Regulations	Unregistered User

Regulation

21 CFR Part 1 General Enforcement Regulations 21 CFR Part 2 General Administrative Rulings and Decisions 21 CFR Part 3 Product Jurisdiction 21 CFR Part 5 Organization 21 CFR Part 7 Enforcement Policy 21 CFR Part 10 Administrative Practices and Procedures 21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 12 Formal Evidentiary Public Hearing 21 CFR Part 13 Public Hearing Before a Public Board of Inquiry 21 CFR Part 14 Public Hearing Before a Public Advisory Committee 21 CFR Part 15 Public Hearing Before the Commissioner 21 CFR Part 16 Regulatory Hearing Before the Food and Drug Administration 21 CFR Part 17 Civil Money Penalties Hearings 21 CFR Part 19 Standards of Conduct and Conflicts of Interest 21 CFR Part 20 Public Information 21 CFR Part 21 Protection of Privacy 21 CFR Part 25 Environmental Impact Considerations 21 CFR Part 26 System Audit Reports and Certain Medical Device Product Evaluation Reports: US and EU 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 54 Financial Disclosure By Clinical Investigators 21 CFR Part 56 Institutional Review Boards 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies 21 CFR Part 60 Patent Term Restoration 21 CFR Part 70 Color Additives 21 CFR Part 71 Color Additive Petitions 21 CFR Part 73 Listing of Color Additives Exempt From Certification 21 CFR Part 74 Listing of Color Additives Subject to Certification 21 CFR Part 80 Color Additive Certification 21 CFR Part 81 General Specifications and General Restrictions for Provisional Color Additives .. 21 CFR Part 82 Listing of Certified Provisionally Listed Colors and Specifications 21 CFR Part 99 Dissemination of Information on Unapproved/New Uses for Marketed Drugs .. 21 CFR Part 100 General 21 CFR Part 101 Food Labeling 21 CFR Part 102 Common or Usual Name for Nonstandardized Foods 21 CFR Part 104 Nutritional Quality Guidelines for Foods 21 CFR Part 105 Foods for Special Dietary Use 21 CFR Part 106 Infant Formula Quality Control Procedures 21 CFR Part 107 Infant Formula 21 CFR Part 108 Emergency Permit Control 21 CFR Part 109 Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material 21 CFR Part 110 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food 21 CFR Part 113 Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers 21 CFR Part 114 Acidified Foods 21 CFR Part 115 Shell Eggs 21 CFR Part 119 Dietary Supplements That Present a Significant or Unreasonable Risk 21 CFR Part 120 Hazard Analysis and Critical Control Point (HACCP) Systems 21 CFR Part 123 Fish and Fishery Products 21 CFR Part 128 Obsolete--Republished as Part 100 21 CFR Part 129 Processing and Bottling of Bottled Drinking Water 21 CFR Part 130 Food Standards: General 21 CFR Part 131 Milk and Cream 21 CFR Part 133 Cheeses and Related Cheese Products 21 CFR Part 135 Frozen Desserts 21 CFR Part 136 Bakery Products 21 CFR Part 137 Cereal Flours and Related Products 21 CFR Part 139 Macaroni and Noodle Products 21 CFR Part 145 Canned Fruits 21 CFR Part 146 Canned Fruit Juices 21 CFR Part 150 Fruit Butters, Jellies, Preserves, and Related Products 21 CFR Part 152 Fruit Pies 21 CFR Part 155 Canned Vegetables 21 CFR Part 156 Vegetable Juices 21 CFR Part 158 Frozen Vegetables 21 CFR Part 160 Eggs and Egg Products 21 CFR Part 161 Fish and Shellfish 21 CFR Part 163 Cacao Products 21 CFR Part 164 Tree Nut and Peanut Products 21 CFR Part 165 Beverages 21 CFR Part 166 Margarine 21 CFR Part 168 Sweeteners and Table Sirups 21 CFR Part 169 Food Dressings and Flavorings 21 CFR Part 170 Food Additives 21 CFR Part 171 Food Additive Petitions 21 CFR Part 172 Food Additives Permitted for Direct Addition to Food for Human Consumption 21 CFR Part 173 Secondary Direct Food Additives Permitted in Food for Human Consumption 21 CFR Part 174 Indirect Food Additives: General 21 CFR Part 175 Indirect Food Additives: Adhesives and Components of Coatings 21 CFR Part 176 Indirect Food Additives: Paper and Paperboard Components 21 CFR Part 177 Indirect Food Additives: Polymers 21 CFR Part 178 Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers 21 CFR Part 179 Irradiation in the Production, Processing and Handling of Food 21 CFR Part 180 Food Additives Permitted in Food or in Contact With Food on an Interim Basis .. 21 CFR Part 181 Prior-Sanctioned Food Ingredients 21 CFR Part 182 Substances Generally Recognized as Safe 21 CFR Part 184 Direct Food Substances Affirmed as Generally Recognized as Safe 21 CFR Part 186 Indirect Food Substances Affirmed as Generally Recognized as Safe 21 CFR Part 189 Substances Prohibited From Use in Human Food 21 CFR Part 190 Dietary Supplements 21 CFR Part 200 General 21 CFR Part 201 Labeling 21 CFR Part 202 Prescription Drug Advertising 21 CFR Part 203 Prescription Drug Marketing 21 CFR Part 205 Guidelines for State Licensing of Wholesale Prescription Drug Distributors 21 CFR Part 206 Imprinting of Solid Oral Dosage Form Drug Products for Human Use 21 CFR Part 207 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution 21 CFR Part 208 Medication Guides for Prescription Drug Products 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs.. 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR Part 216 Pharmacy Compounding 21 CFR Part 225 Current Good Manufacturing Practice for Medicated Feeds 21 CFR Part 226 Current Good Manufacturing Practice for Type a Medicated Articles 21 CFR Part 250 Special Requirements for Specific Human Drugs 21 CFR Part 290 Controlled Drugs 21 CFR Part 299 Drugs; Official Names and Established Names 21 CFR Part 300 General 21 CFR Part 310 New Drugs 21 CFR Part 312 Investigational New Drug Application 21 CFR Part 314 Applications for FDA Approval to Market a New Drug 21 CFR Part 315 Diagnostic Radiopharmaceuticals 21 CFR Part 316 Orphan Drugs 21 CFR Part 320 Bioavailability and Bioequivalence Requirements 21 CFR Part 328 Over-The-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol 21 CFR Part 330 Over-The-Counter Human Drugs Which Are Generally Recognized as Safe and Effective .. 21 CFR Part 331 Antacid Products for Over-The-Counter (OTC) Human Use 21 CFR Part 332 Antiflatulent Products for Over-The-Counter Human Use 21 CFR Part 333 Topical Antimicrobial Drug Products for Over-The-Counter Human Use 21 CFR Part 335 Antidiarrheal Drug Products for Over-The-Counter Human Use 21 CFR Part 336 Antiemetic Drug Products for Over-The-Counter Human Use 21 CFR Part 338 Nighttime Sleep-Aid Drug Products for Over-The-Counter Human Use 21 CFR Part 340 Stimulant Drug Products for Over-The-Counter Human Use 21 CFR Part 341 Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Drug Products for Over-The-Counter .. 21 CFR Part 343 Internal Anagesic, Antipyretic, and Antirheumatic Drug Products for Over-The-Counter .. 21 CFR Part 344 Topical Otic Drug Products for Over-The-Counter Human Use 21 CFR Part 346 Anorectal Drug Products for Over-The-Counter Human Use 21 CFR Part 347 Skin Protectant Drug Products for Over-The-Counter Human Use 21 CFR Part 348 External Analgesic Drug Products for Over-The-Counter Human Use 21 CFR Part 349 Ophthalmic Drug Products for Over-The-Counter Human Use 21 CFR Part 350 Antiperspirant Drug Products for Over-The-Counter Human Use 21 CFR Part 352 Sunscreen Drug Products for Over-The-Counter Human Use [Stayed Indefinitely] 21 CFR Part 355 Anticaries Drug Products for Over-The-Counter Human Use 21 CFR Part 357 Miscellaneous Internal Drug Products for Over-The-Counter Human Use 21 CFR Part 358 Miscellaneous External Drug Products for Over-The-Counter Human Use 21 CFR Part 361 Prescription Drugs for Human Use Generally Recognized as Safe and Effective ..: Drugs Used in Research 21 CFR Part 369 Interpretative Statements Re Warnings on Drugs and Devices for Over-The-Counter Sale 21 CFR Part 500 General 21 CFR Part 501 Animal Food Labeling 21 CFR Part 502 Common or Usual Names for Nonstandardized Animal Foods 21 CFR Part 509 Unavoidable Contaminants in Animal Food and Food-Packaging Material 21 CFR Part 510 New Animal Drugs 21 CFR Part 511 New Animal Drugs for Investigational Use 21 CFR Part 514 New Animal Drug Applications 21 CFR Part 515 Medicated Feed Mill License 21 CFR Part 520 Oral Dosage Form New Animal Drugs 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs 21 CFR Part 526 Intramammary Dosage Forms 21 CFR Part 529 Certain Other Dosage Form New Animal Drugs 21 CFR Part 530 Extralabel Drug Use in Animals 21 CFR Part 556 Tolerances for Residues of New Animal Drugs in Food 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds 21 CFR Part 570 Food Additives 21 CFR Part 571 Food Additive Petitions 21 CFR Part 573 Food Additives Permitted in Feed and Drinking Water of Animals 21 CFR Part 579 Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food 21 CFR Part 582 Substances Generally Recognized as Safe 21 CFR Part 584 Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of Animals 21 CFR Part 589 Substances Prohibited From Use in Animal Food or Feed 21 CFR Part 600 Biological Products: General 21 CFR Part 601 Licensing 21 CFR Part 606 Current Good Manufacturing Practice for Blood and Blood Components 21 CFR Part 607 Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products 21 CFR Part 610 General Biological Products Standards 21 CFR Part 630 General Requirements for Blood, Blood Components, and Blood Derivatives 21 CFR Part 640 Additional Standards for Human Blood and Blood Products 21 CFR Part 660 Additional Standards for Diagnostic Substances for Laboratory Tests 21 CFR Part 680 Additional Standards for Miscellaneous Products 21 CFR Part 700 General 21 CFR Part 701 Cosmetic Labeling 21 CFR Part 710 Voluntary Registration of Cosmetic Product Establishments 21 CFR Part 720 Voluntary Filing of Cosmetic Product Ingredient Composition Statements 21 CFR Part 740 Cosmetic Product Warning Statements 21 CFR Part 800 General 21 CFR Part 801 Labeling 21 CFR Part 803 Medical Device Reporting 21 CFR Part 804 Obsolete--Integrated Into 803 21 CFR Part 806 Medical Devices; Reports of Corrections and Removals 21 CFR Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices 21 CFR Part 808 Exemptions From Federal Preemption of State and Local Medical Device Requirements 21 CFR Part 809 In Vitro Diagnostic Products for Human Use 21 CFR Part 810 Medical Device Recall Authority 21 CFR Part 812 Investigational Device Exemptions 21 CFR Part 814 Premarket Approval of Medical Devices 21 CFR Part 820 Quality System Regulation 21 CFR Part 821 Medical Device Tracking Requirements 21 CFR Part 822 Postmarket Surveillance 21 CFR Part 860 Medical Device Classification Procedures 21 CFR Part 861 Procedures for Performance Standards Development 21 CFR Part 862 Clinical Chemistry and Clinical Toxicology Devices 21 CFR Part 864 Hematology and Pathology Devices 21 CFR Part 866 Immunology and Microbiology Devices 21 CFR Part 868 Anesthesiology Devices 21 CFR Part 870 Cardiovascular Devices 21 CFR Part 872 Dental Devices 21 CFR Part 874 Ear, Nose, and Throat Devices 21 CFR Part 876 Gastroenterology-Urology Devices 21 CFR Part 878 General and Plastic Surgery Devices 21 CFR Part 880 General Hospital and Personal Use Devices 21 CFR Part 882 Neurological Devices 21 CFR Part 884 Obstetrical and Gynecological Devices 21 CFR Part 886 Ophthalmic Devices 21 CFR Part 888 Orthopedic Devices 21 CFR Part 890 Physical Medicine Devices 21 CFR Part 892 Radiology Devices 21 CFR Part 895 Banned Devices 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables 21 CFR Part 900 Mammography 21 CFR Part 1000 General 21 CFR Part 1002 Records and Reports 21 CFR Part 1003 Notification of Defects or Failure to Comply 21 CFR Part 1004 Repurchase, Repairs, or Replacement of Electronic Products 21 CFR Part 1005 Importation of Electronic Products 21 CFR Part 1010 Performance Standards for Electronic Products: General 21 CFR Part 1020 Performance Standards for Ionizing Radiation Emitting Products 21 CFR Part 1030 Performance Standards for Microwave and Radio Frequency Emitting Products 21 CFR Part 1040 Performance Standards for Light-Emitting Products 21 CFR Part 1050 Ultrasonic Radiation-Emitting Products 21 CFR Part 1240 Control of Communicable Diseases 21 CFR Part 1250 Interstate Conveyance Sanitation 21 CFR Part 1270 Human Tissue Intended for Transplantation 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products 21 CFR Part 1300 Definitions 21 CFR Part 1301 Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances 21 CFR Part 1302 Labeling and Packaging Requirements for Controlled Substances 21 CFR Part 1303 Quotas 21 CFR Part 1304 Records and Reports of Registrants 21 CFR Part 1305 Orders for Schedule I and II Controlled Substances 21 CFR Part 1306 Prescriptions 21 CFR Part 1307 Miscellaneous 21 CFR Part 1308 Schedules of Controlled Substances 21 CFR Part 1309 Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals 21 CFR Part 1310 Records and Reports of Listed Chemicals and Certain Machines 21 CFR Part 1311 Digital Certificates 21 CFR Part 1312 Importation and Exportation of Controlled Substances 21 CFR Part 1313 Importation and Exportation of Precursors and Essential Chemicals 21 CFR Part 1316 Administrative Functions, Practices, and Procedures 21 CFR Part 1401 Public Availability of Information 21 CFR Part 1402 Mandatory Declassification Review 21 CFR Part 1403 Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments 21 CFR Part 1404 Governmentwide Debarment and Suspension (Nonprocurement) 21 CFR Part 1405 Governmentwide Requirements for Drug-Free Workplace (Financial Assistance) 45 CFR Part 160 General Administrative Requirements 45 CFR Part 162 Administrative Requirements 45 CFR Part 164 Security and Privacy

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