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United States · Bill · HR

H.R. 9541 (95th)

Drug Safety Amendments

referredUnited States· United States Congress· EN

Introduced

12 October 1977

Last action

Status

Referred to House Committee on Interstate and Foreign Commerce.

Sponsors

Subjects

Discovery layer

Source updated

2 September 2025

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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Sources

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