty acids.
5367. § 573.920 Selenium.
5368. § 573.940 Silicon dioxide.
5369. § 573.960 Sorbitan monostearate.
5370. § 573.980 Taurine.
5371. § 573.1000 Verxite.
5372. § 573.1010 Xanthan gum.
5373. § 573.1020 Yellow prussiate of soda.
5374. PART 579 IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD
5375. Subpart A General Provisions
5376. § 579.12 Incorporation of regulations in part 179.
5377. Subpart B Radiation and Radiation Sources
5378. § 579.22 Ionizing radiation for treatment of animal diets.
5379. § 579.40 Ionizing radiation for the treatment of poultry feed and poultry feed ingredients.
5380. PART 582 SUBSTANCES GENERALLY RECOGNIZED AS SAFE
5381. Subpart A General Provisions
5382. § 582.1 Substances that are generally recognized as safe.
5383. § 582.10 Spices and other natural seasonings and flavorings.
5384. § 582.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).
5385. § 582.30 Natural substances used in conjunction with spices and other natural seasonings and flavorings.
5386. § 582.40 Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings.
5387. § 582.50 Certain other spices, seasonings, essential oils, oleoresins, and natural extracts.
5388. § 582.60 Synthetic flavoring substances and adjuvants.
5389. § 582.80 Trace minerals added to animal feeds.
5390. § 582.99 Adjuvants for pesticide chemicals.
5391. Subpart B General Purpose Food Additives
5392. § 582.1005 Acetic acid.
5393. § 582.1009 Adipic acid.
5394. § 582.1033 Citric acid.
5395. § 582.1057 Hydrochloric acid.
5396. § 582.1061 Lactic acid.
5397. § 582.1069 Malic acid.
5398. § 582.1073 Phosphoric acid.
5399. § 582.1077 Potassium acid tartrate.
5400. § 582.1087 Sodium acid pyrophosphate.
5401. § 582.1091 Succinic acid.
5402. § 582.1095 Sulfuric acid.
5403. § 582.1099 Tartaric acid.
5404. § 582.1125 Aluminum sulfate.
5405. § 582.1127 Aluminum ammonium sulfate.
5406. § 582.1129 Aluminum potassium sulfate.
5407. § 582.1131 Aluminum sodium sulfate.
5408. § 582.1135 Ammonium bicarbonate.
5409. § 582.1137 Ammonium carbonate.
5410. § 582.1139 Ammonium hydroxide.
5411. § 582.1141 Ammonium phosphate.
5412. § 582.1143 Ammonium sulfate.
5413. § 582.1155 Bentonite.
5414. § 582.1165 Butane.
5415. § 582.1191 Calcium carbonate.
5416. § 582.1193 Calcium chloride.
5417. § 582.1195 Calcium citrate.
5418. § 582.1199 Calcium gluconate.
5419. § 582.1205 Calcium hydroxide.
5420. § 582.1207 Calcium lactate.
5421. § 582.1210 Calcium oxide.
5422. § 582.1217 Calcium phosphate.
5423. § 582.1235 Caramel.
5424. § 582.1240 Carbon dioxide.
5425. § 582.1275 Dextrans.
5426. § 582.1320 Glycerin.
5427. § 582.1324 Glyceryl monostearate.
5428. § 582.1355 Helium.
5429. § 582.1366 Hydrogen peroxide.
5430. § 582.1400 Lecithin.
5431. § 582.1425 Magnesium carbonate.
5432. § 582.1428 Magnesium hydroxide.
5433. § 582.1431 Magnesium oxide.
5434. § 582.1480 Methylcellulose.
5435. § 582.1500 Monoammonium glutamate.
5436. § 582.1516 Monopotassium glutamate.
5437. § 582.1540 Nitrogen.
5438. § 582.1585 Papain.
5439. § 582.1613 Potassium bicarbonate.
5440. § 582.1619 Potassium carbonate.
5441. § 582.1625 Potassium citrate.
5442. § 582.1631 Potassium hydroxide.
5443. § 582.1643 Potassium sulfate.
5444. § 582.1655 Propane.
5445. § 582.1666 Propylene glycol.
5446. § 582.1685 Rennet.
5447. § 582.1711 Silica aerogel.
5448. § 582.1721 Sodium acetate.
5449. § 582.1736 Sodium bicarbonate.
5450. § 582.1742 Sodium carbonate.
5451. § 582.1745 Sodium carboxymethylcellulose.
5452. § 582.1748 Sodium caseinate.
5453. § 582.1751 Sodium citrate.
5454. § 582.1763 Sodium hydroxide.
5455. § 582.1775 Sodium pectinate.
5456. § 582.1778 Sodium phosphate.
5457. § 582.1781 Sodium aluminum phosphate.
5458. § 582.1792 Sodium sesquicarbonate.
5459. § 582.1804 Sodium potassium tartrate.
5460. § 582.1810 Sodium tripolyphosphate.
5461. § 582.1901 Triacetin.
5462. § 582.1973 Beeswax.
5463. § 582.1975 Bleached beeswax.
5464. § 582.1978 Carnauba wax.
5465. Subpart C Anticaking Agents
5466. § 582.2122 Aluminum calcium silicate.
5467. § 582.2227 Calcium silicate.
5468. § 582.2437 Magnesium silicate.
5469. § 582.2727 Sodium aluminosilicate.
5470. § 582.2729 Hydrated sodium calcium aluminosilicate.
5471. § 582.2906 Tricalcium silicate.
5472. Subpart D Chemical Preservatives
5473. § 582.3013 Ascorbic acid.
5474. § 582.3021 Benzoic acid.
5475. § 582.3041 Erythorbic acid.
5476. § 582.3081 Propionic acid.
5477. § 582.3089 Sorbic acid.
5478. § 582.3109 Thiodipropionic acid.
5479. § 582.3149 Ascorbyl palmitate.
5480. § 582.3169 Butylated hydroxyanisole.
5481. § 582.3173 Butylated hydroxytoluene.
5482. § 582.3189 Calcium ascorbate.
5483. § 582.3221 Calcium propionate.
5484. § 582.3225 Calcium sorbate.
5485. § 582.3280 Dilauryl thiodipropionate.
5486. § 582.3336 Gum guaiac.
5487. § 582.3490 Methylparaben.
5488. § 582.3616 Potassium bisulfite.
5489. § 582.3637 Potassium metabisulfite.
5490. § 582.3640 Potassium sorbate.
5491. § 582.3660 Propyl gallate.
5492. § 582.3670 Propylparaben.
5493. § 582.3731 Sodium ascorbate.
5494. § 582.3733 Sodium benzoate.
5495. § 582.3739 Sodium bisulfite.
5496. § 582.3766 Sodium metabisulfite.
5497. § 582.3784 Sodium propionate.
5498. § 582.3795 Sodium sorbate.
5499. § 582.3798 Sodium sulfite.
5500. § 582.3845 Stannous chloride.
5501. § 582.3862 Sulfur dioxide.
5502. § 582.3890 Tocopherols.
5503. Subpart E Emulsifying Agents
5504. § 582.4101 Diacetyl tartaric acid esters of mono- and diglycerides of edible fats or oils, or edible fat-forming fatty acids.
5505. § 582.4505 Mono- and diglycerides of edible fats or oils, or edible fat-forming acids.
5506. § 582.4521 Monosodium phosphate derivatives of mono- and diglycerides of edible fats or oils, or edible fat-forming fatty acids.
5507. § 582.4666 Propylene glycol.
5508. Subpart F Nutrients and/or Dietary Supplements 1
5509. § 582.5013 Ascorbic acid.
5510. § 582.5017 Aspartic acid.
5511. § 582.5049 Aminoacetic acid.
5512. § 582.5065 Linoleic acid.
5513. § 582.5118 Alanine.
5514. § 582.5145 Arginine.
5515. § 582.5159 Biotin.
5516. § 582.5191 Calcium carbonate.
5517. § 582.5195 Calcium citrate.
5518. § 582.5201 Calcium glycerophosphate.
5519. § 582.5210 Calcium oxide.
5520. § 582.5212 Calcium pantothenate.
5521. § 582.5217 Calcium phosphate.
5522. § 582.5223 Calcium pyrophosphate.
5523. § 582.5230 Calcium sulfate.
5524. § 582.5245 Carotene.
5525. § 582.5250 Choline bitartrate.
5526. § 582.5252 Choline chloride.
5527. § 582.5260 Copper gluconate.
5528. § 582.5271 Cysteine.
5529. § 582.5273 Cystine.
5530. § 582.5301 Ferric phosphate.
5531. § 582.5304 Ferric pyrophosphate.
5532. § 582.5306 Ferric sodium pyrophosphate.
5533. § 582.5308 Ferrous gluconate.
5534. § 582.5311 Ferrous lactate.
5535. § 582.5315 Ferrous sulfate.
5536. § 582.5361 Histidine.
5537. § 582.5370 Inositol.
5538. § 582.5375 Iron reduced.
5539. § 582.5381 Isoleucine.
5540. § 582.5406 Leucine.
5541. § 582.5411 Lysine.
5542. § 582.5431 Magnesium oxide.
5543. § 582.5434 Magnesium phosphate.
5544. § 582.5443 Magnesium sulfate.
5545. § 582.5446 Manganese chloride.
5546. § 582.5449 Manganese citrate.
5547. § 582.5452 Manganese gluconate.
5548. § 582.5455 Manganese glycerophosphate.
5549. § 582.5458 Manganese hypophosphite.
5550. § 582.5461 Manganese sulfate.
5551. § 582.5464 Manganous oxide.
5552. § 582.5470 Mannitol.
5553. § 582.5475 Methionine.
5554. § 582.5477 Methionine hydroxy analog and its calcium salts.
5555. § 582.5530 Niacin.
5556. § 582.5535 Niacinamide.
5557. § 582.5580 D-Pantothenyl alcohol.
5558. § 582.5590 Phenylalanine.
5559. § 582.5622 Potassium chloride.
5560. § 582.5628 Potassium glycerophosphate.
5561. § 582.5634 Potassium iodide.
5562. § 582.5650 Proline.
5563. § 582.5676 Pyridoxine hydrochloride.
5564. § 582.5695 Riboflavin.
5565. § 582.5697 Riboflavin-5-phosphate.
5566. § 582.5701 Serine.
5567. § 582.5772 Sodium pantothenate.
5568. § 582.5778 Sodium phosphate.
5569. § 582.5835 Sorbitol.
5570. § 582.5875 Thiamine hydrochloride.
5571. § 582.5878 Thiamine mononitrate.
5572. § 582.5881 Threonine.
5573. § 582.5890 Tocopherols.
5574. § 582.5892 a-Tocopherol acetate.
5575. § 582.5915 Tryptophane.
5576. § 582.5920 Tyrosine.
5577. § 582.5925 Valine.
5578. § 582.5930 Vitamin A.
5579. § 582.5933 Vitamin A acetate.
5580. § 582.5936 Vitamin A palmitate.
5581. § 582.5945 Vitamin B12.
5582. § 582.5950 Vitamin D2.
5583. § 582.5953 Vitamin D3.
5584. § 582.5985 Zinc chloride.
5585. § 582.5988 Zinc gluconate.
5586. § 582.5991 Zinc oxide.
5587. § 582.5994 Zinc stearate.
5588. § 582.5997 Zinc sulfate.
5589. Subpart G Sequestrants 2
5590. § 582.6033 Citric acid.
5591. § 582.6085 Sodium acid phosphate.
5592. § 582.6099 Tartaric acid.
5593. § 582.6185 Calcium acetate.
5594. § 582.6193 Calcium chloride.
5595. § 582.6195 Calcium citrate.
5596. § 582.6197 Calcium diacetate.
5597. § 582.6199 Calcium gluconate.
5598. § 582.6203 Calcium hexametaphosphate.
5599. § 582.6215 Monobasic calcium phosphate.
5600. § 582.6219 Calcium phytate.
5601. § 582.6285 Dipotassium phosphate.
5602. § 582.6290 Disodium phosphate.
5603. § 582.6386 Isopropyl citrate.
5604. § 582.6511 Monoisopropyl citrate.
5605. § 582.6625 Potassium citrate.
5606. § 582.6751 Sodium citrate.
5607. § 582.6754 Sodium diacetate.
5608. § 582.6757 Sodium gluconate.
5609. § 582.6760 Sodium hexametaphosphate.
5610. § 582.6769 Sodium metaphosphate.
5611. § 582.6778 Sodium phosphate.
5612. § 582.6787 Sodium pyrophosphate.
5613. § 582.6789 Tetra sodium pyrophosphate.
5614. § 582.6801 Sodium tartrate.
5615. § 582.6804 Sodium potassium tartrate.
5616. § 582.6807 Sodium thiosulfate.
5617. § 582.6810 Sodium tripolyphosphate.
5618. § 582.6851 Stearyl citrate.
5619. Subpart H Stabilizers
5620. § 582.7115 Agar-agar.
5621. § 582.7133 Ammonium alginate.
5622. § 582.7187 Calcium alginate.
5623. § 582.7255 Chondrus extract.
5624. § 582.7330 Gum arabic.
5625. § 582.7333 Gum ghatti.
5626. § 582.7339 Guar gum.
5627. § 582.7343 Locust bean gum.
5628. § 582.7349 Sterculia gum.
5629. § 582.7351 Gum tragacanth.
5630. § 582.7610 Potassium alginate.
5631. § 582.7724 Sodium alginate.
5632. PART 584 FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS
5633. A Subpart A [Reserved]
5634. Subpart B Listing of Specific Substances Affirmed as GRAS
5635. § 584.200 Ethyl alcohol containing ethyl acetate.
5636. § 584.700 Hydrophobic silicas.
5637. § 584.725 25-Hydroxyvitamin D3.
5638. PART 589 SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
5639. Subpart A General Provisions
5640. § 589.1 Substances prohibited from use in animal food or feed.
5641. Subpart B Listing of Specific Substances Prohibited From Use in Animal Food or Feed
5642. § 589.1000 Gentian violet.
5643. § 589.1001 Propylene glycol in or on cat food.
5644. § 589.2000 Animal proteins prohibited in ruminant feed.
5645. § 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy.
5646. 590-599 PARTS 590-599 [RESERVED]
5647. CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
5648. SUBCHAPTER F BIOLOGICS
5649. PART 600 BIOLOGICAL PRODUCTS: GENERAL
5650. Subpart A General Provisions
5651. § 600.2 Mailing addresses.
5652. § 600.3 Definitions.
5653. Subpart B Establishment Standards
5654. § 600.10 Personnel.
5655. § 600.11 Physical establishment, equipment, animals, and care.
5656. § 600.12 Records.
5657. § 600.13 Retention samples.
5658. § 600.14 Reporting of biological product deviations by licensed manufacturers.
5659. § 600.15 Temperatures during shipment.
5660. Subpart C Establishment Inspection
5661. § 600.20 Inspectors.
5662. § 600.21 Time of inspection.
5663. § 600.22 [Reserved]
5664. Subpart D Reporting of Adverse Experiences
5665. § 600.80 Postmarketing reporting of adverse experiences.
5666. § 600.81 Distribution reports.
5667. § 600.82 Notification of a permanent discontinuance or an interruption in manufacturing.
5668. § 600.90 Waivers.
5669. PART 601 LICENSING
5670. Subpart A General Provisions
5671. § 601.2 Applications for biologics licenses; procedures for filing.
5672. § 601.3 Complete response letter to the applicant.
5673. § 601.4 Issuance and denial of license.
5674. § 601.5 Revocation of license.
5675. § 601.6 Suspension of license.
5676. § 601.7 Procedure for hearings.
5677. § 601.8 Publication of revocation.
5678. § 601.9 Licenses; reissuance.
5679. B Subpart B [Reserved]
5680. Subpart C Biologics Licensing
5681. § 601.12 Changes to an approved application.
5682. § 601.14 Regulatory submissions in electronic format.
5683. § 601.15 Foreign establishments and products: samples for each importation.
5684. § 601.20 Biologics licenses; issuance and conditions.
5685. § 601.21 Products under development.
5686. § 601.22 Products in short supply; initial manufacturing at other than licensed location.
5687. § 601.27 Pediatric studies.
5688. § 601.28 Annual reports of postmarketing pediatric studies.
5689. § 601.29 Guidance documents.
5690. Subpart D Diagnostic Radiopharmaceuticals
5691. § 601.30 Scope.
5692. § 601.31 Definition.
5693. § 601.32 General factors relevant to safety and effectiveness.
5694. § 601.33 Indications.
5695. § 601.34 Evaluation of effectiveness.
5696. § 601.35 Evaluation of safety.
5697. Subpart E Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
5698. § 601.40 Scope.
5699. § 601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
5700. § 601.42 Approval with restrictions to assure safe use.
5701. § 601.43 Withdrawal procedures.
5702. § 601.44 Postmarketing safety reporting.
5703. § 601.45 Promotional materials.
5704. § 601.46 Termination of requirements.
5705. Subpart F Confidentiality of Information
5706. § 601.50 Confidentiality of data and information in an investigational new drug notice for a biological product.
5707. § 601.51 Confidentiality of data and information in applications for biologics licenses.
5708. Subpart G Postmarketing Studies
5709. § 601.70 Annual progress reports of postmarketing studies.
5710. Subpart H Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible
5711. § 601.90 Scope.
5712. § 601.91 Approval based on evidence of effectiveness from studies in animals.
5713. § 601.92 Withdrawal procedures.
5714. § 601.93 Postmarketing safety reporting.
5715. § 601.94 Promotional materials.
5716. § 601.95 Termination of requirements.
5717. PART 606 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
5718. Subpart A General Provisions
5719. § 606.3 Definitions.
5720. Subpart B Organization and Personnel
5721. § 606.20 Personnel.
5722. Subpart C Plant and Facilities
5723. § 606.40 Facilities.
5724. Subpart D Equipment
5725. § 606.60 Equipment.
5726. § 606.65 Supplies and reagents.
5727. E Subpart E [Reserved]
5728. Subpart F Production and Process Controls
5729. § 606.100 Standard operating procedures.
5730. § 606.110 Plateletpheresis, leukapheresis, and plasmapheresis.
5731. Subpart G Additional Labeling Standards for Blood and Blood Components
5732. § 606.120 Labeling, general requirements.
5733. § 606.121 Container label.
5734. § 606.122 Circular of information.
5735. Subpart H Laboratory Controls
5736. § 606.140 Laboratory controls.
5737. § 606.145 Control of bacterial contamination of platelets.
5738. § 606.151 Compatibility testing.
5739. Subpart I Records and Reports
5740. § 606.160 Records.
5741. § 606.165 Distribution and receipt; procedures and records.
5742. § 606.170 Adverse reaction file.
5743. § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.
5744. PART 607 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES
5745. Subpart A General Provisions
5746. § 607.1 Scope.
5747. § 607.3 Definitions.
5748. § 607.7 Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.
5749. Subpart B Procedures for Domestic Blood Product Establishments
5750. § 607.20 Who must register and submit a blood product list.
5751. § 607.21 Times for establishment registration and blood product listing.
5752. § 607.22 How to register establishments and list blood products.
5753. § 607.25 Information required for establishment registration and blood product listing.
5754. § 607.26 Amendments to establishment registration.
5755. § 607.30 Updating blood product listing information.
5756. § 607.31 Additional blood product listing information.
5757. § 607.35 Blood product establishment registration number.
5758. § 607.37 Public disclosure of establishment registration and blood product listing information.
5759. § 607.39 Misbranding by reference to establishment registration, validation of registration, or to registration number.
5760. Subpart C Procedures for Foreign Blood Product Establishments
5761. § 607.40 Establishment registration and blood product listing requirements for foreign blood product establishments.
5762. Subpart D Exemptions
5763. § 607.65 Exemptions for blood product establishments.
5764. Subpart E Establishment Registration and Product Listing Of Licensed Devices
5765. § 607.80 Applicability of part 607 to licensed devices.
5766. PART 610 GENERAL BIOLOGICAL PRODUCTS STANDARDS
5767. Subpart A Release Requirements
5768. § 610.1 Tests prior to release required for each lot.
5769. § 610.2 Requests for samples and protocols; official release.
5770. Subpart B General Provisions
5771. § 610.9 Equivalent methods and processes.
5772. § 610.10 Potency.
5773. § 610.11-610.11a [Reserved]
5774. § 610.12 Sterility.
5775. § 610.13 Purity.
5776. § 610.14 Identity.
5777. § 610.15 Constituent materials.
5778. § 610.16 Total solids in serums.
5779. § 610.17 Permissible combinations.
5780. § 610.18 Cultures.
5781. Subparts C D [Reserved]
5782. Subpart E Testing Requirements for Relevant Transfusion-Transmitted Infections
5783. § 610.39 Definitions.
5784. § 610.40 Test requirements.
5785. § 610.41 Donor deferral.
5786. § 610.42 Restrictions on use for further manufacture of medical devices.
5787. § 610.44 Use of reference panels by manufacturers of test kits.
5788. § 610.46 Human immunodeficiency virus (HIV) “lookback” requirements.
5789. § 610.47 Hepatitis C virus (HCV) “lookback” requirements.
5790. § 610.48 [Reserved]
5791. Subpart F Dating Period Limitations
5792. § 610.50 Date of manufacture for biological products.
5793. § 610.53 Dating periods for Whole Blood and blood components.
5794. Subpart G Labeling Standards
5795. § 610.60 Container label.
5796. § 610.61 Package label.
5797. § 610.62 Proper name; package label; legible type.
5798. § 610.63 Divided manufacturing responsibility to be shown.
5799. § 610.64 Name and address of distributor.
5800. § 610.65 Products for export.
5801. § 610.67 Bar code label requirements.
5802. § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.
5803. PART 630 REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE
5804. Subpart A General Provisions
5805. § 630.1 Purpose and scope.
5806. § 630.3 Definitions.
5807. Subpart B Donor Eligibility Requirements
5808. § 630.5 Medical supervision.
5809. § 630.10 General donor eligibility requirements.
5810. § 630.15 Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis.
5811. § 630.20 Exceptions for certain ineligible donors.
5812. § 630.25 Exceptions from certain donor eligibility requirements for infrequent plasma donors.
5813. § 630.30 Donation suitability requirements.
5814. § 630.35 Requalification of previously deferred donors.
5815. Subpart C Donor Notification
5816. § 630.40 Requirements for notifying deferred donors.
5817. PART 640 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
5818. Subpart A Whole Blood
5819. § 640.1 Whole Blood.
5820. § 640.2 General requirements.
5821. § 640.4 Collection of the blood.
5822. § 640.5 Testing the blood.
5823. § 640.6 Modifications of Whole Blood.
5824. Subpart B Red Blood Cells
5825. § 640.10 Red Blood Cells.
5826. § 640.11 General requirements.
5827. § 640.12 Eligibility of donor.
5828. § 640.13 Collection of the blood.
5829. § 640.14 Testing the blood.
5830. § 640.15 Segments for testing.
5831. § 640.16 Processing.
5832. § 640.17 Modifications for specific products.
5833. Subpart C Platelets
5834. § 640.20 Platelets.
5835. § 640.21 Eligibility of donors.
5836. § 640.22 Collection of source material.
5837. § 640.23 Testing the blood.
5838. § 640.24 Processing.
5839. § 640.25 General requirements.
5840. Subpart D Plasma
5841. § 640.30 Plasma.
5842. § 640.31 Eligibility of donors.
5843. § 640.32 Collection of source material.
5844. § 640.33 Testing the blood.
5845. § 640.34 Processing.
5846. E Subpart E [Reserved]
5847. Subpart F Cryoprecipitate
5848. § 640.50 Cryoprecipitated AHF.
5849. § 640.51 Eligibility of donors.
5850. § 640.52 Collection of source material.
5851. § 640.53 Testing the blood.
5852. § 640.54 Processing.
5853. § 640.55 U.S. Standard preparation.
5854. § 640.56 Quality control test for potency.
5855. Subpart G Source Plasma
5856. § 640.60 Source Plasma.
5857. § 640.64 Collection of blood for Source Plasma.
5858. § 640.65 Plasmapheresis.
5859. § 640.66 Immunization of donors.
5860. § 640.67 Laboratory tests.
5861. § 640.68 Processing.
5862. § 640.69 General requirements.
5863. § 640.71 Manufacturing responsibility.
5864. § 640.72 Records.
5865. § 640.73 Reporting of fatal donor reactions.
5866. § 640.74 Modification of Source Plasma.
5867. § 640.76 Products stored or shipped at unacceptable temperatures.
5868. Subpart H Albumin (Human)
5869. § 640.80 Albumin (Human).
5870. § 640.81 Processing.
5871. § 640.82 Tests on final product.
5872. § 640.83 General requirements.
5873. § 640.84 Labeling.
5874. Subpart I Plasma Protein Fraction (Human)
5875. § 640.90 Plasma Protein Fraction (Human).
5876. § 640.91 Processing.
5877. § 640.92 Tests on final product.
5878. § 640.93 General requirements.
5879. § 640.94 Labeling.
5880. Subpart J Immune Globulin (Human)
5881. § 640.100 Immune Globulin (Human).
5882. § 640.101 General requirements.
5883. § 640.102 Manufacture of Immune Globulin (Human).
5884. § 640.103 The final product.
5885. § 640.104 Potency.
5886. K Subpart K [Reserved]
5887. Subpart L Alternative Procedures
5888. § 640.120 Alternative procedures.
5889. Subpart M Definitions and Medical Supervision
5890. § 640.125 Definitions.
5891. § 640.130 Medical supervision.
5892. PART 660 ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
5893. Subpart A Antibody to Hepatitis B Surface Antigen
5894. § 660.1 Antibody to Hepatitis B Surface Antigen.
5895. § 660.2 General requirements.
5896. § 660.3 Reference panel.
5897. § 660.4 Potency test.
5898. § 660.5 Specificity.
5899. § 660.6 Samples; protocols; official release.
5900. B Subpart B [Reserved]
5901. Subpart C Blood Grouping Reagent
5902. § 660.20 Blood Grouping Reagent.
5903. § 660.21 Processing.
5904. § 660.22 Potency requirements with reference preparations.
5905. § 660.25 Potency tests without reference preparations.
5906. § 660.26 Specificity tests and avidity tests.
5907. § 660.28 Labeling.
5908. Subpart D Reagent Red Blood Cells
5909. § 660.30 Reagent Red Blood Cells.
5910. § 660.31 Eligibility of donor.
5911. § 660.32 Collection of source material.
5912. § 660.33 Testing of source material.
5913. § 660.34 Processing.
5914. § 660.35 Labeling.
5915. § 660.36 Samples and protocols.
5916. Subpart E Hepatitis B Surface Antigen
5917. § 660.40 Hepatitis B Surface Antigen.
5918. § 660.41 Processing.
5919. § 660.43 Potency test.
5920. § 660.44 Specificity.
5921. § 660.45 Labeling.
5922. § 660.46 Samples; protocols; official release.
5923. Subpart F Anti-Human Globulin
5924. § 660.50 Anti-Human Globulin.
5925. § 660.51 Processing.
5926. § 660.52 Reference preparations.
5927. § 660.53 Controls for serological procedures.
5928. § 660.54 Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
5929. § 660.55 Labeling.
5930. PART 680 ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
5931. § 680.1 Allergenic Products.
5932. § 680.2 Manufacture of Allergenic Products.
5933. § 680.3 Tests.
5934. SUBCHAPTER G COSMETICS
5935. PART 700 GENERAL
5936. Subpart A General Provisions
5937. § 700.3 Definitions.
5938. Subpart B Requirements for Specific Cosmetic Products
5939. § 700.11 Cosmetics containing bithionol.
5940. § 700.13 Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs.
5941. § 700.14 Use of vinyl chloride as an ingredient, including propellant of cosmetic aerosol products.
5942. § 700.15 Use of certain halogenated salicylanilides as ingredients in cosmetic products.
5943. § 700.16 Use of aerosol cosmetic products containing zirconium.
5944. § 700.18 Use of chloroform as an ingredient in cosmetic products.
5945. § 700.19 Use of methylene chloride as an ingredient of cosmetic products.
5946. § 700.23 Chlorofluorocarbon propellants.
5947. § 700.25 Tamper-resistant packaging requirements for cosmetic products.
5948. § 700.27 Use of prohibited cattle materials in cosmetic products.
5949. § 700.35 Cosmetics containing sunscreen ingredients.
5950. PART 701 COSMETIC LABELING
5951. Subpart A General Provisions
5952. § 701.1 Misbranding.
5953. § 701.2 Form of stating labeling requirements.
5954. § 701.3 Designation of ingredients.
5955. § 701.9 Exemptions from labeling requirements.
5956. Subpart B Package Form
5957. § 701.10 Principal display panel.
5958. § 701.11 Identity labeling.
5959. § 701.12 Name and place of business of manufacturer, packer, or distributor.
5960. § 701.13 Declaration of net quantity of contents.
5961. Subpart C Labeling of Specific Ingredients
5962. § 701.20 Detergent substances, other than soap, intended for use in cleansing the body.
5963. § 701.30 Ingredient names established for cosmetic ingredient labeling.
5964. PART 710 VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS
5965. § 710.1 Who should register.
5966. § 710.2 Time for registration.
5967. § 710.3 How and where to register.
5968. § 710.4 Information requested.
5969. § 710.5 Amendments to registration.
5970. § 710.6 Notification of registrant; cosmetic product establishment registration number.
5971. § 710.7 Inspection of registrations.
5972. § 710.8 Misbranding by reference to registration or to registration number.
5973. § 710.9 Exemptions.
5974. PART 720 VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS
5975. § 720.1 Who should file.
5976. § 720.2 Times for filing.
5977. § 720.3 How and where to file.
5978. § 720.4 Information requested about cosmetic products.
5979. § 720.5 [Reserved]
5980. § 720.6 Amendments to statement.
5981. § 720.7 Notification of person submitting cosmetic product ingredient statement.
5982. § 720.8 Confidentiality of statements.
5983. § 720.9 Misbranding by reference to filing or to statement number.
5984. PART 740 COSMETIC PRODUCT WARNING STATEMENTS
5985. Subpart A General
5986. § 740.1 Establishment of warning statements.
5987. § 740.2 Conspicuousness of warning statements.
5988. Subpart B Warning Statements
5989. § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.
5990. § 740.11 Cosmetics in self-pressurized containers.
5991. § 740.12 Feminine deodorant sprays.
5992. § 740.17 Foaming detergent bath products.
5993. § 740.18 Coal tar hair dyes posing a risk of cancer.
5994. § 740.19 Suntanning preparations.
5995. 741-799 PARTS 741-799 [RESERVED]
5996. CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
5997. SUBCHAPTER H MEDICAL DEVICES
5998. PART 800 GENERAL
5999. A Subpart A [Reserved]
6000. Subpart B Requirements for Specific Medical Devices
6001. § 800.10 Contact lens solutions; sterility.
6002. § 800.12 Contact lens solutions and tablets; tamper-resistant packaging.
6003. § 800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration.
6004. § 800.30 Over-the-counter hearing aid controls.
6005. Subpart C Administrative Practices and Procedures
6006. § 800.55 Administrative detention.
6007. § 800.75 Requests for supervisory review of certain decisions made by the Center for Devices and Radiological Health.
6008. PART 801 LABELING
6009. Subpart A General Labeling Provisions
6010. § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
6011. § 801.3 Definitions.
6012. § 801.4 Meaning of intended uses.
6013. § 801.5 Medical devices; adequate directions for use.
6014. § 801.6 Medical devices; misleading statements.
6015. § 801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
6016. § 801.16 Medical devices; Spanish-language version of certain required statements.
6017. § 801.18 Format of dates provided on a medical device label.
6018. Subpart B Labeling Requirements for Unique Device Identification
6019. § 801.20 Label to bear a unique device identifier.
6020. § 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
6021. § 801.35 Voluntary labeling of a device with a unique device identifier.
6022. § 801.40 Form of a unique device identifier.
6023. § 801.45 Devices that must be directly marked with a unique device identifier.
6024. § 801.50 Labeling requirements for stand-alone software.
6025. § 801.55 Request for an exception from or alternative to a unique device identifier requirement.
6026. § 801.57 Discontinuation of legacy FDA identification numbers assigned to devices.
6027. Subpart C Labeling Requirements for Over-the-Counter Devices
6028. § 801.60 Principal display panel.
6029. § 801.61 Statement of identity.
6030. § 801.62 Declaration of net quantity of contents.
6031. § 801.63 Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.
6032. Subpart D Exemptions From Adequate Directions for Use
6033. § 801.109 Prescription devices.
6034. § 801.110 Retail exemption for prescription devices.
6035. § 801.116 Medical devices having commonly known directions.
6036. § 801.119 In vitro diagnostic products.
6037. § 801.122 Medical devices for processing, repacking, or manufacturing.
6038. § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis.
6039. § 801.127 Medical devices; expiration of exemptions.
6040. § 801.128 Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
6041. Subpart E Other Exemptions
6042. § 801.150 Medical devices; processing, labeling, or repacking.
6043. F Subparts F-G [Reserved]
6044. Subpart H Special Requirements for Specific Devices
6045. § 801.405 Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
6046. § 801.410 Use of impact-resistant lenses in eyeglasses and sunglasses.
6047. § 801.415 Maximum acceptable level of ozone.
6048. § 801.417 Chlorofluorocarbon propellants.
6049. § 801.422 Prescription hearing aid labeling.
6050. § 801.430 User labeling for menstrual tampons.
6051. § 801.433 Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
6052. § 801.435 User labeling for latex condoms.
6053. § 801.437 User labeling for devices that contain natural rubber.
6054. PART 803 MEDICAL DEVICE REPORTING
6055. Subpart A General Provisions
6056. § 803.1 What does this part cover?
6057. § 803.3 How does FDA define the terms used in this part?
6058. § 803.9 What information from the reports do we disclose to the public?
6059. § 803.10 Generally, what are the reporting requirements that apply to me?
6060. § 803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms?
6061. § 803.12 How do I submit initial and supplemental or followup reports?
6062. § 803.13 Do I need to submit reports in English?
6063. § 803.15 How will I know if you require more information about my medical device report?
6064. § 803.16 When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
6065. § 803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
6066. § 803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me?
6067. § 803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
6068. Subpart B Generally Applicable Requirements for Individual Adverse Event Reports
6069. § 803.20 How do I complete and submit an individual adverse event report?
6070. § 803.21 Where can I find the reporting codes for adverse events that I use with medical device reports?
6071. § 803.22 What are the circumstances in which I am not required to file a report?
6072. § 803.23 Where can I find information on how to prepare and submit an MDR in electronic format?
6073. Subpart C User Facility Reporting Requirements
6074. § 803.30 If I am a user facility, what reporting requirements apply to me?
6075. § 803.32 If I am a user facility, what information must I submit in my individual adverse event reports?
6076. § 803.33 If I am a user facility, what must I include when I submit an annual report?
6077. Subpart D Importer Reporting Requirements
6078. § 803.40 If I am an importer, what reporting requirements apply to me?
6079. § 803.42 If I am an importer, what information must I submit in my individual adverse event reports?
6080. Subpart E Manufacturer Reporting Requirements
6081. § 803.50 If I am a manufacturer, what reporting requirements apply to me?
6082. § 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports?
6083. § 803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report?
6084. § 803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
6085. § 803.58 Foreign manufacturers.
6086. PART 806 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
6087. Subpart A General Provisions
6088. § 806.1 Scope.
6089. § 806.2 Definitions.
6090. Subpart B Reports and Records
6091. § 806.10 Reports of corrections and removals.
6092. § 806.20 Records of corrections and removals not required to be reported.
6093. § 806.30 FDA access to records.
6094. § 806.40 Public availability of reports.
6095. PART 807 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
6096. Subpart A General Provisions
6097. § 807.3 Definitions.
6098. Subpart B Procedures for Device Establishments
6099. § 807.20 Who must register and submit a device list?
6100. § 807.21 How to register establishments and list devices.
6101. § 807.22 Times for establishment registration and device listing.
6102. § 807.25 Information required for device establishment registration and device listing.
6103. § 807.26 Additional listing information.
6104. § 807.28 Updating device listing information.
6105. § 807.34 Summary of requirements for owners or operators granted a waiver from submitting required information electronically.
6106. § 807.35 Notification of registrant.
6107. § 807.37 Public availability of establishment registration and device listing information.
6108. § 807.39 Misbranding by reference to establishment registration or to registration number.
6109. Subpart C Procedures for Foreign Device Establishments
6110. § 807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.
6111. § 807.41 Identification of importers and persons who import or offer for import.
6112. Subpart D Exemptions
6113. § 807.65 Exemptions for device establishments.
6114. Subpart E Premarket Notification Procedures
6115. § 807.81 When a premarket notification submission is required.
6116. § 807.85 Exemption from premarket notification.
6117. § 807.87 Information required in a premarket notification submission.
6118. § 807.90 Format of a premarket notification submission.
6119. § 807.92 Content and format of a 510(k) summary.
6120. § 807.93 Content and format of a 510(k) statement.
6121. § 807.94 Format of a class III certification.
6122. § 807.95 Confidentiality of information.
6123. § 807.97 Misbranding by reference to premarket notification.
6124. § 807.100 FDA action on a premarket notification.
6125. PART 808 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
6126. Subpart A General Provisions
6127. § 808.1 Scope.
6128. § 808.3 Definitions.
6129. § 808.5 Advisory opinions.
6130. Subpart B Exemption Procedures
6131. § 808.20 Application.
6132. § 808.25 Procedures for processing an application.
6133. § 808.35 Revocation of an exemption.
6134. Subpart C Listing of Specific State and Local Exemptions
6135. § 808.53 [Reserved]
6136. § 808.55 California.
6137. §§ 808.57--808.101 [Reserved]
6138. PART 809 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
6139. Subpart A General Provisions
6140. § 809.3 Definitions.
6141. § 809.4 Confidentiality of submitted information.
6142. Subpart B Labeling
6143. § 809.10 Labeling for in vitro diagnostic products.
6144. § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
6145. Subpart C Requirements for Manufacturers and Producers
6146. § 809.20 General requirements for manufacturers and producers of in vitro diagnostic products.
6147. § 809.30 Restrictions on the sale, distribution and use of analyte specific reagents.
6148. § 809.40 Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.
6149. PART 810 MEDICAL DEVICE RECALL AUTHORITY
6150. Subpart A General Provisions
6151. § 810.1 Scope.
6152. § 810.2 Definitions.
6153. § 810.3 Computation of time.
6154. § 810.4 Service of orders.
6155. Subpart B Mandatory Medical Device Recall Procedures
6156. § 810.10 Cease distribution and notification order.
6157. § 810.11 Regulatory hearing.
6158. § 810.12 Written request for review of cease distribution and notification order.
6159. § 810.13 Mandatory recall order.
6160. § 810.14 Cease distribution and notification or mandatory recall strategy.
6161. § 810.15 Communications concerning a cease distribution and notification or mandatory recall order.
6162. § 810.16 Cease distribution and notification or mandatory recall order status reports.
6163. § 810.17 Termination of a cease distribution and notification or mandatory recall order.
6164. § 810.18 Public notice.
6165. PART 812 INVESTIGATIONAL DEVICE EXEMPTIONS
6166. Subpart A General Provisions
6167. § 812.1 Scope.
6168. § 812.2 Applicability.
6169. § 812.3 Definitions.
6170. § 812.5 Labeling of investigational devices.
6171. § 812.7 Prohibition of promotion and other practices.
6172. § 812.10 Waivers.
6173. § 812.18 Import and export requirements.
6174. § 812.19 Address for IDE correspondence.
6175. Subpart B Application and Administrative Action
6176. § 812.20 Application.
6177. § 812.25 Investigational plan.
6178. § 812.27 Report of prior investigations.
6179. § 812.28 Acceptance of data from clinical investigations conducted outside the United States.
6180. § 812.30 FDA action on applications.
6181. § 812.35 Supplemental applications.
6182. § 812.36 Treatment use of an investigational device.
6183. § 812.38 Confidentiality of data and information.
6184. Subpart C Responsibilities of Sponsors
6185. § 812.40 General responsibilities of sponsors.
6186. § 812.42 FDA and IRB approval.
6187. § 812.43 Selecting investigators and monitors.
6188. § 812.45 Informing investigators.
6189. § 812.46 Monitoring investigations.
6190. § 812.47 Emergency research under § 50.24 of this chapter.
6191. Subpart D IRB Review and Approval
6192. § 812.60 IRB composition, duties, and functions.
6193. § 812.62 IRB approval.
6194. § 812.64 IRB's continuing review.
6195. § 812.65 [Reserved]
6196. § 812.66 Significant risk device determinations.
6197. Subpart E Responsibilities of Investigators
6198. § 812.100 General responsibilities of investigators.
6199. § 812.110 Specific responsibilities of investigators.
6200. § 812.119 Disqualification of a clinical investigator.
6201. F Subpart F [Reserved]
6202. Subpart G Records and Reports
6203. § 812.140 Records.
6204. § 812.145 Inspections.
6205. § 812.150 Reports.
6206. 813 PART 813 [RESERVED]
6207. PART 814 PREMARKET APPROVAL OF MEDICAL DEVICES
6208. Subpart A General
6209. § 814.1 Scope.
6210. § 814.2 Purpose.
6211. § 814.3 Definitions.
6212. § 814.9 Confidentiality of data and information in a premarket approval application (PMA) file.
6213. § 814.15 Research conducted outside the United States.
6214. § 814.17 Service of orders.
6215. § 814.19 Product development protocol (PDP).
6216. Subpart B Premarket Approval Application (PMA)
6217. § 814.20 Application.
6218. § 814.37 PMA amendments and resubmitted PMAs.
6219. § 814.39 PMA supplements.
6220. Subpart C FDA Action on a PMA
6221. § 814.40 Time frames for reviewing a PMA.
6222. § 814.42 Filing a PMA.
6223. § 814.44 Procedures for review of a PMA.
6224. § 814.45 Denial of approval of a PMA.
6225. § 814.46 Withdrawal of approval of a PMA.
6226. § 814.47 Temporary suspension of approval of a PMA.
6227. Subpart D Administrative Review [Reserved]
6228. Subpart E Postapproval Requirements
6229. § 814.80 General.
6230. § 814.82 Postapproval requirements.
6231. § 814.84 Reports.
6232. F Subparts F-G [Reserved]
6233. Subpart H Humanitarian Use Devices
6234. § 814.100 Purpose and scope.
6235. § 814.102 Designation of HUD status.
6236. § 814.104 Original applications.
6237. § 814.106 HDE amendments and resubmitted HDE's.
6238. § 814.108 Supplemental applications.
6239. § 814.110 New indications for use.
6240. § 814.112 Filing an HDE.
6241. § 814.114 Timeframes for reviewing an HDE.
6242. § 814.116 Procedures for review of an HDE.
6243. § 814.118 Denial of approval or withdrawal of approval of an HDE.
6244. § 814.120 Temporary suspension of approval of an HDE.
6245. § 814.122 Confidentiality of data and information.
6246. § 814.124 Institutional Review Board requirements.
6247. § 814.126 Postapproval requirements and reports.
6248. PART 820 QUALITY MANAGEMENT SYSTEM REGULATION
6249. Subpart A General Provisions
6250. § 820.1 Scope.
6251. § 820.3 Definitions.
6252. § 820.5 [Reserved]
6253. § 820.7 Incorporation by reference.
6254. § 820.10 Requirements for a quality management system.
6255. Subpart B Supplemental Provisions
6256. §§ 820.20--820.30 [Reserved]
6257. § 820.35 Control of records.
6258. § 820.40 [Reserved]
6259. § 820.45 Device labeling and packaging controls.
6260. C Subparts C-O [Reserved]
6261. PART 821 MEDICAL DEVICE TRACKING REQUIREMENTS
6262. Subpart A General Provisions
6263. § 821.1 Scope.
6264. § 821.2 Exemptions and variances.
6265. § 821.3 Definitions.
6266. § 821.4 Imported devices.
6267. Subpart B Tracking Requirements
6268. § 821.20 Devices subject to tracking.
6269. § 821.25 Device tracking system and content requirements: manufacturer requirements.
6270. Subpart C Additional Requirements and Responsibilities
6271. § 821.30 Tracking obligations of persons other than device manufacturers: distributor requirements.
6272. Subpart D Records and Inspections
6273. § 821.50 Availability.
6274. § 821.55 Confidentiality.
6275. § 821.60 Retention of records.
6276. PART 822 POSTMARKET SURVEILLANCE
6277. Subpart A General Provisions
6278. § 822.1 What does this part cover?
6279. § 822.2 What is the purpose of this part?
6280. § 822.3 How do you define the terms used in this part?
6281. § 822.4 Does this part apply to me?
6282. Subpart B Notification
6283. § 822.5 How will I know if I must conduct postmarket surveillance?
6284. § 822.6 When will you notify me that I am required to conduct postmarket surveillance?
6285. § 822.7 What should I do if I do not agree that postmarket surveillance is appropriate?
6286. Subpart C Postmarket Surveillance Plan
6287. § 822.8 When, where, and how must I submit my postmarket surveillance plan?
6288. § 822.9 What must I include in my submission?
6289. § 822.10 What must I include in my surveillance plan?
6290. § 822.11 What should I consider when designing my plan to conduct postmarket surveillance?
6291. § 822.12 Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?
6292. § 822.13 [Reserved]
6293. § 822.14 May I reference information previously submitted instead of submitting it again?
6294. § 822.15 How long must I conduct postmarket surveillance of my device?
6295. Subpart D FDA Review and Action
6296. § 822.16 What will you consider in the review of my submission?
6297. § 822.17 How long will your review of my submission take?
6298. § 822.18 How will I be notified of your decision?
6299. § 822.19 What kinds of decisions may you make?
6300. § 822.20 What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct surveillance in accordance with my approved plan?
6301. § 822.21 What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?
6302. § 822.22 What recourse do I have if I do not agree with your decision?
6303. § 822.23 Is the information in my submission considered confidential?
6304. Subpart E Responsibilities of Manufacturers
6305. § 822.24 What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
6306. § 822.25 What are my responsibilities after my postmarket surveillance plan has been approved?
6307. § 822.26 If my company changes ownership, what must I do?
6308. § 822.27 If I go out of business, what must I do?
6309. § 822.28 If I stop marketing the device subject to postmarket surveillance, what must I do?
6310. Subpart F Waivers and Exemptions
6311. § 822.29 May I request a waiver of a specific requirement of this part?
6312. § 822.30 May I request exemption from the requirement to conduct postmarket surveillance?
6313. Subpart G Records and Reports
6314. § 822.31 What records am I required to keep?
6315. § 822.32 What records are the investigators in my surveillance plan required to keep?
6316. § 822.33 How long must we keep the records?
6317. § 822.34 What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
6318. § 822.35 Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
6319. § 822.36 Can you inspect and copy the records related to my postmarket surveillance plan?
6320. § 822.37 Under what circumstances would you inspect records identifying subjects?
6321. § 822.38 What reports must I submit to you?
6322. PART 830 UNIQUE DEVICE IDENTIFICATION
6323. Subpart A General Provisions
6324. § 830.3 Definitions.
6325. Subpart B Requirements for a Unique Device Identifier
6326. § 830.10 Incorporation by reference.
6327. § 830.20 Requirements for a unique device identifier.
6328. § 830.40 Use and discontinuation of a device identifier.
6329. § 830.50 Changes that require use of a new device identifier.
6330. § 830.60 Relabeling of a device that is required to bear a unique device identifier.
6331. Subpart C FDA Accreditation of an Issuing Agency
6332. § 830.100 FDA accreditation of an issuing agency.
6333. § 830.110 Application for accreditation as an issuing agency.
6334. § 830.120 Responsibilities of an FDA-accredited issuing agency.
6335. § 830.130 Suspension or revocation of the accreditation of an issuing agency.
6336. Subpart D FDA as an Issuing Agency
6337. § 830.200 When FDA will act as an issuing agency.
6338. § 830.210 Eligibility for use of FDA as an issuing agency.
6339. § 830.220 Termination of FDA service as an issuing agency.
6340. Subpart E Global Unique Device Identification Database
6341. § 830.300 Devices subject to device identification data submission requirements.
6342. § 830.310 Information required for unique device identification.
6343. § 830.320 Submission of unique device identification information.
6344. § 830.330 Times for submission of unique device identification information.
6345. § 830.340 Voluntary submission of ancillary device identification information.
6346. § 830.350 Correction of information submitted to the Global Unique Device Identification Database.
6347. § 830.360 Records to be maintained by the labeler.
6348. PART 860 MEDICAL DEVICE CLASSIFICATION PROCEDURES
6349. Subpart A General
6350. § 860.1 Scope.
6351. § 860.3 Definitions.
6352. § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification.
6353. § 860.7 Determination of safety and effectiveness.
6354. § 860.10 Implants and life-supporting or life-sustaining devices.
6355. § 860.15 Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.
6356. Subpart B Classification
6357. § 860.84 Classification procedures for “preamendments devices.”
6358. § 860.90 Consultation with panels.
6359. Subpart C Reclassification
6360. § 860.120 General.
6361. § 860.123 Reclassification petition: Content and form.
6362. § 860.125 Consultation with panels.
6363. § 860.130 General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.
6364. § 860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.
6365. § 860.133 Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.
6366. § 860.134 Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
6367. § 860.136 Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.
6368. Subpart D De Novo Classification
6369. § 860.200 Purpose and applicability.
6370. § 860.210 De Novo request format.
6371. § 860.220 De Novo request content.
6372. § 860.230 Accepting a De Novo request.
6373. § 860.240 Procedures for review of a De Novo request.
6374. § 860.250 Withdrawal of a De Novo request.
6375. § 860.260 Granting or declining a De Novo request.
6376. PART 861 PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
6377. Subpart A General
6378. § 861.1 Purpose and scope.
6379. § 861.5 Statement of policy.
6380. § 861.7 Contents of standards.
6381. Subpart B Procedures for Performance Standards Development and Publication
6382. § 861.20 Summary of standards development process.
6383. § 861.24 Existing standard as a proposed standard.
6384. § 861.30 Development of standards.
6385. § 861.34 Amendment or revocation of a standard.
6386. § 861.36 Effective dates.
6387. § 861.38 Standards advisory committees.
6388. PART 862 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
6389. Subpart A General Provisions
6390. § 862.1 Scope.
6391. § 862.2 Regulation of calibrators.
6392. § 862.3 Effective dates of requirement for premarket approval.
6393. § 862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
6394. Subpart B Clinical Chemistry Test Systems
6395. § 862.1020 Acid phosphatase (total or prostatic) test system.
6396. § 862.1025 Adrenocorticotropic hormone (ACTH) test system.
6397. § 862.1030 Alanine amino transferase (ALT/SGPT) test system.
6398. § 862.1035 Albumin test system.
6399. § 862.1040 Aldolase test system.
6400. § 862.1045 Aldosterone test system.
6401. § 862.1050 Alkaline phosphatase or isoenzymes test system.
6402. § 862.1055 Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
6403. § 862.1060 Delta-aminolevulinic acid test system.
6404. § 862.1065 Ammonia test system.
6405. § 862.1070 Amylase test system.
6406. § 862.1075 Androstenedione test system.
6407. § 862.1080 Androsterone test system.
6408. § 862.1085 Angiotensin I and renin test system.
6409. § 862.1090 Angiotensin converting enzyme (A.C.E.) test system.
6410. § 862.1092 Anti-mullerian hormone test system.
6411. § 862.1093 Menopause test system.
6412. § 862.1095 Ascorbic acid test system.
6413. § 862.1100 Aspartate amino transferase (AST/SGOT) test system.
6414. § 862.1110 Bilirubin (total or direct) test system.
6415. § 862.1113 Bilirubin (total and unbound) in the neonate test system.
6416. § 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system.
6417. § 862.1117 B-type natriuretic peptide test system.
6418. § 862.1118 Biotinidase test system.
6419. § 862.1120 Blood gases (PCO2, PO2) and blood pH test system.
6420. § 862.1130 Blood volume test system.
6421. § 862.1135 C-peptides of proinsulin test system.
6422. § 862.1140 Calcitonin test system.
6423. § 862.1145 Calcium test system.
6424. § 862.1150 Calibrator.
6425. § 862.1155 Human chorionic gonadotropin (HCG) test system.
6426. § 862.1160 Bicarbonate/carbon dioxide test system.
6427. § 862.1163 Cardiac allograft gene expression profiling test system.
6428. § 862.1164 Setmelanotide eligibility gene variant detection system.
6429. § 862.1165 Catecholamines (total) test system.
6430. § 862.1170 Chloride test system.
6431. § 862.1175 Cholesterol (total) test system.
6432. § 862.1177 Cholylglycine test system.
6433. § 862.1180 Chymotrypsin test system.
6434. § 862.1185 Compound S (11-deoxycortisol) test system.
6435. § 862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
6436. § 862.1190 Copper test system.
6437. § 862.1195 Corticoids test system.
6438. § 862.1200 Corticosterone test system.
6439. § 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
6440. § 862.1210 Creatine test system.
6441. § 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
6442. § 862.1220 Acute kidney injury test system.
6443. § 862.1223 Prognostic test for assessment of chronic kidney disease progression.
6444. § 862.1225 Creatinine test system.
6445. § 862.1230 Cyclic AMP test system.
6446. § 862.1235 Cyclosporine test system.
6447. § 862.1240 Cystine test system.
6448. § 862.1245 Dehydroepiandrosterone (free and sulfate) test system.
6449. § 862.1250 Desoxycorticosterone test system.
6450. § 862.1255 2,3-Diphosphoglyceric acid test system.
6451. § 862.1260 Estradiol test system.
6452. § 862.1265 Estriol test system.
6453. § 862.1270 Estrogens (total, in pregnancy) test system.
6454. § 862.1275 Estrogens (total, nonpregnancy) test system.
6455. § 862.1280 Estrone test system.
6456. § 862.1285 Etiocholanolone test system.
6457. § 862.1290 Fatty acids test system.
6458. § 862.1295 Folic acid test system.
6459. § 862.1300 Follicle-stimulating hormone test system.
6460. § 862.1305 Formiminoglutamic acid (FIGLU) test system.
6461. § 862.1310 Galactose test system.
6462. § 862.1315 Galactose-1-phosphate uridyl transferase test system.
6463. § 862.1320 Gastric acidity test system.
6464. § 862.1325 Gastrin test system.
6465. § 862.1330 Globulin test system.
6466. § 862.1335 Glucagon test system.
6467. § 862.1340 Urinary glucose (nonquantitative) test system.
6468. § 862.1345 Glucose test system.
6469. § 862.1350 Continuous glucose monitor secondary alarm system.
6470. § 862.1355 Integrated continuous glucose monitoring system.
6471. § 862.1356 Interoperable automated glycemic controller.
6472. § 862.1358 Insulin therapy adjustment device.
6473. § 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
6474. § 862.1365 Glutathione test system.
6475. § 862.1370 Human growth hormone test system.
6476. § 862.1373 Hemoglobin A1c test system.
6477. § 862.1375 Histidine test system.
6478. § 862.1377 Urinary homocystine (nonquantitative) test system.
6479. § 862.1380 Hydroxybutyric dehydrogenase test system.
6480. § 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
6481. § 862.1390 5-Hydroxyindole acetic acid/serotonin test system.
6482. § 862.1395 17-Hydroxyprogesterone test system.
6483. § 862.1400 Hydroxyproline test system.
6484. § 862.1405 Immunoreactive insulin test system.
6485. § 862.1410 Iron (non-heme) test system.
6486. § 862.1415 Iron-binding capacity test system.
6487. § 862.1420 Isocitric dehydrogenase test system.
6488. § 862.1430 17-Ketosteroids test system.
6489. § 862.1435 Ketones (nonquantitative) test system.
6490. § 862.1440 Lactate dehydrogenase test system.
6491. § 862.1445 Lactate dehydrogenase isoenzymes test system.
6492. § 862.1450 Lactic acid test system.
6493. § 862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.
6494. § 862.1460 Leucine aminopeptidase test system.
6495. § 862.1465 Lipase test system.
6496. § 862.1470 Lipid (total) test system.
6497. § 862.1475 Lipoprotein test system.
6498. § 862.1485 Luteinizing hormone test system.
6499. § 862.1488 Lysosomal storage disorder newborn screening test system.
6500. § 862.1490 Lysozyme (muramidase) test system.
6501. § 862.1493 Breast milk macronutrients test system.
6502. § 862.1495 Magnesium test system.
6503. § 862.1500 Malic dehydrogenase test system.
6504. § 862.1505 Mucopolysaccharides (nonquantitative) test system.
6505. § 862.1506 Muscular dystrophy newborn screening test.
6506. § 862.1509 Methylmalonic acid (nonquantitative) test system.
6507. § 862.1510 Nitrite (nonquantitative) test system.
6508. § 862.1515 Nitrogen (amino-nitrogen) test system.
6509. § 862.1520 5′-Nucleotidase test system.
6510. § 862.1530 Plasma oncometry test system.
6511. § 862.1535 Ornithine carbamyl transferase test system.
6512. § 862.1540 Osmolality test system.
6513. § 862.1542 Oxalate test system.
6514. § 862.1545 Parathyroid hormone test system.
6515. § 862.1550 Urinary pH (nonquantitative) test system.
6516. § 862.1555 Phenylalanine test system.
6517. § 862.1560 Urinary phenylketones (nonquantitative) test system.
6518. § 862.1565 6-Phosphogluconate dehydrogenase test system.
6519. § 862.1570 Phosphohexose isomerase test system.
6520. § 862.1575 Phospholipid test system.
6521. § 862.1580 Phosphorus (inorganic) test system.
6522. § 862.1585 Human placental lactogen test system.
6523. § 862.1590 Porphobilinogen test system.
6524. § 862.1595 Porphyrins test system.
6525. § 862.1600 Potassium test system.
6526. § 862.1602 Prognostic test for development or progression of preeclampsia.
6527. § 862.1605 Pregnanediol test system.
6528. § 862.1610 Pregnanetriol test system.
6529. § 862.1615 Pregnenolone test system.
6530. § 862.1620 Progesterone test system.
6531. § 862.1622 Prognostic test for assessment of liver related disease progression.
6532. § 862.1625 Prolactin (lactogen) test system.
6533. § 862.1630 Protein (fractionation) test system.
6534. § 862.1635 Total protein test system.
6535. § 862.1640 Protein-bound iodine test system.
6536. § 862.1645 Urinary protein or albumin (nonquantitative) test system.
6537. § 862.1650 Pyruvate kinase test system.
6538. § 862.1655 Pyruvic acid test system.
6539. § 862.1660 Quality control material (assayed and unassayed).
6540. § 862.1665 Sodium test system.
6541. § 862.1670 Sorbitol dehydrogenase test system.
6542. § 862.1675 Blood specimen collection device.
6543. § 862.1676 Blood collection device for cell-free nucleic acids.
6544. § 862.1678 Tacrolimus test system.
6545. § 862.1680 Testosterone test system.
6546. § 862.1685 Thyroxine-binding globulin test system.
6547. § 862.1690 Thyroid stimulating hormone test system.
6548. § 862.1695 Free thyroxine test system.
6549. § 862.1700 Total thyroxine test system.
6550. § 862.1705 Triglyceride test system.
6551. § 862.1710 Total triiodothyronine test system.
6552. § 862.1715 Triiodothyronine uptake test system.
6553. § 862.1720 Triose phosphate isomerase test system.
6554. § 862.1725 Trypsin test system.
6555. § 862.1730 Free tyrosine test system.
6556. § 862.1770 Urea nitrogen test system.
6557. § 862.1775 Uric acid test system.
6558. § 862.1780 Urinary calculi (stones) test system.
6559. § 862.1785 Urinary urobilinogen (nonquantitative) test system.
6560. § 862.1790 Uroporphyrin test system.
6561. § 862.1795 Vanilmandelic acid test system.
6562. § 862.1805 Vitamin A test system.
6563. § 862.1810 Vitamin B12 test system.
6564. § 862.1815 Vitamin E test system.
6565. § 862.1820 Xylose test system.
6566. § 862.1825 Vitamin D test system.
6567. § 862.1840 Total 25-hydroxyvitamin D mass spectrometry test system.
6568. Subpart C Clinical Laboratory Instruments
6569. § 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
6570. § 862.2100 Calculator/data processing module for clinical use.
6571. § 862.2120 Continuous glucose monitor data management system.
6572. § 862.2140 Centrifugal chemistry analyzer for clinical use.
6573. § 862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use.
6574. § 862.2160 Discrete photometric chemistry analyzer for clinical use.
6575. § 862.2170 Micro chemistry analyzer for clinical use.
6576. § 862.2230 Chromatographic separation material for clinical use.
6577. § 862.2250 Gas liquid chromatography system for clinical use.
6578. § 862.2260 High pressure liquid chromatography system for clinical use.
6579. § 862.2265 High throughput genomic sequence analyzer for clinical use.
6580. § 862.2270 Thin-layer chromatography system for clinical use.
6581. § 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
6582. § 862.2310 Clinical sample concentrator.
6583. § 862.2320 Beta or gamma counter for clinical use.
6584. § 862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
6585. § 862.2485 Electrophoresis apparatus for clinical use.
6586. § 862.2500 Enzyme analyzer for clinical use.
6587. § 862.2540 Flame emission photometer for clinical use.
6588. § 862.2560 Fluorometer for clinical use.
6589. § 862.2570 Instrumentation for clinical multiplex test systems.
6590. § 862.2680 Microtitrator for clinical use.
6591. § 862.2700 Nephelometer for clinical use.
6592. § 862.2720 Plasma oncometer for clinical use.
6593. § 862.2730 Osmometer for clinical use.
6594. § 862.2750 Pipetting and diluting system for clinical use.
6595. § 862.2800 Refractometer for clinical use.
6596. § 862.2850 Atomic absorption spectrophotometer for clinical use.
6597. § 862.2860 Mass spectrometer for clinical use.
6598. § 862.2900 Automated urinalysis system.
6599. § 862.2920 Plasma viscometer for clinical use.
6600. Subpart D Clinical Toxicology Test Systems
6601. § 862.3030 Acetaminophen test system.
6602. § 862.3035 Amikacin test system.
6603. § 862.3040 Alcohol test system.
6604. § 862.3050 Breath-alcohol test system.
6605. § 862.3080 Breath nitric oxide test system.
6606. § 862.3100 Amphetamine test system.
6607. § 862.3110 Antimony test system.
6608. § 862.3115 Anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease.
6609. § 862.3120 Arsenic test system.
6610. § 862.3150 Barbiturate test system.
6611. § 862.3170 Benzodiazepine test system.
6612. § 862.3200 Clinical toxicology calibrator.
6613. § 862.3220 Carbon monoxide test system.
6614. § 862.3240 Cholinesterase test system.
6615. § 862.3245 Clozapine test system.
6616. § 862.3250 Cocaine and cocaine metabolite test system.
6617. § 862.3270 Codeine test system.
6618. § 862.3280 Clinical toxicology control material.
6619. § 862.3300 Digitoxin test system.
6620. § 862.3320 Digoxin test system.
6621. § 862.3350 Diphenylhydantoin test system.
6622. § 862.3360 Drug metabolizing enzyme genotyping system.
6623. § 862.3364 Pharmacogenetic assessment system.
6624. § 862.3380 Ethosuximide test system.
6625. § 862.3450 Gentamicin test system.
6626. § 862.3460 Plazomicin test system.
6627. § 862.3520 Kanamycin test system.
6628. § 862.3550 Lead test system.
6629. § 862.3555 Lidocaine test system.
6630. § 862.3560 Lithium test system.
6631. § 862.3580 Lysergic acid diethylamide (LSD) test system.
6632. § 862.3590 Meprobamate test system.
6633. § 862.3600 Mercury test system.
6634. § 862.3610 Methamphetamine test system.
6635. § 862.3620 Methadone test system.
6636. § 862.3630 Methaqualone test system.
6637. § 862.3640 Morphine test system.
6638. § 862.3645 Neuroleptic drugs radioreceptor assay test system.
6639. § 862.3650 Opiate test system.
6640. § 862.3652 Organophosphate test system.
6641. § 862.3660 Phenobarbital test system.
6642. § 862.3670 Phenothiazine test system.
6643. § 862.3680 Primidone test system.
6644. § 862.3700 Propoxyphene test system.
6645. § 862.3750 Quinine test system.
6646. § 862.3800 Reagents for molecular diagnostic instrument test systems.
6647. § 862.3830 Salicylate test system.
6648. § 862.3840 Sirolimus test system.
6649. § 862.3850 Sulfonamide test system.
6650. § 862.3870 Cannabinoid test system.
6651. § 862.3880 Theophylline test system.
6652. § 862.3900 Tobramycin test system.
6653. § 862.3910 Tricyclic antidepressant drugs test system.
6654. § 862.3950 Vancomycin test system.
6655. § 862.3970 Voriconazole test system.
6656. PART 864 HEMATOLOGY AND PATHOLOGY DEVICES
6657. Subpart A General Provisions
6658. § 864.1 Scope.
6659. § 864.3 Effective dates of requirement for premarket approval.
6660. § 864.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
6661. Subpart B Biological Stains
6662. § 864.1850 Dye and chemical solution stains.
6663. § 864.1860 Immunohistochemistry reagents and kits.
6664. § 864.1865 Cervical intraepithelial neoplasia (CIN) test system.
6665. § 864.1866 Lynch syndrome test systems.
6666. § 864.1870 Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
6667. § 864.1880 Fluorescence in situ hybridization (FISH)-based detection of chromosomal abnormalities from patients with hematologic malignancies.
6668. § 864.1890 In situ hybridization test systems for use with a corresponding approved oncology therapeutic product.
6669. Subpart C Cell And Tissue Culture Products
6670. § 864.2220 Synthetic cell and tissue culture media and components.
6671. § 864.2240 Cell and tissue culture supplies and equipment.
6672. § 864.2260 Chromosome culture kit.
6673. § 864.2280 Cultured animal and human cells.
6674. § 864.2360 Mycoplasma detection media and components.
6675. § 864.2800 Animal and human sera.
6676. § 864.2875 Balanced salt solutions or formulations.
6677. Subpart D Pathology Instrumentation and Accessories
6678. § 864.3010 Tissue processing equipment.
6679. § 864.3250 Specimen transport and storage container.
6680. § 864.3260 OTC test sample collection systems for drugs of abuse testing.
6681. § 864.3300 Cytocentrifuge.
6682. § 864.3400 Device for sealing microsections.
6683. § 864.3600 Microscopes and accessories.
6684. § 864.3700 Whole slide imaging system.
6685. § 864.3750 Software algorithm device to assist users in digital pathology.
6686. § 864.3800 Automated slide stainer.
6687. § 864.3875 Automated tissue processor.
6688. Subpart E Specimen Preparation Reagents
6689. § 864.4010 General purpose reagent.
6690. § 864.4020 Analyte specific reagents.
6691. § 864.4400 Enzyme preparations.
6692. Subpart F Automated and Semi-Automated Hematology Devices
6693. § 864.5200 Automated cell counter.
6694. § 864.5220 Automated differential cell counter.
6695. § 864.5240 Automated blood cell diluting apparatus.
6696. § 864.5260 Automated cell-locating device.
6697. § 864.5300 Red cell indices device.
6698. § 864.5350 Microsedimentation centrifuge.
6699. § 864.5400 Coagulation instrument.
6700. § 864.5425 Multipurpose system for in vitro coagulation studies.
6701. § 864.5430 Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients.
6702. § 864.5600 Automated hematocrit instrument.
6703. § 864.5620 Automated hemoglobin system.
6704. § 864.5680 Automated heparin analyzer.
6705. § 864.5700 Automated platelet aggregation system.
6706. § 864.5800 Automated sedimentation rate device.
6707. § 864.5850 Automated slide spinner.
6708. § 864.5950 Blood volume measuring device.
6709. Subpart G Manual Hematology Devices
6710. § 864.6100 Bleeding time device.
6711. § 864.6150 Capillary blood collection tube.
6712. § 864.6160 Manual blood cell counting device.
6713. § 864.6400 Hematocrit measuring device.
6714. § 864.6550 Occult blood test.
6715. § 864.6600 Osmotic fragility test.
6716. § 864.6650 Platelet adhesion test.
6717. § 864.6675 Platelet aggregometer.
6718. § 864.6700 Erythrocyte sedimentation rate test.
6719. Subpart H Hematology Kits and Packages
6720. § 864.7010 Flow cytometric test system for hematopoietic neoplasms.
6721. § 864.7040 Adenosine triphosphate release assay.
6722. § 864.7060 Antithrombin III assay.
6723. § 864.7100 Red blood cell enzyme assay.
6724. § 864.7140 Activated whole blood clotting time tests.
6725. § 864.7250 Erythropoietin assay.
6726. § 864.7275 Euglobulin lysis time tests.
6727. § 864.7280 Factor V Leiden DNA mutation detection systems.
6728. § 864.7290 Factor deficiency test.
6729. § 864.7293 Von Willebrand factor assay.
6730. § 864.7295 Heparin and direct oral factor Xa inhibitor drug test system.
6731. § 864.7300 Fibrin monomer paracoagulation test.
6732. § 864.7320 Fibrinogen/fibrin degradation products assay.
6733. § 864.7340 Fibrinogen determination system.
6734. § 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
6735. § 864.7375 Glutathione reductase assay.
6736. § 864.7400 Hemoglobin A2 assay.
6737. § 864.7415 Abnormal hemoglobin assay.
6738. § 864.7425 Carboxyhemoglobin assay.
6739. § 864.7440 Electrophoretic hemoglobin analysis system.
6740. § 864.7455 Fetal hemoglobin assay.
6741. § 864.7470 Glycosylated hemoglobin assay.
6742. § 864.7490 Sulfhemoglobin assay.
6743. § 864.7500 Whole blood hemoglobin assays.
6744. § 864.7525 Heparin assay.
6745. § 864.7660 Leukocyte alkaline phosphatase test.
6746. § 864.7675 Leukocyte peroxidase test.
6747. § 864.7695 Platelet factor 4 radioimmunoassay.
6748. § 864.7720 Prothrombin consumption test.
6749. § 864.7735 Prothrombin-proconvertin test and thrombotest.
6750. § 864.7750 Prothrombin time test.
6751. § 864.7825 Sickle cell test.
6752. § 864.7875 Thrombin time test.
6753. § 864.7900 Thromboplastin generation test.
6754. § 864.7925 Partial thromboplastin time tests.
6755. Subpart I Hematology Reagents
6756. § 864.8100 Bothrops atrox reagent.
6757. § 864.8150 Calibrator for cell indices.
6758. § 864.8165 Calibrator for hemoglobin or hematocrit measurement.
6759. § 864.8175 Calibrator for platelet counting.
6760. § 864.8185 Calibrator for red cell and white cell counting.
6761. § 864.8200 Blood cell diluent.
6762. § 864.8500 Lymphocyte separation medium.
6763. § 864.8540 Red cell lysing reagent.
6764. § 864.8625 Hematology quality control mixture.
6765. § 864.8950 Russell viper venom reagent.
6766. Subpart J Products Used In Establishments That Manufacture Blood and Blood Products
6767. § 864.9050 Blood bank supplies.
6768. § 864.9100 Empty container for the collection and processing of blood and blood components.
6769. § 864.9115 Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
6770. § 864.9125 Vacuum-assisted blood collection system.
6771. § 864.9145 Processing system for frozen blood.
6772. § 864.9160 Blood group substances of nonhuman origin for in vitro diagnostic use.
6773. § 864.9165 Blood establishment computer software and accessories.
6774. § 864.9175 Automated blood grouping and antibody test system.
6775. § 864.9185 Blood grouping view box.
6776. § 864.9195 Blood mixing devices and blood weighing devices.
6777. § 864.9205 Blood and plasma warming device.
6778. § 864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use.
6779. § 864.9245 Automated blood cell separator.
6780. § 864.9275 Blood bank centrifuge for in vitro diagnostic use.
6781. § 864.9285 Automated cell-washing centrifuge for immuno-hematology.
6782. § 864.9300 Automated Coombs test systems.
6783. § 864.9320 Copper sulfate solution for specific gravity determinations.
6784. § 864.9400 Stabilized enzyme solution.
6785. § 864.9550 Lectins and protectins.
6786. § 864.9575 Environmental chamber for storage of platelet concentrate.
6787. § 864.9600 Potentiating media for in vitro diagnostic use.
6788. § 864.9650 Quality control kit for blood banking reagents.
6789. § 864.9700 Blood storage refrigerator and blood storage freezer.
6790. § 864.9750 Heat-sealing device.
6791. § 864.9875 Transfer set.
6792. Subpart K Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
6793. § 864.9900 Cord blood processing system and storage container.
6794. PART 866 IMMUNOLOGY AND MICROBIOLOGY DEVICES
6795. Subpart A General Provisions
6796. § 866.1 Scope.
6797. § 866.3 Effective dates of requirement for premarket approval.
6798. § 866.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
6799. Subpart B Diagnostic Devices
6800. § 866.1620 Antimicrobial susceptibility test disc.
6801. § 866.1640 Antimicrobial susceptibility test powder.
6802. § 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
6803. § 866.1650 A cellular analysis system for multiplexed antimicrobial susceptibility testing.
6804. § 866.1655 System for detection of microorganisms and antimicrobial resistance using reporter expression.
6805. § 866.1700 Culture medium for antimicrobial susceptibility tests.
6806. Subpart C Microbiology Devices
6807. § 866.2050 Staphylococcal typing bacteriophage.
6808. § 866.2120 Anaerobic chamber.
6809. § 866.2160 Coagulase plasma.
6810. § 866.2170 Automated colony counter.
6811. § 866.2180 Manual colony counter.
6812. § 866.2190 Automated image assessment system for microbial colonies on solid culture media.
6813. § 866.2300 Multipurpose culture medium.
6814. § 866.2320 Differential culture medium.
6815. § 866.2330 Enriched culture medium.
6816. § 866.2350 Microbiological assay culture medium.
6817. § 866.2360 Selective culture medium.
6818. § 866.2390 Transport culture medium.
6819. § 866.2410 Culture medium for pathogenic Neisseria spp.
6820. § 866.2420 Oxidase screening test for gonorrhea.
6821. § 866.2440 Automated medium dispensing and stacking device.
6822. § 866.2450 Supplement for culture media.
6823. § 866.2480 Quality control kit for culture media.
6824. § 866.2500 Microtiter diluting and dispensing device.
6825. § 866.2540 Microbiological incubator.
6826. § 866.2560 Microbial growth monitor.
6827. § 866.2580 Gas-generating device.
6828. § 866.2600 Wood's fluorescent lamp.
6829. § 866.2660 Microorganism differentiation and identification device.
6830. § 866.2680 Streptococcus spp. nucleic acid-based assay.
6831. § 866.2850 Automated zone reader.
6832. § 866.2900 Microbiological specimen collection and transport device.
6833. § 866.2950 Microbial nucleic acid storage and stabilization device.
6834. § 866.2952 Device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples.
6835. Subpart D Serological Reagents
6836. § 866.3010 Acinetobacter calcoaceticus serological reagents.
6837. § 866.3020 Adenovirus serological reagents.
6838. § 866.3035 Arizona spp. serological reagents.
6839. § 866.3040 Aspergillus spp. serological reagents.
6840. § 866.3045 In vitro diagnostic device for Bacillus spp. detection.
6841. § 866.3046 Simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples.
6842. § 866.3050 Beta-glucan serological assays.
6843. § 866.3060 Blastomyces dermatitidis serological reagents.
6844. § 866.3065 Bordetella spp. serological reagents.
6845. § 866.3085 Brucella spp. serological reagents.
6846. § 866.3110 Campylobacter fetus serological reagents.
6847. § 866.3120 Chlamydia serological reagents.
6848. § 866.3125 Citrobacter spp. serological reagents.
6849. § 866.3130 Clostridium difficile toxin gene amplification assay.
6850. § 866.3135 Coccidioides immitis serological reagents.
6851. § 866.3140 Corynebacterium spp. serological reagents.
6852. § 866.3145 Coxsackievirus serological reagents.
6853. § 866.3165 Cryptococcus neoformans serological reagents.
6854. § 866.3169 Hepatitis C virus antibody tests.
6855. § 866.3170 Nucleic acid-based hepatitis C virus ribonucleic acid tests.
6856. § 866.3172 Qualitative hepatitis B virus antigen assays.
6857. § 866.3173 Hepatitis B virus antibody assays.
6858. § 866.3174 Hepatitis B virus nucleic acid-based assays.
6859. § 866.3175 Cytomegalovirus serological reagents.
6860. § 866.3180 Quantitative cytomegalovirus nucleic acid tests for transplant patient management.
6861. § 866.3181 Cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection.
6862. § 866.3183 Quantitative viral nucleic acid test for transplant patient management.
6863. § 866.3200 Echinococcus spp. serological reagents.
6864. § 866.3205 Echovirus serological reagents.
6865. § 866.3210 Endotoxin assay.
6866. § 866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
6867. § 866.3220 Entamoeba histolytica serological reagents.
6868. § 866.3225 Enterovirus nucleic acid assay.
6869. § 866.3230 Device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections.
6870. § 866.3231 Device to detect bacterial protease activity in chronic wound fluid.
6871. § 866.3235 Epstein-Barr virus serological reagents.
6872. § 866.3236 Device to detect or measure nucleic acid from viruses associated with head and neck cancers.
6873. § 866.3240 Equine encephalomyelitis virus serological reagents.
6874. § 866.3250 Erysipelothrix rhusiopathiae serological reagents.
6875. § 866.3255 Escherichia coli serological reagents.
6876. § 866.3270 Flavobacterium spp. serological reagents.
6877. § 866.3280 Francisella tularensis serological reagents.
6878. § 866.3290 Gonococcal antibody test (GAT).
6879. § 866.3300 Haemophilus spp. serological reagents.
6880. § 866.3305 Herpes simplex virus serological assays.
6881. § 866.3307 Herpes simplex virus nucleic acid-based assay for central nervous system infections.
6882. § 866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
6883. § 866.3310 Hepatitis A virus (HAV) serological assays.
6884. § 866.3320 Histoplasma capsulatum serological reagents.
6885. § 866.3328 Influenza virus antigen detection test system.
6886. § 866.3330 Influenza virus serological reagents.
6887. § 866.3332 Reagents for detection of specific novel influenza A viruses.
6888. § 866.3336 John Cunningham Virus serological reagents.
6889. § 866.3340 Klebsiella spp. serological reagents.
6890. § 866.3350 Leptospira spp. serological reagents.
6891. § 866.3355 Listeria spp. serological reagents.
6892. § 866.3360 Lymphocytic choriomeningitis virus serological reagents.
6893. § 866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.
6894. § 866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
6895. § 866.3367 Device to detect and identify microbial nucleic acids by FISH in clinical specimens.
6896. § 866.3370 Mycobacterium tuberculosis immunofluorescent reagents.
6897. § 866.3372 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
6898. § 866.3373 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens.
6899. § 866.3375 Mycoplasma spp. serological reagents.
6900. § 866.3376 Device to detect and identify fungal nucleic acids directly in respiratory specimens.
6901. § 866.3378 Clinical mass spectrometry microorganism identification and differentiation system.
6902. § 866.3380 Mumps virus serological reagents.
6903. § 866.3385 System for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens.
6904. § 866.3390 Neisseria spp. direct serological test reagents.
6905. § 866.3393 Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).
6906. § 866.3395 Norovirus serological reagents.
6907. § 866.3400 Parainfluenza virus serological reagents.
6908. § 866.3402 Plasmodium species antigen detection assays.
6909. § 866.3405 Poliovirus serological reagents.
6910. § 866.3410 Proteus spp. (Weil-Felix) serological reagents.
6911. § 866.3415 Pseudomonas spp. serological reagents.
6912. § 866.3460 Rabiesvirus immunofluorescent reagents.
6913. § 866.3470 Reovirus serological reagents.
6914. § 866.3480 Respiratory syncytial virus serological reagents.
6915. § 866.3490 Rhinovirus serological reagents.
6916. § 866.3500 Rickettsia serological reagents.
6917. § 866.3510 Rubella virus serological reagents.
6918. § 866.3520 Rubeola (measles) virus serological reagents.
6919. § 866.3550 Salmonella spp. serological reagents.
6920. § 866.3600 Schistosoma spp. serological reagents.
6921. § 866.3630 Serratia spp. serological reagents.
6922. § 866.3660 Shigella spp. serological reagents.
6923. § 866.3680 Sporothrix schenckii serological reagents.
6924. § 866.3700 Staphylococcus aureus serological reagents.
6925. § 866.3720 Streptococcus spp. exoenzyme reagents.
6926. § 866.3740 Streptococcus spp. serological reagents.
6927. § 866.3780 Toxoplasma gondii serological reagents.
6928. § 866.3820 Treponema pallidum nontreponemal test reagents.
6929. § 866.3830 Treponema pallidum treponemal test reagents.
6930. § 866.3850 Trichinella spiralis serological reagents.
6931. § 866.3860 Trichomonas vaginalis nucleic acid assay.
6932. § 866.3870 Trypanosoma spp. serological reagents.
6933. § 866.3900 Varicella-zoster virus serological reagents.
6934. § 866.3920 Assayed quality control material for clinical microbiology assays.
6935. § 866.3930 Vibrio cholerae serological reagents.
6936. § 866.3935 Zika virus serological reagents.
6937. § 866.3940 West Nile virus serological reagents.
6938. § 866.3945 Dengue virus serological reagents.
6939. § 866.3946 Dengue virus nucleic acid amplification test reagents.
6940. § 866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
6941. § 866.3955 Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.
6942. § 866.3956 Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test.
6943. § 866.3957 Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test.
6944. § 866.3958 Human immunodeficiency virus (HIV) viral load monitoring test.
6945. § 866.3960 Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
6946. § 866.3966 Device to detect and identify selected microbial agents that cause acute febrile illness.
6947. § 866.3970 Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
6948. § 866.3975 Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis.
6949. § 866.3980 Respiratory viral panel multiplex nucleic acid assay.
6950. § 866.3981 Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.
6951. § 866.3982 Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.
6952. § 866.3983 SARS-CoV-2 serology test.
6953. § 866.3984 Over-the-counter test to detect SARS-CoV-2 from clinical specimens.
6954. § 866.3985 Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
6955. § 866.3988 Device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection.
6956. § 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
6957. § 866.4001 A multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens.
6958. Subpart E Immunology Laboratory Equipment and Reagents
6959. § 866.4070 RNA Preanalytical Systems.
6960. § 866.4100 Complement reagent.
6961. § 866.4500 Immunoelectrophoresis equipment.
6962. § 866.4520 Immunofluorometer equipment.
6963. § 866.4540 Immunonephelometer equipment.
6964. § 866.4600 Ouchterlony agar plate.
6965. § 866.4700 Automated fluorescence in situ hybridization (FISH) enumeration systems.
6966. § 866.4750 Automated indirect immunofluorescence microscope and software-assisted system.
6967. § 866.4800 Radial immunodiffusion plate.
6968. § 866.4830 Rocket immunoelectrophoresis equipment.
6969. § 866.4900 Support gel.
6970. Subpart F Immunological Test Systems
6971. § 866.5040 Albumin immunological test system.
6972. § 866.5060 Prealbumin immunological test system.
6973. § 866.5065 Human allotypic marker immunological test system.
6974. § 866.5080 Alpha-1-antichymotrypsin immunological test system.
6975. § 866.5090 Antimitochondrial antibody immunological test system.
6976. § 866.5100 Antinuclear antibody immunological test system.
6977. § 866.5110 Antiparietal antibody immunological test system.
6978. § 866.5120 Antismooth muscle antibody immunological test system.
6979. § 866.5130 Alpha-1-antitrypsin immunological test system.
6980. § 866.5150 Bence-Jones proteins immunological test system.
6981. § 866.5160 Beta-globulin immunological test system.
6982. § 866.5170 Breast milk immunological test system.
6983. § 866.5180 Fecal calprotectin immunological test system.
6984. § 866.5200 Carbonic anhydrase B and C immunological test system.
6985. § 866.5210 Ceruloplasmin immunological test system.
6986. § 866.5220 Cohn fraction II immunological test system.
6987. § 866.5230 Colostrum immunological test system.
6988. § 866.5240 Complement components immunological test system.
6989. § 866.5250 Complement C1 inhibitor (inactivator) immunological test system.
6990. § 866.5260 Complement C3b inactivator immunological test system.
6991. § 866.5270 C-reactive protein immunological test system.
6992. § 866.5320 Properdin factor B immunological test system.
6993. § 866.5330 Factor XIII, A, S, immunological test system.
6994. § 866.5340 Ferritin immunological test system.
6995. § 866.5350 Fibrinopeptide A immunological test system.
6996. § 866.5360 Cohn fraction IV immunological test system.
6997. § 866.5370 Cohn fraction V immunological test system.
6998. § 866.5380 Free secretory component immunological test system.
6999. § 866.5400 Alpha-globulin immunological test system.
7000. § 866.5420 Alpha-1-glycoproteins immunological test system.
7001. § 866.5425 Alpha-2-glycoproteins immunological test system.
7002. § 866.5430 Beta-2-glycoprotein I immunological test system.
7003. § 866.5440 Beta-2-glycoprotein III immunological test system.
7004. § 866.5460 Haptoglobin immunological test system.
7005. § 866.5470 Hemoglobin immunological test system.
7006. § 866.5490 Hemopexin immunological test system.
7007. § 866.5500 Hypersensitivity pneumonitis immunological test system.
7008. § 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
7009. § 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
7010. § 866.5530 Immunoglobulin G (Fc fragment specific) immunological test system.
7011. § 866.5540 Immunoglobulin G (Fd fragment specific) immunological test system.
7012. § 866.5550 Immunoglobulin (light chain specific) immunological test system.
7013. § 866.5560 Lactic dehydrogenase immunological test system.
7014. § 866.5570 Lactoferrin immunological test system.
7015. § 866.5580 Alpha-1-lipoprotein immunological test system.
7016. § 866.5590 Lipoprotein X immunological test system.
7017. § 866.5600 Low-density lipoprotein immunological test system.
7018. § 866.5620 Alpha-2-macroglobulin immunological test system.
7019. § 866.5630 Beta-2-microglobulin immunological test system.
7020. § 866.5640 Infectious mononucleosis immunological test system.
7021. § 866.5660 Multiple autoantibodies immunological test system.
7022. § 866.5665 Aquaporin-4 autoantibody immunological test system.
7023. § 866.5670 Zinc transporter 8 autoantibody immunological test system.
7024. § 866.5680 Myoglobin immunological test system.
7025. § 866.5700 Whole human plasma or serum immunological test system.
7026. § 866.5715 Plasminogen immunological test system.
7027. § 866.5735 Prothrombin immunological test system.
7028. § 866.5750 Radioallergosorbent (RAST) immunological test system.
7029. § 866.5760 Tryptase test system.
7030. § 866.5765 Retinol-binding protein immunological test system.
7031. § 866.5775 Rheumatoid factor immunological test system.
7032. § 866.5780 Anti-phospholipase A2 receptor immunological test system.
7033. § 866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
7034. § 866.5800 Seminal fluid (sperm) immunological test system.
7035. § 866.5820 Systemic lupus erythematosus immunological test system.
7036. § 866.5830 Brain trauma assessment test.
7037. § 866.5840 Alzheimer's disease pathology assessment test.
7038. § 866.5860 Total spinal fluid immunological test system.
7039. § 866.5870 Thyroid autoantibody immunological test system.
7040. § 866.5880 Transferrin immunological test system.
7041. § 866.5890 Inter-alpha trypsin inhibitor immunological test system.
7042. § 866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
7043. § 866.5910 Quality control material for cystic fibrosis nucleic acid assays.
7044. § 866.5920 Postnatal chromosomal copy number variation detection system.
7045. § 866.5930 Newborn screening test for severe combined immunodeficiency disorder (SCID).
7046. § 866.5940 Autosomal recessive carrier screening gene mutation detection system.
7047. § 866.5950 Genetic health risk assessment system.
7048. § 866.5960 Human leukocyte antigen typing companion diagnostic test.
7049. § 866.5970 Inherited nucleotide repeat disorder DNA test.
7050. § 866.5980 Spinal Muscular Atrophy newborn screening test system.
7051. Subpart G Tumor Associated Antigen immunological Test Systems
7052. § 866.6000 Whole exome sequencing constituent device.
7053. § 866.6010 Tumor-associated antigen immunological test system.
7054. § 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
7055. § 866.6030 AFP-L3% immunological test system.
7056. § 866.6040 Gene expression profiling test system for breast cancer prognosis.
7057. § 866.6050 Ovarian adnexal mass assessment score test system.
7058. § 866.6060 BCR-ABL quantitation test.
7059. § 866.6070 Mutation detection test for myeloproliferative neoplasms.
7060. § 866.6080 Next generation sequencing based tumor profiling test.
7061. § 866.6090 Cancer predisposition risk assessment system.
7062. § 866.6095 High throughput DNA sequencing for hereditary cancer predisposition assessment test system.
7063. § 866.6100 DNA-based test to measure minimal residual disease in hematological malignancies.
7064. § 866.6110 Circulating tumor cell enrichment device.
7065. § 866.6120 Hematopoietic cell enrichment kit.
7066. PART 868 ANESTHESIOLOGY DEVICES
7067. Subpart A General Provisions
7068. § 868.1 Scope.
7069. § 868.3 Effective dates of requirement for premarket approval.
7070. § 868.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
7071. Subpart B Diagnostic Devices
7072. § 868.1030 Manual algesimeter.
7073. § 868.1040 Powered algesimeter.
7074. § 868.1075 Argon gas analyzer.
7075. § 868.1100 Arterial blood sampling kit.
7076. § 868.1120 Indwelling blood oxyhemoglobin concentration analyzer.
7077. § 868.1150 Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
7078. § 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.
7079. § 868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer.
7080. § 868.1400 Carbon dioxide gas analyzer.
7081. § 868.1430 Carbon monoxide gas analyzer.
7082. § 868.1500 Enflurane gas analyzer.
7083. § 868.1505 Ventilatory electrical impedance tomograph.
7084. § 868.1575 Gas collection vessel.
7085. § 868.1620 Halothane gas analyzer.
7086. § 868.1640 Helium gas analyzer.
7087. § 868.1670 Neon gas analyzer.
7088. § 868.1690 Nitrogen gas analyzer.
7089. § 868.1700 Nitrous oxide gas analyzer.
7090. § 868.1720 Oxygen gas analyzer.
7091. § 868.1730 Oxygen uptake computer.
7092. § 868.1750 Pressure plethysmograph.
7093. § 868.1760 Volume plethysmograph.
7094. § 868.1780 Inspiratory airway pressure meter.
7095. § 868.1800 Rhinoanemometer.
7096. § 868.1840 Diagnostic spirometer.
7097. § 868.1850 Monitoring spirometer.
7098. § 868.1860 Peak-flow meter for spirometry.
7099. § 868.1870 Gas volume calibrator.
7100. § 868.1880 Pulmonary-function data calculator.
7101. § 868.1890 Predictive pulmonary-function value calculator.
7102. § 868.1900 Diagnostic pulmonary-function interpretation calculator.
7103. § 868.1910 Esophageal stethoscope.
7104. § 868.1920 Esophageal stethoscope with electrical conductors.
7105. § 868.1930 Stethoscope head.
7106. § 868.1965 Switching valve (ploss).
7107. § 868.1975 Water vapor analyzer.
7108. § 868.1980 Real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia.
7109. Subpart C Monitoring Devices
7110. § 868.2025 Ultrasonic air embolism monitor.
7111. § 868.2200 Adjunctive pain measurement device for anesthesiology.
7112. § 868.2250 Monitor for opioid induced impairment of oxygenation.
7113. § 868.2300 Bourdon gauge flowmeter.
7114. § 868.2320 Uncompensated thorpe tube flowmeter.
7115. § 868.2340 Compensated thorpe tube flowmeter.
7116. § 868.2350 Gas calibration flowmeter.
7117. § 868.2375 Breathing frequency monitor.
7118. § 868.2376 Device for sleep apnea testing based on mandibular movement.
7119. § 868.2377 Apnea monitor.
7120. § 868.2380 Nitric oxide analyzer.
7121. § 868.2385 Nitrogen dioxide analyzer.
7122. § 868.2450 Lung water monitor.
7123. § 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
7124. § 868.2500 Cutaneous oxygen (PcO2) monitor.
7125. § 868.2550 Pneumotachometer.
7126. § 868.2600 Airway pressure monitor.
7127. § 868.2610 Gas pressure gauge.
7128. § 868.2620 Gas pressure calibrator.
7129. § 868.2700 Pressure regulator.
7130. § 868.2775 Electrical peripheral nerve stimulator.
7131. § 868.2875 Differential pressure transducer.
7132. § 868.2885 Gas flow transducer.
7133. § 868.2900 Gas pressure transducer.
7134. D Subparts D-E [Reserved]
7135. Subpart F Therapeutic Devices
7136. § 868.5090 Emergency airway needle.
7137. § 868.5095 Retrograde intubation device.
7138. § 868.5100 Nasopharyngeal airway.
7139. § 868.5105 External negative pressure airway aid.
7140. § 868.5110 Oropharyngeal airway.
7141. § 868.5115 Device to relieve acute upper airway obstruction.
7142. § 868.5120 Anesthesia conduction catheter.
7143. § 868.5130 Anesthesia conduction filter.
7144. § 868.5140 Anesthesia conduction kit.
7145. § 868.5150 Anesthesia conduction needle.
7146. § 868.5160 Gas machine for anesthesia or analgesia.
7147. § 868.5165 Nitric oxide administration apparatus.
7148. § 868.5170 Laryngotracheal topical anesthesia applicator.
7149. § 868.5180 Rocking bed.
7150. § 868.5220 Blow bottle.
7151. § 868.5240 Anesthesia breathing circuit.
7152. § 868.5250 Breathing circuit circulator.
7153. § 868.5260 Breathing circuit bacterial filter.
7154. § 868.5270 Breathing system heater.
7155. § 868.5273 Positive airway pressure delivery system.
7156. § 868.5280 Breathing tube support.
7157. § 868.5300 Carbon dioxide absorbent.
7158. § 868.5310 Carbon dioxide absorber.
7159. § 868.5320 Reservoir bag.
7160. § 868.5330 Breathing gas mixer.
7161. § 868.5340 Nasal oxygen cannula.
7162. § 868.5350 Nasal oxygen catheter.
7163. § 868.5365 Posture chair for cardiac or pulmonary treatment.
7164. § 868.5375 Heat and moisture condenser (artificial nose).
7165. § 868.5400 Electroanesthesia apparatus.
7166. § 868.5420 Ether hook.
7167. § 868.5430 Gas-scavenging apparatus.
7168. § 868.5440 Portable oxygen generator.
7169. § 868.5450 Respiratory gas humidifier.
7170. § 868.5454 High flow humidified oxygen delivery device.
7171. § 868.5460 Therapeutic humidifier for home use.
7172. § 868.5470 Hyperbaric chamber.
7173. § 868.5480 Isocapnic ventilation device.
7174. § 868.5530 Flexible laryngoscope.
7175. § 868.5540 Rigid laryngoscope.
7176. § 868.5550 Anesthetic gas mask.
7177. § 868.5560 Gas mask head strap.
7178. § 868.5570 Nonrebreathing mask.
7179. § 868.5580 Oxygen mask.
7180. § 868.5590 Scavenging mask.
7181. § 868.5600 Venturi mask.
7182. § 868.5620 Breathing mouthpiece.
7183. § 868.5630 Nebulizer.
7184. § 868.5640 Medicinal nonventilatory nebulizer (atomizer).
7185. § 868.5650 Esophageal obturator.
7186. § 868.5655 Portable liquid oxygen unit.
7187. § 868.5665 Powered percussor.
7188. § 868.5675 Rebreathing device.
7189. § 868.5690 Incentive spirometer.
7190. § 868.5700 Nonpowered oxygen tent.
7191. § 868.5710 Electrically powered oxygen tent.
7192. § 868.5720 Bronchial tube.
7193. § 868.5730 Tracheal tube.
7194. § 868.5740 Tracheal/bronchial differential ventilation tube.
7195. § 868.5750 Inflatable tracheal tube cuff.
7196. § 868.5760 Cuff spreader.
7197. § 868.5770 Tracheal tube fixation device.
7198. § 868.5780 Tube introduction forceps.
7199. § 868.5790 Tracheal tube stylet.
7200. § 868.5795 Tracheal tube cleaning brush.
7201. § 868.5800 Tracheostomy tube and tube cuff.
7202. § 868.5810 Airway connector.
7203. § 868.5820 Dental protector.
7204. § 868.5830 Autotransfusion apparatus.
7205. § 868.5860 Pressure tubing and accessories.
7206. § 868.5870 Nonrebreathing valve.
7207. § 868.5880 Anesthetic vaporizer.
7208. § 868.5895 Continuous ventilator.
7209. § 868.5905 Noncontinuous ventilator (IPPB).
7210. § 868.5915 Manual emergency ventilator.
7211. § 868.5925 Powered emergency ventilator.
7212. § 868.5935 External negative pressure ventilator.
7213. § 868.5955 Intermittent mandatory ventilation attachment.
7214. § 868.5965 Positive end expiratory pressure breathing attachment.
7215. § 868.5975 Ventilator tubing.
7216. § 868.5995 Tee drain (water trap).
7217. Subpart G Miscellaneous
7218. § 868.6100 Anesthetic cabinet, table, or tray.
7219. § 868.6175 Cardiopulmonary emergency cart.
7220. § 868.6225 Nose clip.
7221. § 868.6250 Portable air compressor.
7222. § 868.6400 Calibration gas.
7223. § 868.6700 Anesthesia stool.
7224. § 868.6810 Tracheobronchial suction catheter.
7225. § 868.6820 Patient position support.
7226. § 868.6885 Medical gas yoke assembly.
7227. PART 870 CARDIOVASCULAR DEVICES
7228. Subpart A General Provisions
7229. § 870.1 Scope.
7230. § 870.3 Effective dates of requirement for premarket approval.
7231. § 870.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
7232. Subpart B Cardiovascular Diagnostic Devices
7233. § 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
7234. § 870.1100 Blood pressure alarm.
7235. § 870.1110 Blood pressure computer.
7236. § 870.1120 Blood pressure cuff.
7237. § 870.1130 Noninvasive blood pressure measurement system.
7238. § 870.1140 Venous blood pressure manometer.
7239. § 870.1200 Diagnostic intravascular catheter.
7240. § 870.1210 Continuous flush catheter.
7241. § 870.1220 Electrode recording catheter or electrode recording probe.
7242. § 870.1230 Fiberoptic oximeter catheter.
7243. § 870.1240 Flow-directed catheter.
7244. § 870.1250 Percutaneous catheter.
7245. § 870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.
7246. § 870.1252 Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.
7247. § 870.1255 Balloon aortic valvuloplasty catheter.
7248. § 870.1270 Intracavitary phonocatheter system.
7249. § 870.1280 Steerable catheter.
7250. § 870.1290 Steerable catheter control system.
7251. § 870.1300 Catheter cannula.
7252. § 870.1310 Vessel dilator for percutaneous catheterization.
7253. § 870.1330 Catheter guide wire.
7254. § 870.1340 Catheter introducer.
7255. § 870.1342 Reverse central venous recanalization system.
7256. § 870.1345 Intravascular bleed monitor.
7257. § 870.1350 Catheter balloon repair kit.
7258. § 870.1360 Trace microsphere.
7259. § 870.1370 Catheter tip occluder.
7260. § 870.1380 Catheter stylet.
7261. § 870.1390 Trocar.
7262. § 870.1405 Interventional cardiovascular implant simulation software device.
7263. § 870.1415 Coronary vascular physiologic simulation software device.
7264. § 870.1420 Coronary artery disease risk indicator using acoustic heart signals.
7265. § 870.1425 Programmable diagnostic computer.
7266. § 870.1435 Single-function, preprogrammed diagnostic computer.
7267. § 870.1450 Densitometer.
7268. § 870.1650 Angiographic injector and syringe.
7269. § 870.1660 Indicator injector.
7270. § 870.1670 Syringe actuator for an injector.
7271. § 870.1750 External programmable pacemaker pulse generator.
7272. § 870.1800 Withdrawal-infusion pump.
7273. § 870.1875 Stethoscope.
7274. § 870.1915 Thermodilution probe.
7275. Subpart C Cardiovascular Monitoring Devices
7276. § 870.2050 Biopotential amplifier and signal conditioner.
7277. § 870.2060 Transducer signal amplifier and conditioner.
7278. § 870.2100 Cardiovascular blood flowmeter.
7279. § 870.2120 Extravascular blood flow probe.
7280. § 870.2200 Adjunctive cardiovascular status indicator.
7281. § 870.2210 Adjunctive predictive cardiovascular indicator.
7282. § 870.2220 Adjunctive hemodynamic indicator with decision point.
7283. § 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
7284. § 870.2310 Apex cardiograph (vibrocardiograph).
7285. § 870.2320 Ballistocardiograph.
7286. § 870.2330 Echocardiograph.
7287. § 870.2340 Electrocardiograph.
7288. § 870.2345 Electrocardiograph software for over-the-counter use.
7289. § 870.2350 Electrocardiograph lead switching adaptor.
7290. § 870.2360 Electrocardiograph electrode.
7291. § 870.2370 Electrocardiograph surface electrode tester.
7292. § 870.2380 Cardiovascular machine learning-based notification software.
7293. § 870.2390 Phonocardiograph.
7294. § 870.2400 Vectorcardiograph.
7295. § 870.2450 Medical cathode-ray tube display.
7296. § 870.2600 Signal isolation system.
7297. § 870.2620 Line isolation monitor.
7298. § 870.2640 Portable leakage current alarm.
7299. § 870.2675 Oscillometer.
7300. § 870.2700 Oximeter.
7301. § 870.2705 Infant pulse rate and oxygen saturation monitor for over-the-counter use.
7302. § 870.2710 Ear oximeter.
7303. § 870.2720 Hyperoxia monitoring device adjunct to pulse oximetry.
7304. § 870.2750 Impedance phlebograph.
7305. § 870.2770 Impedance plethysmograph.
7306. § 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
7307. § 870.2785 Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
7308. § 870.2786 Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
7309. § 870.2790 Photoplethysmograph analysis software for over-the-counter use.
7310. § 870.2800 Medical magnetic tape recorder.
7311. § 870.2810 Paper chart recorder.
7312. § 870.2840 Apex cardiographic transducer.
7313. § 870.2850 Extravascular blood pressure transducer.
7314. § 870.2855 Implantable Intra-aneurysm Pressure Measurement System.
7315. § 870.2860 Heart sound transducer.
7316. § 870.2870 Catheter tip pressure transducer.
7317. § 870.2880 Ultrasonic transducer.
7318. § 870.2890 Vessel occlusion transducer.
7319. § 870.2900 Patient transducer and electrode cable (including connector).
7320. § 870.2910 Radiofrequency physiological signal transmitter and receiver.
7321. § 870.2920 Telephone electrocardiograph transmitter and receiver.
7322. Subpart D Cardiovascular Prosthetic Devices
7323. § 870.3250 Vascular clip.
7324. § 870.3260 Vena cava clip.
7325. § 870.3300 Vascular embolization device.
7326. § 870.3375 Cardiovascular intravascular filter.
7327. § 870.3450 Vascular graft prosthesis.
7328. § 870.3460 Endovascular Suturing System.
7329. § 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
7330. § 870.3535 Intra-aortic balloon and control system.
7331. § 870.3545 Ventricular bypass (assist) device.
7332. § 870.3600 External pacemaker pulse generator.
7333. § 870.3605 Pacing system analyzer.
7334. § 870.3610 Implantable pacemaker pulse generator.
7335. § 870.3620 Pacemaker lead adaptor.
7336. § 870.3630 Pacemaker generator function analyzer.
7337. § 870.3640 Indirect pacemaker generator function analyzer.
7338. § 870.3650 Pacemaker polymeric mesh bag.
7339. § 870.3670 Pacemaker charger.
7340. § 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
7341. § 870.3690 Pacemaker test magnet.
7342. § 870.3700 Pacemaker programmers.
7343. § 870.3710 Pacemaker repair or replacement material.
7344. § 870.3720 Pacemaker electrode function tester.
7345. § 870.3730 Pacemaker service tools.
7346. § 870.3800 Annuloplasty ring.
7347. § 870.3850 Carotid sinus nerve stimulator.
7348. § 870.3925 Replacement heart valve.
7349. § 870.3935 Prosthetic heart valve holder.
7350. § 870.3945 Prosthetic heart valve sizer.
7351. Subpart E Cardiovascular Surgical Devices
7352. § 870.4075 Endomyocardial biopsy device.
7353. § 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
7354. § 870.4150 Extracorporeal system for carbon dioxide removal.
7355. § 870.4200 Cardiopulmonary bypass accessory equipment.
7356. § 870.4205 Cardiopulmonary bypass bubble detector.
7357. § 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
7358. § 870.4220 Cardiopulmonary bypass heart-lung machine console.
7359. § 870.4230 Cardiopulmonary bypass defoamer.
7360. § 870.4240 Cardiopulmonary bypass heat exchanger.
7361. § 870.4250 Cardiopulmonary bypass temperature controller.
7362. § 870.4260 Cardiopulmonary bypass arterial line blood filter.
7363. § 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
7364. § 870.4280 Cardiopulmonary prebypass filter.
7365. § 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
7366. § 870.4300 Cardiopulmonary bypass gas control unit.
7367. § 870.4310 Cardiopulmonary bypass coronary pressure gauge.
7368. § 870.4320 Cardiopulmonary bypass pulsatile flow generator.
7369. § 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
7370. § 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
7371. § 870.4350 Cardiopulmonary bypass oxygenator.
7372. § 870.4360 Nonroller-type blood pump.
7373. § 870.4370 Roller-type cardiopulmonary bypass blood pump.
7374. § 870.4380 Cardiopulmonary bypass pump speed control.
7375. § 870.4390 Cardiopulmonary bypass pump tubing.
7376. § 870.4400 Cardiopulmonary bypass blood reservoir.
7377. § 870.4410 Cardiopulmonary bypass in-line blood gas sensor.
7378. § 870.4420 Cardiopulmonary bypass cardiotomy return sucker.
7379. § 870.4430 Cardiopulmonary bypass intracardiac suction control.
7380. § 870.4450 Vascular clamp.
7381. § 870.4475 Surgical vessel dilator.
7382. § 870.4500 Cardiovascular surgical instruments.
7383. § 870.4510 Apical closure device.
7384. § 870.4600 Extravascular support for an arteriovenous fistula for vascular access.
7385. § 870.4875 Intraluminal artery stripper.
7386. § 870.4885 External vein stripper.
7387. Subpart F Cardiovascular Therapeutic Devices
7388. § 870.5050 Patient care suction apparatus.
7389. § 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
7390. § 870.5125 Laser-powered inferior vena cava filter retrieval catheter.
7391. § 870.5150 Embolectomy catheter.
7392. § 870.5175 Septostomy catheter.
7393. § 870.5200 External cardiac compressor.
7394. § 870.5210 Cardiopulmonary resuscitation (CPR) aid.
7395. § 870.5225 External counter-pulsating device.
7396. § 870.5300 DC-defibrillator (including paddles).
7397. § 870.5310 Automated external defibrillator system.
7398. § 870.5325 Defibrillator tester.
7399. § 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
7400. § 870.5600 Adjunctive open loop fluid therapy recommender.
7401. § 870.5700 Steerable cardiac ablation catheter remote control system.
7402. § 870.5710 Mechanical deviation device for esophageal protection during cardiac ablation procedures.
7403. § 870.5720 Temperature regulation device for esophageal protection during cardiac ablation procedures.
7404. § 870.5800 Compressible limb sleeve.
7405. § 870.5900 Thermal regulating system.
7406. § 870.5910 Esophageal thermal regulation device.
7407. § 870.5925 Automatic rotating tourniquet.
7408. PART 872 DENTAL DEVICES
7409. Subpart A General Provisions
7410. § 872.1 Scope.
7411. § 872.3 Effective dates of requirement for premarket approval.
7412. § 872.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
7413. Subpart B Diagnostic Devices
7414. § 872.1500 Gingival fluid measurer.
7415. § 872.1720 Pulp tester.
7416. § 872.1730 Electrode gel for pulp testers.
7417. § 872.1740 Caries detection device.
7418. § 872.1745 Laser fluorescence caries detection device.
7419. § 872.1800 Extraoral source x-ray system.
7420. § 872.1810 Intraoral source x-ray system.
7421. § 872.1820 Dental x-ray exposure alignment device.
7422. § 872.1830 Cephalometer.
7423. § 872.1840 Dental x-ray position indicating device.
7424. § 872.1850 Lead-lined position indicator.
7425. § 872.1870 Sulfide detection device.
7426. § 872.1905 Dental x-ray film holder.
7427. § 872.2050 Dental sonography device.
7428. § 872.2060 Jaw tracking device.
7429. C Subpart C [Reserved]
7430. Subpart D Prosthetic Devices
7431. § 872.3060 Noble metal alloy.
7432. § 872.3070 Dental amalgam, mercury, and amalgam alloy.
7433. § 872.3080 Mercury and alloy dispenser.
7434. § 872.3100 Dental amalgamator.
7435. § 872.3110 Dental amalgam capsule.
7436. § 872.3130 Preformed anchor.
7437. § 872.3140 Resin applicator.
7438. § 872.3150 Articulator.
7439. § 872.3165 Precision attachment.
7440. § 872.3200 Resin tooth bonding agent.
7441. § 872.3220 Facebow.
7442. § 872.3240 Dental bur.
7443. § 872.3250 Calcium hydroxide cavity liner.
7444. § 872.3260 Cavity varnish.
7445. § 872.3275 Dental cement.
7446. § 872.3285 Preformed clasp.
7447. § 872.3300 Hydrophilic resin coating for dentures.
7448. § 872.3310 Coating material for resin fillings.
7449. § 872.3330 Preformed crown.
7450. § 872.3350 Gold or stainless steel cusp.
7451. § 872.3360 Preformed cusp.
7452. § 872.3400 Karaya and sodium borate with or without acacia denture adhesive.
7453. § 872.3410 Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.
7454. § 872.3420 Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive.
7455. § 872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive.
7456. § 872.3480 Polyacrylamide polymer (modified cationic) denture adhesive.
7457. § 872.3490 Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
7458. § 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
7459. § 872.3520 OTC denture cleanser.
7460. § 872.3530 Mechanical denture cleaner.
7461. § 872.3540 OTC denture cushion or pad.
7462. § 872.3560 OTC denture reliner.
7463. § 872.3570 OTC denture repair kit.
7464. § 872.3580 Preformed gold denture tooth.
7465. § 872.3590 Preformed plastic denture tooth.
7466. § 872.3600 Partially fabricated denture kit.
7467. § 872.3630 Endosseous dental implant abutment.
7468. § 872.3640 Endosseous dental implant.
7469. § 872.3645 Subperiosteal implant material.
7470. § 872.3660 Impression material.
7471. § 872.3661 Optical Impression Systems for CAD/CAM.
7472. § 872.3670 Resin impression tray material.
7473. § 872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials.
7474. § 872.3690 Tooth shade resin material.
7475. § 872.3710 Base metal alloy.
7476. § 872.3730 Pantograph.
7477. § 872.3740 Retentive and splinting pin.
7478. § 872.3750 Bracket adhesive resin and tooth conditioner.
7479. § 872.3760 Denture relining, repairing, or rebasing resin.
7480. § 872.3765 Pit and fissure sealant and conditioner.
7481. § 872.3770 Temporary crown and bridge resin.
7482. § 872.3810 Root canal post.
7483. § 872.3820 Root canal filling resin.
7484. § 872.3830 Endodontic paper point.
7485. § 872.3840 Endodontic silver point.
7486. § 872.3850 Gutta percha.
7487. § 872.3890 Endodontic stabilizing splint.
7488. § 872.3900 Posterior artificial tooth with a metal insert.
7489. § 872.3910 Backing and facing for an artificial tooth.
7490. § 872.3920 Porcelain tooth.
7491. § 872.3930 Bone grafting material.
7492. § 872.3940 Total temporomandibular joint prosthesis.
7493. § 872.3950 Glenoid fossa prosthesis.
7494. § 872.3960 Mandibular condyle prosthesis.
7495. § 872.3970 Interarticular disc prosthesis (interpositional implant).
7496. § 872.3980 Endosseous dental implant accessories.
7497. Subpart E Surgical Devices
7498. § 872.4120 Bone cutting instrument and accessories.
7499. § 872.4130 Intraoral dental drill.
7500. § 872.4200 Dental handpiece and accessories.
7501. § 872.4465 Gas-powered jet injector.
7502. § 872.4475 Spring-powered jet injector.
7503. § 872.4535 Dental diamond instrument.
7504. § 872.4565 Dental hand instrument.
7505. § 872.4600 Intraoral ligature and wire lock.
7506. § 872.4620 Fiber optic dental light.
7507. § 872.4630 Dental operating light.
7508. § 872.4730 Dental injecting needle.
7509. § 872.4760 Bone plate.
7510. § 872.4770 Temporary mandibular condyle reconstruction plate.
7511. § 872.4840 Rotary scaler.
7512. § 872.4850 Ultrasonic scaler.
7513. § 872.4880 Intraosseous fixation screw or wire.
7514. § 872.4920 Dental electrosurgical unit and accessories.
7515. Subpart F Therapeutic Devices
7516. § 872.5410 Orthodontic appliance and accessories.
7517. § 872.5470 Orthodontic plastic bracket.
7518. § 872.5500 Extraoral orthodontic headgear.
7519. § 872.5525 Preformed tooth positioner.
7520. § 872.5550 Teething ring.
7521. § 872.5560 Electrical salivary stimulatory system.
7522. § 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
7523. § 872.5571 Auto titration device for oral appliances.
7524. § 872.5575 Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea.
7525. § 872.5580 Oral rinse to reduce the adhesion of dental plaque.
7526. § 872.5590 Intraoral cooling device.
7527. Subpart G Miscellaneous Devices
7528. § 872.6010 Abrasive device and accessories.
7529. § 872.6030 Oral cavity abrasive polishing agent.
7530. § 872.6050 Saliva absorber.
7531. § 872.6070 Ultraviolet activator for polymerization.
7532. § 872.6080 Airbrush.
7533. § 872.6100 Anesthetic warmer.
7534. § 872.6140 Articulation paper.
7535. § 872.6200 Base plate shellac.
7536. § 872.6250 Dental chair and accessories.
7537. § 872.6290 Prophylaxis cup.
7538. § 872.6300 Rubber dam and accessories.
7539. § 872.6350 Ultraviolet detector.
7540. § 872.6390 Dental floss.
7541. § 872.6475 Heat source for bleaching teeth.
7542. § 872.6510 Oral irrigation unit.
7543. § 872.6570 Impression tube.
7544. § 872.6640 Dental operative unit and accessories.
7545. § 872.6650 Massaging pick or tip for oral hygiene.
7546. § 872.6660 Porcelain powder for clinical use.
7547. § 872.6670 Silicate protector.
7548. § 872.6710 Boiling water sterilizer.
7549. § 872.6730 Endodontic dry heat sterilizer.
7550. § 872.6770 Cartridge syringe.
7551. § 872.6855 Manual toothbrush.
7552. § 872.6865 Powered toothbrush.
7553. § 872.6866 Radiofrequency toothbrush.
7554. § 872.6870 Disposable fluoride tray.
7555. § 872.6880 Preformed impression tray.
7556. § 872.6890 Intraoral dental wax.
7557. PART 874 EAR, NOSE, AND THROAT DEVICES
7558. Subpart A General Provisions
7559. § 874.1 Scope.
7560. § 874.3 Effective dates of requirement for premarket approval.
7561. § 874.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
7562. Subpart B Diagnostic Devices
7563. § 874.1050 Audiometer.
7564. § 874.1060 Acoustic chamber for audiometric testing.
7565. § 874.1070 Short increment sensitivity index (SISI) adapter.
7566. § 874.1080 Audiometer calibration set.
7567. § 874.1090 Auditory impedance tester.
7568. § 874.1100 Earphone cushion for audiometric testing.
7569. § 874.1120 Electronic noise generator for audiometric testing.
7570. § 874.1325 Electroglottograph.
7571. § 874.1500 Gustometer.
7572. § 874.1600 Olfactory test device.
7573. § 874.1800 Air or water caloric stimulator.
7574. § 874.1820 Surgical nerve stimulator/locator.
7575. § 874.1925 Toynbee diagnostic tube.
7576. C Subpart C [Reserved]
7577. Subpart D Prosthetic Devices
7578. § 874.3300 Air-conduction hearing aid.
7579. § 874.3302 Bone-conduction hearing aid.
7580. § 874.3305 Wireless air-conduction hearing aid.
7581. § 874.3310 Hearing aid calibrator and analysis system.
7582. § 874.3315 Tympanic membrane contact hearing aid.
7583. § 874.3320 Group hearing aid or group auditory trainer.
7584. § 874.3325 Self-fitting air-conduction hearing aid.
7585. § 874.3330 Master hearing aid.
7586. § 874.3340 Active implantable bone conduction hearing system.
7587. § 874.3375 Battery-powered artificial larynx.
7588. § 874.3400 Tinnitus masker.
7589. § 874.3410 Combined acoustic and electrical external stimulation device for the relief of tinnitus.
7590. § 874.3430 Middle ear mold.
7591. § 874.3450 Partial ossicular replacement prosthesis.
7592. § 874.3495 Total ossicular replacement prosthesis.
7593. § 874.3540 Prosthesis modification instrument for ossicular replacement surgery.
7594. § 874.3620 Ear, nose, and throat synthetic polymer material.
7595. § 874.3695 Mandibular implant facial prosthesis.
7596. § 874.3730 Laryngeal prosthesis (Taub design).
7597. § 874.3760 Sacculotomy tack (Cody tack)
7598. § 874.3820 Endolymphatic shunt.
7599. § 874.3850 Endolymphatic shunt tube with valve.
7600. § 874.3880 Tympanostomy tube.
7601. § 874.3900 Nasal dilator.
7602. § 874.3930 Tympanostomy tube with semipermeable membrane.
7603. § 874.3950 Transcutaneous air conduction hearing aid system.
7604. Subpart E Surgical Devices
7605. § 874.4100 Epistaxis balloon.
7606. § 874.4140 Ear, nose, and throat bur.
7607. § 874.4175 Nasopharyngeal catheter.
7608. § 874.4180 Eustachian tube balloon dilation system.
7609. § 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
7610. § 874.4350 Ear, nose, and throat fiberoptic light source and carrier.
7611. § 874.4420 Ear, nose, and throat manual surgical instrument.
7612. § 874.4450 Powered insertion system for a cochlear implant electrode array.
7613. § 874.4460 Cooperative powered surgical assist device for ENT surgery.
7614. § 874.4490 Argon laser for otology, rhinology, and laryngology.
7615. § 874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.
7616. § 874.4680 Bronchoscope (flexible or rigid) and accessories.
7617. § 874.4710 Esophagoscope (flexible or rigid) and accessories.
7618. § 874.4720 Mediastinoscope and accessories.
7619. § 874.4750 Laryngostroboscope.
7620. § 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
7621. § 874.4770 Otoscope.
7622. § 874.4780 Intranasal splint.
7623. § 874.4800 Bone particle collector.
7624. Subpart F Therapeutic Devices
7625. § 874.5220 Ear, nose, and throat drug administration device.
7626. § 874.5300 Ear, nose, and throat examination and treatment unit.
7627. § 874.5350 Suction antichoke device.
7628. § 874.5370 Tongs antichoke device.
7629. § 874.5550 Powered nasal irrigator.
7630. § 874.5800 External nasal splint.
7631. § 874.5840 Antistammering device.
7632. § 874.5900 External upper esophageal sphincter compression device.
7633. § 874.5950 Oropharyngeal electrical stimulator.
7634. § 874.6000 Transcutaneous electrical nerve stimulator for the relief of congestion.
7635. PART 876 GASTROENTEROLOGY-UROLOGY DEVICES
7636. Subpart A General Provisions
7637. § 876.1 Scope.
7638. § 876.3 Effective dates of requirement for premarket approval.
7639. § 876.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
7640. Subpart B Diagnostic Devices
7641. § 876.1050 Endoscopic transhepatic venous access needle.
7642. § 876.1075 Gastroenterology-urology biopsy instrument.
7643. § 876.1080 Gastroenterology-urology accessories to a biopsy instrument.
7644. § 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
7645. § 876.1310 Magnetically maneuvered capsule endoscopy system.
7646. § 876.1330 Colon capsule endoscopy system.
7647. § 876.1390 Ingestible gastrointestinal blood detection capsule.
7648. § 876.1400 Stomach pH electrode.
7649. § 876.1450 Esophageal tissue characterization system.
7650. § 876.1500 Endoscope and accessories.
7651. § 876.1510 Anchored esophageal sheath.
7652. § 876.1520 Gastrointestinal lesion software detection system.
7653. § 876.1530 Endoscopic light-projecting measuring device.
7654. § 876.1620 Urodynamics measurement system.
7655. § 876.1725 Gastrointestinal motility monitoring system.
7656. § 876.1735 Electrogastrography system.
7657. § 876.1800 Urine flow or volume measuring system.
7658. Subpart C Monitoring Devices
7659. § 876.2040 Enuresis alarm.
7660. § 876.2050 Prostate lesion documentation system.
7661. § 876.2100 Pressure ulcer management tool.
7662. Subpart D Prosthetic Devices
7663. § 876.3350 Penile inflatable implant.
7664. § 876.3500 Penile implant surgical accessories.
7665. § 876.3630 Penile rigidity implant.
7666. § 876.3750 Testicular prosthesis.
7667. Subpart E Surgical Devices
7668. § 876.4020 Fiberoptic light ureteral catheter.
7669. § 876.4100 Flushing and storage solution for vascular autografts at room temperature.
7670. § 876.4270 Colostomy rod.
7671. § 876.4300 Endoscopic electrosurgical unit and accessories.
7672. § 876.4310 Endoscopic electrosurgical clip cutting system.
7673. § 876.4330 Endoscopic pancreatic debridement device.
7674. § 876.4340 High intensity ultrasound system for prostate tissue ablation.
7675. § 876.4350 Fluid jet system for prostate tissue removal.
7676. § 876.4370 Gastroenterology-urology evacuator.
7677. § 876.4400 Hemorrhoidal ligator.
7678. § 876.4410 Endoscopic traction device.
7679. § 876.4480 Electrohydraulic lithotriptor.
7680. § 876.4500 Mechanical lithotriptor.
7681. § 876.4530 Gastroenterology-urology fiberoptic retractor.
7682. § 876.4560 Ribdam.
7683. § 876.4590 Interlocking urethral sound.
7684. § 876.4620 Ureteral stent.
7685. § 876.4630 Ureteral stent accessories.
7686. § 876.4650 Water jet renal stone dislodger system.
7687. § 876.4680 Ureteral stone dislodger.
7688. § 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
7689. § 876.4770 Urethrotome.
7690. § 876.4890 Urological table and accessories.
7691. Subpart F Therapeutic Devices
7692. § 876.5010 Biliary catheter and accessories.
7693. § 876.5011 Metallic biliary stent system for benign strictures.
7694. § 876.5012 Biliary stent, drain, and dilator accessories.
7695. § 876.5015 Pancreatic drainage stent and delivery system.
7696. § 876.5020 External penile rigidity devices.
7697. § 876.5021 Non-medicated topical formulation for treatment of erectile dysfunction.
7698. § 876.5025 Vibrator for climax control of premature ejaculation.
7699. § 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation.
7700. § 876.5030 Continent ileostomy catheter.
7701. § 876.5090 Suprapubic urological catheter and accessories.
7702. § 876.5100 Suprapubic catheter accessories.
7703. § 876.5130 Urological catheter and accessories.
7704. § 876.5140 Urethral insert with pump for bladder drainage.
7705. § 876.5160 Urological clamp.
7706. § 876.5210 Enema kit.
7707. § 876.5220 Colonic irrigation system.
7708. § 876.5250 Urine collector and accessories.
7709. § 876.5270 Implanted electrical urinary continence device.
7710. § 876.5280 Implanted mechanical/hydraulic urinary continence device.
7711. § 876.5290 Implanted mechanical/hydraulic urinary continence device surgical accessories.
7712. § 876.5305 Implanted tibial electrical urinary continence device.
7713. § 876.5310 Nonimplanted, peripheral electrical continence device.
7714. § 876.5320 Nonimplanted electrical continence device.
7715. § 876.5330 Transcutaneous electrical continence device.
7716. § 876.5340 Nonimplanted nerve stimulator for functional abdominal pain relief.
7717. § 876.5360 Laparoscopic gastrointestinal sizing tool.
7718. § 876.5365 Esophageal dilator.
7719. § 876.5450 Rectal dilator.
7720. § 876.5470 Ureteral dilator.
7721. § 876.5510 Temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia.
7722. § 876.5520 Urethral dilator.
7723. § 876.5530 Implantable transprostatic tissue retractor system.
7724. § 876.5540 Blood access device and accessories.
7725. § 876.5550 Prostatic artery embolization device.
7726. § 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
7727. § 876.5630 Peritoneal dialysis system and accessories.
7728. § 876.5665 Water purification system for hemodialysis.
7729. § 876.5820 Hemodialysis system and accessories.
7730. § 876.5830 Hemodialyzer with disposable insert (Kiil type).
7731. § 876.5860 High permeability hemodialysis system.
7732. § 876.5861 Pediatric continuous renal replacement therapy system.
7733. § 876.5862 Hemodialyzer with expanded solute removal profile.
7734. § 876.5870 Sorbent hemoperfusion system.
7735. § 876.5880 Isolated kidney perfusion and transport system and accessories.
7736. § 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.
7737. § 876.5895 Ostomy irrigator.
7738. § 876.5900 Ostomy pouch and accessories.
7739. § 876.5920 Protective garment for incontinence.
7740. § 876.5930 Rectal control system.
7741. § 876.5940 Orally ingested transient device for constipation.
7742. § 876.5955 Peritoneo-venous shunt.
7743. § 876.5960 Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.
7744. § 876.5970 Hernia support.
7745. § 876.5980 Gastrointestinal tube and accessories.
7746. § 876.5981 Oral removable palatal space occupying device for weight management and/or weight loss.
7747. § 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss.
7748. § 876.5983 Endoscopic suturing device for altering gastric anatomy for weight loss.
7749. § 876.5985 Enzyme packed cartridge.
7750. § 876.5990 Extracorporeal shock wave lithotripter.
7751. PART 878 GENERAL AND PLASTIC SURGERY DEVICES
7752. Subpart A General Provisions
7753. § 878.1 Scope.
7754. § 878.3 Effective dates of requirement for premarket approval.
7755. § 878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
7756. Subpart B Diagnostic Devices
7757. § 878.1800 Speculum and accessories.
7758. § 878.1820 Software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.
7759. C Subpart C [Reserved]
7760. Subpart D Prosthetic Devices
7761. § 878.3250 External facial fracture fixation appliance.
7762. § 878.3300 Surgical mesh.
7763. § 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
7764. § 878.3510 Carbon dioxide gas controlled tissue expander.
7765. § 878.3530 Silicone inflatable breast prosthesis.
7766. § 878.3540 Silicone gel-filled breast prosthesis.
7767. § 878.3550 Chin prosthesis.
7768. § 878.3590 Ear prosthesis.
7769. § 878.3610 Esophageal prosthesis.
7770. § 878.3680 Nose prosthesis.
7771. § 878.3720 Tracheal prosthesis.
7772. § 878.3750 External prosthesis adhesive.
7773. § 878.3800 External aesthetic restoration prosthesis.
7774. § 878.3900 Inflatable extremity splint.
7775. § 878.3910 Noninflatable extremity splint.
7776. § 878.3925 Plastic surgery kit and accessories.
7777. Subpart E Surgical Devices
7778. § 878.4010 Tissue adhesive.
7779. § 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
7780. § 878.4014 Nonresorbable gauze/sponge for external use.
7781. § 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
7782. § 878.4018 Hydrophilic wound dressing.
7783. § 878.4020 Occlusive wound dressing.
7784. § 878.4022 Hydrogel wound dressing and burn dressing.
7785. § 878.4025 Silicone sheeting.
7786. § 878.4040 Surgical apparel.
7787. § 878.4100 Organ bag.
7788. § 878.4160 Surgical camera and accessories.
7789. § 878.4165 Wound autofluorescence imaging device.
7790. § 878.4200 Introduction/drainage catheter and accessories.
7791. § 878.4300 Implantable clip.
7792. § 878.4320 Removable skin clip.
7793. § 878.4340 Contact cooling system for aesthetic use.
7794. § 878.4350 Cryosurgical unit and accessories.
7795. § 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
7796. § 878.4370 Surgical drape and drape accessories.
7797. § 878.4371 Irrigating wound retractor device.
7798. § 878.4380 Drape adhesive.
7799. § 878.4400 Electrosurgical cutting and coagulation device and accessories.
7800. § 878.4405 Focused ultrasound system for non-thermal, mechanical tissue ablation.
7801. § 878.4410 Low energy ultrasound wound cleaner.
7802. § 878.4420 Electrosurgical device for over-the-counter aesthetic use.
7803. § 878.4425 Skin patch for treatment of hyperhidrosis.
7804. § 878.4430 Microneedling device for aesthetic use.
7805. § 878.4440 Eye pad.
7806. § 878.4450 Nonabsorbable gauze for internal use.
7807. § 878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.
7808. § 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
7809. § 878.4456 Hemostatic device for intraluminal gastrointestinal use.
7810. § 878.4460 Non-powdered surgeon's glove.
7811. § 878.4470 Surgeon's gloving cream.
7812. § 878.4490 Absorbable hemostatic agent and dressing.
7813. § 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
7814. § 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
7815. § 878.4495 Stainless steel suture.
7816. § 878.4520 Polytetrafluoroethylene injectable.
7817. § 878.4550 Autofluorescence detection device for general surgery and dermatological use.
7818. § 878.4580 Surgical lamp.
7819. § 878.4590 Focused ultrasound stimulator system for aesthetic use.
7820. § 878.4630 Ultraviolet lamp for dermatologic disorders.
7821. § 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
7822. § 878.4660 Skin marker.
7823. § 878.4670 Internal tissue marker.
7824. § 878.4675 Breast implant suction retrieval system.
7825. § 878.4680 Nonpowered, single patient, portable suction apparatus.
7826. § 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
7827. § 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.
7828. § 878.4700 Surgical microscope and accessories.
7829. § 878.4730 Surgical skin degreaser or adhesive tape solvent.
7830. § 878.4740 Surgical stapler.
7831. § 878.4750 Implantable staple.
7832. § 878.4755 Absorbable lung biopsy plug.
7833. § 878.4760 Removable skin staple.
7834. § 878.4780 Powered suction pump.
7835. § 878.4783 Negative pressure wound therapy device for reduction of wound complications.
7836. § 878.4790 Powered surgical instrument for improvement in the appearance of cellulite.
7837. § 878.4800 Manual surgical instrument for general use.
7838. § 878.4805 Manual percutaneous surgical set assembled in the abdomen.
7839. § 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
7840. § 878.4815 Magnetic surgical instrument system.
7841. § 878.4820 Surgical instrument motors and accessories/attachments.
7842. § 878.4825 General laparoscopic power morcellation containment system.
7843. § 878.4830 Absorbable surgical gut suture.
7844. § 878.4840 Absorbable polydioxanone surgical suture.
7845. § 878.4850 Blood lancets.
7846. § 878.4860 Light based energy source device for topical application.
7847. § 878.4880 Phototherapy device for reducing the appearance of acute post-surgical incisions.
7848. § 878.4930 Suture retention device.
7849. § 878.4950 Manual operating table and accessories and manual operating chair and accessories.
7850. § 878.4960 Operating tables and accessories and operating chairs and accessories.
7851. § 878.4961 Mountable electromechanical surgical system for transluminal approaches.
7852. § 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
7853. § 878.5010 Nonabsorbable polypropylene surgical suture.
7854. § 878.5020 Nonabsorbable polyamide surgical suture.
7855. § 878.5030 Natural nonabsorbable silk surgical suture.
7856. § 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
7857. § 878.5040 Suction lipoplasty system.
7858. § 878.5050 Surgical smoke precipitator.
7859. Subpart F Therapeutic Devices
7860. § 878.5070 Air-handling apparatus for a surgical operating room.
7861. § 878.5080 Air-handling apparatus accessory.
7862. § 878.5350 Needle-type epilator.
7863. § 878.5360 Tweezer-type epilator.
7864. § 878.5400 Low level laser system for aesthetic use
7865. § 878.5650 Topical oxygen chamber for extremities.
7866. § 878.5900 Nonpneumatic tourniquet.
7867. § 878.5910 Pneumatic tourniquet.
7868. PART 880 GENERAL HOSPITAL AND PERSONAL USE DEVICES
7869. Subpart A General Provisions
7870. § 880.1 Scope.
7871. § 880.3 Effective dates of requirement for premarket approval.
7872. § 880.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
7873. B Subpart B [Reserved]
7874. Subpart C General Hospital and Personal Use Monitoring Devices
7875. § 880.2200 Liquid crystal forehead temperature strip.
7876. § 880.2400 Bed-patient monitor.
7877. § 880.2420 Electronic monitor for gravity flow infusion systems.
7878. § 880.2460 Electrically powered spinal fluid pressure monitor.
7879. § 880.2500 Spinal fluid manometer.
7880. § 880.2700 Stand-on patient scale.
7881. § 880.2720 Patient scale.
7882. § 880.2740 Surgical sponge scale.
7883. § 880.2750 Image processing device for estimation of external blood loss.
7884. § 880.2800 Sterilization process indicator.
7885. § 880.2900 Clinical color change thermometer.
7886. § 880.2910 Clinical electronic thermometer.
7887. § 880.2920 Clinical mercury thermometer.
7888. § 880.2930 Apgar timer.
7889. D Subparts D-E [Reserved]
7890. Subpart F General Hospital and Personal Use Therapeutic Devices
7891. § 880.5025 I.V. container.
7892. § 880.5045 Medical recirculating air cleaner.
7893. § 880.5075 Elastic bandage.
7894. § 880.5090 Liquid bandage.
7895. § 880.5100 AC-powered adjustable hospital bed.
7896. § 880.5110 Hydraulic adjustable hospital bed.
7897. § 880.5120 Manual adjustable hospital bed.
7898. § 880.5130 Infant radiant warmer.
7899. § 880.5140 Pediatric medical crib.
7900. § 880.5145 Medical bassinet.
7901. § 880.5150 Nonpowered flotation therapy mattress.
7902. § 880.5160 Therapeutic medical binder.
7903. § 880.5180 Burn sheet.
7904. § 880.5200 Intravascular catheter.
7905. § 880.5210 Intravascular catheter securement device.
7906. § 880.5220 Intravenous catheter force-activated separation device.
7907. § 880.5240 Medical adhesive tape and adhesive bandage.
7908. § 880.5270 Neonatal eye pad.
7909. § 880.5300 Medical absorbent fiber.
7910. § 880.5400 Neonatal incubator.
7911. § 880.5405 Active noise attenuation system for infant incubators.
7912. § 880.5410 Neonatal transport incubator.
7913. § 880.5420 Pressure infusor for an I.V. bag.
7914. § 880.5430 Nonelectrically powered fluid injector.
7915. § 880.5440 Intravascular administration set.
7916. § 880.5445 Intravascular administration set, automated air removal system.
7917. § 880.5450 Patient care reverse isolation chamber.
7918. § 880.5475 Jet lavage.
7919. § 880.5500 AC-powered patient lift.
7920. § 880.5510 Non-AC-powered patient lift.
7921. § 880.5550 Alternating pressure air flotation mattress.
7922. § 880.5560 Temperature regulated water mattress.
7923. § 880.5570 Hypodermic single lumen needle.
7924. § 880.5580 Acupuncture needle.
7925. § 880.5630 Nipple shield.
7926. § 880.5640 Lamb feeding nipple.
7927. § 880.5680 Pediatric position holder.
7928. § 880.5690 Infant supine sleep system.
7929. § 880.5700 Neonatal phototherapy unit.
7930. § 880.5725 Infusion pump.
7931. § 880.5730 Alternate controller enabled infusion pump.
7932. § 880.5735 Diabetes digital behavioral therapeutic device.
7933. § 880.5740 Suction snakebite kit.
7934. § 880.5760 Chemical cold pack snakebite kit.
7935. § 880.5780 Medical support stocking.
7936. § 880.5820 Therapeutic scrotal support.
7937. § 880.5860 Piston syringe.
7938. § 880.5950 Umbilical occlusion device.
7939. § 880.5960 Lice removal kit.
7940. § 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
7941. § 880.5970 Percutaneous, implanted, long-term intravascular catheter.
7942. Subpart G General Hospital and Personal Use Miscellaneous Devices
7943. § 880.6025 Absorbent tipped applicator.
7944. § 880.6050 Ice bag.
7945. § 880.6060 Medical disposable bedding.
7946. § 880.6070 Bed board.
7947. § 880.6080 Cardiopulmonary resuscitation board.
7948. § 880.6085 Hot/cold water bottle.
7949. § 880.6100 Ethylene oxide gas aerator cabinet.
7950. § 880.6140 Medical chair and table.
7951. § 880.6150 Ultrasonic cleaner for medical instruments.
7952. § 880.6175 [Reserved]
7953. § 880.6185 Cast cover.
7954. § 880.6190 Mattress cover for medical purposes.
7955. § 880.6200 Ring cutter.
7956. § 880.6210 Sharps needle destruction device.
7957. § 880.6230 Tongue depressor.
7958. § 880.6250 Non-powdered patient examination glove.
7959. § 880.6260 Filtering facepiece respirator for use by the general public in public health medical emergencies.
7960. § 880.6265 Examination gown.
7961. § 880.6280 Medical insole.
7962. § 880.6300 Implantable radiofrequency transponder system for patient identification and health information.
7963. § 880.6305 Ingestible event marker.
7964. § 880.6310 Medical device data system.
7965. § 880.6315 Remote Medication Management System.
7966. § 880.6320 AC-powered medical examination light.
7967. § 880.6350 Battery-powered medical examination light.
7968. § 880.6375 Patient lubricant.
7969. § 880.6430 Liquid medication dispenser.
7970. § 880.6450 Skin pressure protectors.
7971. § 880.6500 Medical ultraviolet air purifier.
7972. § 880.6510 Whole room microbial reduction device.
7973. § 880.6600 Ultraviolet (UV) radiation chamber disinfection device.
7974. § 880.6710 Medical ultraviolet water purifier.
7975. § 880.6730 Body waste receptacle.
7976. § 880.6740 Vacuum-powered body fluid suction apparatus.
7977. § 880.6760 Protective restraint.
7978. § 880.6775 Powered patient transfer device.
7979. § 880.6785 Manual patient transfer device.
7980. § 880.6800 Washers for body waste receptacles.
7981. § 880.6820 Medical disposable scissors.
7982. § 880.6850 Sterilization wrap.
7983. § 880.6855 Rigid sterilization container with electronic monitoring.
7984. § 880.6860 Ethylene oxide gas sterilizer.
7985. § 880.6870 Dry-heat sterilizer.
7986. § 880.6880 Steam sterilizer.
7987. § 880.6885 Liquid chemical sterilants/high level disinfectants.
7988. § 880.6886 Foam or gel chemical sterilant/high level disinfectant.
7989. § 880.6887 Spore test strip.
7990. § 880.6890 General purpose disinfectants.
7991. § 880.6900 Hand-carried stretcher.
7992. § 880.6910 Wheeled stretcher.
7993. § 880.6920 Syringe needle introducer.
7994. § 880.6960 Irrigating syringe.
7995. § 880.6970 Liquid crystal vein locator.
7996. § 880.6980 Vein stabilizer.
7997. § 880.6990 Infusion stand.
7998. § 880.6991 Medical washer.
7999. § 880.6992 Medical washer-disinfector.
8000. PART 882 NEUROLOGICAL DEVICES
8001. Subpart A General Provisions
8002. § 882.1 Scope.
8003. § 882.3 Effective dates of requirement for premarket approval.
8004. § 882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
8005. Subpart B Neurological Diagnostic Devices
8006. § 882.1020 Rigidity analyzer.
8007. § 882.1030 Ataxiagraph.
8008. § 882.1200 Two-point discriminator.
8009. § 882.1240 Echoencephalograph.
8010. § 882.1275 Electroconductive media.
8011. § 882.1310 Cortical electrode.
8012. § 882.1320 Cutaneous electrode.
8013. § 882.1330 Depth electrode.
8014. § 882.1340 Nasopharyngeal electrode.
8015. § 882.1350 Needle electrode.
8016. § 882.1400 Electroencephalograph.
8017. § 882.1410 Electroencephalograph electrode/lead tester.
8018. § 882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
8019. § 882.1430 Electroencephalograph test signal generator.
8020. § 882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid.
8021. § 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.
8022. § 882.1455 Traumatic brain injury eye movement assessment aid.
8023. § 882.1460 Nystagmograph.
8024. § 882.1470 Computerized cognitive assessment aid.
8025. § 882.1471 Computerized cognitive assessment aid for concussion.
8026. § 882.1480 Neurological endoscope.
8027. § 882.1491 Pediatric Autism Spectrum Disorder diagnosis aid.
8028. § 882.1500 Esthesiometer.
8029. § 882.1525 Tuning fork.
8030. § 882.1540 Galvanic skin response measurement device.
8031. § 882.1550 Nerve conduction velocity measurement device.
8032. § 882.1560 Skin potential measurement device.
8033. § 882.1561 Evoked photon image capture device.
8034. § 882.1565 Brain temperature measurement system.
8035. § 882.1570 Powered direct-contact temperature measurement device.
8036. § 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
8037. § 882.1610 Alpha monitor.
8038. § 882.1620 Intracranial pressure monitoring device.
8039. § 882.1630 Cranial motion measurement device.
8040. § 882.1700 Percussor.
8041. § 882.1750 Pinwheel.
8042. § 882.1790 Ocular plethysmograph.
8043. § 882.1825 Rheoencephalograph.
8044. § 882.1835 Physiological signal amplifier.
8045. § 882.1845 Physiological signal conditioner.
8046. § 882.1855 Electroencephalogram (EEG) telemetry system.
8047. § 882.1870 Evoked response electrical stimulator.
8048. § 882.1880 Evoked response mechanical stimulator.
8049. § 882.1890 Evoked response photic stimulator.
8050. § 882.1900 Evoked response auditory stimulator.
8051. § 882.1925 Ultrasonic scanner calibration test block.
8052. § 882.1935 Near Infrared (NIR) Brain Hematoma Detector.
8053. § 882.1950 Tremor transducer.
8054. C Subparts C-D [Reserved]
8055. Subpart E Neurological Surgical Devices
8056. § 882.4030 Skull plate anvil.
8057. § 882.4060 Ventricular cannula.
8058. § 882.4100 Ventricular catheter.
8059. § 882.4125 Neurosurgical chair.
8060. § 882.4150 Scalp clip.
8061. § 882.4175 Aneurysm clip applier.
8062. § 882.4190 Clip forming/cutting instrument.
8063. § 882.4200 Clip removal instrument.
8064. § 882.4215 Clip rack.
8065. § 882.4250 Cryogenic surgical device.
8066. § 882.4275 Dowel cutting instrument.
8067. § 882.4300 Manual cranial drills, burrs, trephines, and their accessories
8068. § 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
8069. § 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
8070. § 882.4325 Cranial drill handpiece (brace).
8071. § 882.4360 Electric cranial drill motor.
8072. § 882.4370 Pneumatic cranial drill motor.
8073. § 882.4400 Radiofrequency lesion generator.
8074. § 882.4440 Neurosurgical headrests.
8075. § 882.4460 Neurosurgical head holder (skull clamp).
8076. § 882.4500 Cranioplasty material forming instrument.
8077. § 882.4525 Microsurgical instrument.
8078. § 882.4535 Nonpowered neurosurgical instrument.
8079. § 882.4545 Shunt system implantation instrument.
8080. § 882.4560 Stereotaxic instrument.
8081. § 882.4565 Field generator positioning device.
8082. § 882.4600 Leukotome.
8083. § 882.4650 Neurosurgical suture needle.
8084. § 882.4700 Neurosurgical paddie.
8085. § 882.4725 Radiofrequency lesion probe.
8086. § 882.4750 Skull punch.
8087. § 882.4800 Self-retaining retractor for neurosurgery.
8088. § 882.4840 Manual rongeur.
8089. § 882.4845 Powered rongeur.
8090. § 882.4900 Skullplate screwdriver.
8091. § 882.4950 Diagnostic neurosurgical microscope filter.
8092. Subpart F Neurological Therapeutic Devices
8093. § 882.5030 Methyl methacrylate for aneurysmorrhaphy.
8094. § 882.5050 Biofeedback device.
8095. § 882.5060 Conditioning tool for eating disorders.
8096. § 882.5070 Bite block.
8097. § 882.5150 Intravascular occluding catheter.
8098. § 882.5175 Carotid artery clamp.
8099. § 882.5200 Aneurysm clip.
8100. § 882.5225 Implanted malleable clip.
8101. § 882.5235 Aversive conditioning device.
8102. § 882.5250 Burr hole cover.
8103. § 882.5275 Nerve cuff.
8104. § 882.5300 Methyl methacrylate for cranioplasty.
8105. § 882.5320 Preformed alterable cranioplasty plate.
8106. § 882.5330 Preformed nonalterable cranioplasty plate.
8107. § 882.5360 Cranioplasty plate fastener.
8108. § 882.5500 Lesion temperature monitor.
8109. § 882.5550 Central nervous system fluid shunt and components.
8110. § 882.5560 Cerebrospinal fluid shunt system.
8111. § 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
8112. § 882.5700 Thermal system for insomnia.
8113. § 882.5705 Digital therapy device to reduce sleep disturbance for psychiatric conditions.
8114. § 882.5800 Cranial electrotherapy stimulator.
8115. § 882.5801 Computerized behavioral therapy device for psychiatric disorders.
8116. § 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
8117. § 882.5803 Digital therapy device for Attention Deficit Hyperactivity Disorder.
8118. § 882.5804 Computerized behavioral therapy device for the treatment of fibromyalgia symptoms.
8119. § 882.5805 Repetitive transcranial magnetic stimulation system.
8120. § 882.5808 Transcranial magnetic stimulator for headache.
8121. § 882.5810 External functional neuromuscular stimulator.
8122. § 882.5820 Implanted cerebellar stimulator.
8123. § 882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
8124. § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief.
8125. § 882.5850 Implanted spinal cord stimulator for bladder evacuation.
8126. § 882.5855 Brain stimulation programming planning software.
8127. § 882.5860 Implanted neuromuscular stimulator.
8128. § 882.5870 Implanted peripheral nerve stimulator for pain relief.
8129. § 882.5880 Implanted spinal cord stimulator for pain relief.
8130. § 882.5887 External lower extremity nerve stimulator for Restless Legs Syndrome.
8131. § 882.5888 Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.
8132. § 882.5889 Electrical tongue nerve stimulator to treat motor deficits.
8133. § 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
8134. § 882.5891 Transcutaneous electrical nerve stimulator to treat headache.
8135. § 882.5892 External vagal nerve stimulator for headache.
8136. § 882.5893 Thermal vestibular stimulator for headache.
8137. § 882.5894 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
8138. § 882.5895 Vibratory counter-stimulation device.
8139. § 882.5896 Percutaneous nerve stimulator for substance use disorders.
8140. § 882.5897 External upper limb tremor stimulator.
8141. § 882.5898 Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
8142. § 882.5899 Trunk and limb electrical stimulator to treat headache.
8143. § 882.5900 Preformed craniosynostosis strip.
8144. § 882.5910 Dura substitute.
8145. § 882.5940 Electroconvulsive therapy device.
8146. § 882.5950 Neurovascular embolization device.
8147. § 882.5955 Temporary coil embolization assist device.
8148. § 882.5960 Skull tongs for traction.
8149. § 882.5970 Cranial orthosis.
8150. PART 884 OBSTETRICAL AND GYNECOLOGICAL DEVICES
8151. Subpart A General Provisions
8152. § 884.1 Scope.
8153. § 884.3 Effective dates of requirement for premarket approval.
8154. § 884.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
8155. Subpart B Obstetrical and Gynecological Diagnostic Devices
8156. § 884.1040 Viscometer for cervical mucus.
8157. § 884.1050 Endocervical aspirator.
8158. § 884.1060 Endometrial aspirator.
8159. § 884.1100 Endometrial brush.
8160. § 884.1175 Endometrial suction curette and accessories.
8161. § 884.1185 Endometrial washer.
8162. § 884.1300 Uterotubal carbon dioxide insufflator and accessories.
8163. § 884.1425 Perineometer.
8164. § 884.1550 Amniotic fluid sampler (amniocentesis tray).
8165. § 884.1560 Fetal blood sampler.
8166. § 884.1600 Transabdominal amnioscope (fetoscope) and accessories.
8167. § 884.1630 Colposcope.
8168. § 884.1640 Culdoscope and accessories.
8169. § 884.1660 Transcervical endoscope (amnioscope) and accessories.
8170. § 884.1690 Hysteroscope and accessories.
8171. § 884.1700 Hysteroscopic insufflator.
8172. § 884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator.
8173. § 884.1720 Gynecologic laparoscope and accessories.
8174. § 884.1730 Laparoscopic insufflator.
8175. Subpart C Obstetrical and Gynecological Monitoring Devices
8176. § 884.2050 Obstetric data analyzer.
8177. § 884.2225 Obstetric-gynecologic ultrasonic imager.
8178. § 884.2600 Fetal cardiac monitor.
8179. § 884.2620 Fetal electroencephalographic monitor.
8180. § 884.2640 Fetal phonocardiographic monitor and accessories.
8181. § 884.2660 Fetal ultrasonic monitor and accessories.
8182. § 884.2675 Fetal scalp circular (spiral) electrode and applicator.
8183. § 884.2685 Fetal scalp clip electrode and applicator.
8184. § 884.2700 Intrauterine pressure monitor and accessories.
8185. § 884.2720 External uterine contraction monitor and accessories.
8186. § 884.2730 Home uterine activity monitor.
8187. § 884.2740 Perinatal monitoring system and accessories.
8188. § 884.2800 Computerized Labor Monitoring System.
8189. § 884.2900 Fetal stethoscope.
8190. § 884.2960 Obstetric ultrasonic transducer and accessories.
8191. § 884.2980 Telethermographic system.
8192. § 884.2982 Liquid crystal thermographic system.
8193. § 884.2990 Breast lesion documentation system.
8194. Subpart D Obstetrical and Gynecological Prosthetic Devices
8195. § 884.3200 Cervical drain.
8196. § 884.3575 Vaginal pessary.
8197. § 884.3650 Fallopian tube prosthesis.
8198. § 884.3900 Vaginal stent.
8199. Subpart E Obstetrical and Gynecological Surgical Devices
8200. § 884.4050 Gynecologic laparoscopic power morcellation containment system.
8201. § 884.4100 Endoscopic electrocautery and accessories.
8202. § 884.4120 Gynecologic electrocautery and accessories.
8203. § 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
8204. § 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
8205. § 884.4250 Expandable cervical dilator.
8206. § 884.4260 Hygroscopic Laminaria cervical dilator.
8207. § 884.4270 Vibratory cervical dilators.
8208. § 884.4340 Fetal vacuum extractor.
8209. § 884.4350 Fetal head elevator.
8210. § 884.4400 Obstetric forceps.
8211. § 884.4500 Obstetric fetal destructive instrument.
8212. § 884.4520 Obstetric-gynecologic general manual instrument.
8213. § 884.4530 Obstetric-gynecologic specialized manual instrument.
8214. § 884.4550 Gynecologic surgical laser.
8215. § 884.4900 Obstetric table and accessories.
8216. § 884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.
8217. Subpart F Obstetrical and Gynecological Therapeutic Devices
8218. § 884.5050 Metreurynter-balloon abortion system.
8219. § 884.5070 Vacuum abortion system.
8220. § 884.5100 Obstetric anesthesia set.
8221. § 884.5150 Nonpowered breast pump.
8222. § 884.5160 Powered breast pump.
8223. § 884.5200 Hemorrhoid prevention pressure wedge.
8224. § 884.5210 Pressure wedge for the reduction of cesarean delivery.
8225. § 884.5225 Abdominal decompression chamber.
8226. § 884.5250 Cervical cap.
8227. § 884.5300 Condom.
8228. § 884.5305 External condom for anal intercourse or vaginal intercourse.
8229. § 884.5310 Condom with spermicidal lubricant.
8230. § 884.5320 Glans sheath.
8231. § 884.5330 Multiple-use female condom.
8232. § 884.5340 Single-use internal condom.
8233. § 884.5350 Contraceptive diaphragm and accessories.
8234. § 884.5360 Contraceptive intrauterine device (IUD) and introducer.
8235. § 884.5370 Software application for contraception.
8236. § 884.5380 Contraceptive tubal occlusion device (TOD) and introducer.
8237. § 884.5390 Perineal heater.
8238. § 884.5400 Menstrual cup.
8239. § 884.5425 Scented or scented deodorized menstrual pad.
8240. § 884.5435 Unscented menstrual pad.
8241. § 884.5460 Scented or scented deodorized menstrual tampon.
8242. § 884.5470 Unscented menstrual tampon.
8243. § 884.5900 Therapeutic vaginal douche apparatus.
8244. § 884.5920 Vaginal insufflator.
8245. § 884.5940 Powered vaginal muscle stimulator for therapeutic use.
8246. § 884.5960 Genital vibrator for therapeutic use.
8247. § 884.5970 Clitoral engorgement device.
8248. § 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
8249. Subpart G Assisted Reproduction Devices
8250. § 884.6100 Assisted reproduction needles.
8251. § 884.6110 Assisted reproduction catheters.
8252. § 884.6120 Assisted reproduction accessories.
8253. § 884.6130 Assisted reproduction microtools.
8254. § 884.6140 Assisted reproduction micropipette fabrication instruments.
8255. § 884.6150 Assisted reproduction micromanipulators and microinjectors.
8256. § 884.6160 Assisted reproduction labware.
8257. § 884.6165 Intravaginal culture system.
8258. § 884.6170 Assisted reproduction water and water purification systems.
8259. § 884.6180 Reproductive media and supplements.
8260. § 884.6190 Assisted reproductive microscopes and microscope accessories.
8261. § 884.6195 Assisted Reproduction Embryo Image Assessment System.
8262. § 884.6200 Assisted reproduction laser system.
8263. PART 886 OPHTHALMIC DEVICES
8264. Subpart A General Provisions
8265. § 886.1 Scope.
8266. § 886.3 Effective dates of requirement for premarket approval.
8267. § 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
8268. Subpart B Diagnostic Devices
8269. § 886.1040 Ocular esthesiometer.
8270. § 886.1050 Adaptometer (biophotometer).
8271. § 886.1070 Anomaloscope.
8272. § 886.1090 Haidinger brush.
8273. § 886.1100 Retinal diagnostic software device.
8274. § 886.1120 Ophthalmic camera.
8275. § 886.1140 Ophthalmic chair.
8276. § 886.1150 Visual acuity chart.
8277. § 886.1160 Color vision plate illuminator.
8278. § 886.1170 Color vision tester.
8279. § 886.1190 Distometer.
8280. § 886.1200 Optokinetic drum.
8281. § 886.1220 Corneal electrode.
8282. § 886.1250 Euthyscope.
8283. § 886.1270 Exophthalmometer.
8284. § 886.1290 Fixation device.
8285. § 886.1300 Afterimage flasher.
8286. § 886.1320 Fornixscope.
8287. § 886.1330 Amsler grid.
8288. § 886.1340 Haploscope.
8289. § 886.1342 Strabismus detection device.
8290. § 886.1350 Keratoscope.
8291. § 886.1360 Visual field laser instrument.
8292. § 886.1375 Bagolini lens.
8293. § 886.1380 Diagnostic condensing lens.
8294. § 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
8295. § 886.1390 Flexible diagnostic Fresnel lens.
8296. § 886.1395 Diagnostic Hruby fundus lens.
8297. § 886.1400 Maddox lens.
8298. § 886.1405 Ophthalmic trial lens set.
8299. § 886.1410 Ophthalmic trial lens clip.
8300. § 886.1415 Ophthalmic trial lens frame.
8301. § 886.1420 Ophthalmic lens gauge.
8302. § 886.1425 Lens measuring instrument.
8303. § 886.1430 Ophthalmic contact lens radius measuring device.
8304. § 886.1435 Maxwell spot.
8305. § 886.1450 Corneal radius measuring device.
8306. § 886.1460 Stereopsis measuring instrument.
8307. § 886.1500 Headband mirror.
8308. § 886.1510 Eye movement monitor.
8309. § 886.1570 Ophthalmoscope.
8310. § 886.1605 Perimeter.
8311. § 886.1630 AC-powered photostimulator.
8312. § 886.1640 Ophthalmic preamplifier.
8313. § 886.1650 Ophthalmic bar prism.
8314. § 886.1655 Ophthalmic Fresnel prism.
8315. § 886.1660 Gonioscopic prism.
8316. § 886.1665 Ophthalmic rotary prism.
8317. § 886.1670 Ophthalmic isotope uptake probe.
8318. § 886.1680 Ophthalmic projector.
8319. § 886.1690 Pupillograph.
8320. § 886.1700 Pupillometer.
8321. § 886.1750 Skiascopic rack.
8322. § 886.1760 Ophthalmic refractometer.
8323. § 886.1770 Manual refractor.
8324. § 886.1780 Retinoscope.
8325. § 886.1790 Nearpoint ruler.
8326. § 886.1800 Schirmer strip.
8327. § 886.1810 Tangent screen (campimeter).
8328. § 886.1840 Simulatan (including crossed cylinder).
8329. § 886.1850 AC-powered slitlamp biomicroscope.
8330. § 886.1860 Ophthalmic instrument stand.
8331. § 886.1870 Stereoscope.
8332. § 886.1880 Fusion and stereoscopic target.
8333. § 886.1905 Nystagmus tape.
8334. § 886.1910 Spectacle dissociation test system.
8335. § 886.1925 Diurnal pattern recorder system.
8336. § 886.1930 Tonometer and accessories.
8337. § 886.1940 Tonometer sterilizer.
8338. § 886.1945 Transilluminator.
8339. C Subpart C [Reserved]
8340. Subpart D Prosthetic Devices
8341. § 886.3100 Ophthalmic tantalum clip.
8342. § 886.3130 Ophthalmic conformer.
8343. § 886.3200 Artificial eye.
8344. § 886.3300 Absorbable implant (scleral buckling method).
8345. § 886.3320 Eye sphere implant.
8346. § 886.3340 Extraocular orbital implant.
8347. § 886.3400 Keratoprosthesis.
8348. § 886.3600 Intraocular lens.
8349. § 886.3800 Scleral shell.
8350. § 886.3920 Aqueous shunt.
8351. Subpart E Surgical Devices
8352. § 886.4070 Powered corneal burr.
8353. § 886.4100 Radiofrequency electrosurgical cautery apparatus.
8354. § 886.4115 Thermal cautery unit.
8355. § 886.4150 Vitreous aspiration and cutting instrument.
8356. § 886.4155 Scleral plug.
8357. § 886.4170 Cryophthalmic unit.
8358. § 886.4230 Ophthalmic knife test drum.
8359. § 886.4250 Ophthalmic electrolysis unit.
8360. § 886.4270 Intraocular gas.
8361. § 886.4275 Intraocular fluid.
8362. § 886.4280 Intraocular pressure measuring device.
8363. § 886.4300 Intraocular lens guide.
8364. § 886.4320 Corneal storage medium with preservatives including antifungals.
8365. § 886.4335 Operating headlamp.
8366. § 886.4350 Manual ophthalmic surgical instrument.
8367. § 886.4355 Corneal inlay inserter handle.
8368. § 886.4360 Ocular surgery irrigation device.
8369. § 886.4370 Keratome.
8370. § 886.4390 Ophthalmic laser.
8371. § 886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
8372. § 886.4400 Electronic metal locator.
8373. § 886.4440 AC-powered magnet.
8374. § 886.4445 Permanent magnet.
8375. § 886.4570 Ophthalmic surgical marker.
8376. § 886.4610 Ocular pressure applicator.
8377. § 886.4670 Phacofragmentation system.
8378. § 886.4690 Ophthalmic photocoagulator.
8379. § 886.4750 Ophthalmic eye shield.
8380. § 886.4770 Ophthalmic operating spectacles (loupes).
8381. § 886.4790 Ophthalmic sponge.
8382. § 886.4855 Ophthalmic instrument table.
8383. Subpart F Therapeutic Devices
8384. § 886.5100 Ophthalmic beta radiation source.
8385. § 886.5120 Low-power binocular loupe.
8386. § 886.5200 Eyelid thermal pulsation system.
8387. § 886.5201 Intense pulsed light device for managing dry eye.
8388. § 886.5300 Tear electrostimulation device.
8389. § 886.5305 Electromechanical tear stimulator.
8390. § 886.5310 Intranasal electrostimulation device for dry eye symptoms.
8391. § 886.5350 Ultrasound cyclodestructive device.
8392. § 886.5420 Contact lens inserter/remover.
8393. § 886.5500 Digital therapy device for amblyopia.
8394. § 886.5540 Low-vision magnifier.
8395. § 886.5600 Ptosis crutch.
8396. § 886.5700 Eyelid weight.
8397. § 886.5800 Ophthalmic bar reader. P>(a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device is placed directly onto reading material to magnify print.
8398. § 886.5810 Ophthalmic prism reader.
8399. § 886.5820 Closed-circuit television reading system.
8400. § 886.5838 Nasolacrimal compression device.
8401. § 886.5840 Magnifying spectacles.
8402. § 886.5842 Spectacle frame.
8403. § 886.5844 Prescription spectacle lens.
8404. § 886.5850 Sunglasses (nonprescription).
8405. § 886.5870 Low-vision telescope.
8406. § 886.5900 Electronic vision aid.
8407. § 886.5905 Oral electronic vision aid.
8408. § 886.5910 Image intensification vision aid.
8409. § 886.5915 Optical vision aid.
8410. § 886.5916 Rigid gas permeable contact lens.
8411. § 886.5918 Rigid gas permeable contact lens care products.
8412. § 886.5919 Hydrophilic re-coating solution.
8413. § 886.5925 Soft (hydrophilic) contact lens.
8414. § 886.5928 Soft (hydrophilic) contact lens care products.
8415. § 886.5933 [Reserved]
8416. PART 888 ORTHOPEDIC DEVICES
8417. Subpart A General Provisions
8418. § 888.1 Scope.
8419. § 888.3 Effective dates of requirement for premarket approval.
8420. § 888.5 Resurfacing technique.
8421. § 888.6 Degree of constraint.
8422. § 888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
8423. Subpart B Diagnostic Devices
8424. § 888.1100 Arthroscope.
8425. § 888.1240 AC-powered dynamometer.
8426. § 888.1250 Nonpowered dynamometer.
8427. § 888.1500 Goniometer.
8428. § 888.1520 Nonpowered goniometer.
8429. § 888.1600 Bone indentation device.
8430. C Subpart C [Reserved]
8431. Subpart D Prosthetic Devices
8432. § 888.3000 Bone cap.
8433. § 888.3010 Bone fixation cerclage.
8434. § 888.3015 Bone heterograft.
8435. § 888.3020 Intramedullary fixation rod.
8436. § 888.3023 In vivo cured intramedullary fixation rod.
8437. § 888.3025 Passive tendon prosthesis.
8438. § 888.3027 Polymethylmethacrylate (PMMA) bone cement.
8439. § 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
8440. § 888.3040 Smooth or threaded metallic bone fixation fastener.
8441. § 888.3041 Absorbable metallic bone fixation fastener.
8442. § 888.3043 Screw sleeve bone fixation device.
8443. § 888.3044 Resorbable implant for anterior cruciate ligament (ACL) repair.
8444. § 888.3045 Resorbable calcium salt bone void filler device.
8445. § 888.3046 Resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial.
8446. § 888.3050 Spinal interlaminal fixation orthosis.
8447. § 888.3060 Spinal intervertebral body fixation orthosis.
8448. § 888.3070 Thoracolumbosacral pedicle screw system.
8449. § 888.3075 Posterior cervical screw system.
8450. § 888.3080 Intervertebral body fusion device.
8451. § 888.3083 Spinal spheres for use in intervertebral fusion procedures.
8452. § 888.3085 Intervertebral body graft containment device.
8453. § 888.3090 Intraoperative orthopedic strain sensor.
8454. § 888.3100 Ankle joint metal/composite semi-constrained cemented prosthesis.
8455. § 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
8456. § 888.3120 Ankle joint metal/polymer non-constrained cemented prosthesis.
8457. § 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
8458. § 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
8459. § 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
8460. § 888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
8461. § 888.3200 Finger joint metal/metal constrained uncemented prosthesis.
8462. § 888.3210 Finger joint metal/metal constrained cemented prosthesis.
8463. § 888.3220 Finger joint metal/polymer constrained cemented prosthesis.
8464. § 888.3230 Finger joint polymer constrained prosthesis.
8465. § 888.3300 Hip joint metal constrained cemented or uncemented prosthesis.
8466. § 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
8467. § 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
8468. § 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
8469. § 888.3340 Hip joint metal/composite semi-constrained cemented prosthesis.
8470. § 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
8471. § 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
8472. § 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
8473. § 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
8474. § 888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis.
8475. § 888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
8476. § 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
8477. § 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
8478. § 888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
8479. § 888.3480 Knee joint femorotibial metallic constrained cemented prosthesis.
8480. § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
8481. § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
8482. § 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
8483. § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
8484. § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
8485. § 888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
8486. § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
8487. § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.
8488. § 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
8489. § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
8490. § 888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
8491. § 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
8492. § 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
8493. § 888.3600 Implantable post-surgical kinematic measurement knee device.
8494. § 888.3610 Medial knee implanted shock absorber.
8495. § 888.3630 Resorbable shoulder spacer.
8496. § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
8497. § 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
8498. § 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
8499. § 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
8500. § 888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
8501. § 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
8502. § 888.3695 Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis.
8503. § 888.3720 Toe joint polymer constrained prosthesis.
8504. § 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
8505. § 888.3750 Wrist joint carpal lunate polymer prosthesis.
8506. § 888.3760 Wrist joint carpal scaphoid polymer prosthesis.
8507. § 888.3770 Wrist joint carpal trapezium polymer prosthesis.
8508. § 888.3780 Wrist joint polymer constrained prosthesis.
8509. § 888.3790 Wrist joint metal constrained cemented prosthesis.
8510. § 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
8511. § 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
8512. Subpart E Surgical Devices
8513. § 888.4150 Calipers for clinical use.
8514. § 888.4200 Cement dispenser.
8515. § 888.4210 Cement mixer for clinical use.
8516. § 888.4220 Cement monomer vapor evacuator.
8517. § 888.4230 Cement ventilation tube.
8518. § 888.4300 Depth gauge for clinical use.
8519. § 888.4505 Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.
8520. § 888.4510 Manual surgical instrument for appropriate patient selection for orthopedic implant.
8521. § 888.4515 Orthopedic manual surgical instrumentation for use with total disc replacement devices.
8522. § 888.4520 Orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices.
8523. § 888.4540 Orthopedic manual surgical instrument.
8524. § 888.4560 Intraoperative surgical angle measurement tool.
8525. § 888.4580 Sonic surgical instrument and accessories/attachments.
8526. § 888.4600 Protractor for clinical use.
8527. § 888.4800 Template for clinical use.
8528. § 888.5850 Nonpowered orthopedic traction apparatus and accessories.
8529. § 888.5890 Noninvasive traction component.
8530. § 888.5940 Cast component.
8531. § 888.5960 Cast removal instrument.
8532. § 888.5980 Manual cast application and removal instrument.
8533. PART 890 PHYSICAL MEDICINE DEVICES
8534. Subpart A General Provisions
8535. § 890.1 Scope.
8536. § 890.3 Effective dates of requirement for premarket approval.
8537. § 890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
8538. Subpart B Physical Medicine Diagnostic Devices
8539. § 890.1175 Electrode cable.
8540. § 890.1225 Chronaximeter.
8541. § 890.1375 Diagnostic electromyograph.
8542. § 890.1385 Diagnostic electromyograph needle electrode.
8543. § 890.1450 Powered reflex hammer.
8544. § 890.1575 Force-measuring platform.
8545. § 890.1600 Intermittent pressure measurement system.
8546. § 890.1615 Miniature pressure transducer.
8547. § 890.1850 Diagnostic muscle stimulator.
8548. § 890.1925 Isokinetic testing and evaluation system.
8549. C Subpart C [Reserved]
8550. Subpart D Physical Medicine Prosthetic Devices
8551. § 890.3025 Prosthetic and orthotic accessory.
8552. § 890.3050 External compression device for internal jugular vein compression.
8553. § 890.3075 Cane.
8554. § 890.3100 Mechanical chair.
8555. § 890.3110 Electric positioning chair.
8556. § 890.3150 Crutch.
8557. § 890.3175 Flotation cushion.
8558. § 890.3410 External limb orthotic component.
8559. § 890.3420 External limb prosthetic component.
8560. § 890.3450 Upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components.
8561. § 890.3475 Limb orthosis.
8562. § 890.3480 Powered lower extremity exoskeleton.
8563. § 890.3490 Truncal orthosis.
8564. § 890.3500 External assembled lower limb prosthesis.
8565. § 890.3520 Plinth.
8566. § 890.3610 Rigid pneumatic structure orthosis.
8567. § 890.3640 Arm sling.
8568. § 890.3665 Congenital hip dislocation abduction splint.
8569. § 890.3675 Denis Brown splint.
8570. § 890.3690 Powered wheeled stretcher.
8571. § 890.3700 Nonpowered communication system.
8572. § 890.3710 Powered communication system.
8573. § 890.3725 Powered environmental control system.
8574. § 890.3750 Mechanical table.
8575. § 890.3760 Powered table.
8576. § 890.3790 Cane, crutch, and walker tips and pads.
8577. § 890.3800 Motorized three-wheeled vehicle.
8578. § 890.3825 Mechanical walker.
8579. § 890.3850 Mechanical wheelchair.
8580. § 890.3860 Powered wheelchair.
8581. § 890.3880 Special grade wheelchair.
8582. § 890.3890 Stair-climbing wheelchair.
8583. § 890.3900 Standup wheelchair.
8584. § 890.3910 Wheelchair accessory.
8585. § 890.3920 Wheelchair component.
8586. § 890.3930 Wheelchair elevator.
8587. § 890.3940 Wheelchair platform scale.
8588. E Subpart E [Reserved]
8589. Subpart F Physical Medicine Therapeutic Devices
8590. § 890.5050 Daily activity assist device.
8591. § 890.5100 Immersion hydrobath.
8592. § 890.5110 Paraffin bath.
8593. § 890.5125 Nonpowered sitz bath.
8594. § 890.5150 Powered patient transport.
8595. § 890.5160 Air-fluidized bed.
8596. § 890.5170 Powered flotation therapy bed.
8597. § 890.5180 Manual patient rotation bed.
8598. § 890.5225 Powered patient rotation bed.
8599. § 890.5250 Moist steam cabinet.
8600. § 890.5275 Microwave diathermy.
8601. § 890.5290 Shortwave diathermy.
8602. § 890.5300 Ultrasonic diathermy.
8603. § 890.5350 Exercise component.
8604. § 890.5360 Measuring exercise equipment.
8605. § 890.5370 Nonmeasuring exercise equipment.
8606. § 890.5380 Powered exercise equipment.
8607. § 890.5410 Powered finger exerciser.
8608. § 890.5420 Electroencephalography (EEG)-driven upper extremity powered exerciser.
8609. § 890.5500 Infrared lamp.
8610. § 890.5525 Iontophoresis device.
8611. § 890.5575 Powered external limb overload warning device.
8612. § 890.5650 Powered inflatable tube massager.
8613. § 890.5660 Therapeutic massager.
8614. § 890.5670 Internal therapeutic massager.
8615. § 890.5700 Cold pack.
8616. § 890.5710 Hot or cold disposable pack.
8617. § 890.5720 Water circulating hot or cold pack.
8618. § 890.5730 Moist heat pack.
8619. § 890.5740 Powered heating pad.
8620. § 890.5760 Nonpowered lower extremity pressure wrap.
8621. § 890.5765 Pressure-applying device.
8622. § 890.5800 Virtual reality behavioral therapy device for pain relief.
8623. § 890.5850 Powered muscle stimulator.
8624. § 890.5860 Ultrasound and muscle stimulator.
8625. § 890.5870 Non-invasive bone growth stimulator.
8626. § 890.5880 Multi-function physical therapy table.
8627. § 890.5900 Power traction equipment.
8628. § 890.5925 Traction accessory.
8629. § 890.5940 Chilling unit.
8630. § 890.5950 Powered heating unit.
8631. § 890.5975 Therapeutic vibrator.
8632. PART 892 RADIOLOGY DEVICES
8633. Subpart A General Provisions
8634. § 892.1 Scope.
8635. § 892.3 Effective dates of requirement for premarket approval.
8636. § 892.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
8637. Subpart B Diagnostic Devices
8638. § 892.1000 Magnetic resonance diagnostic device.
8639. § 892.1001 Liver iron concentration imaging companion diagnostic for deferasirox.
8640. § 892.1100 Scintillation (gamma) camera.
8641. § 892.1110 Positron camera.
8642. § 892.1130 Nuclear whole body counter.
8643. § 892.1170 Bone densitometer.
8644. § 892.1180 Bone sonometer.
8645. § 892.1200 Emission computed tomography system.
8646. § 892.1220 Fluorescent scanner.
8647. § 892.1300 Nuclear rectilinear scanner.
8648. § 892.1310 Nuclear tomography system.
8649. § 892.1320 Nuclear uptake probe.
8650. § 892.1330 Nuclear whole body scanner.
8651. § 892.1350 Nuclear scanning bed.
8652. § 892.1360 Radionuclide dose calibrator.
8653. § 892.1370 Nuclear anthropomorphic phantom.
8654. § 892.1380 Nuclear flood source phantom.
8655. § 892.1390 Radionuclide rebreathing system.
8656. § 892.1400 Nuclear sealed calibration source.
8657. § 892.1410 Nuclear electrocardiograph synchronizer.
8658. § 892.1420 Radionuclide test pattern phantom.
8659. § 892.1540 Nonfetal ultrasonic monitor.
8660. § 892.1550 Ultrasonic pulsed doppler imaging system.
8661. § 892.1560 Ultrasonic pulsed echo imaging system.
8662. § 892.1570 Diagnostic ultrasonic transducer.
8663. § 892.1600 Angiographic x-ray system.
8664. § 892.1610 Diagnostic x-ray beam-limiting device.
8665. § 892.1620 Cine or spot fluorographic x-ray camera.
8666. § 892.1630 Electrostatic x-ray imaging system.
8667. § 892.1640 Radiographic film marking system.
8668. § 892.1650 Image-intensified fluoroscopic x-ray system.
8669. § 892.1660 Non-image-intensified fluoroscopic x-ray system.
8670. § 892.1670 Spot-film device.
8671. § 892.1680 Stationary x-ray system.
8672. § 892.1700 Diagnostic x-ray high voltage generator.
8673. § 892.1710 Mammographic x-ray system.
8674. § 892.1715 Full-field digital mammography system.
8675. § 892.1720 Mobile x-ray system.
8676. § 892.1730 Photofluorographic x-ray system.
8677. § 892.1740 Tomographic x-ray system.
8678. § 892.1750 Computed tomography x-ray system.
8679. § 892.1760 Diagnostic x-ray tube housing assembly.
8680. § 892.1770 Diagnostic x-ray tube mount.
8681. § 892.1820 Pneumoencephalographic chair.
8682. § 892.1830 Radiologic patient cradle.
8683. § 892.1840 Radiographic film.
8684. § 892.1850 Radiographic film cassette.
8685. § 892.1860 Radiographic film/cassette changer.
8686. § 892.1870 Radiographic film/cassette changer programmer.
8687. § 892.1880 Wall-mounted radiographic cassette holder.
8688. § 892.1890 Radiographic film illuminator.
8689. § 892.1900 Automatic radiographic film processor.
8690. § 892.1910 Radiographic grid.
8691. § 892.1920 Radiographic head holder.
8692. § 892.1940 Radiologic quality assurance instrument.
8693. § 892.1950 Radiographic anthropomorphic phantom.
8694. § 892.1960 Radiographic intensifying screen.
8695. § 892.1970 Radiographic ECG/respirator synchronizer.
8696. § 892.1980 Radiologic table.
8697. § 892.1990 Transilluminator for breast evaluation.
8698. § 892.2010 Medical image storage device.
8699. § 892.2020 Medical image communications device.
8700. § 892.2030 Medical image digitizer.
8701. § 892.2040 Medical image hardcopy device.
8702. § 892.2050 Medical image management and processing system.
8703. § 892.2055 Radiological machine learning-based quantitative imaging software with predetermined change control plan.
8704. § 892.2060 Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
8705. § 892.2070 Medical image analyzer.
8706. § 892.2080 Radiological computer aided triage and notification software.
8707. § 892.2090 Radiological computer-assisted detection and diagnosis software.
8708. § 892.2100 892.2100 Radiological acquisition and/or optimization guidance system.
8709. C Subparts C-E [Reserved]
8710. Subpart F Therapeutic Devices
8711. § 892.5050 Medical charged-particle radiation therapy system.
8712. § 892.5060 Fludeoxyglucose F18-guided radiation therapy system.
8713. § 892.5300 Medical neutron radiation therapy system.
8714. § 892.5650 Manual radionuclide applicator system.
8715. § 892.5700 Remote controlled radionuclide applicator system.
8716. § 892.5710 Radiation therapy beam-shaping block.
8717. § 892.5720 Rectal balloon for prostate immobilization.
8718. § 892.5725 Absorbable perirectal spacer.
8719. § 892.5727 Phase-changing fiducial marker for radiation therapy.
8720. § 892.5730 Radionuclide brachytherapy source.
8721. § 892.5735 Vaginal hydrogel packing system.
8722. § 892.5740 Radionuclide teletherapy source.
8723. § 892.5750 Radionuclide radiation therapy system.
8724. § 892.5770 Powered radiation therapy patient support assembly.
8725. § 892.5780 Light beam patient position indicator.
8726. § 892.5785 Radiation therapy marking device.
8727. § 892.5840 Radiation therapy simulation system.
8728. § 892.5900 X-ray radiation therapy system.
8729. § 892.5930 Therapeutic x-ray tube housing assembly.
8730. Subpart G Miscellaneous Devices
8731. § 892.6500 Personnel protective shield.
8732. § 892.6510 Cream for x-ray attenuation.
8733. PART 895 BANNED DEVICES
8734. Subpart A General Provisions
8735. § 895.1 Scope.
8736. § 895.20 General.
8737. § 895.21 Procedures for banning a device.
8738. § 895.22 Submission of data and information by the manufacturer, distributor, or importer.
8739. § 895.25 Labeling.
8740. § 895.30 Special effective date.
8741. Subpart B Listing of Banned Devices
8742. § 895.101 Prosthetic hair fibers.
8743. § 895.102 Powdered surgeon's glove.
8744. § 895.103 Powdered patient examination glove.
8745. § 895.104 Absorbable powder for lubricating a surgeon's glove.
8746. § 895.105 Electrical stimulation devices for self-injurious or aggressive behavior.
8747. PART 898 PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
8748. § 898.11 Applicability.
8749. § 898.12 Performance standard.
8750. § 898.13 Compliance dates.
8751. § 898.14 Exemptions and variances.
8752. SUBCHAPTER I MAMMOGRAPHY QUALITY STANDARDS ACT
8753. PART 900 MAMMOGRAPHY
8754. Subpart A Accreditation
8755. § 900.1 Scope.
8756. § 900.2 Definitions.
8757. § 900.3 Application for approval as an accreditation body.
8758. § 900.4 Standards for accreditation bodies.
8759. § 900.5 Evaluation.
8760. § 900.6 Withdrawal of approval.
8761. § 900.7 Hearings.
8762. §§ 900.8-900.9 [Reserved]
8763. Subpart B Quality Standards and Certification
8764. § 900.10 Applicability.
8765. § 900.11 Requirements for certification.
8766. § 900.12 Quality standards.
8767. § 900.13 Revocation of accreditation and revocation of accreditation body approval.
8768. § 900.14 Suspension or revocation of certificates.
8769. § 900.15 Appeals of adverse accreditation or reaccreditation decisions that preclude certification or recertification.
8770. § 900.16 Appeals of denials of certification.
8771. § 900.17 [Reserved]
8772. § 900.18 Alternative requirements for § 900.12 quality standards.
8773. Subpart C States as Certifiers
8774. § 900.20 Scope.
8775. § 900.21 Application for approval as a certification agency.
8776. § 900.22 Standards for certification agencies.
8777. § 900.23 Evaluation.
8778. § 900.24 Withdrawal of approval.
8779. § 900.25 Hearings and appeals.
8780. SUBCHAPTER J RADIOLOGICAL HEALTH
8781. PART 1000 GENERAL
8782. Subpart A General Provisions
8783. § 1000.1 General.
8784. § 1000.3 Definitions.
8785. Subpart B Statements of Policy and Interpretation
8786. § 1000.15 Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968.
8787. PART 1002 RECORDS AND REPORTS
8788. Subpart A General Provisions
8789. § 1002.1 Applicability.
8790. § 1002.2 [Reserved]
8791. § 1002.3 Notification to user of performance and technical data.
8792. § 1002.4 Confidentiality of information.
8793. § 1002.7 Submission of data and reports.
8794. Subpart B Required Manufacturers' Reports for Listed Electronic Products
8795. § 1002.10 Product reports.
8796. § 1002.11 Supplemental reports.
8797. § 1002.12 Abbreviated reports.
8798. § 1002.13 Annual reports.
8799. Subpart C Manufacturers' Reports on Accidental Radiation Occurrences
8800. § 1002.20 Reporting of accidental radiation occurrences.
8801. Subpart D Manufacturers' Records
8802. § 1002.30 Records to be maintained by manufacturers.
8803. § 1002.31 Preservation and inspection of records.
8804. Subpart E Dealer and Distributor Records
8805. § 1002.40 Records to be obtained by dealers and distributors.
8806. § 1002.41 Disposition of records obtained by dealers and distributors.
8807. § 1002.42 Confidentiality of records furnished by dealers and distributors.
8808. Subpart F Exemptions From Records and Reports Requirements
8809. § 1002.50 Special exemptions.
8810. § 1002.51 Exemptions for manufacturers of products intended for the U.S. Government.
8811. PART 1003 NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
8812. Subpart A General Provisions
8813. § 1003.1 Applicability.
8814. § 1003.2 Defect in an electronic product.
8815. § 1003.5 Effect of regulations on other laws.
8816. Subpart B Discovery of Defect or Failure To Comply
8817. § 1003.10 Discovery of defect or failure of compliance by manufacturer; notice requirements.
8818. § 1003.11 Determination by Secretary that product fails to comply or has a defect.
8819. Subpart C Notification
8820. § 1003.20 Notification by the manufacturer to the Secretary.
8821. § 1003.21 Notification by the manufacturer to affected persons.
8822. § 1003.22 Copies of communications sent to purchasers, dealers or distributors.
8823. Subpart D Exemptions From Notification Requirements
8824. § 1003.30 Application for exemption from notification requirements.
8825. § 1003.31 Granting the exemption.
8826. PART 1004 REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS
8827. § 1004.1 Manufacturer's obligation to repair, replace, or refund cost of electronic products.
8828. § 1004.2 Plans for the repair of electronic products.
8829. § 1004.3 Plans for the replacement of electronic products.
8830. § 1004.4 Plans for refunding the cost of electronic products.
8831. § 1004.6 Approval of plans.
8832. PART 1005 IMPORTATION OF ELECTRONIC PRODUCTS
8833. Subpart A General Provisions
8834. § 1005.1 Applicability.
8835. § 1005.2 Definitions.
8836. § 1005.3 Importation of noncomplying goods prohibited.
8837. Subpart B Inspection and Testing
8838. § 1005.10 Notice of sampling.
8839. § 1005.11 Payment for samples.
8840. Subpart C Bonding and Compliance Procedures
8841. § 1005.20 Hearing.
8842. § 1005.21 Application for permission to bring product into compliance.
8843. § 1005.22 Granting permission to bring product into compliance.
8844. § 1005.23 Bonds.
8845. § 1005.24 Costs of bringing product into compliance.
8846. § 1005.25 Service of process on manufacturers.
8847. PART 1010 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
8848. Subpart A General Provisions
8849. § 1010.1 Scope.
8850. § 1010.2 Certification.
8851. § 1010.3 Identification.
8852. § 1010.4 Variances.
8853. § 1010.5 Exemptions for products intended for United States Government use.
8854. Subpart B Alternate Test Procedures
8855. § 1010.13 Special test procedures.
8856. Subpart C Exportation of Electronic Products
8857. § 1010.20 Electronic products intended for export.
8858. PART 1020 PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
8859. § 1020.10 Television receivers.
8860. § 1020.20 Cold-cathode gas discharge tubes.
8861. § 1020.30 Diagnostic x-ray systems and their major components.
8862. § 1020.31 Radiographic equipment.
8863. § 1020.32 Fluoroscopic equipment.
8864. § 1020.33 Computed tomography (CT) equipment.
8865. § 1020.40 Cabinet x-ray systems.
8866. PART 1030 PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS
8867. § 1030.10 Microwave ovens.
8868. PART 1040 PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
8869. § 1040.10 Laser products.
8870. § 1040.11 Specific purpose laser products.
8871. § 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
8872. § 1040.30 High-intensity mercury vapor discharge lamps.
8873. SUBCHAPTER K TOBACCO PRODUCTS
8874. PART 1100 General
8875. Subpart A Tobacco Products Subject to FDA Authority
8876. § 1100.1 Scope.
8877. § 1100.2 Requirements.
8878. § 1100.3 Definitions.
8879. § 1100.5 Exclusion from tobacco regulation.
8880. B Subpart B [Reserved]
8881. Subpart C Maintenance of Records Demonstrating That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.
8882. § 1100.200 Purpose and scope.
8883. § 1100.202 Definitions.
8884. § 1100.204 Recordkeeping requirements.
8885. PART 1105 GENERAL
8886. Subpart A General Submission Requirements
8887. § 1105.10 Refusal to accept a premarket submission.
8888. PART 1107 EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS
8889. Subpart A Exemptions
8890. § 1107.1 Exemptions.
8891. § 1107.3 Recordkeeping.
8892. Subpart B General
8893. § 1107.10 Scope.
8894. § 1107.12 Definitions.
8895. Subpart C Substantial Equivalence Reports
8896. § 1107.16 Submission of a substantial equivalence report.
8897. § 1107.18 Required content and format of an SE Report.
8898. § 1107.19 Comparison information.
8899. § 1107.20 Amendments.
8900. § 1107.22 Withdrawal by applicant.
8901. § 1107.24 Change in ownership of an SE Report.
8902. Subpart D FDA Review
8903. § 1107.40 Communications between FDA and applicants.
8904. § 1107.42 Review cycles.
8905. § 1107.44 FDA action on an SE Report.
8906. § 1107.46 Issuance of an order finding a new tobacco product substantially equivalent.
8907. § 1107.48 Issuance of an order denying marketing authorization.
8908. § 1107.50 Rescission of order.
8909. Subpart E Miscellaneous
8910. § 1107.58 Record retention.
8911. § 1107.60 Confidentiality.
8912. § 1107.62 Electronic submission.
8913. PART 1114 PREMARKET TOBACCO PRODUCT APPLICATIONS
8914. Subpart A General Provisions
8915. § 1114.1 Scope.
8916. § 1114.3 Definitions.
8917. Subpart B Premarket Tobacco Product Applications
8918. § 1114.5 Application submission.
8919. § 1114.7 Required content and format.
8920. § 1114.9 Amendments.
8921. § 1114.11 Withdrawal by applicant.
8922. § 1114.13 Change in ownership of an application.
8923. § 1114.15 Supplemental applications.
8924. § 1114.17 Resubmissions.
8925. Subpart C FDA Review
8926. § 1114.25 Communication between FDA and applicants.
8927. § 1114.27 Review procedure.
8928. § 1114.29 FDA action on an application.
8929. § 1114.31 Issuance of a marketing granted order.
8930. § 1114.33 Issuance of a marketing denial order.
8931. § 1114.35 Withdrawal of a marketing granted order.
8932. § 1114.37 Temporary suspension of a marketing granted order.
8933. Subpart D Postmarket Requirements
8934. § 1114.39 Postmarket changes.
8935. § 1114.41 Reporting requirements.
8936. Subpart E Miscellaneous
8937. § 1114.45 Record retention.
8938. § 1114.47 Confidentiality.
8939. § 1114.49 Electronic submission.
8940. PART 1140 CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO PRODUCTS
8941. Subpart A General Provisions
8942. § 1140.1 Scope.
8943. § 1140.2 Purpose.
8944. § 1140.3 Definitions.
8945. Subpart B Prohibition of Sale and Distribution to Persons Younger Than 21 Years of Age
8946. § 1140.10 General responsibilities of manufacturers, distributors, and retailers.
8947. § 1140.12 Additional responsibilities of manufacturers.
8948. § 1140.14 Additional responsibilities of retailers.
8949. § 1140.16 Conditions of manufacture, sale, and distribution.
8950. C Subpart C [Reserved]
8951. Subpart D Labeling and Advertising
8952. § 1140.30 Scope of permissible forms of labeling and advertising.
8953. § 1140.32 Format and content requirements for labeling and advertising.
8954. § 1140.34 Sale and distribution of nontobacco items and services, gifts, and sponsorship of events.
8955. PART 1141 REQUIRED WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS
8956. Subpart A General Provisions
8957. § 1141.1 Scope.
8958. § 1141.3 Definitions.
8959. § 1141.5 Incorporation by reference.
8960. Subpart B Required Warnings for Cigarette Packages and Advertisements
8961. § 1141.10 Required warnings.
8962. § 1141.12 Misbranding of cigarettes.
8963. PART 1143 MINIMUM REQUIRED WARNING STATEMENTS
8964. § 1143.1 Definitions.
8965. § 1143.3 Required warning statement regarding addictiveness of nicotine.
8966. § 1143.5 Required warning statements for cigars.
8967. § 1143.7 Language requirements for required warning statements.
8968. § 1143.9 Irremovable or permanent required warning statements.
8969. § 1143.11 Does not apply to foreign distribution.
8970. § 1143.13 Effective date.
8971. PART 1150 USER FEES
8972. § 1150.1 Scope.
8973. § 1150.3 Definitions.
8974. § 1150.5 Required information.
8975. § 1150.7 Yearly class allocation.
8976. § 1150.9 Domestic manufacturer or importer assessment.
8977. § 1150.11 Notification of assessments.
8978. § 1150.13 Payment of assessments.
8979. § 1150.15 Disputes.
8980. § 1150.17 Penalties.
8981. SUBCHAPTER L REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
8982. PART 1210 REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
8983. Subpart A General Provisions
8984. § 1210.1 Authority.
8985. § 1210.2 Scope of act.
8986. § 1210.3 Definitions.
8987. Subpart B Inspection and Testing
8988. § 1210.10 Availability for examination and inspection.
8989. § 1210.11 Sanitary inspection of dairy farms.
8990. § 1210.12 Physical examination of cows.
8991. § 1210.13 Tuberculin test.
8992. § 1210.14 Sanitary inspection of plants.
8993. § 1210.15 Pasteurization; equipment and methods.
8994. § 1210.16 Method of bacterial count.
8995. § 1210.17 Authority to sample and inspect.
8996. § 1210.18 Scoring.
8997. Subpart C Permit Control
8998. § 1210.20 Application for permit.
8999. § 1210.21 Permit number.
9000. § 1210.22 Form of tag.
9001. § 1210.23 Permits granted on certificates.
9002. § 1210.24 Temporary permits.
9003. § 1210.25 Permits for pasteurized milk or cream.
9004. § 1210.26 Permits for raw milk or cream.
9005. § 1210.27 Permits waiving clauses 2 and 5, section 2 of the Federal Import Milk Act.
9006. § 1210.28 Permits waiving clause 4, section 2 of the Federal Import Milk Act.
9007. Subpart D Hearings
9008. § 1210.30 Hearing procedure for permit denial, suspension, and revocation.
9009. § 1210.31 Hearing before prosecution.
9010. PART 1230 REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
9011. Subpart A General Provisions
9012. § 1230.2 Scope of the act.
9013. § 1230.3 Definitions.
9014. Subpart B Labeling
9015. § 1230.10 Placement.
9016. § 1230.11 Required wording.
9017. § 1230.12 Manufacturer; distributor.
9018. § 1230.13 Labeling of “poison”.
9019. § 1230.14 Directions for treatment.
9020. § 1230.15 Responsibility for labeling directions for treatment.
9021. § 1230.16 Exemption from labeling directions for treatment.
9022. Subpart C Guaranty
9023. § 1230.20 General guaranty.
9024. § 1230.21 Specific guaranty.
9025. Subpart D Administrative Procedures
9026. § 1230.30 Collection of samples.
9027. § 1230.31 Where samples may be collected.
9028. § 1230.32 Analyzing of samples.
9029. § 1230.33 Investigations.
9030. § 1230.34 Analysis.
9031. § 1230.35 Hearings.
9032. § 1230.36 Hearings; when not provided for.
9033. § 1230.37 Publication.
9034. Subpart E Imports
9035. § 1230.40 Required label information.
9036. § 1230.41 Delivery of containers.
9037. § 1230.42 Invoices.
9038. § 1230.43 Enforcement.
9039. § 1230.44 Samples.
9040. § 1230.45 No violation; release.
9041. § 1230.46 Violation.
9042. § 1230.47 Rejected containers.
9043. § 1230.48 Relabeling of containers.
9044. § 1230.49 Penalties.
9045. PART 1240 CONTROL OF COMMUNICABLE DISEASES
9046. Subpart A General Provisions
9047. § 1240.3 General definitions.
9048. § 1240.10 Effective bactericidal treatment.
9049. Subpart B Administrative Procedures
9050. § 1240.20 Issuance and posting of certificates following inspections.
9051. § 1240.30 Measures in the event of inadequate local control.
9052. § 1240.45 Report of disease.
9053. C Subpart C [Reserved]
9054. Subpart D Specific Administrative Decisions Regarding Interstate Shipments
9055. § 1240.60 Molluscan shellfish.
9056. § 1240.61 Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption.
9057. § 1240.62 Turtles intrastate and interstate requirements.
9058. § 1240.65 Psittacine birds.
9059. § 1240.75 Garbage.
9060. Subpart E Source and Use of Potable Water
9061. § 1240.80 General requirements for water for drinking and culinary purposes.
9062. § 1240.83 Approval of watering points.
9063. § 1240.86 Protection of pier water system.
9064. § 1240.90 Approval of treatment aboard conveyances.
9065. § 1240.95 Sanitation of water boats.
9066. PART 1250 INTERSTATE CONVEYANCE SANITATION
9067. Subpart A General Provisions
9068. § 1250.3 Definitions.
9069. Subpart B Food Service Sanitation on Land and Air Conveyances, and Vessels
9070. § 1250.20 Applicability.
9071. § 1250.21 Inspection.
9072. § 1250.22 General requirements.
9073. § 1250.25 Source identification and inspection of food and drink.
9074. § 1250.26 Special food requirements.
9075. § 1250.27 Storage of perishables.
9076. § 1250.28 Source and handling of ice.
9077. § 1250.30 Construction, maintenance and use of places where food is prepared, served, or stored.
9078. § 1250.32 Food-handling operations.
9079. § 1250.33 Utensils and equipment.
9080. § 1250.34 Refrigeration equipment.
9081. § 1250.35 Health of persons handling food.
9082. § 1250.38 Toilet and lavatory facilities for use of food-handling employees.
9083. § 1250.39 Garbage equipment and disposition.
9084. Subpart C Equipment and Operation of Land and Air Conveyances
9085. § 1250.40 Applicability.
9086. § 1250.41 Submittal of construction plans.
9087. § 1250.42 Water systems; constant temperature bottles.
9088. § 1250.43 Ice.
9089. § 1250.44 Drinking utensils and toilet articles.
9090. § 1250.45 Food handling facilities on railroad conveyances.
9091. § 1250.49 Cleanliness of conveyances.
9092. § 1250.50 Toilet and lavatory facilities.
9093. § 1250.51 Railroad conveyances; discharge of wastes.
9094. § 1250.52 Discharge of wastes on highway conveyances.
9095. § 1250.53 Discharge of wastes on air conveyances.
9096. Subpart D Servicing Areas for Land and Air Conveyances
9097. § 1250.60 Applicability.
9098. § 1250.61 Inspection and approval.
9099. § 1250.62 Submittal of construction plans.
9100. § 1250.63 General requirements.
9101. § 1250.65 Drainage.
9102. § 1250.67 Watering equipment.
9103. § 1250.70 Employee conveniences.
9104. § 1250.75 Disposal of human wastes.
9105. § 1250.79 Garbage disposal.
9106. Subpart E Sanitation Facilities and Conditions on Vessels
9107. § 1250.80 Applicability.
9108. § 1250.81 Inspection.
9109. § 1250.82 Potable water systems.
9110. § 1250.83 Storage of water prior to treatment.
9111. § 1250.84 Water in galleys and medical care spaces.
9112. § 1250.85 Drinking fountains and coolers; ice; constant temperature bottles.
9113. § 1250.86 Water for making ice.
9114. § 1250.87 Wash water.
9115. § 1250.89 Swimming pools.
9116. § 1250.90 Toilets and lavatories.
9117. § 1250.93 Discharge of wastes.
9118. § 1250.95 Insect control.
9119. § 1250.96 Rodent control.
9120. 1251-1270 PARTS 1251-1270 [RESERVED]
9121. PART 1271 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
9122. Subpart A General Provisions
9123. § 1271.1 What are the purpose and scope of this part?
9124. § 1271.3 How does FDA define important terms in this part?
9125. § 1271.10 Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?
9126. § 1271.15 Are there any exceptions from the requirements of this part?
9127. § 1271.20 If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?
9128. Subpart B Procedures for Registration and Listing
9129. § 1271.21 When do I register, submit an HCT/P list, and submit updates?
9130. § 1271.22 How do I register and submit an HCT/P list?
9131. § 1271.23 How is a waiver from the electronic format requirements requested?
9132. § 1271.25 What information is required for establishment registration and HCT/P listing?
9133. § 1271.26 When must I amend my establishment registration?
9134. § 1271.27 Will FDA assign me a registration number?
9135. § 1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?
9136. Subpart C Donor Eligibility
9137. § 1271.45 What requirements does this subpart contain?
9138. § 1271.47 What procedures must I establish and maintain?
9139. § 1271.50 How do I determine whether a donor is eligible?
9140. § 1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
9141. § 1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete?
9142. § 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
9143. § 1271.75 How do I screen a donor?
9144. § 1271.80 What are the general requirements for donor testing?
9145. § 1271.85 What donor testing is required for different types of cells and tissues?
9146. § 1271.90 Are there other exceptions and what labeling requirements apply?
9147. Subpart D Current Good Tissue Practice
9148. § 1271.145 Prevention of the introduction, transmission, or spread of communicable diseases.
9149. § 1271.150 Current good tissue practice requirements.
9150. § 1271.155 Exemptions and alternatives.
9151. § 1271.160 Establishment and maintenance of a quality program.
9152. § 1271.170 Personnel.
9153. § 1271.180 Procedures.
9154. § 1271.190 Facilities.
9155. § 1271.195 Environmental control and monitoring.
9156. § 1271.200 Equipment.
9157. § 1271.210 Supplies and reagents.
9158. § 1271.215 Recovery.
9159. § 1271.220 Processing and process controls.
9160. § 1271.225 Process changes.
9161. § 1271.230 Process validation.
9162. § 1271.250 Labeling controls.
9163. § 1271.260 Storage.
9164. § 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
9165. § 1271.270 Records.
9166. § 1271.290 Tracking.
9167. § 1271.320 Complaint file.
9168. Subpart E Additional Requirements for Establishments Described in § 1271.10
9169. § 1271.330 Applicability.
9170. § 1271.350 Reporting.
9171. § 1271.370 Labeling.
9172. Subpart F Inspection and Enforcement of Establishments Described in § 1271.10
9173. § 1271.390 Applicability.
9174. § 1271.400 Inspections.
9175. § 1271.420 HCT/Ps offered for import.
9176. § 1271.440 Orders of retention, recall, destruction, and cessation of manufacturing.
9177. 1272-1299 PARTS 1272-1299 [RESERVED]
9178. CHAPTER II DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
9179. PART 1300 DEFINITIONS
9180. § 1300.01 Definitions relating to controlled substances.
9181. § 1300.02 Definitions relating to listed chemicals.
9182. § 1300.03 Definitions relating to electronic orders for controlled substances and electronic prescriptions for controlled substances.
9183. § 1300.04 Definitions relating to the dispensing of controlled substances by means of the Internet.
9184. § 1300.05 Definitions relating to the disposal of controlled substances.
9185. § 1300.06 Definitions relating to emergency medical services agencies.
9186. PART 1301 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
9187. 1 General Information
9188. § 1301.01 Scope of this part 1301.
9189. § 1301.02 Definitions. Link
9190. § 1301.03 Information; special instructions.
9191. 2 Registration
9192. § 1301.11 Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy.
9193. § 1301.12 Separate registrations for separate locations.
9194. § 1301.13 Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.
9195. § 1301.14 Filing of application; acceptance for filing; defective applications.
9196. § 1301.15 Additional information.
9197. § 1301.16 Amendments to and withdrawal of applications.
9198. § 1301.17 Special procedures for certain applications.
9199. § 1301.18 Research protocols.
9200. § 1301.19 Special requirements for online pharmacies.
9201. § 1301.20 Registration for emergency medical services agencies.
9202. 3 Exceptions to Registration and Fees
9203. § 1301.21 Exemption from fees.
9204. § 1301.22 Exemption of agents and employees; affiliated practitioners.
9205. § 1301.23 Exemption of certain military and other personnel.
9206. § 1301.24 Exemption of law enforcement officials.
9207. § 1301.25 Registration regarding ocean vessels, aircraft, and other entities.
9208. § 1301.26 Exemptions from import or export requirements for personal medical use.
9209. § 1301.27 Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities.
9210. §§ 1301.28-1301.29 [Reserved]
9211. 4 Action on Application for Registration: Revocation or Suspension of Registration
9212. § 1301.31 Administrative review generally.
9213. § 1301.32 Action on applications for research in Schedule I substances.
9214. § 1301.33 Application for bulk manufacture of Schedule I and II substances.
9215. § 1301.34 Application for importation of Schedule I and II substances.
9216. § 1301.35 Certificate of registration; denial of registration.
9217. § 1301.36 Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order.
9218. § 1301.37 Order to show cause.
9219. 5 Hearings
9220. § 1301.41 Hearings generally.
9221. § 1301.42 Purpose of hearing.
9222. § 1301.43 Request for hearing or appearance; waiver; default.
9223. § 1301.44 Burden of proof.
9224. § 1301.45 Time and place of hearing.
9225. § 1301.46 Final order.
9226. 6 Modification, Transfer and Termination of Registration
9227. § 1301.51 Modification in registration.
9228. § 1301.52 Termination of registration; transfer of registration; distribution upon discontinuance of business.
9229. 7 Security Requirements
9230. § 1301.71 Security requirements generally.
9231. § 1301.72 Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs; storage areas.
9232. § 1301.73 Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas.
9233. § 1301.74 Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs.
9234. § 1301.75 Physical security controls for practitioners.
9235. § 1301.76 Other security controls for practitioners.
9236. § 1301.77 Security controls for freight forwarding facilities.
9237. § 1301.78-1301.79 [Reserved]
9238. § 1301.80 Security controls for emergency medical services agencies.
9239. Employee Screening Non-Practitioners
9240. § 1301.90 Employee screening procedures.
9241. § 1301.91 Employee responsibility to report drug diversion.
9242. § 1301.92 Illicit activities by employees.
9243. § 1301.93 Sources of information for employee checks.
9244. PART 1302 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
9245. § 1302.01 Scope of part 1302.
9246. § 1302.02 Definitions.
9247. § 1302.03 Symbol required; exceptions.
9248. § 1302.04 Location and size of symbol on label and labeling.
9249. § 1302.05 Effective dates of labeling requirements.
9250. § 1302.06 Sealing of controlled substances.
9251. § 1302.07 Labeling and packaging requirements for imported and exported substances.
9252. § 1302.08 False labeling of anabolic steroids.
9253. PART 1303 QUOTAS
9254. 9 General Information
9255. § 1303.01 Scope of part 1303.
9256. § 1303.02 Definitions.
9257. § 1303.03 Types of quotas.
9258. § 1303.04 Subcategories of manufacturing and procurement quotas.
9259. § 1303.05 Estimation of Diversion.
9260. 10 Aggregate Production Quotas
9261. § 1303.11 Aggregate production quotas.
9262. § 1303.12 [Reserved]
9263. § 1303.13 Adjustments of aggregate production quotas.
9264. 11 Procurement Quotas
9265. § 1303.15 Procurement quotas.
9266. § 1303.16 Inventory allowance for procurement quotas.
9267. § 1303.17 Abandonment of procurement quota.
9268. 12 Individual Manufacturing Quotas
9269. § 1303.21 Individual manufacturing quotas.
9270. § 1303.22 Procedure for applying for individual manufacturing quotas.
9271. § 1303.23 Procedure for fixing individual manufacturing quotas.
9272. § 1303.24 Inventory allowance for individual manufacturing quotas.
9273. § 1303.25 Increase in individual manufacturing quotas.
9274. § 1303.26 Reduction in individual manufacturing quotas.
9275. § 1303.27 Abandonment of quota for Individual Manufacturing Quota.
9276. 13 Hearings
9277. § 1303.31 Hearings generally.
9278. § 1303.32 Purpose of hearing.
9279. § 1303.33 Waiver or modification of rules.
9280. § 1303.34 Request for hearing or appearance; waiver.
9281. § 1303.35 Burden of proof.
9282. § 1303.36 Time and place of hearing.
9283. § 1303.37 Final order.
9284. PART 1304 RECORDS AND REPORTS OF REGISTRANTS
9285. 14 General Information
9286. § 1304.01 Scope of part 1304.
9287. § 1304.02 Definitions.
9288. § 1304.03 Persons required to keep records and file reports.
9289. § 1304.04 Maintenance of records and inventories.
9290. § 1304.05 Records of authorized central fill pharmacies and retail pharmacies.
9291. § 1304.06 Records and reports for electronic prescriptions.
9292. 15 Inventory Requirements
9293. § 1304.11 Inventory requirements.
9294. 16 Continuing Records
9295. § 1304.21 General requirements for continuing records.
9296. § 1304.22 Records for manufacturers, distributors, dispensers, researchers, importers, exporters, registrants that reverse distribute, and collectors.
9297. § 1304.23 Records for chemical analysts.
9298. § 1304.24 Records for maintenance treatment programs, mobile narcotic treatment programs, and detoxification treatment programs.
9299. § 1304.25 Records for treatment programs that compound narcotics for treatment programs and other locations.
9300. § 1304.26 Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid.
9301. § 1304.27 Additional recordkeeping requirements applicable to emergency medical services agencies.
9302. 17 Reports
9303. § 1304.31 Reports from manufacturers importing narcotic raw material.
9304. § 1304.32 Reports of manufacturers importing coca leaves.
9305. § 1304.33 Reports to Automation of Reports and Consolidated Orders System (ARCOS).
9306. 18 Online Pharmacies
9307. § 1304.40 Notification by online pharmacies.
9308. § 1304.45 Internet Web site disclosure requirements.
9309. § 1304.50 Disclosure requirements for Web sites of nonpharmacy practitioners that dispense controlled substances by means of the Internet.
9310. § 1304.55 Reports by online pharmacies.
9311. PART 1305 ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
9312. Subpart A General Requirements
9313. § 1305.01 Scope of part 1305.
9314. § 1305.02 Definitions.
9315. § 1305.03 Distributions requiring a Form 222 or a digitally signed electronic order.
9316. § 1305.04 Persons entitled to order Schedule I and II controlled substances.
9317. § 1305.05 Power of attorney.
9318. § 1305.06 Persons entitled to fill orders for Schedule I and II controlled substances.
9319. § 1305.07 Special procedure for filling certain orders.
9320. Subpart B DEA Form 222
9321. § 1305.11 Procedure for obtaining DEA Forms 222.
9322. § 1305.12 Procedure for executing DEA Forms 222.
9323. § 1305.13 Procedure for filling DEA Forms 222.
9324. § 1305.14 Procedure for endorsing DEA Forms 222.
9325. § 1305.15 Unaccepted and defective DEA Forms 222.
9326. § 1305.16 Lost and stolen DEA Forms 222.
9327. § 1305.17 Preservation of DEA Forms 222.
9328. § 1305.18 Return of unused DEA Forms 222.
9329. § 1305.19 Cancellation and voiding of DEA Forms 222.
9330. § 1305.20 [Reserved]
9331. Subpart C Electronic Orders
9332. § 1305.21 Requirements for electronic orders.
9333. § 1305.22 Procedure for filling electronic orders.
9334. § 1305.23 Endorsing electronic orders.
9335. § 1305.24 Central processing of orders.
9336. § 1305.25 Unaccepted and defective electronic orders.
9337. § 1305.26 Lost electronic orders.
9338. § 1305.27 Preservation of electronic orders.
9339. § 1305.28 Canceling and voiding electronic orders.
9340. § 1305.29 Reporting to DEA.
9341. PART 1306 PRESCRIPTIONS
9342. 19 General Information
9343. § 1306.01 Scope of part 1306.
9344. § 1306.02 Definitions.
9345. § 1306.03 Persons entitled to issue prescriptions.
9346. § 1306.04 Purpose of issue of prescription.
9347. § 1306.05 Manner of issuance of prescriptions.
9348. § 1306.06 Persons entitled to fill prescriptions.
9349. § 1306.07 Administering or dispensing of narcotic drugs.
9350. § 1306.08 Electronic prescriptions.
9351. § 1306.09 Prescription requirements for online pharmacies.
9352. 20 Controlled Substances Listed in Schedule II
9353. § 1306.11 Requirement of prescription.
9354. § 1306.12 Refilling prescriptions; issuance of multiple prescriptions.
9355. § 1306.13 Partial filling of prescriptions.
9356. § 1306.14 Labeling of substances and filling of prescriptions.
9357. § 1306.15 Provision of prescription information between retail pharmacies and central fill pharmacies for prescriptions of Schedule II controlled substances.
9358. 21 Controlled Substances Listed in Schedules III, IV, and V
9359. § 1306.21 Requirement of prescription.
9360. § 1306.22 Refilling of prescriptions.
9361. § 1306.23 Partial filling of prescriptions.
9362. § 1306.24 Labeling of substances and filling of prescriptions.
9363. § 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes.
9364. § 1306.26 Dispensing without prescription.
9365. § 1306.27 Provision of prescription information between retail pharmacies and central fill pharmacies for initial and refill prescriptions of Schedule III, IV, or V controlled substances.
9366. § 1306.28-1306.49 [Reserved]
9367. 22 Special Circumstances for Telemedicine Prescribing
9368. § 1306.51 1306.51 Telemedicine prescribing of schedule III-V medications for the treatment of Opioid Use Disorder.
9369. § 1306.52 Other circumstances where Department of Veterans Affairs practitioners may prescribe controlled substances via the practice of telemedicine.
9370. PART 1307 MISCELLANEOUS
9371. 23 General Information
9372. § 1307.01 Definitions.
9373. § 1307.02 Application of State law and other Federal law.
9374. § 1307.03 Exceptions to regulations.
9375. 24 Special Exceptions for Manufacture and Distribution of Controlled Substances
9376. § 1307.11 Distribution by dispenser to another practitioner.
9377. § 1307.13 Incidental manufacture of controlled substances.
9378. § 1307.14 Delivery of controlled substances to designated locations of emergency medical services agencies.
9379. § 1307.15 Delivery of controlled substances in emergency situations.
9380. 25 Disposal of Controlled Substances
9381. § 1307.22 Delivery of surrendered and forfeited controlled substances.
9382. 26 Special Exempt Persons
9383. § 1307.31 Native American Church.
9384. 27 Special Exceptions Related to Telemedicine
9385. § 1307.41 Temporary extension of certain COVID-19 telemedicine flexibilities for prescription of controlled medications.
9386. PART 1308 SCHEDULES OF CONTROLLED SUBSTANCES
9387. 28 General Information
9388. § 1308.01 Scope of this part.
9389. § 1308.02 Definitions.
9390. § 1308.03 Administration Controlled Substances Code Number.
9391. 29 Schedules
9392. § 1308.11 Schedule I.
9393. § 1308.12 Schedule II.
9394. § 1308.13 Schedule III.
9395. § 1308.14 Schedule IV.
9396. § 1308.15 Schedule V.
9397. 30 Excluded Nonnarcotic Substances
9398. § 1308.21 Application for exclusion of a nonnarcotic substance.
9399. § 1308.22 Excluded substances.
9400. 31 Exempt Chemical Preparations
9401. § 1308.23 Exemption of certain chemical preparations; application.
9402. § 1308.24 Exempt chemical preparations.
9403. 32 Excluded Veterinary Anabolic Steroid Implant Products
9404. § 1308.25 Exclusion of a veterinary anabolic steroid implant product; application.
9405. § 1308.26 Excluded veterinary anabolic steroid implant products.
9406. 33 Exempted Prescription Products
9407. § 1308.31 Application for exemption of a nonnarcotic prescription product.
9408. § 1308.32 Exempted prescription products.
9409. 34 Exempt Anabolic Steroid Products
9410. § 1308.33 Exemption of certain anabolic steroid products; application.
9411. § 1308.34 Exempt anabolic steroid products.
9412. 35 Exempt Cannabis Plant Material, and Products Made Therefrom, that Contain Tetrahydrocannabinols
9413. § 1308.35 Exemption of certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols.
9414. 36 Hearings
9415. § 1308.41 Hearings generally.
9416. § 1308.42 Purpose of hearing.
9417. § 1308.43 Initiation of proceedings for rulemaking.
9418. § 1308.44 Request for hearing or appearance; waiver.
9419. § 1308.45 Final order.
9420. § 1308.46 Control required under international treaty.
9421. § 1308.47 Control of immediate precursors.
9422. § 1308.49 Temporary scheduling.
9423. § 1308.50 Temporary and permanent scheduling of recently emerged anabolic steroids.
9424. PART 1309 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS
9425. 37 General Information
9426. § 1309.01 Scope of part 1309.
9427. § 1309.02 Definitions.
9428. § 1309.03 Information; special instructions.
9429. 38 Fees for Registration and Reregistration
9430. § 1309.11 Fee Amounts.
9431. § 1309.12 Time and method of payment; refund.
9432. 39 Requirements for Registration
9433. § 1309.21 Persons required to register.
9434. § 1309.22 Separate registration for independent activities.
9435. § 1309.23 Separate registration for separate locations.
9436. § 1309.24 Waiver of registration requirement for certain activities.
9437. § 1309.25 Temporary exemption from registration for chemical registration applicants.
9438. § 1309.26 Exemption of law enforcement officials.
9439. 40 Application for Registration
9440. § 1309.31 Time for application for registration; expiration date.
9441. § 1309.32 Application forms; contents; signature.
9442. § 1309.33 Filing of application; joint filings.
9443. § 1309.34 Acceptance for filing; defective applications.
9444. § 1309.35 Additional information.
9445. § 1309.36 Amendments to and withdrawals of applications.
9446. 41 Action on Applications for Registration: Revocation or Suspension of Registration
9447. § 1309.41 Administrative review generally.
9448. § 1309.42 Certificate of registration; denial of registration.
9449. § 1309.43 Suspension or revocation of registration.
9450. § 1309.44 Suspension of registration pending final order.
9451. § 1309.45 Extension of registration pending final order.
9452. § 1309.46 Order to show cause.
9453. 42 Hearings
9454. § 1309.51 Hearings generally.
9455. § 1309.52 Purpose of hearing.
9456. § 1309.53 Request for hearing or appearance; waiver; default.
9457. § 1309.54 Burden of proof.
9458. § 1309.55 Time and place of hearing.
9459. 43 Modification, Transfer and Termination of Registration
9460. § 1309.61 Modification in registration.
9461. § 1309.62 Termination of registration.
9462. § 1309.63 Transfer of registration.
9463. 44 Security Requirements
9464. § 1309.71 General security requirements.
9465. § 1309.72 Felony conviction; employer responsibilities.
9466. § 1309.73 Employee responsibility to report diversion.
9467. PART 1310 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES
9468. § 1310.01 Definitions.
9469. § 1310.02 Substances covered.
9470. § 1310.03 Persons required to keep records and file reports.
9471. § 1310.04 Maintenance of records.
9472. § 1310.05 Reports.
9473. § 1310.06 Content of records and reports.
9474. § 1310.07 Proof of identity.
9475. § 1310.08 Excluded transactions.
9476. § 1310.09 Temporary exemption from registration.
9477. § 1310.10 Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act.
9478. § 1310.11 Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.
9479. § 1310.12 Exempt chemical mixtures.
9480. § 1310.13 Exemption of chemical mixtures; application.
9481. § 1310.14 Removal of exemption from definition of regulated transaction.
9482. § 1310.16 Exemptions for certain scheduled listed chemical products.
9483. § 1310.21 Sale by Federal departments or agencies of chemicals which could be used to manufacture controlled substances.
9484. PART 1311 REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS
9485. Subpart A General
9486. § 1311.01 Scope.
9487. § 1311.02 Definitions.
9488. § 1311.05 Standards for technologies for electronic transmission of orders.
9489. § 1311.08 Incorporation by reference.
9490. Subpart B Obtaining and Using Digital Certificates for Electronic Orders
9491. § 1311.10 Eligibility to obtain a CSOS digital certificate.
9492. § 1311.15 Limitations on CSOS digital certificates.
9493. § 1311.20 Coordinators for CSOS digital certificate holders.
9494. § 1311.25 Requirements for obtaining a CSOS digital certificate.
9495. § 1311.30 Requirements for storing and using a private key for digitally signing orders.
9496. § 1311.35 Number of CSOS digital certificates needed.
9497. § 1311.40 Renewal of CSOS digital certificates.
9498. § 1311.45 Requirements for registrants that allow powers of attorney to obtain CSOS digital certificates under their DEA registration.
9499. § 1311.50 Requirements for recipients of digitally signed orders.
9500. § 1311.55 Requirements for systems used to process digitally signed orders.
9501. § 1311.60 Recordkeeping.
9502. Subpart C Electronic Prescriptions
9503. § 1311.100 General.
9504. § 1311.102 Practitioner responsibilities.
9505. § 1311.105 Requirements for obtaining an authentication credential—Individual practitioners.
9506. § 1311.110 Requirements for obtaining an authentication credential—Individual practitioners eligible to use an electronic prescription application of an institutional practitioner.
9507. § 1311.115 Additional requirements for two-factor authentication.
9508. § 1311.116 Additional requirements for biometrics.
9509. § 1311.120 Electronic prescription application requirements.
9510. § 1311.125 Requirements for establishing logical access control—Individual practitioner.
9511. § 1311.130 Requirements for establishing logical access control—Institutional practitioner.
9512. § 1311.135 Requirements for creating a controlled substance prescription.
9513. § 1311.140 Requirements for signing a controlled substance prescription.
9514. § 1311.145 Digitally signing the prescription with the individual practitioner's private key.
9515. § 1311.150 Additional requirements for internal application audits.
9516. § 1311.170 Transmission requirements.
9517. § 1311.200 Pharmacy responsibilities.
9518. § 1311.205 Pharmacy application requirements.
9519. § 1311.210 Archiving the initial record.
9520. § 1311.215 Internal audit trail.
9521. § 1311.300 Application provider requirements—Third-party audits or certifications.
9522. § 1311.302 Additional application provider requirements.
9523. § 1311.305 Recordkeeping.
9524. PART 1312 IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
9525. § 1312.01 Scope of part 1312.
9526. § 1312.02 Definitions.
9527. § 1312.03 Forms applicable to this part.
9528. 45 Importation of Controlled Substances
9529. § 1312.11 Requirement of authorization to import.
9530. § 1312.12 Application for import permit; return information.
9531. § 1312.13 Issuance of import permit.
9532. § 1312.14 Distribution of import permits.
9533. § 1312.15 Shipments in greater or less amount than authorized.
9534. § 1312.16 Amendment, cancellation, expiration of import permit.
9535. § 1312.17 Special report from importers.
9536. § 1312.18 Import declaration.
9537. § 1312.19 Distribution of import declaration.
9538. 46 Exportation of Controlled Substances
9539. § 1312.21 Requirement of authorization to export.
9540. § 1312.22 Application for export or reexport permit; return information.
9541. § 1312.23 Issuance of export permit.
9542. § 1312.24 Distribution of export permit.
9543. § 1312.25 Amendment, cancellation, expiration of export permit.
9544. § 1312.26 Records required of exporter.
9545. § 1312.27 Export/reexport declaration.
9546. § 1312.28 Distribution of export declaration.
9547. § 1312.29 Domestic release prohibited.
9548. § 1312.30 Schedule III, IV, and V non-narcotic controlled substances requiring an import and export permit.
9549. 47 Transshipment and In-Transit Shipment of Controlled Substances
9550. § 1312.31 Schedule I: Application for prior written approval.
9551. § 1312.32 Schedules II, III, IV: Advance notice.
9552. 48 Hearings
9553. § 1312.41 Hearings generally.
9554. § 1312.42 Purpose of hearing.
9555. § 1312.43 Waiver or modification of rules.
9556. § 1312.44 Request for hearing or appearance; waiver.
9557. § 1312.45 Burden of proof.
9558. § 1312.46 Time and place of hearing.
9559. § 1312.47 Final order.
9560. PART 1313 IMPORTATION AND EXPORTATION OF LIST I AND LIST II CHEMICALS
9561. § 1313.01 Scope.
9562. § 1313.02 Definitions.
9563. § 1313.03 Forms applicable to this part.
9564. § 1313.05 Requirements for an established business relationship.
9565. § 1313.08 Requirements for establishing a record as an importer.
9566. 49 Importation of Listed Chemicals
9567. § 1313.12 Notification prior to import.
9568. § 1313.13 Requirements of import declaration.
9569. § 1313.14 Disposition of import declaration.
9570. § 1313.15 Qualification of regular importers.
9571. § 1313.16 Updated notice for change in circumstances.
9572. § 1313.17 Return declaration for imports.
9573. 50 Exportation of Listed Chemicals
9574. § 1313.21 Notification prior to export.
9575. § 1313.22 Export declaration.
9576. § 1313.23 Disposition of export declaration.
9577. § 1313.24 Waiver of 15-day advance notice for chemical exporters.
9578. § 1313.25 Foreign import restrictions.
9579. § 1313.26 Updated notice for change in circumstances.
9580. § 1313.27 Return declaration for exports.
9581. 51 Transshipments, In-Transit Shipments and International Transactions Involving Listed Chemicals
9582. § 1313.31 Advance notice of importation for transshipment or transfer.
9583. § 1313.32 Notification of international transactions.
9584. § 1313.33 Contents of an international transaction declaration.
9585. § 1313.34 Disposition of the international transaction declaration.
9586. § 1313.35 Return declaration or amendment to Form 486 for international transactions.
9587. § 1313.41 Suspension of shipments.
9588. § 1313.42 Prohibition of shipments from certain foreign sources.
9589. 52 Hearings
9590. § 1313.51 Hearings generally.
9591. § 1313.52 Purpose of hearing.
9592. § 1313.53 Waiver of modification of rules.
9593. § 1313.54 Request for hearing.
9594. § 1313.55 Burden of proof.
9595. § 1313.56 Time and place of hearing.
9596. § 1313.57 Final order.
9597. PART 1314 RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS
9598. Subpart A General
9599. § 1314.01 Scope.
9600. § 1314.02 Applicability.
9601. § 1314.03 Definitions.
9602. § 1314.05 Requirements regarding packaging of nonliquid forms.
9603. § 1314.10 Effect on State laws.
9604. § 1314.15 Loss reporting.
9605. Subpart B Sales by Regulated Sellers
9606. § 1314.20 Restrictions on sales quantity.
9607. § 1314.25 Requirements for retail transactions.
9608. § 1314.30 Recordkeeping for retail transactions.
9609. § 1314.35 Training of sales personnel.
9610. § 1314.40 Self-certification.
9611. § 1314.42 Self-certification fee; time and method of fee payment.
9612. § 1314.45 Privacy protections.
9613. § 1314.50 Employment measures.
9614. Subpart C Mail-Order Sales
9615. § 1314.100 Sales limits for mail-order sales.
9616. § 1314.101 Training of sales personnel.
9617. § 1314.102 Self-certification.
9618. § 1314.103 Self-certification fee; time and method of fee payment.
9619. § 1314.105 Verification of identity for mail-order sales.
9620. § 1314.110 Reports for mail-order sales.
9621. § 1314.115 Distributions not subject to reporting requirements.
9622. Subpart D Order to Show Cause
9623. § 1314.150 Order To show cause.
9624. § 1314.155 Suspension pending final order.
9625. PART 1315 IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE
9626. Subpart A General Information
9627. § 1315.01 Scope.
9628. § 1315.02 Definitions.
9629. § 1315.03 Personal use exemption.
9630. § 1315.05 Applicability.
9631. § 1315.06 Assessment of Annual Needs; Types of quotas.
9632. § 1315.07 Subcategories of manufacturing and procurement quota.
9633. Subpart B Assessment of Annual Needs
9634. § 1315.11 Assessment of annual needs.
9635. § 1315.13 Adjustments of the assessment of annual needs.
9636. Subpart C Individual Manufacturing Quotas
9637. § 1315.21 Individual manufacturing quotas.
9638. § 1315.22 Procedure for applying for individual manufacturing quotas.
9639. § 1315.23 Procedure for fixing individual manufacturing quotas.
9640. § 1315.24 Inventory allowance for individual manufacturing quotas.
9641. § 1315.25 Increase in individual manufacturing quotas.
9642. § 1315.26 Reduction in individual manufacturing quotas.
9643. § 1315.27 Abandonment of quota.
9644. Subpart D Procurement and Import Quotas
9645. § 1315.30 Procurement and import quotas.
9646. § 1315.31 Inventory allowance for procurement quotas.
9647. § 1315.32 Obtaining a procurement quota.
9648. § 1315.33 Power of attorney.
9649. § 1315.34 Obtaining an import quota.
9650. § 1315.36 Amending an import quota.
9651. § 1315.37 Abandonment of procurement quota.
9652. Subpart E Hearings
9653. § 1315.50 Hearings generally.
9654. § 1315.52 Purpose of hearing.
9655. § 1315.54 Waiver or modification of rules.
9656. § 1315.56 Request for hearing or appearance; waiver.
9657. § 1315.58 Burden of proof.
9658. § 1315.60 Time and place of hearing.
9659. § 1315.62 Final order.
9660. PART 1316 ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
9661. Subpart A Administrative Inspections
9662. § 1316.01 Scope of subpart A.
9663. § 1316.02 Definitions.
9664. § 1316.03 Authority to make inspections.
9665. § 1316.04 Exclusion from inspection.
9666. § 1316.05 Entry.
9667. § 1316.06 Notice of inspection.
9668. § 1316.07 Requirement for administrative inspection warrant; exceptions.
9669. § 1316.08 Consent to inspection.
9670. § 1316.09 Application for administrative inspection warrant.
9671. § 1316.10 Administrative probable cause.
9672. § 1316.11 Execution of warrants.
9673. § 1316.12 Refusal to allow inspection with an administrative warrant.
9674. § 1316.13 Frequency of administrative inspections.
9675. Subpart B Protection of Researchers and Research Subjects
9676. § 1316.21 Definitions.
9677. § 1316.22 Exemption.
9678. § 1316.23 Confidentiality of identity of research subjects.
9679. § 1316.24 Exemption from prosecution for researchers.
9680. Subpart C Enforcement Proceedings
9681. § 1316.31 Authority for enforcement proceeding.
9682. § 1316.32 Notice of proceeding; time and place.
9683. § 1316.33 Conduct of proceeding.
9684. § 1316.34 Records of proceeding.
9685. Subpart D Administrative Hearings
9686. § 1316.41 Scope of subpart D.
9687. § 1316.42 Definitions.
9688. § 1316.43 Information; special instructions.
9689. § 1316.44 Waiver or modification of rules.
9690. § 1316.45 Filings; address; hours.
9691. § 1316.46 Inspection of record.
9692. § 1316.47 Request for hearing; answer.
9693. § 1316.48 Notice of appearance.
9694. § 1316.49 Waiver of hearing.
9695. § 1316.50 Appearance; representation; authorization.
9696. § 1316.51 Conduct of hearing and parties; ex parte communications.
9697. § 1316.52 Presiding officer.
9698. § 1316.53 Time and place of hearing.
9699. § 1316.54 Prehearing conference.
9700. § 1316.55 Prehearing ruling.
9701. § 1316.56 Burden of proof.
9702. § 1316.57 Submission of documentary evidence and affidavits and identification of witnesses subsequent to prehearing conference.
9703. § 1316.58 Summary of testimony; affidavits.
9704. § 1316.59 Submission and receipt of evidence.
9705. § 1316.60 Objections; offer of proof.
9706. § 1316.61 Exceptions to rulings.
9707. § 1316.62 Interlocutory appeals from rulings of the presiding officer.
9708. § 1316.63 Official transcript; index; corrections.
9709. § 1316.64 Proposed findings of fact and conclusions of law.
9710. § 1316.65 Report and record.
9711. § 1316.66 Exceptions.
9712. § 1316.67 Final order.
9713. § 1316.68 Copies of petitions for judicial review.
9714. PART 1317 DISPOSAL
9715. § 1317.01 Scope.
9716. Subpart A Disposal of Controlled Substances by Registrants
9717. § 1317.05 Registrant disposal.
9718. § 1317.10 Registrant return or recall.
9719. § 1317.15 Reverse distributor registration requirements and authorized activities.
9720. Subpart B Disposal of Controlled Substances Collected From Ultimate Users and Other Non-Registrants
9721. § 1317.30 Authorization to collect from non-registrants.
9722. § 1317.35 Collection by law enforcement.
9723. § 1317.40 Registrants authorized to collect and authorized collection activities.
9724. § 1317.55 Reverse distributor and distributor acquisition of controlled substances from collectors or law enforcement.
9725. § 1317.60 Inner liner requirements.
9726. § 1317.65 Take-back events.
9727. § 1317.70 Mail-back programs.
9728. § 1317.75 Collection receptacles.
9729. § 1317.80 Collection receptacles at long-term care facilities.
9730. § 1317.85 Ultimate user delivery for the purpose of recall or investigational use of drugs.
9731. Subpart C Destruction of Controlled Substances
9732. § 1317.90 Methods of destruction.
9733. § 1317.95 Destruction procedures.
9734. PART 1318 CONTROLS TO SATISFY THE REQUIREMENTS OF THE ACT APPLICABLE TO THE MANUFACTURING OF MARIHUANA
9735. § 1318.01 Scope of this part.
9736. § 1318.02 Definitions.
9737. § 1318.03 Implementation of statutory requirements.
9738. § 1318.04 Specific control measures applicable to the bulk manufacture of marihuana.
9739. § 1318.05 Application of the public interest factors.
9740. § 1318.06 Factors affecting prices for the purchase and sale by the Administration of cannabis.
9741. § 1318.07 Non-liability of Drug Enforcement Administration.
9742. PART 1321 DEA MAILING ADDRESSES
9743. § 1321.01 DEA mailing addresses.
9744. 1322-1399 PARTS 1322-1399 [RESERVED]
9745. CHAPTER III OFFICE OF NATIONAL DRUG CONTROL POLICY
9746. 1400 PART 1400 [RESERVED]
9747. PART 1401 PUBLIC AVAILABILITY OF INFORMATION
9748. Subpart A Freedom of Information Act Policies and Procedures
9749. § 1401.1 Purpose.
9750. § 1401.2 The Office of National Drug Control Policy—organization and functions.
9751. § 1401.3 Definitions.
9752. § 1401.4 Access to information.
9753. § 1401.5 Records requiring consultation.
9754. § 1401.6 How to request records—form and content.
9755. § 1401.7 Responses—form and content.
9756. § 1401.8 Expedited process.
9757. § 1401.9 Extension of time.
9758. § 1401.10 Appeal procedures.
9759. § 1401.11 Fees to be charged—general.
9760. § 1401.12 Fees to be charged—miscellaneous provisions.
9761. § 1401.13 Fees to be charged—categories of requesters.
9762. § 1401.14 Restrictions on charging fees.
9763. § 1401.15 Waiver or reduction of fees.
9764. § 1401.16 Aggregation of requests.
9765. § 1401.17 Markings on released documents.
9766. § 1401.18 Confidential commercial information.
9767. Subpart B Privacy Act Policies and Procedures
9768. § 1401.19 Definitions.
9769. § 1401.20 Purpose and scope.
9770. § 1401.21 How do I make a Privacy Act request?
9771. § 1401.22 How will ONDCP respond to my Privacy Act request?
9772. § 1401.23 What can I do if I am dissatisfied with ONDCP's response to my Privacy Act request?
9773. § 1401.24 What does it cost to get records under the Privacy Act?
9774. PART 1402 MANDATORY DECLASSIFICATION REVIEW
9775. § 1402.1 Purpose.
9776. § 1402.2 Responsibility.
9777. § 1402.3 Information in the custody of ONDCP.
9778. § 1402.4 Information classified by another agency.
9779. § 1402.5 Appeal procedure.
9780. § 1402.6 Fees.
9781. § 1402.7 Suggestions and complaints.
9782. 1403-1499 PARTS 1403-1499 [RESERVED]