e-CFR data is current as of April 9, 2021
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES 
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SUBCHAPTER A—GENERAL
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| GENERAL ENFORCEMENT REGULATIONS
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| GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
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| REGULATION OF COMBINATION PRODUCTS
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| ADMINISTRATIVE PRACTICES AND PROCEDURES
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| ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
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| FORMAL EVIDENTIARY PUBLIC HEARING
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| PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
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| PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
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| PUBLIC HEARING BEFORE THE COMMISSIONER
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| REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
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| CIVIL MONEY PENALTIES HEARINGS
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| STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
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| ENVIRONMENTAL IMPACT CONSIDERATIONS
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| MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
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| PROTECTION OF HUMAN SUBJECTS
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| FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
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| INSTITUTIONAL REVIEW BOARDS
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| GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
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| LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
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| LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
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| COLOR ADDITIVE CERTIFICATION
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| GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
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| LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
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| DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
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SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
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| COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
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| NUTRITIONAL QUALITY GUIDELINES FOR FOODS
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| FOODS FOR SPECIAL DIETARY USE
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| INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS
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| UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL
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| CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
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| CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
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| STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
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| THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
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| CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
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| PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS
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| DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK
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| HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
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| MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION
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| FISH AND FISHERY PRODUCTS
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| PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
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| CHEESES AND RELATED CHEESE PRODUCTS
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| CEREAL FLOURS AND RELATED PRODUCTS
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| MACARONI AND NOODLE PRODUCTS
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| FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
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| TREE NUT AND PEANUT PRODUCTS
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| SWEETENERS AND TABLE SIRUPS
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| FOOD DRESSINGS AND FLAVORINGS
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| FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
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| SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
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| INDIRECT FOOD ADDITIVES: GENERAL
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| INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
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| INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
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| INDIRECT FOOD ADDITIVES: POLYMERS
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| INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
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| IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD
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| FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
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| PRIOR-SANCTIONED FOOD INGREDIENTS
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| SUBSTANCES GENERALLY RECOGNIZED AS SAFE
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| DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
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| INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
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| SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
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SUBCHAPTER C—DRUGS: GENERAL
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| PRESCRIPTION DRUG ADVERTISING
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| PRESCRIPTION DRUG MARKETING
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| GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS
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| IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE
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| REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, AND THE NATIONAL DRUG CODE
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| MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
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| REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT
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| CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
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| CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
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| CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
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| CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
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| CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
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| SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
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| SECTION 804 IMPORTATION PROGRAM
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| DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
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SUBCHAPTER D—DRUGS FOR HUMAN USE
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| INVESTIGATIONAL NEW DRUG APPLICATION
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| APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
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| DIAGNOSTIC RADIOPHARMACEUTICALS
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| BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
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| OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
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| NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
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| OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
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| ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
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| ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
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| ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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| PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
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| INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
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SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
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| COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS
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| CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
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| UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL
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| NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
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| NEW ANIMAL DRUG APPLICATIONS
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| MEDICATED FEED MILL LICENSE
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| NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
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| ORAL DOSAGE FORM NEW ANIMAL DRUGS
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| IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
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| OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
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| INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
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| NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS
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| CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
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| EXTRALABEL DRUG USE IN ANIMALS
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| TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
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| NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
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| FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS
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| IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD
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| SUBSTANCES GENERALLY RECOGNIZED AS SAFE
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| FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS
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| SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
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SUBCHAPTER F—BIOLOGICS
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| BIOLOGICAL PRODUCTS: GENERAL
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| CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
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| ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES
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| GENERAL BIOLOGICAL PRODUCTS STANDARDS
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| REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE
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| ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
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| ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
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| ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
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SUBCHAPTER G—COSMETICS
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| VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS
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| VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS
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| COSMETIC PRODUCT WARNING STATEMENTS
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SUBCHAPTER H—MEDICAL DEVICES
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| MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
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| ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
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| EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
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| IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
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| MEDICAL DEVICE RECALL AUTHORITY
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| INVESTIGATIONAL DEVICE EXEMPTIONS
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| PREMARKET APPROVAL OF MEDICAL DEVICES
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| QUALITY SYSTEM REGULATION
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| MEDICAL DEVICE TRACKING REQUIREMENTS
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| UNIQUE DEVICE IDENTIFICATION
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| MEDICAL DEVICE CLASSIFICATION PROCEDURES
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| PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
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| CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
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| HEMATOLOGY AND PATHOLOGY DEVICES
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| IMMUNOLOGY AND MICROBIOLOGY DEVICES
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| EAR, NOSE, AND THROAT DEVICES
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| GASTROENTEROLOGY-UROLOGY DEVICES
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| GENERAL AND PLASTIC SURGERY DEVICES
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| GENERAL HOSPITAL AND PERSONAL USE DEVICES
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| OBSTETRICAL AND GYNECOLOGICAL DEVICES
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| PHYSICAL MEDICINE DEVICES
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| PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
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SUBCHAPTER I—MAMMOGRAPHY QUALITY STANDARDS ACT
SUBCHAPTER J—RADIOLOGICAL HEALTH
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| NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
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| REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS
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| IMPORTATION OF ELECTRONIC PRODUCTS
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| PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
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| PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
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| PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS
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| PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
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| PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
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SUBCHAPTER K—TOBACCO PRODUCTS
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| TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY
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| ESTABLISHMENT REGISTRATION, PRODUCT LISTING, AND SUBSTANTIAL EQUIVALENCE REPORTS
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| CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO PRODUCTS
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| CIGARETTE PACKAGE AND ADVERTISING WARNINGS
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| MINIMUM REQUIRED WARNING STATEMENTS
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SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
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| REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
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| REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
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| CONTROL OF COMMUNICABLE DISEASES
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| INTERSTATE CONVEYANCE SANITATION
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| HUMAN TISSUE INTENDED FOR TRANSPLANTATION
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| HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
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