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Title 21

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eCFR Content

Editorial codification of the general and permanent rules published in the Federal Register.

Title 21 Food and Drugs Part / Section
Chapter I Food and Drug Administration, Department of Health and Human Services 1 – 1299
Subchapter D Drugs for Human Use 300 – 499
Part 300 General 300.50 – 300.100
Part 310 New Drugs 310.3 – 310.548
Part 312 Investigational New Drug Application 312.1 – 312.320
Part 314 Applications for FDA Approval to Market a New Drug 314.1 – 314.650
Part 315 Diagnostic Radiopharmaceuticals 315.1 – 315.6
Part 316 Orphan Drugs 316.1 – 316.52
Part 317 Qualifying Pathogens 317.1 – 317.2
Part 320 Bioavailability and Bioequivalence Requirements 320.1 – 320.63
Part 328 Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol 328.1 – 328.50
Part 329 Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act 329.100
Part 330 Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded 330.1 – 330.15
Part 331 Antacid Products for over-the-Counter (OTC) Human Use 331.1 – 331.80
Part 332 Antiflatulent Products for over-the-Counter Human Use 332.1 – 332.31
Part 333 Topical Antimicrobial Drug Products for over-the-Counter Human Use 333.101 – 333.350
Part 335 Antidiarrheal Drug Products for over-the-Counter Human Use 335.1 – 335.50
Part 336 Antiemetic Drug Products for over-the-Counter Human Use 336.1 – 336.80
Part 338 Nighttime Sleep-Aid Drug Products for over-the-Counter Human Use 338.1 – 338.50
Part 340 Stimulant Drug Products for over-the-Counter Human Use 340.1 – 340.50
Part 341 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for over-the-Counter Human Use 341.1 – 341.90
Part 343 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for over-the-Counter Human Use 343.1 – 343.90
Part 344 Topical Otic Drug Products for over-the-Counter Human Use 344.1 – 344.52
Part 346 Anorectal Drug Products for over-the-Counter Human Use 346.1 – 346.52
Part 347 Skin Protectant Drug Products for over-the-Counter Human Use 347.1 – 347.60
Part 348 External Analgesic Drug Products for over-the-Counter Human Use 348.1 – 348.50
Part 349 Ophthalmic Drug Products for over-the-Counter Human Use 349.1 – 349.80
Part 350 Antiperspirant Drug Products for over-the-Counter Human Use 350.1 – 350.60
Part 352 Sunscreen Drug Products for over-the-Counter Human Use [Stayed Indefinitely] 352.1 – 352.77
Part 355 Anticaries Drug Products for over-the-Counter Human Use 355.1 – 355.70
Part 357 Miscellaneous Internal Drug Products for over-the-Counter Human Use 357.101 – 357.850
Part 358 Miscellaneous External Drug Products for over-the-Counter Human Use 358.101 – 358.760
Part 361 Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research 361.1
Part 369 Interpretative Statements Re Warnings on Drugs and Devices for over-the-Counter Sale 369.1 – 369.21
Parts 370-499 [Reserved]