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Drugs for Human Use
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Drugs for Human Use
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Part
300
General
Part
310
New Drugs
Part
312
Investigational New Drug Application
Part
314
Applications for FDA Approval to Market a New Drug
Part
315
Diagnostic Radiopharmaceuticals
Part
316
Orphan Drugs
Part
317
Qualifying Pathogens
Part
320
Bioavailability and Bioequivalence Requirements
Part
328
Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol
Part
329
Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act
Part
330
Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
Part
331
Antacid Products for Over-the-Counter (OTC) Human Use
Part
332
Antiflatulent Products for Over-the-Counter Human Use
Part
333
Topical Antimicrobial Drug Products for Over-the-Counter Human Use
Part
335
Antidiarrheal Drug Products for Over-the-Counter Human Use
Part
336
Antiemetic Drug Products for Over-the-Counter Human Use
Part
338
Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use
Part
340
Stimulant Drug Products for Over-the-Counter Human Use
Part
341
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
Part
343
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use
Part
344
Topical Otic Drug Products for Over-the-Counter Human Use
Part
346
Anorectal Drug Products for Over-the-Counter Human Use
Part
347
Skin Protectant Drug Products for Over-the-Counter Human Use
Part
348
External Analgesic Drug Products for Over-the-Counter Human Use
Part
349
Ophthalmic Drug Products for Over-the-Counter Human Use
Part
350
Antiperspirant Drug Products for Over-the-Counter Human Use
Part
352
Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]
Part
355
Anticaries Drug Products for Over-the-Counter Human Use
Part
357
Miscellaneous Internal Drug Products for Over-the-Counter Human Use
Part
358
Miscellaneous External Drug Products for Over-the-Counter Human Use
Part
361
Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research
Part
369
Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale
Part
370-499
Parts 370-499 [Reserved]