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TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION,

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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21CFR… Regulatory Definitions

2007 Revision

The 2008 Revision will be published in April.

PARTS 1 TO 99 (Revised April 1, 2007)

PART 1--GENERAL ENFORCEMENT REGULATIONS

PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

PART 3--PRODUCT JURISDICTION

PART 5--DELEGATIONS OF AUTHORITY AND 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

PARTS 100 TO 169 (Revised April 1, 2007)

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 QUALITY CONTROL PROCEDURES

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 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS

PART 114--ACIDIFIED FOODS

PART 115--SHELL EGGS

PART 119--DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK

PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS

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

PARTS 170 TO 199 (REVISED APRIL 1, 2007)

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

191-199 [RESERVED]

PARTS 200 TO 299 (Revised April 1, 2007)

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--REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION

PART 208--MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS

PART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Also see 211 Subparts with guidance.

PART 216--PHARMACY 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

PARTS 300 TO 499 (Revised April 1, 2007)

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 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

PART 328--OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL

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 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 352--SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

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]

PARTS 500 TO 599 (Revised January 1, 2007)

PART 500--GENERAL

PART 501--ANIMAL FOOD LABELING

PART 502--COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS

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 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS Separate Subparts

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

PART 526--INTRAMAMMARY DOSAGE FORMS

PART 530--EXTRALABEL DRUG USE IN ANIMALS

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

PARTS 600 TO 799 (Revised April 1, 2007)

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

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

PART 630--GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES

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

741-799 --[Reserved]

PARTS 800 TO 1299 (Revised April 1, 2007)

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 DISTRIBUTORS 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 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 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

PARTS 1300 TO 1399 (Revised April 1, 2007)

PART 1300--DEFINITIONS

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES

PART 1302--LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES

PART 1303--QUOTAS

PART 1304--RECORDS AND REPORTS OF REGISTRANTS

PART 1305--ORDER FORMS

PART 1306--PRESCRIPTIONS

PART 1307--MISCELLANEOUS

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS

PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES

PART 1311--[RESERVED]

PART 1312--IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES

PART 1313--IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS

PART 1316--ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES

PARTS 1400 TO 1499 (Revised April 1, 2007)

PART 1401--PUBLIC AVAILABILITY OF INFORMATION

PART 1402--MANDATORY DECLASSIFICATION REVIEW

PART 1403--UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS

PART 1404--GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)

PART 1405--GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)

1406-1499--[Reserved]