Amendments to the Federal Food, Drug and Cosmetic Act

Summary

Amendments to the Federal Food, Drug, and Cosmetic Act - Title I: The National Center for Clinical Pharmacology - Establishes the National Center for Clinical Pharmacology within the Department of Health, Education, and Welfare. Title II: Establishment of Food, Drug, Cosmetics and Devices Administration - Establishes the Food , Drug, Cosmetics, and Devices Administration within such Department. Transfers the functions of the Food and Drug Administration to such newly created Administration. Establishes within the Food, Drug, Cosmetics and Devices Administration the Research and Development Review Bureau and the Compliance and Monitoring Bureau. Title III: Drugs and Devices - Establishes procedures and requirements for (1) warnings on drug labels; (2) prescription drugs; (3) new drug approval and limited use marketing; and (4) new prescription drug package inserts. Title IV: Advertising, Marketing, and Promotional Practices - Restricts the transfer by drug manufacturers to physicians and pharmacists of gifts, premiums, and free samples. Requires certain price information on advertisements. Requires manufacturers' representatives to undergo a training program whose standards are to be established by the Commissioner of the Food, Drug, Cosmetics and Devices Administration. Title V: Drug Quality and Interchangeability - Requires the Commissioner to establish requirements for proof of therapeutic equivalence to assure uniform performance among chemically equivalent drugs. Requires the Commissioner to publish a list of interchangeable drugs. Title VI: National Drug Science Board - Establishes the National Drug Science Board to advise the Commissioner concerning the use, regulation, certification, and approval of human and animal drugs. Title VII: Definitions and Miscellaneous - Makes general amendments to the Federal Food, Drug, and Cosmetic Act. Transfers certain duties and powers under specified Acts to such Administration.

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1 official file

• Introduced in Senate

  summary · EN · 11 July 1977

  Open at official source

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