Drug Shortages Shelf Life Extension Act
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 status
in committee
1 of 4 stages cleared
Introduction
Jan 2022
Committee Review
Floor Vote
President
Introduced Jan 12, 2022
Last action Jan 12, 2022
Floor votes
How they voted
No floor votes recorded yet.
Full legislative history
Actions timeline
Total actions
2
Key actions
0
Committee
1
Jan 12, 2022
Committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192)
upper
Jan 12, 2022
Introduced
Introduced in Senate
upper
1 primary · 1 co-sponsor
Sponsors
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