Code of Federal Regulations > Title 21 > Chapter I - CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Jan 21, 2026

Part 300 [§ 300.50 - § 300.200] - PART 300—GENERAL

Part 310 [§ 310.3 - § 310.548] - PART 310—NEW DRUGS

Part 312 [§ 312.1 - § 312.320] - PART 312—INVESTIGATIONAL NEW DRUG APPLICATION

Part 314 [§ 314.1 - § 314.650] - PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

Part 315 [§ 315.1 - § 315.6] - PART 315—DIAGNOSTIC RADIOPHARMACEUTICALS

Part 316 [§ 316.1 - § 316.52] - PART 316—ORPHAN DRUGS

Part 317 [§ 317.1 - § 317.2] - PART 317—QUALIFYING PATHOGENS

Part 320 [§ 320.1 - § 320.63] - PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Part 328 [§ 328.1 - § 328.50] - PART 328—OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL

Part 329 [§ 329.100 - § 329.100] - PART 329—NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

Part 330 [§ 330.1 - § 330.15] - PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

Part 331 [§ 331.1 - § 331.80] - PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE

Part 332 [§ 332.1 - § 332.31] - PART 332—ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 333 [§ 333.101 - § 333.350] - PART 333—TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 335 [§ 335.1 - § 335.50] - PART 335—ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 336 [§ 336.1 - § 336.80] - PART 336—ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 338 [§ 338.1 - § 338.50] - PART 338—NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 340 [§ 340.1 - § 340.50] - PART 340—STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 341 [§ 341.1 - § 341.90] - PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 343 [§ 343.1 - § 343.90] - PART 343—INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 344 [§ 344.1 - § 344.52] - PART 344—TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 346 [§ 346.1 - § 346.52] - PART 346—ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 347 [§ 347.1 - § 347.60] - PART 347—SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 348 [§ 348.1 - § 348.50] - PART 348—EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 349 [§ 349.1 - § 349.80] - PART 349—OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 350 [§ 350.1 - § 350.60] - PART 350—ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 352 [§ 352.1 - § 352.77] - PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]

Part 355 [§ 355.1 - § 355.70] - PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 357 [§ 357.101 - § 357.850] - PART 357—MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 358 [§ 358.101 - § 358.760] - PART 358—MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Part 361 [§ 361.1 - § 361.1] - PART 361—PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH

Part 369 [§ 369.1 - § 369.21] - PART 369—INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE

Part 370-499 - PARTS 370-499 [RESERVED]