Title 21, Chapter I — Chapter I

General Enforcement Regulations

General Administrative Rulings and Decisions

Product Jurisdiction

Regulation of Combination Products

Organization

Enforcement Policy

Administrative Practices and Procedures

Electronic Records; Electronic Signatures

Formal Evidentiary Public Hearing

Public Hearing Before a Public Board of Inquiry

Public Hearing Before a Public Advisory Committee

Public Hearing Before the Commissioner

Regulatory Hearing Before the Food and Drug Administration

Civil Money Penalties Hearings

Standards of Conduct and Conflicts of Interest

Public Information

Protection of Privacy

Environmental Impact Considerations

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

Protection of Human Subjects

Financial Disclosure by Clinical Investigators

Institutional Review Boards

Good Laboratory Practice for Nonclinical Laboratory Studies

Patent Term Restoration

Color Additives

Color Additive Petitions

Listing of Color Additives Exempt From Certification

Listing of Color Additives Subject to Certification

Color Additive Certification

General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics

Listing of Certified Provisionally Listed Colors and Specifications

Dissemination of Information on Unapproved/new Uses for Marketed Drugs, Biologics, and Devices

General

Food Labeling

Common or Usual Name for Nonstandardized Foods

Nutritional Quality Guidelines for Foods

Foods for Special Dietary Use

Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications

Infant Formula

Emergency Permit Control

Unavoidable Contaminants in Food for Human Consumption and Food-packaging Material

Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Thermally Processed Low-acid Foods Packaged in Hermetically Sealed Containers

Acidified Foods

Shell Eggs

Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food

Production, Storage, and Transportation of Shell Eggs

Dietary Supplements That Present a Significant or Unreasonable Risk

Hazard Analysis and Critical Control Point (Haccp) Systems

Mitigation Strategies to Protect Food Against Intentional Adulteration

Fish and Fishery Products

Processing and Bottling of Bottled Drinking Water

Food Standards: General

Milk and Cream

Cheeses and Related Cheese Products

Frozen Desserts

Bakery Products

Cereal Flours and Related Products

Macaroni and Noodle Products

Canned Fruits

Canned Fruit Juices

Fruit Butters, Jellies, Preserves, and Related Products

Canned Vegetables

Vegetable Juices

Frozen Vegetables

Eggs and Egg Products

Fish and Shellfish

Cacao Products

Tree Nut and Peanut Products

Beverages

Margarine

Sweeteners and Table Sirups

Food Dressings and Flavorings

Food Additives

Food Additive Petitions

Food Additives Permitted for Direct Addition to Food for Human Consumption

Secondary Direct Food Additives Permitted in Food for Human Consumption

Indirect Food Additives: General

Indirect Food Additives: Adhesives and Components of Coatings

Indirect Food Additives: Paper and Paperboard Components

Indirect Food Additives: Polymers

Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers

Irradiation in the Production, Processing and Handling of Food

Food Additives Permitted in Food or in Contact With Food on an Interim Basis Pending Additional Study

Prior-sanctioned Food Ingredients

Substances Generally Recognized as Safe

Direct Food Substances Affirmed as Generally Recognized as Safe

Indirect Food Substances Affirmed as Generally Recognized as Safe

Substances Prohibited From Use in Human Food

Dietary Supplements

General

Labeling

Prescription Drug Advertising

Prescription Drug Marketing

Guidelines for State Licensing of Wholesale Prescription Drug Distributors

Imprinting of Solid Oral Dosage Form Drug Products for Human Use

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

Medication Guides for Prescription Drug Products

Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement

Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

Current Good Manufacturing Practice for Finished Pharmaceuticals

Current Good Manufacturing Practice for Positron Emission Tomography Drugs

Current Good Manufacturing Practice for Medical Gases

Human Drug Compounding

Current Good Manufacturing Practice for Medicated Feeds

Current Good Manufacturing Practice for Type a Medicated Articles

Certification and Postmarketing Reporting for Designated Medical Gases

Special Requirements for Specific Human Drugs

Section 804 Importation Program

Controlled Drugs

Drugs; Official Names and Established Names

General

New Drugs

Investigational New Drug Application

Applications for Fda Approval to Market a New Drug

Diagnostic Radiopharmaceuticals

Orphan Drugs

Qualifying Pathogens

Bioavailability and Bioequivalence Requirements

Over-the-counter Drug Products Intended for Oral Ingestion That Contain Alcohol

Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act

Over-the-counter (Otc) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded

Antacid Products for Over-the-counter (Otc) Human Use

Antiflatulent Products for Over-the-counter Human Use

Topical Antimicrobial Drug Products for Over-the-counter Human Use

Antidiarrheal Drug Products for Over-the-counter Human Use

Antiemetic Drug Products for Over-the-counter Human Use

Nighttime Sleep-aid Drug Products for Over-the-counter Human Use

Stimulant Drug Products for Over-the-counter Human Use

Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use

Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-counter Human Use

Topical Otic Drug Products for Over-the-counter Human Use

Anorectal Drug Products for Over-the-counter Human Use

Skin Protectant Drug Products for Over-the-counter Human Use

External Analgesic Drug Products for Over-the-counter Human Use

Ophthalmic Drug Products for Over-the-counter Human Use

Antiperspirant Drug Products for Over-the-counter Human Use

Sunscreen Drug Products for Over-the-counter Human Use [Stayed Indefinitely]

Anticaries Drug Products for Over-the-counter Human Use

Miscellaneous Internal Drug Products for Over-the-counter Human Use

Miscellaneous External Drug Products for Over-the-counter Human Use

Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research

Interpretative Statements Re Warnings on Drugs and Devices for Over-the-counter Sale

General

Animal Food Labeling

Common or Usual Names for Nonstandardized Animal Foods

Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals

Unavoidable Contaminants in Animal Food and Food-packaging Material

New Animal Drugs

New Animal Drugs for Investigational Use

New Animal Drug Applications

Medicated Feed Mill License

New Animal Drugs for Minor Use and Minor Species

Oral Dosage Form New Animal Drugs

Implantation or Injectable Dosage Form New Animal Drugs

Ophthalmic and Topical Dosage Form New Animal Drugs

Intramammary Dosage Form New Animal Drugs

Intentional Genomic Alterations in Animals

Certain Other Dosage Form New Animal Drugs

Extralabel Drug Use in Animals

Tolerances for Residues of New Animal Drugs in Food

New Animal Drugs for Use in Animal Feeds

Food Additives

Food Additive Petitions

Food Additives Permitted in Feed and Drinking Water of Animals

Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food

Substances Generally Recognized as Safe

Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of Animals

Substances Prohibited From Use in Animal Food or Feed

Biological Products: General

Licensing

Current Good Manufacturing Practice for Blood and Blood Components

Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices

General Biological Products Standards

Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use

Additional Standards for Human Blood and Blood Products

Additional Standards for Diagnostic Substances for Laboratory Tests

Additional Standards for Miscellaneous Products

General

Cosmetic Labeling

Voluntary Registration of Cosmetic Product Establishments

Voluntary Filing of Cosmetic Product Ingredient Composition Statements

Cosmetic Product Warning Statements

General

Labeling

Medical Device Reporting

Medical Devices; Reports of Corrections and Removals

Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

Exemptions From Federal Preemption of State and Local Medical Device Requirements

In Vitro Diagnostic Products for Human Use

Medical Device Recall Authority

Investigational Device Exemptions

Premarket Approval of Medical Devices

Quality Management System Regulation

Medical Device Tracking Requirements

Postmarket Surveillance

Unique Device Identification

Medical Device Classification Procedures

Procedures for Performance Standards Development

Clinical Chemistry and Clinical Toxicology Devices

Hematology and Pathology Devices

Immunology and Microbiology Devices

Anesthesiology Devices

Cardiovascular Devices

Dental Devices

Ear, Nose, and Throat Devices

Gastroenterology-urology Devices

General and Plastic Surgery Devices

General Hospital and Personal Use Devices

Neurological Devices

Obstetrical and Gynecological Devices

Ophthalmic Devices

Orthopedic Devices

Physical Medicine Devices

Radiology Devices

Banned Devices

Performance Standard for Electrode Lead Wires and Patient Cables

Mammography

General

Records and Reports

Notification of Defects or Failure to Comply

Repurchase, Repairs, or Replacement of Electronic Products

Importation of Electronic Products

Performance Standards for Electronic Products: General

Performance Standards for Ionizing Radiation Emitting Products

Performance Standards for Microwave and Radio Frequency Emitting Products

Performance Standards for Light-emitting Products

General

General

Exemption Requests and Substantial Equivalence Reports

Premarket Tobacco Product Applications

Cigarettes, Smokeless Tobacco, and Covered Tobacco Products

Required Warnings for Cigarette Packages and Advertisements

Minimum Required Warning Statements

User Fees

Regulations Under the Federal Import Milk Act

Regulations Under the Federal Caustic Poison Act

Control of Communicable Diseases

Interstate Conveyance Sanitation

Human Cells, Tissues, and Cellular and Tissue-based Products