FDA 21 CFR PART 300 TO 369 SUBCHAPTER D — DRUGS FOR HUMAN USE
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21 CFR Part 312 Investigational New Drug Application
21 CFR Part 314 Applications For FDA Approval To Market A New Drug
21 CFR Part 315 Diagnostic Radiopharmaceuticals
21 CFR Part 317 Qualifying Pathogens
21 CFR Part 320 Bioavailability And Bioequivalence Requirements
21 CFR Part 328 Over-The-Counter Drug Products Intended For Oral Ingestion That Contain Alcohol
21 CFR Part 331 Antacid Products For Over-The-Counter (OTC) Human Use
21 CFR Part 332 Antiflatulent Products For Over-The-Counter Human Use
21 CFR Part 333 Topical Antimicrobial Drug Products For Over-The-Counter Human Use
21 CFR Part 335 Antidiarrheal Drug Products For Over-The-Counter Human Use
21 CFR Part 336 Antiemetic Drug Products For Over-The-Counter Human Use
21 CFR Part 338 Nighttime Sleep-Aid Drug Products For Over-The-Counter Human Use
21 CFR Part 340 Stimulant Drug Products For Over-The-Counter Human Use
21 CFR Part 344 Topical Otic Drug Products For Over-The-Counter Human Use
21 CFR Part 346 Anorectal Drug Products For Over-The-Counter Human Use
21 CFR Part 347 Skin Protectant Drug Products For Over-The-Counter Human Use
21 CFR Part 348 External Analgesic Drug Products For Over-The-Counter Human Use
21 CFR Part 349 Ophthalmic Drug Products For Over-The-Counter Human Use
21 CFR Part 350 Antiperspirant Drug Products For Over-The-Counter Human Use
21 CFR Part 352 Sunscreen Drug Products For Over-The-Counter Human Use [Stayed Indefinitely]
21 CFR Part 355 Anticaries Drug Products For Over-The-Counter Human Use
21 CFR Part 357 Miscellaneous Internal Drug Products For Over-The-Counter Human Use
21 CFR Part 358 Miscellaneous External Drug Products For Over-The-Counter Human Use
21 CFR Part 369 Interpretative Statements Re Warnings On Drugs And Devices For Over-The-Counter Sale
FDA 21 CFR Part 300 to 369 Guidelines: