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Small Business Guide to FDA
(last revised on 03/31/04)

HOW TO OBTAIN FDA STATUTES AND REGULATIONS

The Federal Food, Drug, and Cosmetic Act, as Amended, sections of the Public Health Service Act pertaining to biological products, the Radiation Control for Health and Education Act, the Safe Medical Devices Act, the Mammography Quality Standards Act, the Fair Packaging and Labeling Act, the Infant Formula Act, the Nutrition Labeling and Education Act, and the Dietary Supplement Health and Education Act are among the statues enforced by the FDA. They are compiled in one booklet, "Federal Food, Drug, and Cosmetic Act as Amended and Related Laws," which is available from the Superintendent of Documents. The regulations over which FDA has jurisdiction are codified under Title 21, Code of Federal Regulations (CFR). These are updated on April 1 of each year and are available for sale approximately four months later. Nine volumes are applicable to FDA and may be purchased singly or as a set from the Superintendent of Documents. These regulations are accessible on the Internet at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. The contents of each volume are listed below:

  • Parts 1 to 99. General regulations for the enforcement of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Color additives.

  • Parts 100 to 169. Food standards, good manufacturing practice for foods, low-acid canned foods, acidified foods, and food labeling.

  • Parts 170 to 199. Food additives.

  • Parts 200 to 299. General regulations for drugs.

  • Parts 300 to 499. Drugs for human use.

  • Parts 500 to 599. Animal drugs, feeds, and related products.

  • Parts 600 to 799. Biologics and cosmetics.

  • Parts 800 to 1299. Medical devices and radiological health. Regulations under the Federal Import Milk Act, the Federal Tea Importation Act, the Federal Caustic Poison Act, and for control of communicable diseases and interstate conveyance sanitation.

  • Parts 1300 through end. Drug Enforcement Administration regulations and requirements.