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United States · Bill · HR

H.R. 8891 (95th)

Drug Safety Amendments

referredUnited States· United States Congress· EN

Introduced

5 August 1977

Last action

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Status

Referred to House Committee on Interstate and Foreign Commerce.

Sponsors

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Subjects

Discovery layer

Source updated

2 September 2025

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Summary

Drug Safety Amendments - Amends the Federal Food, Drug, and Cosmetic Act to require: (1) identification and ingredient information on certain drug labels; (2) drug test recordkeeping; (3) origin certification of imported drugs; and (4) release of information used to determine new drugs' safety. Authorizes the Secretary of Health, Education, and Welfare to: (1) give conditional marketing approval to new drugs; (2) conduct drug studies; and (3) suspend approval of new human or animal drugs. Establishes a drug development protocol for testing and marketing of new drugs. Prohibits the export of misbranded drugs unless they meet safety standards established by the Secretary.

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Documents

1 official file

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