Title 21 · FDA
Food and Drugs
276 parts
Parts in this title
- § 1 General Enforcement Regulations
- § 2 General Administrative Rulings And Decisions
- § 3 Product Jurisdiction
- § 4 Regulation Of Combination Products
- § 5 Organization
- § 7 Enforcement Policy
- § 10 Administrative Practices And Procedures
- § 11 Electronic Records; Electronic Signatures
- § 12 Formal Evidentiary Public Hearing
- § 13 Public Hearing Before A Public Board Of Inquiry
- § 14 Public Hearing Before A Public Advisory Committee
- § 15 Public Hearing Before The Commissioner
- § 16 Regulatory Hearing Before The Food And Drug Administration
- § 17 Civil Money Penalties Hearings
- § 19 Standards Of Conduct And Conflicts Of Interest
- § 20 Public Information
- § 21 Protection Of Privacy
- § 25 Environmental Impact Considerations
- § 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
- § 50 Protection Of Human Subjects
- § 54 Financial Disclosure By Clinical Investigators
- § 56 Institutional Review Boards
- § 58 Good Laboratory Practice For Nonclinical Laboratory Studies
- § 60 Patent Term Restoration
- § 70 Color Additives
- § 71 Color Additive Petitions
- § 73 Listing Of Color Additives Exempt From Certification
- § 74 Listing Of Color Additives Subject To Certification
- § 80 Color Additive Certification
- § 81 General Specifications And General Restrictions For Provisional Color Additives For Use In Foods, Drugs, And Cosmetics
- § 82 Listing Of Certified Provisionally Listed Colors And Specifications
- § 83-98 98 [Reserved]
- § 99 Dissemination Of Information On Unapproved/New Uses For Marketed Drugs, Biologics, And Devices
- § 100 General
- § 101 Food Labeling
- § 102 Common Or Usual Name For Nonstandardized Foods
- § 104 Nutritional Quality Guidelines For Foods
- § 105 Foods For Special Dietary Use
- § 106 Infant Formula Requirements Pertaining To Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records And Reports, And Notifications
- § 107 Infant Formula
- § 108 Emergency Permit Control
- § 109 Unavoidable Contaminants In Food For Human Consumption And Food-Packaging Material
- § 110 Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food
- § 111 Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements
- § 112 Standards For The Growing, Harvesting, Packing, And Holding Of Produce For Human Consumption
- § 113 Thermally Processed Low-Acid Foods Packaged In Hermetically Sealed Containers
- § 114 Acidified Foods
- § 115 Shell Eggs
- § 117 Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Human Food
- § 118 Production, Storage, And Transportation Of Shell Eggs
- § 119 Dietary Supplements That Present A Significant Or Unreasonable Risk
- § 120 Hazard Analysis And Critical Control Point (Haccp) Systems
- § 121 Mitigation Strategies To Protect Food Against Intentional Adulteration
- § 123 Fish And Fishery Products
- § 129 Processing And Bottling Of Bottled Drinking Water
- § 130 Food Standards: General
- § 131 Milk And Cream
- § 133 Cheeses And Related Cheese Products
- § 135 Frozen Desserts
- § 136 Bakery Products
- § 137 Cereal Flours And Related Products
- § 139 Macaroni And Noodle Products
- § 145 Canned Fruits
- § 146 Canned Fruit Juices
- § 150 Fruit Butters, Jellies, Preserves, And Related Products
- § 155 Canned Vegetables
- § 156 Vegetable Juices
- § 158 Frozen Vegetables
- § 160 Eggs And Egg Products
- § 161 Fish And Shellfish
- § 163 Cacao Products
- § 164 Tree Nut And Peanut Products
- § 165 Beverages
- § 166 Margarine
- § 168 Sweeteners And Table Sirups
- § 169 Food Dressings And Flavorings
- § 170 Food Additives
- § 171 Food Additive Petitions
- § 172 Food Additives Permitted For Direct Addition To Food For Human Consumption
- § 173 Secondary Direct Food Additives Permitted In Food For Human Consumption
- § 174 Indirect Food Additives: General
- § 175 Indirect Food Additives: Adhesives And Components Of Coatings
- § 176 Indirect Food Additives: Paper And Paperboard Components
- § 177 Indirect Food Additives: Polymers
- § 178 Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers
- § 179 Irradiation In The Production, Processing And Handling Of Food
- § 180 Food Additives Permitted In Food Or In Contact With Food On An Interim Basis Pending Additional Study
- § 181 Prior-Sanctioned Food Ingredients
- § 182 Substances Generally Recognized As Safe
- § 184 Direct Food Substances Affirmed As Generally Recognized As Safe
- § 186 Indirect Food Substances Affirmed As Generally Recognized As Safe
- § 189 Substances Prohibited From Use In Human Food
- § 190 Dietary Supplements
- § 191-199 199 [Reserved]
- § 200 General
- § 201 Labeling
- § 202 Prescription Drug Advertising
- § 203 Prescription Drug Marketing
- § 205 Guidelines For State Licensing Of Wholesale Prescription Drug Distributors
- § 206 Imprinting Of Solid Oral Dosage Form Drug Products For Human Use
- § 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
- § 208 Medication Guides For Prescription Drug Products
- § 209 Requirement For Authorized Dispensers And Pharmacies To Distribute A Side Effects Statement
- § 210 Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General
- § 211 Current Good Manufacturing Practice For Finished Pharmaceuticals
- § 212 Current Good Manufacturing Practice For Positron Emission Tomography Drugs
- § 213 Xxx
- § 216 Human Drug Compounding
- § 225 Current Good Manufacturing Practice For Medicated Feeds
- § 226 Current Good Manufacturing Practice For Type A Medicated Articles
- § 230 Xxx
- § 250 Special Requirements For Specific Human Drugs
- § 251 Section 804 Importation Program
- § 290 Controlled Drugs
- § 299 Drugs; Official Names And Established Names
- § 300 General
- § 310 New Drugs
- § 312 Investigational New Drug Application
- § 314 Applications For Fda Approval To Market A New Drug
- § 315 Diagnostic Radiopharmaceuticals
- § 316 Orphan Drugs
- § 317 Qualifying Pathogens
- § 320 Bioavailability And Bioequivalence Requirements
- § 328 Over-The-Counter Drug Products Intended For Oral Ingestion That Contain Alcohol
- § 329 Nonprescription Human Drug Products Subject To Section 760 Of The Federal Food, Drug, And Cosmetic Act
- § 330 Over-The-Counter (Otc) Human Drugs Which Are Generally Recognized As Safe And Effective And Not Misbranded
- § 331 Antacid Products For Over-The-Counter (Otc) Human Use
- § 332 Antiflatulent Products For Over-The-Counter Human Use
- § 333 Topical Antimicrobial Drug Products For Over-The-Counter Human Use
- § 335 Antidiarrheal Drug Products For Over-The-Counter Human Use
- § 336 Antiemetic Drug Products For Over-The-Counter Human Use
- § 338 Nighttime Sleep-Aid Drug Products For Over-The-Counter Human Use
- § 340 Stimulant Drug Products For Over-The-Counter Human Use
- § 341 Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use
- § 343 Internal Analgesic, Antipyretic, And Antirheumatic Drug Products For Over-The-Counter Human Use
- § 344 Topical Otic Drug Products For Over-The-Counter Human Use
- § 346 Anorectal Drug Products For Over-The-Counter Human Use
- § 347 Skin Protectant Drug Products For Over-The-Counter Human Use
- § 348 External Analgesic Drug Products For Over-The-Counter Human Use
- § 349 Ophthalmic Drug Products For Over-The-Counter Human Use
- § 350 Antiperspirant Drug Products For Over-The-Counter Human Use
- § 352 Sunscreen Drug Products For Over-The-Counter Human Use [Stayed Indefinitely]
- § 355 Anticaries Drug Products For Over-The-Counter Human Use
- § 357 Miscellaneous Internal Drug Products For Over-The-Counter Human Use
- § 358 Miscellaneous External Drug Products For Over-The-Counter Human Use
- § 361 Prescription Drugs For Human Use Generally Recognized As Safe And Effective And Not Misbranded: Drugs Used In Research
- § 369 Interpretative Statements Re Warnings On Drugs And Devices For Over-The-Counter Sale
- § 370-499 499 [Reserved]
- § 500 General
- § 501 Animal Food Labeling
- § 502 Common Or Usual Names For Nonstandardized Animal Foods
- § 507 Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Food For Animals
- § 509 Unavoidable Contaminants In Animal Food And Food-Packaging Material
- § 510 New Animal Drugs
- § 511 New Animal Drugs For Investigational Use
- § 514 New Animal Drug Applications
- § 515 Medicated Feed Mill License
- § 516 New Animal Drugs For Minor Use And Minor Species
- § 520 Oral Dosage Form New Animal Drugs
- § 522 Implantation Or Injectable Dosage Form New Animal Drugs
- § 524 Ophthalmic And Topical Dosage Form New Animal Drugs
- § 526 Intramammary Dosage Form New Animal Drugs
- § 528 Intentional Genomic Alterations In Animals
- § 529 Certain Other Dosage Form New Animal Drugs
- § 530 Extralabel Drug Use In Animals
- § 556 Tolerances For Residues Of New Animal Drugs In Food
- § 558 New Animal Drugs For Use In Animal Feeds
- § 564 Part 564 [Reserved]
- § 570 Food Additives
- § 571 Food Additive Petitions
- § 573 Food Additives Permitted In Feed And Drinking Water Of Animals
- § 579 Irradiation In The Production, Processing, And Handling Of Animal Feed And Pet Food
- § 582 Substances Generally Recognized As Safe
- § 584 Food Substances Affirmed As Generally Recognized As Safe In Feed And Drinking Water Of Animals
- § 589 Substances Prohibited From Use In Animal Food Or Feed
- § 590-599 599 [Reserved]
- § 600 Biological Products: General
- § 601 Licensing
- § 606 Current Good Manufacturing Practice For Blood And Blood Components
- § 607 Establishment Registration And Product Listing For Manufacturers Of Human Blood And Blood Products And Licensed Devices
- § 610 General Biological Products Standards
- § 630 Requirements For Blood And Blood Components Intended For Transfusion Or For Further Manufacturing Use
- § 640 Additional Standards For Human Blood And Blood Products
- § 660 Additional Standards For Diagnostic Substances For Laboratory Tests
- § 680 Additional Standards For Miscellaneous Products
- § 700 General
- § 701 Cosmetic Labeling
- § 710 Voluntary Registration Of Cosmetic Product Establishments
- § 720 Voluntary Filing Of Cosmetic Product Ingredient Composition Statements
- § 740 Cosmetic Product Warning Statements
- § 741-799 799 [Reserved]
- § 800 General
- § 801 Labeling
- § 803 Medical Device Reporting
- § 806 Medical Devices; Reports Of Corrections And Removals
- § 807 Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
- § 808 Exemptions From Federal Preemption Of State And Local Medical Device Requirements
- § 809 In Vitro Diagnostic Products For Human Use
- § 810 Medical Device Recall Authority
- § 812 Investigational Device Exemptions
- § 813 Part 813 [Reserved]
- § 814 Premarket Approval Of Medical Devices
- § 820 Quality System Regulation
- § 821 Medical Device Tracking Requirements
- § 822 Postmarket Surveillance
- § 830 Unique Device Identification
- § 860 Medical Device Classification Procedures
- § 861 Procedures For Performance Standards Development
- § 862 Clinical Chemistry And Clinical Toxicology Devices
- § 864 Hematology And Pathology Devices
- § 866 Immunology And Microbiology Devices
- § 868 Anesthesiology Devices
- § 870 Cardiovascular Devices
- § 872 Dental Devices
- § 874 Ear, Nose, And Throat Devices
- § 876 Gastroenterology-Urology Devices
- § 878 General And Plastic Surgery Devices
- § 880 General Hospital And Personal Use Devices
- § 882 Neurological Devices
- § 884 Obstetrical And Gynecological Devices
- § 886 Ophthalmic Devices
- § 888 Orthopedic Devices
- § 890 Physical Medicine Devices
- § 892 Radiology Devices
- § 895 Banned Devices
- § 898 Performance Standard For Electrode Lead Wires And Patient Cables
- § 900 Mammography
- § 1000 General
- § 1002 Records And Reports
- § 1003 Notification Of Defects Or Failure To Comply
- § 1004 Repurchase, Repairs, Or Replacement Of Electronic Products
- § 1005 Importation Of Electronic Products
- § 1010 Performance Standards For Electronic Products: General
- § 1020 Performance Standards For Ionizing Radiation Emitting Products
- § 1030 Performance Standards For Microwave And Radio Frequency Emitting Products
- § 1040 Performance Standards For Light-Emitting Products
- § 1100 General
- § 1105 General
- § 1107 Exemption Requests And Substantial Equivalence Reports
- § 1114 Premarket Tobacco Product Applications
- § 1140 Cigarettes, Smokeless Tobacco, And Covered Tobacco Products
- § 1141 Required Warnings For Cigarette Packages And Advertisements
- § 1143 Minimum Required Warning Statements
- § 1150 User Fees
- § 1210 Regulations Under The Federal Import Milk Act
- § 1230 Regulations Under The Federal Caustic Poison Act
- § 1240 Control Of Communicable Diseases
- § 1250 Interstate Conveyance Sanitation
- § 1251-1270 1270 [Reserved]
- § 1271 Human Cells, Tissues, And Cellular And Tissue-Based Products
- § 1272-1299 1299 [Reserved]
- § 1300 Definitions
- § 1301 Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
- § 1302 Labeling And Packaging Requirements For Controlled Substances
- § 1303 Quotas
- § 1304 Records And Reports Of Registrants
- § 1305 Orders For Schedule I And Ii Controlled Substances
- § 1306 Prescriptions
- § 1307 Miscellaneous
- § 1308 Schedules Of Controlled Substances
- § 1309 Registration Of Manufacturers, Distributors, Importers And Exporters Of List I Chemicals
- § 1310 Records And Reports Of Listed Chemicals And Certain Machines; Importation And Exportation Of Certain Machines
- § 1311 Requirements For Electronic Orders And Prescriptions
- § 1312 Importation And Exportation Of Controlled Substances
- § 1313 Importation And Exportation Of List I And List Ii Chemicals
- § 1314 Retail Sale Of Scheduled Listed Chemical Products
- § 1315 Importation And Production Quotas For Ephedrine, Pseudoephedrine, And Phenylpropanolamine
- § 1316 Administrative Functions, Practices, And Procedures
- § 1317 Disposal
- § 1318 Controls To Satisfy The Requirements Of The Act Applicable To The Manufacturing Of Marihuana
- § 1321 Dea Mailing Addresses
- § 1322-1399 1399 [Reserved]
- § 1400 Part 1400 [Reserved]
- § 1401 Public Availability Of Information
- § 1402 Mandatory Declassification Review
- § 1403-1499 1499 [Reserved]