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Title 21

Displaying title 21, up to date as of 6/16/2026. Title 21 was last amended 6/15/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter DDrugs for Human Use300 – 499
Part 300General300.50 – 300.200
Part 310New Drugs310.3 – 310.548
Part 312Investigational New Drug Application312.1 – 312.320
Part 314Applications for FDA Approval to Market a New Drug314.1 – 314.650
Part 315Diagnostic Radiopharmaceuticals315.1 – 315.6
Part 316Orphan Drugs316.1 – 316.52
Part 317Qualifying Pathogens317.1 – 317.2
Part 320Bioavailability and Bioequivalence Requirements320.1 – 320.63
Part 328Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol328.1 – 328.50
Part 329Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act329.100
Part 330Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded330.1 – 330.15
Part 331Antacid Products for Over-the-Counter (OTC) Human Use331.1 – 331.80
Part 332Antiflatulent Products for Over-the-Counter Human Use332.1 – 332.31
Part 333Topical Antimicrobial Drug Products for Over-the-Counter Human Use333.101 – 333.350
Part 335Antidiarrheal Drug Products for Over-the-Counter Human Use335.1 – 335.50
Part 336Antiemetic Drug Products for Over-the-Counter Human Use336.1 – 336.80
Part 338Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use338.1 – 338.50
Part 340Stimulant Drug Products for Over-the-Counter Human Use340.1 – 340.50
Part 341Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use341.1 – 341.90
Part 343Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use343.1 – 343.90
Part 344Topical Otic Drug Products for Over-the-Counter Human Use344.1 – 344.52
Part 346Anorectal Drug Products for Over-the-Counter Human Use346.1 – 346.52
Part 347Skin Protectant Drug Products for Over-the-Counter Human Use347.1 – 347.60
Part 348External Analgesic Drug Products for Over-the-Counter Human Use348.1 – 348.50
Part 349Ophthalmic Drug Products for Over-the-Counter Human Use349.1 – 349.80
Part 350Antiperspirant Drug Products for Over-the-Counter Human Use350.1 – 350.60
Part 352Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]352.1 – 352.77
Part 355Anticaries Drug Products for Over-the-Counter Human Use355.1 – 355.70
Part 357Miscellaneous Internal Drug Products for Over-the-Counter Human Use357.101 – 357.850
Part 358Miscellaneous External Drug Products for Over-the-Counter Human Use358.101 – 358.760
Part 361Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research361.1
Part 369Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale369.1 – 369.21
Parts 370-499 [Reserved]