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PREPARE Act

USA117th CongressS-2740| Senate 
| Updated: 9/14/2021
Sherrod Brown

Sherrod Brown

Democratic Senator

Ohio

Cosponsors (6)
Bill Cassidy (Republican)Marsha Blackburn (Republican)Mark R. Warner (Democratic)Robert P. Casey (Democratic)Tim Kaine (Democratic)Shelley Moore Capito (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Promoting Readiness and Ensuring Proper Active pharmaceutical ingredient Reserves of Essential medicines Act of 2021 or the PREPARE Act This bill establishes the Strategic Active Pharmaceutical Ingredient Reserve. The Department of Health and Human Services (HHS) must annually publish a public list of essential generic medicines that are medically necessary to have available at all times. HHS must report and implement a plan to establish the reserve, which must be designed to minimize the impact of an interruption or reduction in imports of (1) key starting materials (including active pharmaceutical ingredients) for essential generic medicines, and (2) finished dosage forms of essential generic medicines for which key starting materials are not imported. The plan must also contain provisions to strengthen domestic capacity for active pharmaceutical ingredient production, storage, and conversion. Within one year of this bill's enactment, the plan must include at least 25 of the essential generic medicines on the required list. The plan must add at least 25 medicines each year until the full list is covered. HHS must prioritize domestically manufactured key starting materials for the reserve to the maximum extent possible. A manufacturer of an essential generic medicine that switches to an active pharmaceutical ingredient sourced through the reserve shall not have to update the approved application for that medicine. The Government Accountability Office must report to Congress on active pharmaceutical ingredient manufacturing, including the time and costs needed to develop domestic manufacturing capabilities.
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Timeline

Bill from Previous Congress

S 116-4699
PREPARE Act
Sep 14, 2021
Introduced in Senate
Sep 14, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Nov 1, 2022

Latest Companion Bill Action

HR 117-7513
Referred to the Subcommittee on Crime, Terrorism, and Homeland Security.
  • Bill from Previous Congress

    S 116-4699
    PREPARE Act


  • September 14, 2021
    Introduced in Senate


  • September 14, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • November 1, 2022

    Latest Companion Bill Action

    HR 117-7513
    Referred to the Subcommittee on Crime, Terrorism, and Homeland Security.

Health

Related Bills

  • HR 117-5388: PREPARE ACT of 2021
Child healthCongressional oversightDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careGovernment information and archivesGovernment studies and investigationsHealth technology, devices, suppliesManufacturingPrescription drugsPublic contracts and procurementPublic-private cooperationStrategic materials and reserves

PREPARE Act

USA117th CongressS-2740| Senate 
| Updated: 9/14/2021
Promoting Readiness and Ensuring Proper Active pharmaceutical ingredient Reserves of Essential medicines Act of 2021 or the PREPARE Act This bill establishes the Strategic Active Pharmaceutical Ingredient Reserve. The Department of Health and Human Services (HHS) must annually publish a public list of essential generic medicines that are medically necessary to have available at all times. HHS must report and implement a plan to establish the reserve, which must be designed to minimize the impact of an interruption or reduction in imports of (1) key starting materials (including active pharmaceutical ingredients) for essential generic medicines, and (2) finished dosage forms of essential generic medicines for which key starting materials are not imported. The plan must also contain provisions to strengthen domestic capacity for active pharmaceutical ingredient production, storage, and conversion. Within one year of this bill's enactment, the plan must include at least 25 of the essential generic medicines on the required list. The plan must add at least 25 medicines each year until the full list is covered. HHS must prioritize domestically manufactured key starting materials for the reserve to the maximum extent possible. A manufacturer of an essential generic medicine that switches to an active pharmaceutical ingredient sourced through the reserve shall not have to update the approved application for that medicine. The Government Accountability Office must report to Congress on active pharmaceutical ingredient manufacturing, including the time and costs needed to develop domestic manufacturing capabilities.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

S 116-4699
PREPARE Act
Sep 14, 2021
Introduced in Senate
Sep 14, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Nov 1, 2022

Latest Companion Bill Action

HR 117-7513
Referred to the Subcommittee on Crime, Terrorism, and Homeland Security.
  • Bill from Previous Congress

    S 116-4699
    PREPARE Act


  • September 14, 2021
    Introduced in Senate


  • September 14, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • November 1, 2022

    Latest Companion Bill Action

    HR 117-7513
    Referred to the Subcommittee on Crime, Terrorism, and Homeland Security.
Sherrod Brown

Sherrod Brown

Democratic Senator

Ohio

Cosponsors (6)
Bill Cassidy (Republican)Marsha Blackburn (Republican)Mark R. Warner (Democratic)Robert P. Casey (Democratic)Tim Kaine (Democratic)Shelley Moore Capito (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 117-5388: PREPARE ACT of 2021
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Child healthCongressional oversightDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careGovernment information and archivesGovernment studies and investigationsHealth technology, devices, suppliesManufacturingPrescription drugsPublic contracts and procurementPublic-private cooperationStrategic materials and reserves