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