Regulatory Reference
Title 21 CFR Glossary
A searchable reference to every chapter, subchapter, and part of Title 21 of the U.S. Code of Federal Regulations — the FDA's authority over food, drugs, medical devices, biologics, and tobacco products. 275 parts in total.
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eQMS
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Read the definitionChapter I — Food and Drug Administration, Department of Health and Human Services
Subchapter A — General
- Part 1General Enforcement Regulations
- Part 2General Administrative Rulings and Decisions
- Part 3Product Jurisdiction
- Part 4Regulation of Combination Products
- Part 5Organization
- Part 7Enforcement Policy
- Part 10Administrative Practices and Procedures
- Part 11Electronic Records; Electronic Signatures
- Part 12Formal Evidentiary Public Hearing
- Part 13Public Hearing Before a Public Board of Inquiry
- Part 14Public Hearing Before a Public Advisory Committee
- Part 15Public Hearing Before the Commissioner
- Part 16Regulatory Hearing Before the Food and Drug Administration
- Part 17Civil Money Penalties Hearings
- Part 19Standards of Conduct and Conflicts of Interest
- Part 20Public Information
- Part 21Protection of Privacy
- Part 25Environmental Impact Considerations
- Part 50Protection of Human Subjects
- Part 54Financial Disclosure by Clinical Investigators
- Part 56Institutional Review Boards
- Part 58Good Laboratory Practice for Nonclinical Laboratory Studies
- Part 60Patent Term Restoration
- Part 70Color Additives
- Part 71Color Additive Petitions
- Part 73Listing of Color Additives Exempt from Certification
- Part 74Listing of Color Additives Subject to Certification
- Part 80Color Additive Certification
- Part 81General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics
- Part 82Listing of Certified Provisionally Listed Colors and Specifications
- Part 83-98Parts 83-98 [Reserved]
- Part 99Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
Subchapter B — Food for Human Consumption
- Part 100General
- Part 101Food Labeling
- Part 102Common or Usual Name for Nonstandardized Foods
- Part 104Nutritional Quality Guidelines for Foods
- Part 105Foods for Special Dietary Use
- Part 106Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications
- Part 107Infant Formula
- Part 108Emergency Permit Control
- Part 109Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material
- Part 110Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
- Part 111Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- Part 112Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Part 113Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
- Part 114Acidified Foods
- Part 115Shell Eggs
- Part 117Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
- Part 118Production, Storage, and Transportation of Shell Eggs
- Part 119Dietary Supplements That Present a Significant or Unreasonable Risk
- Part 120Hazard Analysis and Critical Control Point (HACCP) Systems
- Part 121Mitigation Strategies to Protect Food Against Intentional Adulteration
- Part 123Fish and Fishery Products
- Part 129Processing and Bottling of Bottled Drinking Water
- Part 130Food Standards: General
- Part 131Milk and Cream
- Part 133Cheeses and Related Cheese Products
- Part 135Frozen Desserts
- Part 136Bakery Products
- Part 137Cereal Flours and Related Products
- Part 139Macaroni and Noodle Products
- Part 145Canned Fruits
- Part 146Canned Fruit Juices
- Part 150Fruit Butters, Jellies, Preserves, and Related Products
- Part 155Canned Vegetables
- Part 156Vegetable Juices
- Part 158Frozen Vegetables
- Part 160Eggs and Egg Products
- Part 161Fish and Shellfish
- Part 163Cacao Products
- Part 164Tree Nut and Peanut Products
- Part 165Beverages
- Part 166Margarine
- Part 168Sweeteners and Table Sirups
- Part 169Food Dressings and Flavorings
- Part 170Food Additives
- Part 171Food Additive Petitions
- Part 172Food Additives Permitted for Direct Addition to Food for Human Consumption
- Part 173Secondary Direct Food Additives Permitted in Food for Human Consumption
- Part 174Indirect Food Additives: General
- Part 175Indirect Food Additives: Adhesives and Components of Coatings
- Part 176Indirect Food Additives: Paper and Paperboard Components
- Part 177Indirect Food Additives: Polymers
- Part 178Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
- Part 179Irradiation in the Production, Processing and Handling of Food
- Part 180Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study
- Part 181Prior-Sanctioned Food Ingredients
- Part 182Substances Generally Recognized as Safe
- Part 184Direct Food Substances Affirmed as Generally Recognized as Safe
- Part 186Indirect Food Substances Affirmed as Generally Recognized as Safe
- Part 189Substances Prohibited from Use in Human Food
- Part 190Dietary Supplements
- Part 191-199Parts 191-199 [Reserved]
Subchapter C — Drugs: General
- Part 200General
- Part 201Labeling
- Part 202Prescription Drug Advertising
- Part 203Prescription Drug Marketing
- Part 205Guidelines for State Licensing of Wholesale Prescription Drug Distributors
- Part 206Imprinting of Solid Oral Dosage Form Drug Products for Human Use
- Part 207Requirements 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 208Medication Guides for Prescription Drug Products
- Part 209Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement
- Part 210Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
- Part 211Current Good Manufacturing Practice for Finished Pharmaceuticals
- Part 212Current Good Manufacturing Practice for Positron Emission Tomography Drugs
- Part 213Current Good Manufacturing Practice for Medical Gases
- Part 216Human Drug Compounding
- Part 225Current Good Manufacturing Practice for Medicated Feeds
- Part 226Current Good Manufacturing Practice for Type a Medicated Articles
- Part 230Certification and Postmarketing Reporting for Designated Medical Gases
- Part 250Special Requirements for Specific Human Drugs
- Part 251Section 804 Importation Program
- Part 290Controlled Drugs
- Part 299Drugs; Official Names and Established Names
Subchapter D — Drugs for Human Use
- Part 300General
- Part 310New Drugs
- Part 312Investigational New Drug Application
- Part 314Applications for FDA Approval to Market a New Drug
- Part 315Diagnostic Radiopharmaceuticals
- Part 316Orphan Drugs
- Part 317Qualifying Pathogens
- Part 320Bioavailability and Bioequivalence Requirements
- Part 328Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol
- Part 329Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act
- Part 330Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
- Part 331Antacid Products for Over-the-Counter (OTC) Human Use
- Part 332Antiflatulent Products for Over-the-Counter Human Use
- Part 333Topical Antimicrobial Drug Products for Over-the-Counter Human Use
- Part 335Antidiarrheal Drug Products for Over-the-Counter Human Use
- Part 336Antiemetic Drug Products for Over-the-Counter Human Use
- Part 338Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use
- Part 340Stimulant Drug Products for Over-the-Counter Human Use
- Part 341Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
- Part 343Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use
- Part 344Topical Otic Drug Products for Over-the-Counter Human Use
- Part 346Anorectal Drug Products for Over-the-Counter Human Use
- Part 347Skin Protectant Drug Products for Over-the-Counter Human Use
- Part 348External Analgesic Drug Products for Over-the-Counter Human Use
- Part 349Ophthalmic Drug Products for Over-the-Counter Human Use
- Part 350Antiperspirant Drug Products for Over-the-Counter Human Use
- Part 352Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]
- Part 355Anticaries Drug Products for Over-the-Counter Human Use
- Part 357Miscellaneous Internal Drug Products for Over-the-Counter Human Use
- Part 358Miscellaneous External Drug Products for Over-the-Counter Human Use
- Part 361Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research
- Part 369Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale
- Part 370-499Parts 370-499 [Reserved]
Subchapter E — Animal Drugs, Feeds, and Related Products
- Part 500General
- Part 501Animal Food Labeling
- Part 502Common or Usual Names for Nonstandardized Animal Foods
- Part 507Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
- Part 509Unavoidable Contaminants in Animal Food and Food-Packaging Material
- Part 510New Animal Drugs
- Part 511New Animal Drugs for Investigational Use
- Part 514New Animal Drug Applications
- Part 515Medicated Feed Mill License
- Part 516New Animal Drugs for Minor Use and Minor Species
- Part 520Oral Dosage Form New Animal Drugs
- Part 522Implantation or Injectable Dosage Form New Animal Drugs
- Part 524Ophthalmic and Topical Dosage Form New Animal Drugs
- Part 526Intramammary Dosage Form New Animal Drugs
- Part 528Intentional Genomic Alterations in Animals
- Part 529Certain Other Dosage Form New Animal Drugs
- Part 530Extralabel Drug Use in Animals
- Part 556Tolerances for Residues of New Animal Drugs in Food
- Part 558New Animal Drugs for Use in Animal Feeds
- Part 564Part 564 [Reserved]
- Part 570Food Additives
- Part 571Food Additive Petitions
- Part 573Food Additives Permitted in Feed and Drinking Water of Animals
- Part 579Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food
- Part 582Substances Generally Recognized as Safe
- Part 584Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of Animals
- Part 589Substances Prohibited from Use in Animal Food or Feed
- Part 590-599Parts 590-599 [Reserved]
Subchapter F — Biologics
- Part 600Biological Products: General
- Part 601Licensing
- Part 606Current Good Manufacturing Practice for Blood and Blood Components
- Part 607Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
- Part 610General Biological Products Standards
- Part 630Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
- Part 640Additional Standards for Human Blood and Blood Products
- Part 660Additional Standards for Diagnostic Substances for Laboratory Tests
- Part 680Additional Standards for Miscellaneous Products
Subchapter G — Cosmetics
Subchapter H — Medical Devices
- Part 800General
- Part 801Labeling
- Part 803Medical Device Reporting
- Part 806Medical Devices; Reports of Corrections and Removals
- Part 807Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
- Part 808Exemptions from Federal Preemption of State and Local Medical Device Requirements
- Part 809In Vitro Diagnostic Products for Human Use
- Part 810Medical Device Recall Authority
- Part 812Investigational Device Exemptions
- Part 813Part 813 [Reserved]
- Part 814Premarket Approval of Medical Devices
- Part 820Quality Management System Regulation
- Part 821Medical Device Tracking Requirements
- Part 822Postmarket Surveillance
- Part 830Unique Device Identification
- Part 860Medical Device Classification Procedures
- Part 861Procedures for Performance Standards Development
- Part 862Clinical Chemistry and Clinical Toxicology Devices
- Part 864Hematology and Pathology Devices
- Part 866Immunology and Microbiology Devices
- Part 868Anesthesiology Devices
- Part 870Cardiovascular Devices
- Part 872Dental Devices
- Part 874Ear, Nose, and Throat Devices
- Part 876Gastroenterology-Urology Devices
- Part 878General and Plastic Surgery Devices
- Part 880General Hospital and Personal Use Devices
- Part 882Neurological Devices
- Part 884Obstetrical and Gynecological Devices
- Part 886Ophthalmic Devices
- Part 888Orthopedic Devices
- Part 890Physical Medicine Devices
- Part 892Radiology Devices
- Part 895Banned Devices
- Part 898Performance Standard for Electrode Lead Wires and Patient Cables
Subchapter I — Mammography Quality Standards Act
Subchapter J — Radiological Health
- Part 1000General
- Part 1002Records and Reports
- Part 1003Notification of Defects or Failure to Comply
- Part 1004Repurchase, Repairs, or Replacement of Electronic Products
- Part 1005Importation of Electronic Products
- Part 1010Performance Standards for Electronic Products: General
- Part 1020Performance Standards for Ionizing Radiation Emitting Products
- Part 1030Performance Standards for Microwave and Radio Frequency Emitting Products
- Part 1040Performance Standards for Light-Emitting Products
Subchapter K — Tobacco Products
- Part 1100General
- Part 1105General
- Part 1107Exemption Requests and Substantial Equivalence Reports
- Part 1114Premarket Tobacco Product Applications
- Part 1140Cigarettes, Smokeless Tobacco, and Covered Tobacco Products
- Part 1141Required Warnings for Cigarette Packages and Advertisements
- Part 1143Minimum Required Warning Statements
- Part 1150User Fees
Subchapter L — Regulations Under Certain Other Acts Administered by the Food and Drug Administration
- Part 1210Regulations Under the Federal Import Milk Act
- Part 1230Regulations Under the Federal Caustic Poison Act
- Part 1240Control of Communicable Diseases
- Part 1250Interstate Conveyance Sanitation
- Part 1251-1270Parts 1251-1270 [Reserved]
- Part 1271Human Cells, Tissues, and Cellular and Tissue-Based Products
- Part 1272-1299Parts 1272-1299 [Reserved]
Chapter II — Drug Enforcement Administration, Department of Justice
Parts
- Part 1300Definitions
- Part 1301Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
- Part 1302Labeling and Packaging Requirements for Controlled Substances
- Part 1303Quotas
- Part 1304Records and Reports of Registrants
- Part 1305Orders for Schedule I and II Controlled Substances
- Part 1306Prescriptions
- Part 1307Miscellaneous
- Part 1308Schedules of Controlled Substances
- Part 1309Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals
- Part 1310Records and Reports of Listed Chemicals and Certain Machines; Importation and Exportation of Certain Machines
- Part 1311Requirements for Electronic Orders and Prescriptions
- Part 1312Importation and Exportation of Controlled Substances
- Part 1313Importation and Exportation of List I and List II Chemicals
- Part 1314Retail Sale of Scheduled Listed Chemical Products
- Part 1315Importation and Production Quotas for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
- Part 1316Administrative Functions, Practices, and Procedures
- Part 1317Disposal
- Part 1318Controls to Satisfy the Requirements of the Act Applicable to the Manufacturing of Marihuana
- Part 1321DEA Mailing Addresses
- Part 1322-1399Parts 1322-1399 [Reserved]