CHAPTER I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES  


SUBCHAPTER A — GENERAL
Part 71 - COLOR ADDITIVE PETITIONS
Part 74 - LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
Part 4 - REGULATION OF COMBINATION PRODUCTS
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 17 - CIVIL MONEY PENALTIES HEARINGS
Part 1 - GENERAL ENFORCEMENT REGULATIONS
Part 56 - INSTITUTIONAL REVIEW BOARDS
Part 81 - GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING
Part 50 - PROTECTION OF HUMAN SUBJECTS
Part 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
Part 21 - PROTECTION OF PRIVACY
Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
Part 82 - LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Part 5 - ORGANIZATION
Part 3 - PRODUCT JURISDICTION
Part 19 - STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
Part 80 - COLOR ADDITIVE CERTIFICATION
Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
Part 60 - PATENT TERM RESTORATION
Part 70 - COLOR ADDITIVES
Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER
Part 20 - PUBLIC INFORMATION
Part 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
Part 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES
Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
Part 2 - GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
Part 7 - ENFORCEMENT POLICY
Part 83-98 - [Reserved]
SUBCHAPTER B — FOOD FOR HUMAN CONSUMPTION
Part 115 - SHELL EGGS
Part 111 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
Part 129 - PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
Part 169 - FOOD DRESSINGS AND FLAVORINGS
Part 177 - INDIRECT FOOD ADDITIVES: POLYMERS
Part 155 - CANNED VEGETABLES
Part 186 - INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
Part 150 - FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
Part 137 - CEREAL FLOURS AND RELATED PRODUCTS
Part 156 - VEGETABLE JUICES
Part 174 - INDIRECT FOOD ADDITIVES: GENERAL
Part 182 - SUBSTANCES GENERALLY RECOGNIZED AS SAFE
Part 178 - INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
Part 189 - SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
Part 114 - ACIDIFIED FOODS
Part 113 - THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
Part 161 - FISH AND SHELLFISH
Part 136 - BAKERY PRODUCTS
Part 164 - TREE NUT AND PEANUT PRODUCTS
Part 165 - BEVERAGES
Part 131 - MILK AND CREAM
Part 105 - FOODS FOR SPECIAL DIETARY USE
Part 181 - PRIOR-SANCTIONED FOOD INGREDIENTS
Part 110 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
Part 184 - DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
Part 133 - CHEESES AND RELATED CHEESE PRODUCTS
Part 152 - FRUIT PIES
Part 139 - MACARONI AND NOODLE PRODUCTS
Part 106 - INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS
Part 108 - EMERGENCY PERMIT CONTROL
Part 146 - CANNED FRUIT JUICES
Part 145 - CANNED FRUITS
Part 180 - FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
Part 102 - COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
Part 172 - FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
Part 120 - HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
Part 173 - SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
Part 101 - FOOD LABELING
Part 130 - FOOD STANDARDS: GENERAL
Part 158 - FROZEN VEGETABLES
Part 104 - NUTRITIONAL QUALITY GUIDELINES FOR FOODS
Part 135 - FROZEN DESSERTS
Part 118 - PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS
Part 119 - DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK
Part 123 - FISH AND FISHERY PRODUCTS
Part 107 - INFANT FORMULA
Part 171 - FOOD ADDITIVE PETITIONS
Part 190 - DIETARY SUPPLEMENTS
Part 168 - SWEETENERS AND TABLE SIRUPS
Part 163 - CACAO PRODUCTS
Part 175 - INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
Part 176 - INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
Part 100 - GENERAL
Part 160 - EGGS AND EGG PRODUCTS
Part 109 - UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL
Part 170 - FOOD ADDITIVES
Part 179 - IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD
Part 166 - MARGARINE
Part 117 - CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
Part 112 - STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
Part 121 - MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION
Part 191-199 - [Reserved]
SUBCHAPTER C — DRUGS: GENERAL
Part 201 - LABELING
Part 208 - MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
Part 226 - CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
Part 212 - CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
Part 209 - REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT
Part 202 - PRESCRIPTION DRUG ADVERTISING
Part 200 - GENERAL
Part 206 - IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE
Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
Part 216 - HUMAN DRUG COMPOUNDING
Part 205 - GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS
Part 299 - DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
Part 225 - CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
Part 203 - PRESCRIPTION DRUG MARKETING
Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Part 290 - CONTROLLED DRUGS
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 250 - SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
SUBCHAPTER D — DRUGS FOR HUMAN USE
Part 316 - ORPHAN DRUGS
Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Part 346 - ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Part 347 - SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Part 355 - ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Part 300 - GENERAL
Part 348 - EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Part 352 - SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
Part 357 - MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Part 315 - DIAGNOSTIC RADIOPHARMACEUTICALS
Part 340 - STIMULANT 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 331 - ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
Part 336 - ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Part 343 - INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC 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 332 - ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Part 310 - NEW DRUGS
Part 341 - COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION
Part 344 - TOPICAL OTIC DRUG 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 320 - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Part 369 - INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
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 358 - MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Part 338 - NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Part 317 - QUALIFYING PATHOGENS
Part 329 - NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
Part 370-499 - [Reserved]
SUBCHAPTER E — ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
Part 558 - NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Part 528 - NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS
Part 526 - INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
Part 502 - COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS
Part 571 - FOOD ADDITIVE PETITIONS
Part 570 - FOOD ADDITIVES
Part 529 - CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
Part 510 - NEW ANIMAL DRUGS
Part 500 - GENERAL
Part 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS
Part 579 - IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD
Part 524 - OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
Part 511 - NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
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 516 - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
Part 556 - TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
Part 522 - IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
Part 514 - NEW ANIMAL DRUG APPLICATIONS
Part 530 - EXTRALABEL DRUG USE IN ANIMALS
Part 573 - FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS
Part 509 - UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL
Part 582 - SUBSTANCES GENERALLY RECOGNIZED AS SAFE
Part 564 - [Reserved]
Part 515 - MEDICATED FEED MILL LICENSE
Part 501 - ANIMAL FOOD LABELING
Part 507 - CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
Part 590-599 - [Reserved]
SUBCHAPTER F — BIOLOGICS
Part 640 - ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Part 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
Part 600 - BIOLOGICAL PRODUCTS: GENERAL
Part 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
Part 630 - REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE
Part 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS
Part 601 - LICENSING
Part 607 - ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES
Part 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
SUBCHAPTER G — COSMETICS
Part 701 - COSMETIC LABELING
Part 740 - COSMETIC PRODUCT WARNING STATEMENTS
Part 710 - VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS
Part 720 - VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS
Part 700 - GENERAL
Part 741-799 - [Reserved]
SUBCHAPTER H — MEDICAL DEVICES
Part 870 - CARDIOVASCULAR DEVICES
Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
Part 800 - GENERAL
Part 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES
Part 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
Part 890 - PHYSICAL MEDICINE DEVICES
Part 830 - UNIQUE DEVICE IDENTIFICATION
Part 864 - HEMATOLOGY AND PATHOLOGY DEVICES
Part 898 - PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
Part 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
Part 808 - EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
Part 820 - QUALITY SYSTEM REGULATION
Part 874 - EAR, NOSE, AND THROAT DEVICES
Part 806 - MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS
Part 878 - GENERAL AND PLASTIC SURGERY DEVICES
Part 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES
Part 882 - NEUROLOGICAL DEVICES
Part 822 - POSTMARKET SURVEILLANCE
Part 886 - OPHTHALMIC DEVICES
Part 810 - MEDICAL DEVICE RECALL AUTHORITY
Part 813 - [Reserved]
Part 868 - ANESTHESIOLOGY DEVICES
Part 860 - MEDICAL DEVICE CLASSIFICATION PROCEDURES
Part 888 - ORTHOPEDIC DEVICES
Part 895 - BANNED DEVICES
Part 821 - MEDICAL DEVICE TRACKING REQUIREMENTS
Part 803 - MEDICAL DEVICE REPORTING
Part 892 - RADIOLOGY DEVICES
Part 861 - PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
Part 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES
Part 801 - LABELING
Part 872 - DENTAL DEVICES
Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Part 876 - GASTROENTEROLOGY-UROLOGY DEVICES
SUBCHAPTER I — MAMMOGRAPHY QUALITY STANDARDS ACT
Part 900 - MAMMOGRAPHY
SUBCHAPTER J — RADIOLOGICAL HEALTH
Part 1000 - GENERAL
Part 1050 - PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
Part 1005 - IMPORTATION OF ELECTRONIC PRODUCTS
Part 1004 - REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS
Part 1002 - RECORDS AND REPORTS
Part 1020 - PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
Part 1010 - PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
Part 1040 - PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
Part 1003 - NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
Part 1030 - PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS
SUBCHAPTER K — TOBACCO PRODUCTS
Part 1141 - CIGARETTE PACKAGE AND ADVERTISING WARNINGS
Part 1140 - CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO PRODUCTS
Part 1107 - ESTABLISHMENT REGISTRATION, PRODUCT LISTING, AND SUBSTANTIAL EQUIVALENCE REPORTS
Part 1150 - USER FEES
Part 1100 - TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY
Part 1143 - MINIMUM REQUIRED WARNING STATEMENTS
Part 1105 - GENERAL
SUBCHAPTER L — REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
Part 1240 - CONTROL OF COMMUNICABLE DISEASES
Part 1250 - INTERSTATE CONVEYANCE SANITATION
Part 1230 - REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
Part 1210 - REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
Part 1271 - HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Part 1270 - HUMAN TISSUE INTENDED FOR TRANSPLANTATION
Part 1251-1269 - [Reserved]
Part 1272-1299 - [Reserved]