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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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Copyright © 2004-2008 ComplianceFDA, Inc. All rights reserved. Last modified: 21 Apr 2008