H.R. 7669 · 117th Congress
Drug Shortages Shelf Life Extension Act
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
MatsuiSponsor3 cosponsors · 2 D, 1 R
0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill requires the Food and Drug Administration (FDA) to issue or revise guidance to address issues relating to extending drug expiration dates.
What it does: CRS summary · Introduced in House · May 6, 2022
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; (2) establishing on drug labels the longest feasible expiration date scientifically supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages and affect product quality; and (3) using innovative approaches to stability modeling to support initial product expiration dates and expiration date extensions.
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Drug Shortages Shelf Life Extension Act
Latest action (May 6, 2022): Referred to the House Committee on Energy and Commerce.
Policy area: Health · Origin: House · Introduced: May 6, 2022
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.