A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the certification of certain drugs other than insulin and antibiotics, and to provide for the submission of certain additional information on drugs by the producers of such drugs.

Summary

Amends the Federal, Food, Drug and Cosmetic Act to permit the Secretary of Health, Education, and Welfare to provide for batch-by-batch certification of a drug within the purview of such Act intended for human use. Establishes the criteria for such certification. Permits the Secretary to issue a release, in lieu of certification, for any batch manufactured prior to the effective date of such certification if the Secretary judges such batch safe. Authorizes the Secretary to exempt certain drugs or categories of drugs from this Act. Permits any interested party to file a petition proposing the issuance, amendment, or repeal of any regulation issued under this Act. Requires the Secretary to: (1) publish notice of such proposal; (2) afford all interested parties an opportunity to present their views; (3) make public his action on such proposals; (4) hold public hearings if objections are made to such action; and (5) make public his action on such objections. Requires every person engaged in the manufacture, compounding, or processing, of any drug within the purview of such Act to maintain records and make such reports relating to clinical experiences as the Secretary determines necessary to assure compliance with such Act.

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Timeline

1. 27 March 1979

   Introduced

   Referred to Senate Committee on Labor and Human Resources.

   Source: IntroReferral

2. 27 March 1979

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

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Versions

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Documents

1 official file

• Introduced in Senate

  summary · EN · 27 March 1979

  Open at official source

Sponsors

• Sen. Nelson, Gaylord [D-WI] · D · Sponsor
• · sshr00 · Standing

Related records

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