Code of Federal Regulations

Betterchem

Health Drug Information DMFs Portal 21CFR Search Site Map

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION,

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Advanced Search - Place exact phrases within quotes! Search the entire 21CFR.

Search the latest revision above.

21CFR… Regulatory Definitions

The text below is from our 2007 archive. Search the current revision using the window above.

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]