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21 CFR Chapter I

Chapter I—Food and Drug Administration, Department of Health and Human Services

2,311,708 words

250 parts

21 CFR Chapter I
Official text on eCFR ↗

Agencies with references in this chapter

Parts

Subchapter A — Subchapter A—General

Part Heading Sections Words
1 Part 1—General Enforcement Regulations 251 93,457
2 Part 2—General Administrative Rulings and Decisions 7 2,729
3 Part 3—Product Jurisdiction 10 2,641
4 Part 4—Regulation of Combination Products 10 3,655
5 Part 5—Organization 1 46
7 Part 7—Enforcement Policy 17 5,777
10 Part 10—Administrative Practices and Procedures 31 21,699
11 Part 11—Electronic Records; Electronic Signatures 10 2,415
12 Part 12—Formal Evidentiary Public Hearing 45 10,055
13 Part 13—Public Hearing Before a Public Board of Inquiry 10 2,710
14 Part 14—Public Hearing Before a Public Advisory Committee 43 15,734
15 Part 15—Public Hearing Before the Commissioner 7 1,321
16 Part 16—Regulatory Hearing Before the Food and Drug Administration 15 3,113
17 Part 17—Civil Money Penalties Hearings 34 7,794
19 Part 19—Standards of Conduct and Conflicts of Interest 7 1,135
20 Part 20—Public Information 75 18,261
21 Part 21—Protection of Privacy 29 9,738
25 Part 25—Environmental Impact Considerations 24 6,659
50 Part 50—Protection of Human Subjects 15 7,200
54 Part 54—Financial Disclosure by Clinical Investigators 6 1,941
56 Part 56—Institutional Review Boards 20 5,602
58 Part 58—Good Laboratory Practice for Nonclinical Laboratory Studies 36 7,258
60 Part 60—Patent Term Restoration 17 4,095
70 Part 70—Color Additives 13 4,779
71 Part 71—Color Additive Petitions 13 4,454
73 Part 73—Listing of Color Additives Exempt from Certification 129 32,426
74 Part 74—Listing of Color Additives Subject to Certification 89 21,294
80 Part 80—Color Additive Certification 10 3,608
81 Part 81—General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics 3 4,528
82 Part 82—Listing of Certified Provisionally Listed Colors and Specifications 39 2,711
83-98 [Reserved] 0 0
99 Part 99—Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices 15 6,899

Subchapter B — Subchapter B—Food for Human Consumption

Part Heading Sections Words
100 Part 100—General 4 3,108
101 Part 101—Food Labeling 50 104,354
102 Part 102—Common or Usual Name for Nonstandardized Foods 18 4,593
104 Part 104—Nutritional Quality Guidelines for Foods 3 2,075
105 Part 105—Foods for Special Dietary Use 4 1,091
106 Part 106—Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications 27 16,059
107 Part 107—Infant Formula 16 4,970
108 Part 108—Emergency Permit Control 9 5,904
109 Part 109—Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material 7 3,432
110 Part 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food 11 5,613
111 Part 111—Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements 84 14,131
112 Part 112—Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption 102 20,182
113 Part 113—Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers 10 17,557
114 Part 114—Acidified Foods 8 3,794
115 Part 115—Shell Eggs 1 2,138
117 Part 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 61 22,738
118 Part 118—Production, Storage, and Transportation of Shell Eggs 11 6,646
119 Part 119—Dietary Supplements That Present a Significant or Unreasonable Risk 1 60
120 Part 120—Hazard Analysis and Critical Control Point (HACCP) Systems 15 5,687
121 Part 121—Mitigation Strategies to Protect Food Against Intentional Adulteration 20 3,951
123 Part 123—Fish and Fishery Products 13 4,786
129 Part 129—Processing and Bottling of Bottled Drinking Water 7 2,963
130 Part 130—Food Standards: General 11 4,878
131 Part 131—Milk and Cream 20 9,318
133 Part 133—Cheeses and Related Cheese Products 75 33,046
135 Part 135—Frozen Desserts 6 4,728
136 Part 136—Bakery Products 6 2,525
137 Part 137—Cereal Flours and Related Products 29 9,205
139 Part 139—Macaroni and Noodle Products 15 6,381
145 Part 145—Canned Fruits 13 23,709
146 Part 146—Canned Fruit Juices 20 8,217
150 Part 150—Fruit Butters, Jellies, Preserves, and Related Products 3 3,107
155 Part 155—Canned Vegetables 9 13,516
156 Part 156—Vegetable Juices 2 1,508
158 Part 158—Frozen Vegetables 2 1,689
160 Part 160—Eggs and Egg Products 10 2,941
161 Part 161—Fish and Shellfish 9 10,339
163 Part 163—Cacao Products 16 4,930
164 Part 164—Tree Nut and Peanut Products 3 2,184
165 Part 165—Beverages 2 10,988
166 Part 166—Margarine 2 1,596
168 Part 168—Sweeteners and Table Sirups 9 2,454
169 Part 169—Food Dressings and Flavorings 11 2,581
170 Part 170—Food Additives 41 14,947
171 Part 171—Food Additive Petitions 8 3,602
172 Part 172—Food Additives Permitted for Direct Addition to Food for Human Consumption 154 47,517
173 Part 173—Secondary Direct Food Additives Permitted in Food for Human Consumption 57 15,964
174 Part 174—Indirect Food Additives: General 2 502
175 Part 175—Indirect Food Additives: Adhesives and Components of Coatings 14 14,139
176 Part 176—Indirect Food Additives: Paper and Paperboard Components 15 5,681
177 Part 177—Indirect Food Additives: Polymers 88 51,968
178 Part 178—Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers 47 28,684
179 Part 179—Irradiation in the Production, Processing and Handling of Food 8 2,403
180 Part 180—Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study 4 3,074
181 Part 181—Prior-Sanctioned Food Ingredients 14 2,020
182 Part 182—Substances Generally Recognized as Safe 85 3,214
184 Part 184—Direct Food Substances Affirmed as Generally Recognized as Safe 215 54,646
186 Part 186—Indirect Food Substances Affirmed as Generally Recognized as Safe 16 2,604
189 Part 189—Substances Prohibited from Use in Human Food 21 3,783
190 Part 190—Dietary Supplements 1 759
191-199 [Reserved] 0 0

Subchapter C — Subchapter C—Drugs: General

Part Heading Sections Words
200 Part 200—General 8 1,588
201 Part 201—Labeling 75 59,865
202 Part 202—Prescription Drug Advertising 1 6,148
203 Part 203—Prescription Drug Marketing 22 7,162
205 Part 205—Guidelines for State Licensing of Wholesale Prescription Drug Distributors 9 2,678
206 Part 206—Imprinting of Solid Oral Dosage Form Drug Products for Human Use 4 861
207 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 24 8,804
208 Part 208—Medication Guides for Prescription Drug Products 5 2,252
209 Part 209—Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement 4 504
210 Part 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General 3 1,566
211 Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals 60 10,826
212 Part 212—Current Good Manufacturing Practice for Positron Emission Tomography Drugs 16 4,615
213 Part 213—Current Good Manufacturing Practice for Medical Gases 36 6,537
216 Part 216—Human Drug Compounding 2 1,160
225 Part 225—Current Good Manufacturing Practice for Medicated Feeds 20 3,672
226 Part 226—Current Good Manufacturing Practice for Type a Medicated Articles 11 2,383
230 Part 230—Certification and Postmarketing Reporting for Designated Medical Gases 15 5,603
250 Part 250—Special Requirements for Specific Human Drugs 11 4,425
251 Part 251—Section 804 Importation Program 21 15,281
290 Part 290—Controlled Drugs 5 403
299 Part 299—Drugs; Official Names and Established Names 3 946

Subchapter D — Subchapter D—Drugs for Human Use

Part Heading Sections Words
300 Part 300—General 3 951
310 Part 310—New Drugs 37 23,181
312 Part 312—Investigational New Drug Application 60 25,059
314 Part 314—Applications for FDA Approval to Market a New Drug 69 63,420
315 Part 315—Diagnostic Radiopharmaceuticals 6 890
316 Part 316—Orphan Drugs 24 7,319
317 Part 317—Qualifying Pathogens 2 88
320 Part 320—Bioavailability and Bioequivalence Requirements 19 8,381
328 Part 328—Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol 4 750
329 Part 329—Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act 1 611
330 Part 330—Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded 10 12,139
331 Part 331—Antacid Products for Over-the-Counter (OTC) Human Use 8 1,773
332 Part 332—Antiflatulent Products for Over-the-Counter Human Use 6 463
333 Part 333—Topical Antimicrobial Drug Products for Over-the-Counter Human Use 16 4,333
335 Part 335—Antidiarrheal Drug Products for Over-the-Counter Human Use 4 1,011
336 Part 336—Antiemetic Drug Products for Over-the-Counter Human Use 5 1,006
338 Part 338—Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use 4 505
340 Part 340—Stimulant Drug Products for Over-the-Counter Human Use 4 374
341 Part 341—Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use 16 14,844
343 Part 343—Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use 10 3,798
344 Part 344—Topical Otic Drug Products for Over-the-Counter Human Use 6 809
346 Part 346—Anorectal Drug Products for Over-the-Counter Human Use 11 3,041
347 Part 347—Skin Protectant Drug Products for Over-the-Counter Human Use 8 4,584
348 Part 348—External Analgesic Drug Products for Over-the-Counter Human Use 4 557
349 Part 349—Ophthalmic Drug Products for Over-the-Counter Human Use 18 2,777
350 Part 350—Antiperspirant Drug Products for Over-the-Counter Human Use 5 941
352 Part 352—Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely] 13 6,092
355 Part 355—Anticaries Drug Products for Over-the-Counter Human Use 8 2,707
357 Part 357—Miscellaneous Internal Drug Products for Over-the-Counter Human Use 15 1,621
358 Part 358—Miscellaneous External Drug Products for Over-the-Counter Human Use 22 5,294
361 Part 361—Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research 1 3,051
369 Part 369—Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale 11 3,689
370-499 [Reserved] 0 0

Subchapter E — Subchapter E—Animal Drugs, Feeds, and Related Products

Part Heading Sections Words
500 Part 500—General 22 5,849
501 Part 501—Animal Food Labeling 14 11,339
502 Part 502—Common or Usual Names for Nonstandardized Animal Foods 2 902
507 Part 507—Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals 57 19,149
509 Part 509—Unavoidable Contaminants in Animal Food and Food-Packaging Material 7 2,303
510 Part 510—New Animal Drugs 24 5,664
511 Part 511—New Animal Drugs for Investigational Use 2 3,220
514 Part 514—New Animal Drug Applications 25 22,161
515 Part 515—Medicated Feed Mill License 12 2,337
516 Part 516—New Animal Drugs for Minor Use and Minor Species 59 15,879
520 Part 520—Oral Dosage Form New Animal Drugs 320 57,994
522 Part 522—Implantation or Injectable Dosage Form New Animal Drugs 190 47,091
524 Part 524—Ophthalmic and Topical Dosage Form New Animal Drugs 91 14,045
526 Part 526—Intramammary Dosage Form New Animal Drugs 13 2,941
528 Part 528—Intentional Genomic Alterations in Animals 5 555
529 Part 529—Certain Other Dosage Form New Animal Drugs 21 3,551
530 Part 530—Extralabel Drug Use in Animals 18 3,280
556 Part 556—Tolerances for Residues of New Animal Drugs in Food 106 6,524
558 Part 558—New Animal Drugs for Use in Animal Feeds 63 15,492
564 [Reserved] 0 0
570 Part 570—Food Additives 28 7,216
571 Part 571—Food Additive Petitions 8 3,095
573 Part 573—Food Additives Permitted in Feed and Drinking Water of Animals 70 15,848
579 Part 579—Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food 3 398
582 Part 582—Substances Generally Recognized as Safe 243 7,307
584 Part 584—Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of Animals 3 506
589 Part 589—Substances Prohibited from Use in Animal Food or Feed 5 3,658
590-599 [Reserved] 0 0

Subchapter F — Subchapter F—Biologics

Part Heading Sections Words
600 Part 600—Biological Products: General 15 10,644
601 Part 601—Licensing 39 12,414
606 Part 606—Current Good Manufacturing Practice for Blood and Blood Components 17 7,140
607 Part 607—Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices 16 3,386
610 Part 610—General Biological Products Standards 30 9,160
630 Part 630—Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use 10 6,409
640 Part 640—Additional Standards for Human Blood and Blood Products 61 11,714
660 Part 660—Additional Standards for Diagnostic Substances for Laboratory Tests 31 9,729
680 Part 680—Additional Standards for Miscellaneous Products 3 1,272

Subchapter G — Subchapter G—Cosmetics

Part Heading Sections Words
700 Part 700—General 12 4,853
701 Part 701—Cosmetic Labeling 10 7,917
710 Part 710—Voluntary Registration of Cosmetic Product Establishments 9 513
720 Part 720—Voluntary Filing of Cosmetic Product Ingredient Composition Statements 9 2,072
740 Part 740—Cosmetic Product Warning Statements 8 1,420
741-799 [Reserved] 0 0

Subchapter H — Subchapter H—Medical Devices

Part Heading Sections Words
800 Part 800—General 6 9,460
801 Part 801—Labeling 38 17,787
803 Part 803—Medical Device Reporting 26 9,681
806 Part 806—Medical Devices; Reports of Corrections and Removals 6 2,173
807 Part 807—Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices 24 10,169
808 Part 808—Exemptions from Federal Preemption of State and Local Medical Device Requirements 9 3,642
809 Part 809—In Vitro Diagnostic Products for Human Use 7 5,345
810 Part 810—Medical Device Recall Authority 13 4,265
812 Part 812—Investigational Device Exemptions 33 12,404
813 [Reserved] 0 0
814 Part 814—Premarket Approval of Medical Devices 33 14,471
820 Part 820—Quality Management System Regulation 9 2,410
821 Part 821—Medical Device Tracking Requirements 10 3,479
822 Part 822—Postmarket Surveillance 38 3,682
830 Part 830—Unique Device Identification 20 4,393
860 Part 860—Medical Device Classification Procedures 23 12,606
861 Part 861—Procedures for Performance Standards Development 9 2,113
862 Part 862—Clinical Chemistry and Clinical Toxicology Devices 263 30,283
864 Part 864—Hematology and Pathology Devices 126 18,329
866 Part 866—Immunology and Microbiology Devices 261 86,936
868 Part 868—Anesthesiology Devices 154 12,098
870 Part 870—Cardiovascular Devices 172 23,139
872 Part 872—Dental Devices 141 14,971
874 Part 874—Ear, Nose, and Throat Devices 71 9,244
876 Part 876—Gastroenterology-Urology Devices 109 23,204
878 Part 878—General and Plastic Surgery Devices 109 18,650
880 Part 880—General Hospital and Personal Use Devices 125 17,161
882 Part 882—Neurological Devices 144 18,237
884 Part 884—Obstetrical and Gynecological Devices 105 14,675
886 Part 886—Ophthalmic Devices 146 15,583
888 Part 888—Orthopedic Devices 111 20,125
890 Part 890—Physical Medicine Devices 92 13,077
892 Part 892—Radiology Devices 95 12,574
895 Part 895—Banned Devices 11 3,290
898 Part 898—Performance Standard for Electrode Lead Wires and Patient Cables 4 363

Subchapter I — Subchapter I—Mammography Quality Standards Act

Part Heading Sections Words
900 Part 900—Mammography 23 22,356

Subchapter J — Subchapter J—Radiological Health

Part Heading Sections Words
1000 Part 1000—General 3 1,001
1002 Part 1002—Records and Reports 17 3,232
1003 Part 1003—Notification of Defects or Failure to Comply 10 1,855
1004 Part 1004—Repurchase, Repairs, or Replacement of Electronic Products 5 1,113
1005 Part 1005—Importation of Electronic Products 11 1,851
1010 Part 1010—Performance Standards for Electronic Products: General 7 3,598
1020 Part 1020—Performance Standards for Ionizing Radiation Emitting Products 7 19,854
1030 Part 1030—Performance Standards for Microwave and Radio Frequency Emitting Products 1 2,167
1040 Part 1040—Performance Standards for Light-Emitting Products 4 9,912

Subchapter K — Subchapter K—Tobacco Products

Part Heading Sections Words
1100 Part 1100—General 7 1,182
1105 Part 1105—General 1 366
1107 Part 1107—Exemption Requests and Substantial Equivalence Reports 19 11,228
1114 Part 1114—Premarket Tobacco Product Applications 21 15,754
1140 Part 1140—Cigarettes, Smokeless Tobacco, and Covered Tobacco Products 10 3,159
1141 Part 1141—Required Warnings for Cigarette Packages and Advertisements 5 2,055
1143 Part 1143—Minimum Required Warning Statements 7 3,001
1150 Part 1150—User Fees 9 2,054

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

Part Heading Sections Words
1210 Part 1210—Regulations Under the Federal Import Milk Act 23 1,992
1230 Part 1230—Regulations Under the Federal Caustic Poison Act 29 3,418
1240 Part 1240—Control of Communicable Diseases 15 2,725
1250 Part 1250—Interstate Conveyance Sanitation 48 5,536
1251-1270 [Reserved] 0 0
1271 Part 1271—Human Cells, Tissues, and Cellular and Tissue-Based Products 49 15,082
1272-1299 [Reserved] 0 0