Almost every pharmaceuticals professional were heard the word 21 CFR but are all aware about what 21 CFR is and why we use number 21 along with CFR?
Title-1: General Provision, Title-2:
Grants and Agreements, Title-3: The
President, Title-4: Accounts,
Title-5: Administrative Personnel, Title-6:
Domestic Security, Title-7:
Agriculture, Title-8: Aliens and
Nationality, Title-9: Animals and
Animal Product, Title-10: Energy, Title-11: Federal Elections, Title-12: Banks and Banking, Title-13: Business Credit and
Assistance, Title-14: Aeronautics
and Space, Title-15: Commerce and
Foreign Trade, Title-16: Commercial
Practices, Title-17: Commodity and
Securities exchanges, Title-18:
Conservation of Power and water resources, Title-19:
Custom Duties, Title-20: Employees
benefits, Title-21: Food and Drugs, Title-22: Foreign Relations, Title-23:
Highways, Title-24: Housing and
Urban Development, Title-25:Indians,
Title-26: Internal Revenue, Title-27: Alcohol Tobacco Products and
Firearms, Title-28: Judicial
Administrations, Title-29: Labor, Title-30:
Mineral Resources, Title-31: Money
and Finance, Title-32: National
Defense, Title-33: Navigation and
Navigable waters, Title-34: Education, Title-35:
Reserved, Title-36: Parks, Forest
and Public Property, Title-37:
Patents, Trademark, and copyrights, Title-38:
Pensions, Bonuses, and Veterans Relief, Title-39:
Postal Service, Title-40: Protection
of Environment, Title-41: Public
Contracts and Property Management, Title-42:
Public Health, Title-43: Public
Lands, Title-44: Emergency
Management and Assistances, Title-45:
Public Welfare, Title-46: Shipping, Title-47: Telecommunication, Title-48: Federal Acquisition
Regulation System, Title-49:
Transportation, Title-50: Wildlife
and Fisheries.
In above mentioned sections, we can see the Title -21 represents to Food and Drugs. The Title-21 (Food and Drugs) further classified in three Chapters. The chapters are as:
Chapter-I: Food and Drug Administration, Department of
Health and Human Services.
Chapter-I further
classified in 12 subchapters. The subchapters are as below:
Subchapter-A: General (Contains
Part-1 to Part-99)
Subchapter-B: Food and Human consumption (Contains Part-100 to 199)
Subchapter-C: Drugs (General) (Contains Part- 200 to 299)
Subchapter-D: Drugs for Human Use (Contains Part-300 to 499)
Subchapter-E: Animal Drugs, Feeds, and Related Products (Contains part
-500 to 599)
Subchapter-F: Biologics (Contains part 600 to 699)
Subchapter-G: Cosmetics (Contains part 700 to 799)
Subchapter-H: Medical Devices (Contains part 800 to 898)
Subchapter-I: Mammography Quality Standard Act (Contains part-900)
Subchapter-J: Radiological Health (Contains part-1000 to 1040)
Subchapter-K: Tobacco Products (Contains part-1100 to 1150)
Subchapter-L: Regulation under certain other Acts Administrated by the
Food and Drug Administration (Contains part-1210 to 1299)
Chapter-II: Drug
Enforcement Administration, Department of Justice (Contains part-1300 to 1399)
In chapter-II there
are total 20 sections (part) which contains the detailed explanations from
definitions to registration, labelling, distribution, sales and disposal etc.
Chapter-III: Office of National Drug Control Policy
The chapter-III
categorized in two subsections. These are as below:
Part-1401: Public availability of Information
Part-1402: Mandatory declassification review.
Abhishek Singh is the author of Pharma technical support. He is pharmaceutical professionals, having experience of more than 12 years in Quality.
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