FDA 21 CFR Part 300 to 369 Guidelines

FDA 21 CFR PART 300 TO 369 SUBCHAPTER D — DRUGS FOR HUMAN USE

Click on the titles below for complete guidelines

21 CFR Part 300 General

21 CFR Part 310 New Drugs

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 316 Orphan Drugs

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 329 Nonprescription Human Drug Products Subject To Section 760 Of The Federal Food, Drug, And Cosmetic Act

21 CFR Part 330 Over-The-Counter (OTC) Human Drugs Which Are Generally Recognized As Safe And Effective And Not Misbranded

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 341 Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use

21 CFR Part 343 Internal Analgesic, Antipyretic, And Antirheumatic 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 361 Prescription Drugs For Human Use Generally Recognized As Safe And Effective And Not Misbranded: Drugs Used In Research

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: