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Drug Shortage Prevention Act of 2023

USA118th CongressS-2362| Senate 
| Updated: 7/18/2023
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (6)
Elizabeth Warren (Democratic)Tina Smith (Democratic)Susan M. Collins (Republican)Gary C. Peters (Democratic)Ron Wyden (Democratic)Lisa Murkowski (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug Shortage Prevention Act of 2023 This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand, export restriction, or other circumstance that may result in a shortage of certain critical drugs. Currently, drug manufacturers are required to notify the FDA in the event of a discontinuation or interruption in the supply of prescription drugs that are life-supporting, life-sustaining, or used for a debilitating disease or condition, including those used in medical emergencies, surgeries, or public health emergencies. The bill requires drug manufacturers to also notify the FDA if there is an increased demand, export restriction, or other circumstance that may result in a meaningful shortfall or delay in meeting the demand for such drugs. Manufacturers must notify the FDA as soon as possible but no later than 10 days after the onset of the relevant circumstance. The notice must include the reasons for the increased demand, the expected duration, and any other information the FDA requires. The bill's requirements apply to both prescription and nonprescription drugs. Drug manufacturers must also report twice a year (rather than annually) information on the quantities of drugs produced; manufacturers must also provide the names of the suppliers of corresponding active ingredients.
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Timeline
May 5, 2023

Latest Companion Bill Action

HR 118-3008
Referred to the Subcommittee on Health.
Jul 18, 2023
Introduced in Senate
Jul 18, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • May 5, 2023

    Latest Companion Bill Action

    HR 118-3008
    Referred to the Subcommittee on Health.


  • July 18, 2023
    Introduced in Senate


  • July 18, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • S 118-2333: Pandemic and All-Hazards Preparedness and Response Act

Drug Shortage Prevention Act of 2023

USA118th CongressS-2362| Senate 
| Updated: 7/18/2023
Drug Shortage Prevention Act of 2023 This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand, export restriction, or other circumstance that may result in a shortage of certain critical drugs. Currently, drug manufacturers are required to notify the FDA in the event of a discontinuation or interruption in the supply of prescription drugs that are life-supporting, life-sustaining, or used for a debilitating disease or condition, including those used in medical emergencies, surgeries, or public health emergencies. The bill requires drug manufacturers to also notify the FDA if there is an increased demand, export restriction, or other circumstance that may result in a meaningful shortfall or delay in meeting the demand for such drugs. Manufacturers must notify the FDA as soon as possible but no later than 10 days after the onset of the relevant circumstance. The notice must include the reasons for the increased demand, the expected duration, and any other information the FDA requires. The bill's requirements apply to both prescription and nonprescription drugs. Drug manufacturers must also report twice a year (rather than annually) information on the quantities of drugs produced; manufacturers must also provide the names of the suppliers of corresponding active ingredients.
View Full Text

Suggested Questions

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

Timeline
May 5, 2023

Latest Companion Bill Action

HR 118-3008
Referred to the Subcommittee on Health.
Jul 18, 2023
Introduced in Senate
Jul 18, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • May 5, 2023

    Latest Companion Bill Action

    HR 118-3008
    Referred to the Subcommittee on Health.


  • July 18, 2023
    Introduced in Senate


  • July 18, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (6)
Elizabeth Warren (Democratic)Tina Smith (Democratic)Susan M. Collins (Republican)Gary C. Peters (Democratic)Ron Wyden (Democratic)Lisa Murkowski (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 118-2333: Pandemic and All-Hazards Preparedness and Response Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted