PREPARE ACT of 2021

Summary

Promoting Readiness and Ensuring Proper Active pharmaceutical ingredient Reserves of Essential medicines Act of 2021 or the PREPARE Act of 2021 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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 27 September 2021

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 27 September 2021

   Introduced

   Introduced in House

   Source: IntroReferral

3. 27 September 2021

   Introduced

   Introduced in House

   Source: IntroReferral

4. 28 September 2021

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 27 September 2021 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 27 September 2021

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 27 September 2021

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 27 September 2021

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Spanberger, Abigail Davis [D-VA-7] · D · Sponsor
• Rep. McKinley, David B. [R-WV-1] · R · Sponsor
• Rep. Wild, Susan [D-PA-7] · D · Cosponsor
• Rep. Ryan, Tim [D-OH-13] · D · Cosponsor
• Colin Allred · D · Cosponsor
• Rep. Dean, Madeleine [D-PA-4] · D · Cosponsor
• Rep. Bacon, Don [R-NE-2] · R · Cosponsor
• Rep. Houlahan, Chrissy [D-PA-6] · D · Cosponsor
• Rep. Fitzpatrick, Brian K. [R-PA-1] · R · Cosponsor
• Rep. Costa, Jim [D-CA-21] · D · Cosponsor
• Rep. Gottheimer, Josh [D-NJ-5] · D · Cosponsor
• Rep. Schrader, Kurt [D-OR-5] · D · Cosponsor
• Carolyn Bourdeaux · D · Cosponsor
• Rep. Case, Ed [D-HI-1] · D · Cosponsor
• Rep. Higgins, Brian [D-NY-26] · D · Cosponsor
• Rep. Carson, André [D-IN-7] · D · Cosponsor
• · hsif00 · Standing

Related records

• related to → PREPARE ACT of 2024
• related to → PREPARE Act