Legis Daily

PREPARE ACT of 2024

USA118th CongressHR-7709| House 
| Updated: 3/22/2024
Abigail Davis Spanberger

Abigail Davis Spanberger

Democratic Representative

Virginia

Cosponsors (1)
Don Bacon (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines Act of 2024 or the PREPARE ACT of 2024 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

HR 116-4347
PREPARE Act of 2019

Bill from Previous Congress

HR 116-7552
PREPARE Act

Bill from Previous Congress

HR 117-7513
PREPARE Act of 2022

Bill from Previous Congress

HR 117-9179
PREPARE Act of 2022

Bill from Previous Congress

HR 117-5388
PREPARE ACT of 2021

Bill from Previous Congress

HR 117-3207
PREPARE Act

Bill from Previous Congress

HR 117-834
PREPARE Act

Bill from Previous Congress

HR 115-4177
PREPARE Act of 2017
Jul 27, 2023

Latest Companion Bill Action

S 118-2650
Introduced in Senate
Mar 15, 2024
Introduced in House
Mar 15, 2024
Referred to the House Committee on Energy and Commerce.
Mar 22, 2024
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-4347
    PREPARE Act of 2019


  • Bill from Previous Congress

    HR 116-7552
    PREPARE Act


  • Bill from Previous Congress

    HR 117-7513
    PREPARE Act of 2022


  • Bill from Previous Congress

    HR 117-9179
    PREPARE Act of 2022


  • Bill from Previous Congress

    HR 117-5388
    PREPARE ACT of 2021


  • Bill from Previous Congress

    HR 117-3207
    PREPARE Act


  • Bill from Previous Congress

    HR 117-834
    PREPARE Act


  • Bill from Previous Congress

    HR 115-4177
    PREPARE Act of 2017


  • July 27, 2023

    Latest Companion Bill Action

    S 118-2650
    Introduced in Senate


  • March 15, 2024
    Introduced in House


  • March 15, 2024
    Referred to the House Committee on Energy and Commerce.


  • March 22, 2024
    Referred to the Subcommittee on Health.

Health

PREPARE ACT of 2024

USA118th CongressHR-7709| House 
| Updated: 3/22/2024
Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines Act of 2024 or the PREPARE ACT of 2024 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

HR 116-4347
PREPARE Act of 2019

Bill from Previous Congress

HR 116-7552
PREPARE Act

Bill from Previous Congress

HR 117-7513
PREPARE Act of 2022

Bill from Previous Congress

HR 117-9179
PREPARE Act of 2022

Bill from Previous Congress

HR 117-5388
PREPARE ACT of 2021

Bill from Previous Congress

HR 117-3207
PREPARE Act

Bill from Previous Congress

HR 117-834
PREPARE Act

Bill from Previous Congress

HR 115-4177
PREPARE Act of 2017
Jul 27, 2023

Latest Companion Bill Action

S 118-2650
Introduced in Senate
Mar 15, 2024
Introduced in House
Mar 15, 2024
Referred to the House Committee on Energy and Commerce.
Mar 22, 2024
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-4347
    PREPARE Act of 2019


  • Bill from Previous Congress

    HR 116-7552
    PREPARE Act


  • Bill from Previous Congress

    HR 117-7513
    PREPARE Act of 2022


  • Bill from Previous Congress

    HR 117-9179
    PREPARE Act of 2022


  • Bill from Previous Congress

    HR 117-5388
    PREPARE ACT of 2021


  • Bill from Previous Congress

    HR 117-3207
    PREPARE Act


  • Bill from Previous Congress

    HR 117-834
    PREPARE Act


  • Bill from Previous Congress

    HR 115-4177
    PREPARE Act of 2017


  • July 27, 2023

    Latest Companion Bill Action

    S 118-2650
    Introduced in Senate


  • March 15, 2024
    Introduced in House


  • March 15, 2024
    Referred to the House Committee on Energy and Commerce.


  • March 22, 2024
    Referred to the Subcommittee on Health.
Abigail Davis Spanberger

Abigail Davis Spanberger

Democratic Representative

Virginia

Cosponsors (1)
Don Bacon (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

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