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.

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Timeline

1. 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

2. 12 January 2022

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 12 January 2022 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 12 January 2022

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 12 January 2022

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 12 January 2022

  Open at official source

Sponsors

• Rep. Cardin, Benjamin L. [D-MD-3] · D · Sponsor
• Susan Collins · R · Sponsor
• · sshr00 · Standing

Related records

• related to ← PREVENT Pandemics Act
• related to ← Drug Shortages Shelf Life Extension Act