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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTM...
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 1—GENERAL ENFORCEMENT REGULATIONS
PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
PART 3—PRODUCT JURISDICTION
PART 4—REGULATION OF COMBINATION PRODUCTS
PART 5—ORGANIZATION
PART 7—ENFORCEMENT POLICY
PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES
PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
PART 12—FORMAL EVIDENTIARY PUBLIC HEARING
PART 13—PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
PART 15—PUBLIC HEARING BEFORE THE COMMISSIONER
PART 16—REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
PART 17—CIVIL MONEY PENALTIES HEARINGS
PART 19—STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
PART 20—PUBLIC INFORMATION
PART 21—PROTECTION OF PRIVACY
PART 25—ENVIRONMENTAL IMPACT CONSIDERATIONS
PART 26—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
PART 50—PROTECTION OF HUMAN SUBJECTS
PART 54—FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
PART 56—INSTITUTIONAL REVIEW BOARDS
PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
PART 60—PATENT TERM RESTORATION
PART 70—COLOR ADDITIVES
PART 71—COLOR ADDITIVE PETITIONS
PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
PART 80—COLOR ADDITIVE CERTIFICATION
PART 81—GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
PART 82—LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
PART 99—DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
PART 100—GENERAL
PART 101—FOOD LABELING
PART 102—COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
PART 104—NUTRITIONAL QUALITY GUIDELINES FOR FOODS
PART 105—FOODS FOR SPECIAL DIETARY USE
PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS
PART 107—INFANT FORMULA
PART 108—EMERGENCY PERMIT CONTROL
PART 109—UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL
PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
PART 112—STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
PART 113—THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
PART 114—ACIDIFIED FOODS
PART 115—SHELL EGGS
PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
PART 118—PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS
PART 119—DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK
PART 120—HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
PART 121—MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION
PART 123—FISH AND FISHERY PRODUCTS
PART 129—PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
PART 130—FOOD STANDARDS: GENERAL
PART 131—MILK AND CREAM
PART 133—CHEESES AND RELATED CHEESE PRODUCTS
PART 135—FROZEN DESSERTS
PART 136—BAKERY PRODUCTS
PART 137—CEREAL FLOURS AND RELATED PRODUCTS
PART 139—MACARONI AND NOODLE PRODUCTS
PART 145—CANNED FRUITS
PART 146—CANNED FRUIT JUICES
PART 150—FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
PART 152—FRUIT PIES
PART 155—CANNED VEGETABLES
PART 156—VEGETABLE JUICES
PART 158—FROZEN VEGETABLES
PART 160—EGGS AND EGG PRODUCTS
PART 161—FISH AND SHELLFISH
PART 163—CACAO PRODUCTS
PART 164—TREE NUT AND PEANUT PRODUCTS
PART 165—BEVERAGES
PART 166—MARGARINE
PART 168—SWEETENERS AND TABLE SIRUPS
PART 169—FOOD DRESSINGS AND FLAVORINGS
PART 170—FOOD ADDITIVES
PART 171—FOOD ADDITIVE PETITIONS
PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
PART 174—INDIRECT FOOD ADDITIVES: GENERAL
PART 175—INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
PART 176—INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
PART 177—INDIRECT FOOD ADDITIVES: POLYMERS
PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
PART 179—IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD
PART 180—FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
PART 181—PRIOR-SANCTIONED FOOD INGREDIENTS
PART 182—SUBSTANCES GENERALLY RECOGNIZED AS SAFE
PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
PART 186—INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
PART 189—SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
PART 190—DIETARY SUPPLEMENTS
PART 200—GENERAL
PART 201—LABELING
PART 202—PRESCRIPTION DRUG ADVERTISING
PART 203—PRESCRIPTION DRUG MARKETING
PART 205—GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS
PART 206—IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE
PART 207—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
PART 208—MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
PART 209—REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT
PART 210—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
PART 212—CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
PART 216—HUMAN DRUG COMPOUNDING
PART 225—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
PART 226—CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
PART 250—SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
PART 290—CONTROLLED DRUGS
PART 299—DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
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
PART 500—GENERAL
PART 501—ANIMAL FOOD LABELING
PART 502—COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS
PART 507—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
PART 509—UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL
PART 510—NEW ANIMAL DRUGS
PART 511—NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
PART 514—NEW ANIMAL DRUG APPLICATIONS
PART 515—MEDICATED FEED MILL LICENSE
PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
PART 528—NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
PART 530—EXTRALABEL DRUG USE IN ANIMALS
PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
PART 570—FOOD ADDITIVES
PART 571—FOOD ADDITIVE PETITIONS
PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS
PART 579—IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD
PART 582—SUBSTANCES GENERALLY RECOGNIZED AS SAFE
PART 584—FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS
PART 589—SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
PART 600—BIOLOGICAL PRODUCTS: GENERAL
PART 601—LICENSING
PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
PART 630—REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
PART 680—ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
PART 700—GENERAL
PART 701—COSMETIC LABELING
PART 710—VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS
PART 720—VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS
PART 740—COSMETIC PRODUCT WARNING STATEMENTS
PART 800—GENERAL
PART 801—LABELING
PART 803—MEDICAL DEVICE REPORTING
PART 806—MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
PART 808—EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
PART 810—MEDICAL DEVICE RECALL AUTHORITY
PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
PART 820—QUALITY SYSTEM REGULATION
PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS
PART 822—POSTMARKET SURVEILLANCE
PART 830—UNIQUE DEVICE IDENTIFICATION
PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES
PART 861—PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
PART 868—ANESTHESIOLOGY DEVICES
PART 870—CARDIOVASCULAR DEVICES
PART 872—DENTAL DEVICES
PART 874—EAR, NOSE, AND THROAT DEVICES
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
PART 882—NEUROLOGICAL DEVICES
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
PART 886—OPHTHALMIC DEVICES
PART 888—ORTHOPEDIC DEVICES
PART 890—PHYSICAL MEDICINE DEVICES
PART 892—RADIOLOGY DEVICES
PART 895—BANNED DEVICES
PART 898—PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
PART 900—MAMMOGRAPHY
PART 1000—GENERAL
PART 1002—RECORDS AND REPORTS
PART 1003—NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
PART 1004—REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS
PART 1005—IMPORTATION OF ELECTRONIC PRODUCTS
PART 1010—PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
PART 1020—PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
PART 1030—PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS
PART 1040—PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
PART 1050—PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
PART 1100—TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY
PART 1105—GENERAL
PART 1107—ESTABLISHMENT REGISTRATION, PRODUCT LISTING, AND SUBSTANTIAL EQUIVALENCE REPORTS
PART 1140—CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO PRODUCTS
PART 1141—CIGARETTE PACKAGE AND ADVERTISING WARNINGS
PART 1143—MINIMUM REQUIRED WARNING STATEMENTS
PART 1150—USER FEES
PART 1210—REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
PART 1240—CONTROL OF COMMUNICABLE DISEASES
PART 1250—INTERSTATE CONVEYANCE SANITATION
PART 1270—HUMAN TISSUE INTENDED FOR TRANSPLANTATION
PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS