Code of Federal Regulations Title 21, Volume 5, April 1, 2017 contains regulations governing Food and Drugs and may also be referenced as:

- Code of Federal Regulations Title 21, Volume 5, April 1, 2017
- CFR Title 21
- CFR 21, Food and Drugs
- CFR 21, Parts 300 to 499, Food and Drugs

This volume contains Parts 300 to 499:

- 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 ANTIRHEU-MATIC 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
- Parts 370-499; Reserved