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Drug Shortages Shelf Life Extension Act

USA117th CongressS-3493| Senate 
| Updated: 1/12/2022
Benjamin L. Cardin

Benjamin L. Cardin

Democratic Senator

Maryland

Cosponsors (1)
Susan M. Collins (Republican)

Health, Education, Labor, and Pensions 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; 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
Jan 12, 2022
Introduced in Senate
Jan 12, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192)
May 6, 2022

Latest Companion Bill Action

HR 117-7669
Introduced in House
  • January 12, 2022
    Introduced in Senate


  • January 12, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192)


  • May 6, 2022

    Latest Companion Bill Action

    HR 117-7669
    Introduced in House

Health

Related Bills

  • S 117-3799: PREVENT Pandemics Act
  • HR 117-7669: Drug Shortages Shelf Life Extension Act
Congressional oversightDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, suppliesManufacturing

Drug Shortages Shelf Life Extension Act

USA117th CongressS-3493| Senate 
| Updated: 1/12/2022
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; 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.
View Full Text

Suggested Questions

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

Timeline
Jan 12, 2022
Introduced in Senate
Jan 12, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192)
May 6, 2022

Latest Companion Bill Action

HR 117-7669
Introduced in House
  • January 12, 2022
    Introduced in Senate


  • January 12, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S191-192)


  • May 6, 2022

    Latest Companion Bill Action

    HR 117-7669
    Introduced in House
Benjamin L. Cardin

Benjamin L. Cardin

Democratic Senator

Maryland

Cosponsors (1)
Susan M. Collins (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 117-3799: PREVENT Pandemics Act
  • HR 117-7669: Drug Shortages Shelf Life Extension Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, suppliesManufacturing