Legis Daily

Drug Shortages Prevention and Quality Improvement Act

USA118th CongressS-2586| Senate 
| Updated: 7/27/2023
Benjamin L. Cardin

Benjamin L. Cardin

Democratic Senator

Maryland

Cosponsors (2)
Tina Smith (Democratic)Richard Blumenthal (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug Shortages Prevention and Quality Improvement Act This bill establishes several programs and requirements to address potential shortages of critical drugs. For example, the bill requires manufacturers of life-saving drugs to submit data to the Food and Drug Administration (FDA) to help determine the longest possible expiration dates for these drugs. Manufacturers must also notify the FDA of any increased demand for life-saving drugs that could lead to shortages. Manufacturers are subject to civil penalties for violations. The bill also (1) establishes a grant program to support advanced manufacturing of essential sterile injectable drugs that are vulnerable to shortages, and (2) requires the Government Accountability Office to study the extent of recent shortages of drugs for which payment is made to hospitals under Medicare and whether payment changes could minimize shortages.
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Timeline

Bill from Previous Congress

S 117-2595
Drug Shortages Prevention and Quality Improvement Act
Jul 27, 2023
Introduced in Senate
Jul 27, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 117-2595
    Drug Shortages Prevention and Quality Improvement Act


  • July 27, 2023
    Introduced in Senate


  • July 27, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Drug Shortages Prevention and Quality Improvement Act

USA118th CongressS-2586| Senate 
| Updated: 7/27/2023
Drug Shortages Prevention and Quality Improvement Act This bill establishes several programs and requirements to address potential shortages of critical drugs. For example, the bill requires manufacturers of life-saving drugs to submit data to the Food and Drug Administration (FDA) to help determine the longest possible expiration dates for these drugs. Manufacturers must also notify the FDA of any increased demand for life-saving drugs that could lead to shortages. Manufacturers are subject to civil penalties for violations. The bill also (1) establishes a grant program to support advanced manufacturing of essential sterile injectable drugs that are vulnerable to shortages, and (2) requires the Government Accountability Office to study the extent of recent shortages of drugs for which payment is made to hospitals under Medicare and whether payment changes could minimize shortages.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

S 117-2595
Drug Shortages Prevention and Quality Improvement Act
Jul 27, 2023
Introduced in Senate
Jul 27, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 117-2595
    Drug Shortages Prevention and Quality Improvement Act


  • July 27, 2023
    Introduced in Senate


  • July 27, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Benjamin L. Cardin

Benjamin L. Cardin

Democratic Senator

Maryland

Cosponsors (2)
Tina Smith (Democratic)Richard Blumenthal (Democratic)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted