Drug Shortages Shelf Life Extension Act

United States117th CongressS-3493Senate
Updated: Jan 12, 2022

Summary

Drug Shortages Shelf Life Extension Act This bill requires the Food and Drug Administration (FDA) to issue or revise guidance to address issues relating to extending drug expiration dates. Specifically, the guidance must address recommendations to drug companies relating to (1) submitting stability testing data in applications for market approval for drugs or biological products; and (2) establishing on drug labels the longest feasible expiration date supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages. The FDA must also periodically report to Congress certain information about requests to change the expiration date on a drug label, including the number of such requests from the FDA to the manufacturer and the rationale for each request.

Bill texts

Available versions
Introduced (Senate)View official text

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Timeline

Latest companion bill action

HR-7669: Drug Shortages Shelf Life Extension Act

Referred to the House Committee on Energy and Commerce.

  1. Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192)

    Senate

  2. Introduced in Senate

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