Code of Federal Regulations Title 21, Volume 5, April 1, 2016 contains regulations governing Food and Drugs and may also be referenced as: - Code of Federal Regulations Title 21, Volume 5, April 1, 2016 - 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 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 - Parts 370-499; Reserved