SubChapter A—General

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 6 - XXX

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

Parts 83--98 - [Reserved]

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

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 152 - Fruit Pies

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

Parts 191--199 - [Reserved]

SubChapter C—Drugs: General

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

SubChapter D—Drugs for Human Use

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 429 - DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN

Part 430 - ANTIBIOTIC DRUGS; GENERAL

Part 431 - CERTIFICATION OF ANTIBIOTIC DRUGS

Part 432 - PACKAGING AND LABELING OF ANTIBIOTIC DRUGS

Part 433 - EXEMPTIONS FROM ANTIBIOTIC CERTIFICATION AND LABELING REQUIREMENTS

Part 436 - TESTS AND METHODS OF ASSAY OF ANTIBIOTIC AND ANTIBIOTIC-CONTAINING DRUGS

Parts 370--499 - [Reserved]

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 - New Animal Drugs in Genetically Engineered 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 564 - [Reserved]

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

Parts 590--599 - [Reserved]

SubChapter F—Biologics

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

SubChapter G—Cosmetics

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 730 - VOLUNTARY FILING OF COSMETIC PRODUCT EXPERIENCES

Part 740 - Cosmetic Product Warning Statements

Parts 741--799 - [Reserved]

SubChapter H—Medical Devices

Part 800 - General

Part 801 - Labeling

Part 803 - Medical Device Reporting

Part 804 - MEDICAL DEVICE DISTRIBUTOR REPORTING

Part 805 - CARDIAC PACEMAKER REGISTRY

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 813 - [Reserved]

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

SubChapter I—Mammography Quality Standards Act

Part 900 - Mammography

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

Part 1050 - Performance Standards for Sonic, Infrasonic, and Ultrasonic Radiation-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

Part 1140 - Cigarettes, Smokeless Tobacco, and Covered Tobacco Products

Part 1141 - Cigarette Package and Advertising Warnings

Part 1143 - Minimum Required Warning Statements

Part 1150 - User Fees

Part 1220 - REGULATIONS UNDER THE TEA IMPORTATION ACT

SubChapter L—Regulations Under Certain Other Acts Administered by the Food and Drug Administration

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 1270 - Human Tissue Intended for Transplantation

Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products

Parts 1251--1269 - [Reserved]

Parts 1272--1299 - [Reserved]