United States · Bill · S
S. 3493 (117th)
Drug Shortages Shelf Life Extension Act
Introduced
12 January 2022
Last action
12 January 2022 · Introduced
Status
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192)
Sponsors
Sen. Cardin, Benjamin L. [D-MD], Sen. Collins, Susan M. [R-ME]
Subjects
Healthcare
Source updated
21 April 2025
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.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
12 January 2022
Introduced
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192)
Source: IntroReferral
12 January 2022
Introduced
Introduced in Senate
Source: IntroReferral
Votes
No vote records are attached yet.
Versions
- Introduced in Senate · 12 January 2022 · Download file
Documents
3 official files
Introduced in Senate (text)
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Introduced in Senate (text)
Introduced in Senate · EN · 12 January 2022
Introduced in Senate (PDF)
Introduced in Senate · EN · 12 January 2022
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Introduced in Senate
summary · EN · 12 January 2022
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Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Sponsors
- Sen. Cardin, Benjamin L. [D-MD] · D · Sponsor
- Sen. Collins, Susan M. [R-ME] · R · Sponsor
- · sshr00 · Standing
Related records
- related to ← PREVENT Pandemics Act
- related to ← Drug Shortages Shelf Life Extension Act
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/117th-congress/senate-bill/3493
- Open data entity: https://api.congress.gov/v3/bill/117/s/3493
- us · 117-s-3493 · source updated 21 April 2025