Title 21 — Food and Drugs
- Part 1— General Enforcement Regulations
- 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
- 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
- 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
- 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
- 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 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
- 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
- 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— 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 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 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 250— Special Requirements for Specific Human Drugs
- Part 251— Section 804 Importation Program
- Part 290— Controlled Drugs
- Part 299— Drugs; Official Names and Established Names
- 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 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
- 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
- Part 369— Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale
- 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
- 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
- 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 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
- 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
- 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 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 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
- 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 1100— General
- Part 1105— General
- Part 1107— Exemption Requests and Substantial Equivalence Reports
- Part 1114— Premarket Tobacco Product Applications
- 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
- 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 1271— Human Cells, Tissues, and Cellular and Tissue-Based Products
- 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— Orders for Schedule I and II Controlled Substances
- 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; Importation and Exportation of Certain Machines
- Part 1311— Requirements for Electronic Orders and Prescriptions
- Part 1312— Importation and Exportation of Controlled Substances
- 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
- 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
- Part 1401— Public Availability of Information
- Part 1402— Mandatory Declassification Review