Title 21 Food and Drugs Part / Section
Chapter I Food and Drug Administration, Department of Health and Human Services 1 – 1299
Subchapter A General 1 – 99
Part 1 General Enforcement Regulations 1.1 – 1.1465
Part 2 General Administrative Rulings and Decisions 2.5 – 2.125
Part 3 Product Jurisdiction 3.1 – 3.10
Part 4 Regulation of Combination Products 4.1 – 4.105
Part 5 Organization 5.1100 – 5.1110
Part 7 Enforcement Policy 7.1 – 7.87
Part 10 Administrative Practices and Procedures 10.1 – 10.206
Part 11 Electronic Records; Electronic Signatures 11.1 – 11.300
Part 12 Formal Evidentiary Public Hearing 12.1 – 12.159
Part 13 Public Hearing Before a Public Board of Inquiry 13.1 – 13.50
Part 14 Public Hearing Before a Public Advisory Committee 14.1 – 14.174
Part 15 Public Hearing Before the Commissioner 15.1 – 15.45
Part 16 Regulatory Hearing Before the Food and Drug Administration 16.1 – 16.120
Part 17 Civil Money Penalties Hearings 17.1 – 17.54
Part 19 Standards of Conduct and Conflicts of Interest 19.1 – 19.55
Part 20 Public Information 20.1 – 20.120
Part 21 Protection of Privacy 21.1 – 21.75
Part 25 Environmental Impact Considerations 25.1 – 25.60
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 26.0 – 26.81
Part 50 Protection of Human Subjects 50.1 – 50.56
Part 54 Financial Disclosure by Clinical Investigators 54.1 – 54.6
Part 56 Institutional Review Boards 56.101 – 56.124
Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies 58.1 – 58.219
Part 60 Patent Term Restoration 60.1 – 60.46
Part 70 Color Additives 70.3 – 70.55
Part 71 Color Additive Petitions 71.1 – 71.37
Part 73 Listing of Color Additives Exempt from Certification 73.1 – 73.3129
Part 74 Listing of Color Additives Subject to Certification 74.101 – 74.3710
Part 80 Color Additive Certification 80.10 – 80.39
Part 81 General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics 81.1 – 81.30
Part 82 Listing of Certified Provisionally Listed Colors and Specifications 82.3 – 82.2707a
Parts 83-98 Parts 83-98 [Reserved]
Part 99 Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices 99.1 – 99.501
Subchapter B Food for Human Consumption 100 – 199
Part 100 General 100.1 – 100.155
Part 101 Food Labeling 101.1 – 101.108
Part 102 Common or Usual Name for Nonstandardized Foods 102.5 – 102.57
Part 104 Nutritional Quality Guidelines for Foods 104.5 – 104.47
Part 105 Foods for Special Dietary Use 105.3 – 105.66
Part 106 Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications 106.1 – 106.160
Part 107 Infant Formula 107.1 – 107.280
Part 108 Emergency Permit Control 108.3 – 108.35
Part 109 Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material 109.3 – 109.30
Part 110 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food 110.3 – 110.110
Part 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements 111.1 – 111.610
Part 112 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption 112.1 – 112.213
Part 113 Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers 113.3 – 113.100
Part 114 Acidified Foods 114.3 – 114.100
Part 115 Shell Eggs 115.50
Part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 117.1 – 117.475
Part 118 Production, Storage, and Transportation of Shell Eggs 118.1 – 118.12
Part 119 Dietary Supplements That Present a Significant or Unreasonable Risk 119.1
Part 120 Hazard Analysis and Critical Control Point (HACCP) Systems 120.1 – 120.25
Part 121 Mitigation Strategies to Protect Food Against Intentional Adulteration 121.1 – 121.401
Part 123 Fish and Fishery Products 123.3 – 123.28
Part 129 Processing and Bottling of Bottled Drinking Water 129.1 – 129.80
Part 130 Food Standards: General 130.3 – 130.20
Part 131 Milk and Cream 131.3 – 131.200
Part 133 Cheeses and Related Cheese Products 133.3 – 133.196
Part 135 Frozen Desserts 135.3 – 135.160
Part 136 Bakery Products 136.3 – 136.180
Part 137 Cereal Flours and Related Products 137.105 – 137.350
Part 139 Macaroni and Noodle Products 139.110 – 139.180
Part 145 Canned Fruits 145.3 – 145.190
Part 146 Canned Fruit Juices 146.3 – 146.187
Part 150 Fruit Butters, Jellies, Preserves, and Related Products 150.110 – 150.160
Part 155 Canned Vegetables 155.3 – 155.201
Part 156 Vegetable Juices 156.3 – 156.145
Part 158 Frozen Vegetables 158.3 – 158.170
Part 160 Eggs and Egg Products 160.100 – 160.190
Part 161 Fish and Shellfish 161.30 – 161.190
Part 163 Cacao Products 163.5 – 163.155
Part 164 Tree Nut and Peanut Products 164.110 – 164.150
Part 165 Beverages 165.3 – 165.110
Part 166 Margarine 166.40 – 166.110
Part 168 Sweeteners and Table Sirups 168.110 – 168.180
Part 169 Food Dressings and Flavorings 169.3 – 169.182
Part 170 Food Additives 170.3 – 170.285
Part 171 Food Additive Petitions 171.1 – 171.130
Part 172 Food Additives Permitted for Direct Addition to Food for Human Consumption 172.5 – 172.898
Part 173 Secondary Direct Food Additives Permitted in Food for Human Consumption 173.5 – 173.405
Part 174 Indirect Food Additives: General 174.5 – 174.6
Part 175 Indirect Food Additives: Adhesives and Components of Coatings 175.105 – 175.390
Part 176 Indirect Food Additives: Paper and Paperboard Components 176.110 – 176.350
Part 177 Indirect Food Additives: Polymers 177.1010 – 177.2910
Part 178 Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers 178.1005 – 178.3950
Part 179 Irradiation in the Production, Processing and Handling of Food 179.21 – 179.45
Part 180 Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study 180.1 – 180.37
Part 181 Prior-Sanctioned Food Ingredients 181.1 – 181.34
Part 182 Substances Generally Recognized as Safe 182.1 – 182.8997
Part 184 Direct Food Substances Affirmed as Generally Recognized as Safe 184.1 – 184.1985
Part 186 Indirect Food Substances Affirmed as Generally Recognized as Safe 186.1 – 186.1839
Part 189 Substances Prohibited from Use in Human Food 189.1 – 189.301
Part 190 Dietary Supplements 190.6
Parts 191-199 Parts 191-199 [Reserved]
Subchapter C Drugs: General 200 – 299
Part 200 General 200.5 – 200.200
Part 201 Labeling 201.1 – 201.328
Part 202 Prescription Drug Advertising 202.1
Part 203 Prescription Drug Marketing 203.1 – 203.70
Part 205 Guidelines for State Licensing of Wholesale Prescription Drug Distributors 205.1 – 205.50
Part 206 Imprinting of Solid Oral Dosage Form Drug Products for Human Use 206.1 – 206.10
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 207.1 – 207.81
Part 208 Medication Guides for Prescription Drug Products 208.1 – 208.26
Part 209 Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement 209.1 – 209.11
Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General 210.1 – 210.3
Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals 211.1 – 211.208
Part 212 Current Good Manufacturing Practice for Positron Emission Tomography Drugs 212.1 – 212.110
Part 213 XXX
Part 216 Human Drug Compounding 216.23 – 216.24
Part 225 Current Good Manufacturing Practice for Medicated Feeds 225.1 – 225.202
Part 226 Current Good Manufacturing Practice for Type a Medicated Articles 226.1 – 226.115
Part 230 XXX
Part 250 Special Requirements for Specific Human Drugs 250.11 – 250.250
Part 251 Section 804 Importation Program 251.1 – 251.21
Part 290 Controlled Drugs 290.1 – 290.10
Part 299 Drugs; Official Names and Established Names 299.3 – 299.5
Subchapter D Drugs for Human Use 300 – 499
Part 300 General 300.50 – 300.200
Part 310 New Drugs 310.3 – 310.548
Part 312 Investigational New Drug Application 312.1 – 312.320
Part 314 Applications for FDA Approval to Market a New Drug 314.1 – 314.650
Part 315 Diagnostic Radiopharmaceuticals 315.1 – 315.6
Part 316 Orphan Drugs 316.1 – 316.52
Part 317 Qualifying Pathogens 317.1 – 317.2
Part 320 Bioavailability and Bioequivalence Requirements 320.1 – 320.63
Part 328 Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol 328.1 – 328.50
Part 329 Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act 329.100
Part 330 Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded 330.1 – 330.15
Part 331 Antacid Products for Over-the-Counter (OTC) Human Use 331.1 – 331.80
Part 332 Antiflatulent Products for Over-the-Counter Human Use 332.1 – 332.31
Part 333 Topical Antimicrobial Drug Products for Over-the-Counter Human Use 333.101 – 333.350
Part 335 Antidiarrheal Drug Products for Over-the-Counter Human Use 335.1 – 335.50
Part 336 Antiemetic Drug Products for Over-the-Counter Human Use 336.1 – 336.80
Part 338 Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use 338.1 – 338.50
Part 340 Stimulant Drug Products for Over-the-Counter Human Use 340.1 – 340.50
Part 341 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use 341.1 – 341.90
Part 343 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use 343.1 – 343.90
Part 344 Topical Otic Drug Products for Over-the-Counter Human Use 344.1 – 344.52
Part 346 Anorectal Drug Products for Over-the-Counter Human Use 346.1 – 346.52
Part 347 Skin Protectant Drug Products for Over-the-Counter Human Use 347.1 – 347.60
Part 348 External Analgesic Drug Products for Over-the-Counter Human Use 348.1 – 348.50
Part 349 Ophthalmic Drug Products for Over-the-Counter Human Use 349.1 – 349.80
Part 350 Antiperspirant Drug Products for Over-the-Counter Human Use 350.1 – 350.60
Part 352 Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely] 352.1 – 352.77
Part 355 Anticaries Drug Products for Over-the-Counter Human Use 355.1 – 355.70
Part 357 Miscellaneous Internal Drug Products for Over-the-Counter Human Use 357.101 – 357.850
Part 358 Miscellaneous External Drug Products for Over-the-Counter Human Use 358.101 – 358.760
Part 361 Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research 361.1
Part 369 Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale 369.1 – 369.21
Parts 370-499 Parts 370-499 [Reserved]
Subchapter E Animal Drugs, Feeds, and Related Products 500 – 599
Part 500 General 500.23 – 500.1410
Part 501 Animal Food Labeling 501.1 – 501.110
Part 502 Common or Usual Names for Nonstandardized Animal Foods 502.5 – 502.19
Part 507 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals 507.1 – 507.215
Part 509 Unavoidable Contaminants in Animal Food and Food-Packaging Material 509.3 – 509.30
Part 510 New Animal Drugs 510.3 – 510.600
Part 511 New Animal Drugs for Investigational Use 511.1 – 511.3
Part 514 New Animal Drug Applications 514.1 – 514.235
Part 515 Medicated Feed Mill License 515.10 – 515.40
Part 516 New Animal Drugs for Minor Use and Minor Species 516.1 – 516.2980
Part 520 Oral Dosage Form New Animal Drugs 520.23 – 520.2654
Part 522 Implantation or Injectable Dosage Form New Animal Drugs 522.23 – 522.2690
Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs 524.86 – 524.2620
Part 526 Intramammary Dosage Form New Animal Drugs 526.88 – 526.1810
Part 528 Intentional Genomic Alterations in Animals 528.1080 – 528.2010
Part 529 Certain Other Dosage Form New Animal Drugs 529.56 – 529.2620
Part 530 Extralabel Drug Use in Animals 530.1 – 530.41
Part 556 Tolerances for Residues of New Animal Drugs in Food 556.1 – 556.770
Part 558 New Animal Drugs for Use in Animal Feeds 558.3 – 558.680
Part 564 Part 564 [Reserved]
Part 570 Food Additives 570.3 – 570.280
Part 571 Food Additive Petitions 571.1 – 571.130
Part 573 Food Additives Permitted in Feed and Drinking Water of Animals 573.120 – 573.1020
Part 579 Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food 579.12 – 579.40
Part 582 Substances Generally Recognized as Safe 582.1 – 582.7724
Part 584 Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of Animals 584.200 – 584.725
Part 589 Substances Prohibited from Use in Animal Food or Feed 589.1 – 589.2001
Parts 590-599 Parts 590-599 [Reserved]
Subchapter F Biologics 600 – 680
Part 600 Biological Products: General 600.2 – 600.90
Part 601 Licensing 601.2 – 601.95
Part 606 Current Good Manufacturing Practice for Blood and Blood Components 606.3 – 606.171
Part 607 Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices 607.1 – 607.80
Part 610 General Biological Products Standards 610.1 – 610.68
Part 630 Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use 630.1 – 630.40
Part 640 Additional Standards for Human Blood and Blood Products 640.1 – 640.130
Part 660 Additional Standards for Diagnostic Substances for Laboratory Tests 660.1 – 660.55
Part 680 Additional Standards for Miscellaneous Products 680.1 – 680.3
Subchapter G Cosmetics 700 – 799
Part 700 General 700.3 – 700.35
Part 701 Cosmetic Labeling 701.1 – 701.30
Part 710 Voluntary Registration of Cosmetic Product Establishments 710.1 – 710.9
Part 720 Voluntary Filing of Cosmetic Product Ingredient Composition Statements 720.1 – 720.9
Part 740 Cosmetic Product Warning Statements 740.1 – 740.19
Parts 741-799 Parts 741-799 [Reserved]
Subchapter H Medical Devices 800 – 898
Part 800 General 800.10 – 800.75
Part 801 Labeling 801.1 – 801.437
Part 803 Medical Device Reporting 803.1 – 803.58
Part 806 Medical Devices; Reports of Corrections and Removals 806.1 – 806.40
Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices 807.3 – 807.100
Part 808 Exemptions from Federal Preemption of State and Local Medical Device Requirements 808.1 – 808.101
Part 809 In Vitro Diagnostic Products for Human Use 809.3 – 809.40
Part 810 Medical Device Recall Authority 810.1 – 810.18
Part 812 Investigational Device Exemptions 812.1 – 812.150
Part 813 Part 813 [Reserved]
Part 814 Premarket Approval of Medical Devices 814.1 – 814.126
Part 820 Quality System Regulation 820.1 – 820.250
Part 821 Medical Device Tracking Requirements 821.1 – 821.60
Part 822 Postmarket Surveillance 822.1 – 822.38
Part 830 Unique Device Identification 830.3 – 830.360
Part 860 Medical Device Classification Procedures 860.1 – 860.260
Part 861 Procedures for Performance Standards Development 861.1 – 861.38
Part 862 Clinical Chemistry and Clinical Toxicology Devices 862.1 – 862.3950
Part 864 Hematology and Pathology Devices 864.1 – 864.9900
Part 866 Immunology and Microbiology Devices 866.1 – 866.6080
Part 868 Anesthesiology Devices 868.1 – 868.6885
Part 870 Cardiovascular Devices 870.1 – 870.5925
Part 872 Dental Devices 872.1 – 872.6890
Part 874 Ear, Nose, and Throat Devices 874.1 – 874.5900
Part 876 Gastroenterology-Urology Devices 876.1 – 876.5990
Part 878 General and Plastic Surgery Devices 878.1 – 878.5910
Part 880 General Hospital and Personal Use Devices 880.1 – 880.6992
Part 882 Neurological Devices 882.1 – 882.5970
Part 884 Obstetrical and Gynecological Devices 884.1 – 884.6200
Part 886 Ophthalmic Devices 886.1 – 886.5933
Part 888 Orthopedic Devices 888.1 – 888.5980
Part 890 Physical Medicine Devices 890.1 – 890.5975
Part 892 Radiology Devices 892.1 – 892.6500
Part 895 Banned Devices 895.1 – 895.105
Part 898 Performance Standard for Electrode Lead Wires and Patient Cables 898.11 – 898.14
Subchapter I Mammography Quality Standards Act 900
Part 900 Mammography 900.1 – 900.25
Subchapter J Radiological Health 1000 – 1040
Part 1000 General 1000.1 – 1000.15
Part 1002 Records and Reports 1002.1 – 1002.51
Part 1003 Notification of Defects or Failure to Comply 1003.1 – 1003.31
Part 1004 Repurchase, Repairs, or Replacement of Electronic Products 1004.1 – 1004.6
Part 1005 Importation of Electronic Products 1005.1 – 1005.25
Part 1010 Performance Standards for Electronic Products: General 1010.1 – 1010.20
Part 1020 Performance Standards for Ionizing Radiation Emitting Products 1020.10 – 1020.40
Part 1030 Performance Standards for Microwave and Radio Frequency Emitting Products 1030.10
Part 1040 Performance Standards for Light-Emitting Products 1040.10 – 1040.30
Subchapter K Tobacco Products 1100 – 1150
Part 1100 General 1100.1 – 1100.204
Part 1105 General 1105.10
Part 1107 Exemption Requests and Substantial Equivalence Reports 1107.1 – 1107.62
Part 1114 Premarket Tobacco Product Applications 1114.1 – 1114.49
Part 1140 Cigarettes, Smokeless Tobacco, and Covered Tobacco Products 1140.1 – 1140.34
Part 1141 Required Warnings for Cigarette Packages and Advertisements 1141.1 – 1141.12
Part 1143 Minimum Required Warning Statements 1143.1 – 1143.13
Part 1150 User Fees 1150.1 – 1150.17
Subchapter L Regulations Under Certain Other Acts Administered by the Food and Drug Administration 1210 – 1299
Part 1210 Regulations Under the Federal Import Milk Act 1210.1 – 1210.31
Part 1230 Regulations Under the Federal Caustic Poison Act 1230.2 – 1230.49
Part 1240 Control of Communicable Diseases 1240.3 – 1240.95
Part 1250 Interstate Conveyance Sanitation 1250.3 – 1250.96
Parts 1251-1270 Parts 1251-1270 [Reserved]
Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products 1271.1 – 1271.440
Parts 1272-1299 Parts 1272-1299 [Reserved]