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US HR2500

US HR2500
Protecting Americans from Unsafe Drugs Act of 2023


summary

Introduced
04/06/2023
In Committee
04/14/2023
Crossed Over
Passed
Dead
01/03/2025

Introduced Session

118th Congress

Bill Summary

A BILL To amend the Federal Food, Drug, and Cosmetic Act to expand certain authorities with respect to the recall of controlled substances to apply with respect to all drugs, and for other purposes.

AI Summary

This bill amends the Federal Food, Drug, and Cosmetic Act to expand the Food and Drug Administration's (FDA) authority to order the recall of any unsafe drug, not just controlled substances. Specifically, it allows the FDA to order a drug manufacturer to cease distribution and recall a drug if there is a reasonable probability that the drug is unsafe for humans or animals. This expanded authority applies to all drugs, not just controlled substances, as was previously the case. The bill also clarifies that the FDA can issue such orders not just through the Director of the Center for Drug Evaluation and Research, but also through the Director of the Center for Biologics Evaluation and Research.

Committee Categories

Business and Industry, Health and Social Services

Sponsors (2)

Last Action

Referred to the Subcommittee on Health. (on 04/14/2023)

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