TITLE 21 OF THE CFR

Food and Drugs

275 parts8,416 sections

Regulation text is not stored here. Each part opens the official electronic edition, which is kept current by the government.

Food and Drug Administration, Department of Health and Human Services

21 CFR part 1 — General Enforcement Regulations 251 sections
21 CFR part 2 — General Administrative Rulings and Decisions 7 sections
21 CFR part 3 — Product Jurisdiction 10 sections
21 CFR part 4 — Regulation of Combination Products 10 sections
21 CFR part 5 — Organization 1 sections
21 CFR part 7 — Enforcement Policy 17 sections
21 CFR part 10 — Administrative Practices and Procedures 31 sections
21 CFR part 11 — Electronic Records; Electronic Signatures 10 sections
21 CFR part 12 — Formal Evidentiary Public Hearing 45 sections
21 CFR part 13 — Public Hearing Before a Public Board of Inquiry 10 sections
21 CFR part 14 — Public Hearing Before a Public Advisory Committee 43 sections
21 CFR part 15 — Public Hearing Before the Commissioner 7 sections
21 CFR part 16 — Regulatory Hearing Before the Food and Drug Administration 15 sections
21 CFR part 17 — Civil Money Penalties Hearings 34 sections
21 CFR part 19 — Standards of Conduct and Conflicts of Interest 7 sections
21 CFR part 20 — Public Information 75 sections
21 CFR part 21 — Protection of Privacy 29 sections
21 CFR part 25 — Environmental Impact Considerations 24 sections
21 CFR part 50 — Protection of Human Subjects 15 sections
21 CFR part 54 — Financial Disclosure by Clinical Investigators 6 sections
21 CFR part 56 — Institutional Review Boards 20 sections
21 CFR part 58 — Good Laboratory Practice for Nonclinical Laboratory Studies 36 sections
21 CFR part 60 — Patent Term Restoration 17 sections
21 CFR part 70 — Color Additives 13 sections
21 CFR part 71 — Color Additive Petitions 13 sections
21 CFR part 73 — Listing of Color Additives Exempt from Certification 129 sections
21 CFR part 74 — Listing of Color Additives Subject to Certification 89 sections
21 CFR part 80 — Color Additive Certification 10 sections
21 CFR part 81 — General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics 3 sections
21 CFR part 82 — Listing of Certified Provisionally Listed Colors and Specifications 39 sections
21 CFR part 83-98 — Parts 83-98 [Reserved] Reserved
21 CFR part 99 — Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices 15 sections
21 CFR part 100 — General 4 sections
21 CFR part 101 — Food Labeling 50 sections
21 CFR part 102 — Common or Usual Name for Nonstandardized Foods 18 sections
21 CFR part 104 — Nutritional Quality Guidelines for Foods 3 sections
21 CFR part 105 — Foods for Special Dietary Use 4 sections
21 CFR part 106 — Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications 27 sections
21 CFR part 107 — Infant Formula 16 sections
21 CFR part 108 — Emergency Permit Control 9 sections
21 CFR part 109 — Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material 7 sections
21 CFR part 110 — Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food 11 sections
21 CFR part 111 — Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements 84 sections
21 CFR part 112 — Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption 102 sections
21 CFR part 113 — Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers 10 sections
21 CFR part 114 — Acidified Foods 8 sections
21 CFR part 115 — Shell Eggs 1 sections
21 CFR part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 61 sections
21 CFR part 118 — Production, Storage, and Transportation of Shell Eggs 11 sections
21 CFR part 119 — Dietary Supplements That Present a Significant or Unreasonable Risk 1 sections
21 CFR part 120 — Hazard Analysis and Critical Control Point (HACCP) Systems 15 sections
21 CFR part 121 — Mitigation Strategies to Protect Food Against Intentional Adulteration 20 sections
21 CFR part 123 — Fish and Fishery Products 13 sections
21 CFR part 129 — Processing and Bottling of Bottled Drinking Water 7 sections
21 CFR part 130 — Food Standards: General 11 sections
21 CFR part 131 — Milk and Cream 20 sections
21 CFR part 133 — Cheeses and Related Cheese Products 75 sections
21 CFR part 135 — Frozen Desserts 6 sections
21 CFR part 136 — Bakery Products 6 sections
21 CFR part 137 — Cereal Flours and Related Products 29 sections
21 CFR part 139 — Macaroni and Noodle Products 15 sections
21 CFR part 145 — Canned Fruits 13 sections
21 CFR part 146 — Canned Fruit Juices 20 sections
21 CFR part 150 — Fruit Butters, Jellies, Preserves, and Related Products 3 sections
21 CFR part 155 — Canned Vegetables 9 sections
21 CFR part 156 — Vegetable Juices 2 sections
21 CFR part 158 — Frozen Vegetables 2 sections
21 CFR part 160 — Eggs and Egg Products 10 sections
21 CFR part 161 — Fish and Shellfish 9 sections
21 CFR part 163 — Cacao Products 16 sections
21 CFR part 164 — Tree Nut and Peanut Products 3 sections
21 CFR part 165 — Beverages 2 sections
21 CFR part 166 — Margarine 2 sections
21 CFR part 168 — Sweeteners and Table Sirups 9 sections
21 CFR part 169 — Food Dressings and Flavorings 11 sections
21 CFR part 170 — Food Additives 41 sections
21 CFR part 171 — Food Additive Petitions 8 sections
21 CFR part 172 — Food Additives Permitted for Direct Addition to Food for Human Consumption 153 sections
21 CFR part 173 — Secondary Direct Food Additives Permitted in Food for Human Consumption 57 sections
21 CFR part 174 — Indirect Food Additives: General 2 sections
21 CFR part 175 — Indirect Food Additives: Adhesives and Components of Coatings 14 sections
21 CFR part 176 — Indirect Food Additives: Paper and Paperboard Components 15 sections
21 CFR part 177 — Indirect Food Additives: Polymers 88 sections
21 CFR part 178 — Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers 47 sections
21 CFR part 179 — Irradiation in the Production, Processing and Handling of Food 8 sections
21 CFR part 180 — Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study 4 sections
21 CFR part 181 — Prior-Sanctioned Food Ingredients 14 sections
21 CFR part 182 — Substances Generally Recognized as Safe 85 sections
21 CFR part 184 — Direct Food Substances Affirmed as Generally Recognized as Safe 215 sections
21 CFR part 186 — Indirect Food Substances Affirmed as Generally Recognized as Safe 16 sections
21 CFR part 189 — Substances Prohibited from Use in Human Food 21 sections
21 CFR part 190 — Dietary Supplements 1 sections
21 CFR part 191-199 — Parts 191-199 [Reserved] Reserved
21 CFR part 200 — General 8 sections
21 CFR part 201 — Labeling 75 sections
21 CFR part 202 — Prescription Drug Advertising 1 sections
21 CFR part 203 — Prescription Drug Marketing 22 sections
21 CFR part 205 — Guidelines for State Licensing of Wholesale Prescription Drug Distributors 9 sections
21 CFR part 206 — Imprinting of Solid Oral Dosage Form Drug Products for Human Use 4 sections
21 CFR 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 24 sections
21 CFR part 208 — Medication Guides for Prescription Drug Products 5 sections
21 CFR part 209 — Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement 4 sections
21 CFR part 210 — Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General 3 sections
21 CFR part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals 60 sections
21 CFR part 212 — Current Good Manufacturing Practice for Positron Emission Tomography Drugs 16 sections
21 CFR part 213 — Current Good Manufacturing Practice for Medical Gases 36 sections
21 CFR part 216 — Human Drug Compounding 2 sections
21 CFR part 225 — Current Good Manufacturing Practice for Medicated Feeds 20 sections
21 CFR part 226 — Current Good Manufacturing Practice for Type a Medicated Articles 11 sections
21 CFR part 230 — Certification and Postmarketing Reporting for Designated Medical Gases 15 sections
21 CFR part 250 — Special Requirements for Specific Human Drugs 11 sections
21 CFR part 251 — Section 804 Importation Program 21 sections
21 CFR part 290 — Controlled Drugs 5 sections
21 CFR part 299 — Drugs; Official Names and Established Names 3 sections
21 CFR part 300 — General 3 sections
21 CFR part 310 — New Drugs 37 sections
21 CFR part 312 — Investigational New Drug Application 60 sections
21 CFR part 314 — Applications for FDA Approval to Market a New Drug 69 sections
21 CFR part 315 — Diagnostic Radiopharmaceuticals 6 sections
21 CFR part 316 — Orphan Drugs 24 sections
21 CFR part 317 — Qualifying Pathogens 2 sections
21 CFR part 320 — Bioavailability and Bioequivalence Requirements 19 sections
21 CFR part 328 — Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol 4 sections
21 CFR part 329 — Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act 1 sections
21 CFR part 330 — Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded 10 sections
21 CFR part 331 — Antacid Products for Over-the-Counter (OTC) Human Use 8 sections
21 CFR part 332 — Antiflatulent Products for Over-the-Counter Human Use 6 sections
21 CFR part 333 — Topical Antimicrobial Drug Products for Over-the-Counter Human Use 16 sections
21 CFR part 335 — Antidiarrheal Drug Products for Over-the-Counter Human Use 4 sections
21 CFR part 336 — Antiemetic Drug Products for Over-the-Counter Human Use 5 sections
21 CFR part 338 — Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use 4 sections
21 CFR part 340 — Stimulant Drug Products for Over-the-Counter Human Use 4 sections
21 CFR part 341 — Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use 16 sections
21 CFR part 343 — Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use 10 sections
21 CFR part 344 — Topical Otic Drug Products for Over-the-Counter Human Use 6 sections
21 CFR part 346 — Anorectal Drug Products for Over-the-Counter Human Use 11 sections
21 CFR part 347 — Skin Protectant Drug Products for Over-the-Counter Human Use 8 sections
21 CFR part 348 — External Analgesic Drug Products for Over-the-Counter Human Use 4 sections
21 CFR part 349 — Ophthalmic Drug Products for Over-the-Counter Human Use 18 sections
21 CFR part 350 — Antiperspirant Drug Products for Over-the-Counter Human Use 5 sections
21 CFR part 352 — Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely] 13 sections
21 CFR part 355 — Anticaries Drug Products for Over-the-Counter Human Use 8 sections
21 CFR part 357 — Miscellaneous Internal Drug Products for Over-the-Counter Human Use 15 sections
21 CFR part 358 — Miscellaneous External Drug Products for Over-the-Counter Human Use 22 sections
21 CFR part 361 — Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research 1 sections
21 CFR part 369 — Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale 11 sections
21 CFR part 370-499 — Parts 370-499 [Reserved] Reserved
21 CFR part 500 — General 22 sections
21 CFR part 501 — Animal Food Labeling 14 sections
21 CFR part 502 — Common or Usual Names for Nonstandardized Animal Foods 2 sections
21 CFR part 507 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals 57 sections
21 CFR part 509 — Unavoidable Contaminants in Animal Food and Food-Packaging Material 7 sections
21 CFR part 510 — New Animal Drugs 24 sections
21 CFR part 511 — New Animal Drugs for Investigational Use 2 sections
21 CFR part 514 — New Animal Drug Applications 25 sections
21 CFR part 515 — Medicated Feed Mill License 12 sections
21 CFR part 516 — New Animal Drugs for Minor Use and Minor Species 59 sections
21 CFR part 520 — Oral Dosage Form New Animal Drugs 320 sections
21 CFR part 522 — Implantation or Injectable Dosage Form New Animal Drugs 190 sections
21 CFR part 524 — Ophthalmic and Topical Dosage Form New Animal Drugs 91 sections
21 CFR part 526 — Intramammary Dosage Form New Animal Drugs 13 sections
21 CFR part 528 — Intentional Genomic Alterations in Animals 5 sections
21 CFR part 529 — Certain Other Dosage Form New Animal Drugs 21 sections
21 CFR part 530 — Extralabel Drug Use in Animals 18 sections
21 CFR part 556 — Tolerances for Residues of New Animal Drugs in Food 106 sections
21 CFR part 558 — New Animal Drugs for Use in Animal Feeds 63 sections
21 CFR part 564 — Part 564 [Reserved] Reserved
21 CFR part 570 — Food Additives 28 sections
21 CFR part 571 — Food Additive Petitions 8 sections
21 CFR part 573 — Food Additives Permitted in Feed and Drinking Water of Animals 70 sections
21 CFR part 579 — Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food 3 sections
21 CFR part 582 — Substances Generally Recognized as Safe 243 sections
21 CFR part 584 — Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of Animals 3 sections
21 CFR part 589 — Substances Prohibited from Use in Animal Food or Feed 5 sections
21 CFR part 590-599 — Parts 590-599 [Reserved] Reserved
21 CFR part 600 — Biological Products: General 15 sections
21 CFR part 601 — Licensing 39 sections
21 CFR part 606 — Current Good Manufacturing Practice for Blood and Blood Components 17 sections
21 CFR part 607 — Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices 16 sections
21 CFR part 610 — General Biological Products Standards 30 sections
21 CFR part 630 — Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use 10 sections
21 CFR part 640 — Additional Standards for Human Blood and Blood Products 61 sections
21 CFR part 660 — Additional Standards for Diagnostic Substances for Laboratory Tests 31 sections
21 CFR part 680 — Additional Standards for Miscellaneous Products 3 sections
21 CFR part 700 — General 12 sections
21 CFR part 701 — Cosmetic Labeling 10 sections
21 CFR part 710 — Voluntary Registration of Cosmetic Product Establishments 9 sections
21 CFR part 720 — Voluntary Filing of Cosmetic Product Ingredient Composition Statements 9 sections
21 CFR part 740 — Cosmetic Product Warning Statements 8 sections
21 CFR part 741-799 — Parts 741-799 [Reserved] Reserved
21 CFR part 800 — General 6 sections
21 CFR part 801 — Labeling 38 sections
21 CFR part 803 — Medical Device Reporting 26 sections
21 CFR part 806 — Medical Devices; Reports of Corrections and Removals 6 sections
21 CFR part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices 24 sections
21 CFR part 808 — Exemptions from Federal Preemption of State and Local Medical Device Requirements 9 sections
21 CFR part 809 — In Vitro Diagnostic Products for Human Use 7 sections
21 CFR part 810 — Medical Device Recall Authority 13 sections
21 CFR part 812 — Investigational Device Exemptions 33 sections
21 CFR part 813 — Part 813 [Reserved] Reserved
21 CFR part 814 — Premarket Approval of Medical Devices 33 sections
21 CFR part 820 — Quality Management System Regulation 9 sections
21 CFR part 821 — Medical Device Tracking Requirements 10 sections
21 CFR part 822 — Postmarket Surveillance 38 sections
21 CFR part 830 — Unique Device Identification 20 sections
21 CFR part 860 — Medical Device Classification Procedures 23 sections
21 CFR part 861 — Procedures for Performance Standards Development 9 sections
21 CFR part 862 — Clinical Chemistry and Clinical Toxicology Devices 263 sections
21 CFR part 864 — Hematology and Pathology Devices 126 sections
21 CFR part 866 — Immunology and Microbiology Devices 261 sections
21 CFR part 868 — Anesthesiology Devices 154 sections
21 CFR part 870 — Cardiovascular Devices 172 sections
21 CFR part 872 — Dental Devices 141 sections
21 CFR part 874 — Ear, Nose, and Throat Devices 71 sections
21 CFR part 876 — Gastroenterology-Urology Devices 108 sections
21 CFR part 878 — General and Plastic Surgery Devices 109 sections
21 CFR part 880 — General Hospital and Personal Use Devices 125 sections
21 CFR part 882 — Neurological Devices 144 sections
21 CFR part 884 — Obstetrical and Gynecological Devices 105 sections
21 CFR part 886 — Ophthalmic Devices 146 sections
21 CFR part 888 — Orthopedic Devices 111 sections
21 CFR part 890 — Physical Medicine Devices 92 sections
21 CFR part 892 — Radiology Devices 95 sections
21 CFR part 895 — Banned Devices 11 sections
21 CFR part 898 — Performance Standard for Electrode Lead Wires and Patient Cables 4 sections
21 CFR part 900 — Mammography 23 sections
21 CFR part 1000 — General 3 sections
21 CFR part 1002 — Records and Reports 17 sections
21 CFR part 1003 — Notification of Defects or Failure to Comply 10 sections
21 CFR part 1004 — Repurchase, Repairs, or Replacement of Electronic Products 5 sections
21 CFR part 1005 — Importation of Electronic Products 11 sections
21 CFR part 1010 — Performance Standards for Electronic Products: General 7 sections
21 CFR part 1020 — Performance Standards for Ionizing Radiation Emitting Products 7 sections
21 CFR part 1030 — Performance Standards for Microwave and Radio Frequency Emitting Products 1 sections
21 CFR part 1040 — Performance Standards for Light-Emitting Products 4 sections
21 CFR part 1100 — General 7 sections
21 CFR part 1105 — General 1 sections
21 CFR part 1107 — Exemption Requests and Substantial Equivalence Reports 19 sections
21 CFR part 1114 — Premarket Tobacco Product Applications 21 sections
21 CFR part 1140 — Cigarettes, Smokeless Tobacco, and Covered Tobacco Products 10 sections
21 CFR part 1141 — Required Warnings for Cigarette Packages and Advertisements 5 sections
21 CFR part 1143 — Minimum Required Warning Statements 7 sections
21 CFR part 1150 — User Fees 9 sections
21 CFR part 1210 — Regulations Under the Federal Import Milk Act 23 sections
21 CFR part 1230 — Regulations Under the Federal Caustic Poison Act 29 sections
21 CFR part 1240 — Control of Communicable Diseases 15 sections
21 CFR part 1250 — Interstate Conveyance Sanitation 48 sections
21 CFR part 1251-1270 — Parts 1251-1270 [Reserved] Reserved
21 CFR part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products 49 sections
21 CFR part 1272-1299 — Parts 1272-1299 [Reserved] Reserved

Drug Enforcement Administration, Department of Justice

21 CFR part 1300 — Definitions 6 sections
21 CFR part 1301 — Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances 49 sections
21 CFR part 1302 — Labeling and Packaging Requirements for Controlled Substances 8 sections
21 CFR part 1303 — Quotas 25 sections
21 CFR part 1304 — Records and Reports of Registrants 21 sections
21 CFR part 1305 — Orders for Schedule I and II Controlled Substances 26 sections
21 CFR part 1306 — Prescriptions 24 sections
21 CFR part 1307 — Miscellaneous 10 sections
21 CFR part 1308 — Schedules of Controlled Substances 28 sections
21 CFR part 1309 — Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals

Office of National Drug Control Policy

21 CFR part 1400 — Part 1400 [Reserved] Reserved
21 CFR part 1401 — Public Availability of Information 24 sections
21 CFR part 1402 — Mandatory Declassification Review 7 sections
21 CFR part 1403-1499 — Parts 1403-1499 [Reserved] Reserved