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; (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.

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Timeline

1. 6 May 2022

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 6 May 2022

   Introduced

   Introduced in House

   Source: IntroReferral

3. 6 May 2022

   Introduced

   Introduced in House

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in House · 6 May 2022 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 6 May 2022

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 6 May 2022

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 6 May 2022

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Matsui, Doris O. [D-CA-7] · D · Sponsor
• Rep. Bacon, Don [R-NE-2] · R · Cosponsor
• Rep. Lofgren, Zoe [D-CA-18] · D · Cosponsor
• Rep. Lieu, Ted [D-CA-36] · D · Cosponsor
• · hsif00 · Standing

Related records

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