Title 21 — Food and Drugs
- Chapter I Food and Drug Administration, Department of Health and Human Services
- Subchapter A General
- Part 1 – General Enforcement Regulations 1 pending
- Part 2 – General Administrative Rulings and Decisions
- Part 3 – Product Jurisdiction
- Part 4 – Regulation of Combination Products
- Part 5 – Organization
- Part 7 – Enforcement Policy
- Part 10 – Administrative Practices and Procedures 2 pending
- 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 50 – Protection of Human Subjects
- Part 54 – Financial Disclosure by Clinical Investigators
- Part 56 – Institutional Review Boards 2 pending
- 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 7 pending
- Part 74 – Listing of Color Additives Subject to Certification 2 pending
- 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
- Subchapter B Food for Human Consumption
- 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 Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications 2 pending
- 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 111 – Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- Part 112 – Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Part 113 – Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
- Part 114 – Acidified Foods
- Part 115 – Shell Eggs
- Part 117 – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
- Part 118 – Production, Storage, and Transportation of Shell Eggs
- Part 119 – Dietary Supplements That Present a Significant or Unreasonable Risk
- Part 120 – Hazard Analysis and Critical Control Point (HACCP) Systems
- Part 121 – Mitigation Strategies to Protect Food Against Intentional Adulteration
- Part 123 – Fish and Fishery Products
- Part 129 – Processing and Bottling of Bottled Drinking Water
- Part 130 – Food Standards: General 1 pending
- Part 131 – Milk and Cream 1 pending
- Part 133 – Cheeses and Related Cheese Products 1 pending
- Part 135 – Frozen Desserts
- Part 136 – Bakery Products 1 pending
- Part 137 – Cereal Flours and Related Products 1 pending
- Part 139 – Macaroni and Noodle Products 1 pending
- Part 145 – Canned Fruits 1 pending
- Part 146 – Canned Fruit Juices
- Part 150 – Fruit Butters, Jellies, Preserves, and Related Products 1 pending
- Part 155 – Canned Vegetables 1 pending
- Part 156 – Vegetable Juices 1 pending
- Part 158 – Frozen Vegetables 1 pending
- Part 160 – Eggs and Egg Products
- Part 161 – Fish and Shellfish 1 pending
- Part 163 – Cacao Products 1 pending
- Part 164 – Tree Nut and Peanut Products
- Part 165 – Beverages
- Part 166 – Margarine 1 pending
- Part 168 – Sweeteners and Table Sirups 1 pending
- Part 169 – Food Dressings and Flavorings 1 pending
- Part 170 – Food Additives 1 pending
- Part 171 – Food Additive Petitions
- Part 172 – Food Additives Permitted for Direct Addition to Food for Human Consumption 2 pending
- Part 173 – Secondary Direct Food Additives Permitted in Food for Human Consumption 1 pending
- 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 1 pending
- 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
- Subchapter C Drugs: General
- Part 200 – General
- Part 201 – Labeling 3 pending
- 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 – 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 2 pending
- Part 208 – Medication Guides for Prescription Drug Products
- Part 209 – Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement
- Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
- Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- Part 212 – Current Good Manufacturing Practice for Positron Emission Tomography Drugs
- Part 213 – Current Good Manufacturing Practice for Medical Gases
- Part 216 – Human Drug Compounding
- Part 225 – Current Good Manufacturing Practice for Medicated Feeds
- Part 226 – Current Good Manufacturing Practice for Type a Medicated Articles
- Part 230 – Certification and Postmarketing Reporting for Designated Medical Gases
- Part 250 – Special Requirements for Specific Human Drugs
- Part 251 – Section 804 Importation Program 2 pending
- Part 290 – Controlled Drugs
- Part 299 – Drugs; Official Names and Established Names
- Subchapter D Drugs for Human Use
- Part 300 – General
- Part 310 – New Drugs 2 pending
- Part 312 – Investigational New Drug Application 4 pending
- Part 314 – Applications for FDA Approval to Market a New Drug 4 pending
- Part 315 – Diagnostic Radiopharmaceuticals 2 pending
- Part 316 – Orphan Drugs
- Part 317 – Qualifying Pathogens
- Part 320 – Bioavailability and Bioequivalence Requirements
- Part 328 – Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol
- Part 329 – Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act 2 pending
- 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 335 – Antidiarrheal 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 350 – Antiperspirant Drug Products for Over-the-Counter Human Use
- Part 352 – Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]
- 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 2 pending
- Part 369 – Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale
- Subchapter E Animal Drugs, Feeds, and Related Products
- Part 500 – General
- Part 501 – Animal Food Labeling
- Part 502 – Common or Usual Names for Nonstandardized Animal Foods
- Part 507 – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
- 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 516 – New Animal Drugs for Minor Use and Minor Species
- Part 520 – Oral Dosage Form New Animal Drugs
- Part 522 – Implantation or Injectable Dosage Form New Animal Drugs
- Part 524 – Ophthalmic and Topical Dosage Form New Animal Drugs
- Part 526 – Intramammary Dosage Form New Animal Drugs
- Part 528 – Intentional Genomic Alterations in Animals
- Part 529 – Certain Other Dosage Form New Animal Drugs
- Part 530 – Extralabel Drug Use in Animals
- 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 1 pending
- Part 571 – Food Additive Petitions
- Part 573 – Food Additives Permitted in Feed and Drinking Water of Animals 5 pending
- 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
- Subchapter F Biologics
- Part 600 – Biological Products: General 2 pending
- Part 601 – Licensing 2 pending
- 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 and Licensed Devices
- Part 610 – General Biological Products Standards
- Part 630 – Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
- 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
- Subchapter G Cosmetics
- Subchapter H Medical Devices
- Part 800 – General
- Part 801 – Labeling
- Part 803 – Medical Device Reporting 2 pending
- Part 806 – Medical Devices; Reports of Corrections and Removals
- Part 807 – Establishment Registration and Device Listing for Manufacturers and Initial Importers 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 Management System Regulation
- Part 821 – Medical Device Tracking Requirements
- Part 822 – Postmarket Surveillance
- Part 830 – Unique Device Identification
- Part 860 – Medical Device Classification Procedures
- Part 861 – Procedures for Performance Standards Development
- Part 862 – Clinical Chemistry and Clinical Toxicology Devices 2 pending
- Part 864 – Hematology and Pathology Devices
- Part 866 – Immunology and Microbiology Devices 4 pending
- Part 868 – Anesthesiology Devices
- Part 870 – Cardiovascular Devices 3 pending
- Part 872 – Dental Devices
- Part 874 – Ear, Nose, and Throat Devices
- Part 876 – Gastroenterology-Urology Devices 2 pending
- Part 878 – General and Plastic Surgery Devices 2 pending
- Part 880 – General Hospital and Personal Use Devices
- Part 882 – Neurological Devices 2 pending
- Part 884 – Obstetrical and Gynecological Devices
- Part 886 – Ophthalmic Devices
- Part 888 – Orthopedic Devices
- Part 890 – Physical Medicine Devices
- Part 892 – Radiology Devices 3 pending
- Part 895 – Banned Devices
- Part 898 – Performance Standard for Electrode Lead Wires and Patient Cables
- Subchapter I Mammography Quality Standards Act
- Subchapter J Radiological Health
- 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
- Subchapter K Tobacco Products
- Part 1100 – General
- Part 1105 – General
- Part 1107 – Exemption Requests and Substantial Equivalence Reports
- Part 1114 – Premarket Tobacco Product Applications 2 pending
- Part 1140 – Cigarettes, Smokeless Tobacco, and Covered Tobacco Products
- Part 1141 – Required Warnings for Cigarette Packages and Advertisements
- Part 1143 – Minimum Required Warning Statements
- Part 1150 – User Fees
- Subchapter L Regulations Under Certain Other Acts Administered by the Food and Drug Administration
- Subchapter A General
- Chapter II Drug Enforcement Administration, Department of Justice
- Part 1300 – Definitions
- Part 1301 – Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances 2 pending
- Part 1302 – Labeling and Packaging Requirements for Controlled Substances
- Part 1303 – Quotas 1 pending
- Part 1304 – Records and Reports of Registrants
- Part 1305 – Orders for Schedule I and II Controlled Substances
- Part 1306 – Prescriptions
- Part 1307 – Miscellaneous
- Part 1308 – Schedules of Controlled Substances 15 pending
- Part 1309 – Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals
- Part 1310 – Records and Reports of Listed Chemicals and Certain Machines; Importation and Exportation of Certain Machines 2 pending
- Part 1311 – Requirements for Electronic Orders and Prescriptions
- Part 1312 – Importation and Exportation of Controlled Substances 1 pending
- Part 1313 – Importation and Exportation of List I and List II Chemicals
- Part 1314 – Retail Sale of Scheduled Listed Chemical Products
- Part 1315 – Importation and Production Quotas for Ephedrine, Pseudoephedrine, and Phenylpropanolamine 1 pending
- Part 1316 – Administrative Functions, Practices, and Procedures
- Part 1317 – Disposal
- Part 1318 – Controls to Satisfy the Requirements of the Act Applicable to the Manufacturing of Marihuana
- Part 1321 – DEA Mailing Addresses
- Chapter III Office of National Drug Control Policy