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Drug Shortages Shelf Life Extension Act

USA117th CongressHR-7669| House 
| Updated: 5/6/2022
Doris O. Matsui

Doris O. Matsui

Democratic Representative

California

Cosponsors (3)
Ted Lieu (Democratic)Don Bacon (Republican)Zoe Lofgren (Democratic)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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
Jan 12, 2022

Latest Companion Bill Action

S 117-3493
Introduced in Senate
May 6, 2022
Introduced in House
May 6, 2022
Referred to the House Committee on Energy and Commerce.
  • January 12, 2022

    Latest Companion Bill Action

    S 117-3493
    Introduced in Senate


  • May 6, 2022
    Introduced in House


  • May 6, 2022
    Referred to the House Committee on Energy and Commerce.

Health

Related Bills

  • S 117-3493: Drug Shortages Shelf Life Extension Act
  • S 117-3799: PREVENT Pandemics Act
Congressional oversightDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, suppliesManufacturing

Drug Shortages Shelf Life Extension Act

USA117th CongressHR-7669| House 
| Updated: 5/6/2022
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jan 12, 2022

Latest Companion Bill Action

S 117-3493
Introduced in Senate
May 6, 2022
Introduced in House
May 6, 2022
Referred to the House Committee on Energy and Commerce.
  • January 12, 2022

    Latest Companion Bill Action

    S 117-3493
    Introduced in Senate


  • May 6, 2022
    Introduced in House


  • May 6, 2022
    Referred to the House Committee on Energy and Commerce.
Doris O. Matsui

Doris O. Matsui

Democratic Representative

California

Cosponsors (3)
Ted Lieu (Democratic)Don Bacon (Republican)Zoe Lofgren (Democratic)

Energy and Commerce Committee

Health

Related Bills

  • S 117-3493: Drug Shortages Shelf Life Extension Act
  • S 117-3799: PREVENT Pandemics Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, suppliesManufacturing