United States 117th Congress Status: Died 1 D cosponsors

HR 7669 — Drug Shortages Shelf Life Extension Act

Last action — Referred to the House Committee on Energy and Commerce.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 117th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

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; (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.

Bill Text

Sections of law this bill changes

From the bill's own amending language, matched to the official United States Code (current through Public Law 119-124).

Also cites: 21 U.S.C. § 355, 21 U.S.C. § 356e, 42 U.S.C. § 247d, 42 U.S.C. § 262

Action History

  1. Introduced in House

  2. Introduced in House

  3. Referred to the House Committee on Energy and Commerce.

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare health-insurance
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Frequently asked questions

What does HR 7669 do?
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.
Who sponsors HR 7669?
HR 7669 is sponsored by Matsui, Doris O. (Democratic).
What is the current status of HR 7669?
This bill died with 117th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 7669?
Track HR 7669 free on One Click Politics — get push/email alerts when it moves.

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Last checked for changes 3 months ago · updated continuously

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