Federal (United States) · Regulations
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
5,390 sections
220 groups
- Part 1 — GENERAL ENFORCEMENT REGULATIONS251 sections
- Part 3 — PRODUCT JURISDICTION1 section
- Part 4 — REGULATION OF COMBINATION PRODUCTS2 sections
- Part 7 — ENFORCEMENT POLICY2 sections
- Part 10 — ADMINISTRATIVE PRACTICES AND PROCEDURES31 sections
- Part 11 — ELECTRONIC RECORDS; ELECTRONIC SIGNATURES10 sections
- Part 12 — FORMAL EVIDENTIARY PUBLIC HEARING45 sections
- Part 13 — PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY10 sections
- Part 14 — PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE43 sections
- Part 15 — PUBLIC HEARING BEFORE THE COMMISSIONER7 sections
- Part 16 — REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION15 sections
- Part 17 — CIVIL MONEY PENALTIES HEARINGS30 sections
- Part 19 — STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST1 section
- Part 20 — PUBLIC INFORMATION8 sections
- Part 21 — PROTECTION OF PRIVACY1 section
- Part 25 — ENVIRONMENTAL IMPACT CONSIDERATIONS3 sections
- Part 50 — PROTECTION OF HUMAN SUBJECTS1 section
- Part 56 — INSTITUTIONAL REVIEW BOARDS2 sections
- Part 58 — GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES2 sections
- Part 70 — COLOR ADDITIVES1 section
- Part 71 — COLOR ADDITIVE PETITIONS1 section
- Part 73 — LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION15 sections
- Part 74 — LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION8 sections
- Part 80 — COLOR ADDITIVE CERTIFICATION3 sections
- Part 81 — GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS1 section
- Part 82 — LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS4 sections
- Part 99 — DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES1 section
- Part 100 — GENERAL4 sections
- Part 101 — FOOD LABELING54 sections
- Part 102 — COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS17 sections
- Part 104 — NUTRITIONAL QUALITY GUIDELINES FOR FOODS3 sections
- Part 105 — FOODS FOR SPECIAL DIETARY USE4 sections
- Part 106 — INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS27 sections
- Part 107 — INFANT FORMULA16 sections
- Part 108 — EMERGENCY PERMIT CONTROL9 sections
- Part 109 — UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL7 sections
- Part 110 — CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD11 sections
- Part 111 — CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS84 sections
- Part 112 — STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION101 sections
- Part 113 — THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS10 sections
- Part 114 — ACIDIFIED FOODS8 sections
- Part 115 — SHELL EGGS1 section
- Part 117 — CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD61 sections
- Part 118 — PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS11 sections
- Part 119 — DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK1 section
- Part 120 — HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS15 sections
- Part 121 — MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION20 sections
- Part 123 — FISH AND FISHERY PRODUCTS13 sections
- Part 129 — PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER7 sections
- Part 130 — FOOD STANDARDS: GENERAL11 sections
- Part 131 — MILK AND CREAM20 sections
- Part 133 — CHEESES AND RELATED CHEESE PRODUCTS75 sections
- Part 135 — FROZEN DESSERTS6 sections
- Part 136 — BAKERY PRODUCTS6 sections
- Part 137 — CEREAL FLOURS AND RELATED PRODUCTS29 sections
- Part 139 — MACARONI AND NOODLE PRODUCTS15 sections
- Part 145 — CANNED FRUITS13 sections
- Part 146 — CANNED FRUIT JUICES20 sections
- Part 150 — FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS3 sections
- Part 155 — CANNED VEGETABLES9 sections
- Part 156 — VEGETABLE JUICES2 sections
- Part 158 — FROZEN VEGETABLES2 sections
- Part 160 — EGGS AND EGG PRODUCTS10 sections
- Part 161 — FISH AND SHELLFISH9 sections
- Part 163 — CACAO PRODUCTS16 sections
- Part 164 — TREE NUT AND PEANUT PRODUCTS3 sections
- Part 165 — BEVERAGES2 sections
- Part 166 — MARGARINE2 sections
- Part 168 — SWEETENERS AND TABLE SIRUPS9 sections
- Part 169 — FOOD DRESSINGS AND FLAVORINGS11 sections
- Part 170 — FOOD ADDITIVES40 sections
- Part 171 — FOOD ADDITIVE PETITIONS8 sections
- Part 172 — FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION117 sections
- Part 173 — SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION42 sections
- Part 174 — INDIRECT FOOD ADDITIVES: GENERAL2 sections
- Part 175 — INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS14 sections
- Part 176 — INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS13 sections
- Part 177 — INDIRECT FOOD ADDITIVES: POLYMERS87 sections
- Part 178 — INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS32 sections
- Part 180 — FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY1 section
- Part 181 — PRIOR-SANCTIONED FOOD INGREDIENTS1 section
- Part 182 — SUBSTANCES GENERALLY RECOGNIZED AS SAFE5 sections
- Part 184 — DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE28 sections
- Part 189 — SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD1 section
- Part 200 — GENERAL2 sections
- Part 201 — LABELING6 sections
- 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 CODE2 sections
- Part 208 — MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS1 section
- Part 209 — REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT1 section
- Part 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS7 sections
- Part 212 — CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS1 section
- Part 213 — CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES4 sections
- Part 225 — CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS4 sections
- Part 226 — CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES1 section
- Part 230 — CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES1 section
- Part 250 — SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS1 section
- Part 290 — CONTROLLED DRUGS1 section
- Part 310 — NEW DRUGS2 sections
- Part 312 — INVESTIGATIONAL NEW DRUG APPLICATION24 sections
- Part 314 — APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG58 sections
- Part 315 — DIAGNOSTIC RADIOPHARMACEUTICALS6 sections
- Part 316 — ORPHAN DRUGS24 sections
- Part 317 — QUALIFYING PATHOGENS1 section
- Part 320 — BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS19 sections
- Part 328 — OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL4 sections
- Part 329 — NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT1 section
- Part 330 — OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED10 sections
- Part 331 — ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE8 sections
- Part 332 — ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE6 sections
- Part 333 — TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE16 sections
- Part 335 — ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE4 sections
- Part 336 — ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE5 sections
- Part 338 — NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE4 sections
- Part 340 — STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE4 sections
- Part 341 — COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE16 sections
- Part 343 — INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE7 sections
- Part 344 — TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE6 sections
- Part 346 — ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE11 sections
- Part 347 — SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE8 sections
- Part 348 — EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE4 sections
- Part 349 — OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE18 sections
- Part 350 — ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE5 sections
- Part 352 — SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]13 sections
- Part 355 — ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE8 sections
- Part 357 — MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE15 sections
- Part 358 — MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE22 sections
- Part 361 — PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH1 section
- Part 369 — INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE10 sections
- Part 500 — GENERAL22 sections
- Part 501 — ANIMAL FOOD LABELING14 sections
- Part 502 — COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS2 sections
- Part 507 — CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS57 sections
- Part 509 — UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL7 sections
- Part 510 — NEW ANIMAL DRUGS23 sections
- Part 511 — NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE2 sections
- Part 514 — NEW ANIMAL DRUG APPLICATIONS25 sections
- Part 515 — MEDICATED FEED MILL LICENSE12 sections
- Part 516 — NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES56 sections
- Part 520 — ORAL DOSAGE FORM NEW ANIMAL DRUGS264 sections
- Part 522 — IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS175 sections
- Part 524 — OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS77 sections
- Part 526 — INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS13 sections
- Part 528 — INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS4 sections
- Part 529 — CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS18 sections
- Part 530 — EXTRALABEL DRUG USE IN ANIMALS18 sections
- Part 556 — TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD105 sections
- Part 558 — NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS50 sections
- Part 570 — FOOD ADDITIVES28 sections
- Part 571 — FOOD ADDITIVE PETITIONS8 sections
- Part 573 — FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS68 sections
- Part 579 — IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD3 sections
- Part 582 — SUBSTANCES GENERALLY RECOGNIZED AS SAFE239 sections
- Part 584 — FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS2 sections
- Part 589 — SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED5 sections
- Part 600 — BIOLOGICAL PRODUCTS: GENERAL14 sections
- Part 601 — LICENSING39 sections
- Part 606 — CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS17 sections
- Part 607 — ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES16 sections
- Part 610 — GENERAL BIOLOGICAL PRODUCTS STANDARDS28 sections
- Part 630 — REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE10 sections
- Part 640 — ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS61 sections
- Part 660 — ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS31 sections
- Part 680 — ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS3 sections
- Part 700 — GENERAL12 sections
- Part 701 — COSMETIC LABELING10 sections
- Part 710 — VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS9 sections
- Part 720 — VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS8 sections
- Part 740 — COSMETIC PRODUCT WARNING STATEMENTS8 sections
- Part 800 — GENERAL6 sections
- Part 801 — LABELING38 sections
- Part 803 — MEDICAL DEVICE REPORTING26 sections
- Part 806 — MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS6 sections
- Part 807 — ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES24 sections
- Part 808 — EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS7 sections
- Part 809 — IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE7 sections
- Part 810 — MEDICAL DEVICE RECALL AUTHORITY13 sections
- Part 812 — INVESTIGATIONAL DEVICE EXEMPTIONS32 sections
- Part 814 — PREMARKET APPROVAL OF MEDICAL DEVICES33 sections
- Part 820 — QUALITY MANAGEMENT SYSTEM REGULATION6 sections
- Part 821 — MEDICAL DEVICE TRACKING REQUIREMENTS10 sections
- Part 822 — POSTMARKET SURVEILLANCE21 sections
- Part 862 — CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES1 section
- Part 864 — HEMATOLOGY AND PATHOLOGY DEVICES1 section
- Part 870 — CARDIOVASCULAR DEVICES27 sections
- Part 872 — DENTAL DEVICES140 sections
- Part 874 — EAR, NOSE, AND THROAT DEVICES68 sections
- Part 876 — GASTROENTEROLOGY-UROLOGY DEVICES102 sections
- Part 878 — GENERAL AND PLASTIC SURGERY DEVICES105 sections
- Part 880 — GENERAL HOSPITAL AND PERSONAL USE DEVICES119 sections
- Part 882 — NEUROLOGICAL DEVICES140 sections
- Part 884 — OBSTETRICAL AND GYNECOLOGICAL DEVICES104 sections
- Part 886 — OPHTHALMIC DEVICES142 sections
- Part 888 — ORTHOPEDIC DEVICES105 sections
- Part 890 — PHYSICAL MEDICINE DEVICES91 sections
- Part 892 — RADIOLOGY DEVICES91 sections
- Part 895 — BANNED DEVICES11 sections
- Part 898 — PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES4 sections
- Part 900 — MAMMOGRAPHY21 sections
- Part 1000 — GENERAL3 sections
- Part 1002 — RECORDS AND REPORTS16 sections
- Part 1003 — NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY10 sections
- Part 1004 — REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS5 sections
- Part 1005 — IMPORTATION OF ELECTRONIC PRODUCTS11 sections
- Part 1010 — PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL7 sections
- Part 1020 — PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS7 sections
- Part 1030 — PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS1 section
- Part 1040 — PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS4 sections
- Part 1100 — General7 sections
- Part 1105 — GENERAL1 section
- Part 1107 — EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS19 sections
- Part 1114 — PREMARKET TOBACCO PRODUCT APPLICATIONS21 sections
- Part 1140 — CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO PRODUCTS10 sections
- Part 1141 — REQUIRED WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS5 sections
- Part 1143 — MINIMUM REQUIRED WARNING STATEMENTS7 sections
- Part 1150 — USER FEES9 sections
- Part 1210 — REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT23 sections
- Part 1230 — REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT29 sections
- Part 1240 — CONTROL OF COMMUNICABLE DISEASES15 sections
- Part 1250 — INTERSTATE CONVEYANCE SANITATION48 sections
- Part 1271 — HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS49 sections