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Strategic Reserve for Generic Drug Ingredients: Ensuring Constant Supply of Essential Medicines

This Act establishes a Strategic Active Pharmaceutical Ingredient (API) Reserve to secure domestic production and supply of essential generic medicines. The goal is to protect against drug shortages, especially during emergencies, by reducing reliance on foreign supply chains. The legislation aims to ensure that critical medications, defined to include antibiotics and life-supporting drugs, remain available.
Key points
Creation of the API Reserve: A reserve of key ingredients for essential generic medicines is established to prevent market shortages.
List of Essential Medicines: The Secretary will establish and annually update a public list of generic medicines that must be available at all times, including those for pediatric populations.
Support for Domestic Production: The Act mandates prioritizing the purchase of ingredients and contracting with domestic manufacturers to strengthen U.S. production capacity.
Facilitated Source Changes: Holders of approved drug applications may change their ingredient source to the Reserve without requiring a prior application update with the FDA, expediting the process.
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Additional Information
Print number: 118_HR_7709
Sponsor: Rep. Spanberger, Abigail Davis [D-VA-7]
Process start date: 2024-03-15
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Summarized by: gemini-3-pro-preview
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

PREPARE ACT of 2024

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_HR_7709.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2024-03-15.

What are the main provisions?

Key points include:

  • Creation of the API Reserve: A reserve of key ingredients for essential generic medicines is established to prevent market shortages.
  • List of Essential Medicines: The Secretary will establish and annually update a public list of generic medicines that must be available at all times, including those for pediatric populations.
  • Support for Domestic Production: The Act mandates prioritizing the purchase of ingredients and contracting with domestic manufacturers to strengthen U.S. production capacity.
  • Facilitated Source Changes: Holders of approved drug applications may change their ingredient source to the Reserve without requiring a prior application update with the FDA, expediting the process.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Rep. Spanberger, Abigail Davis [D-VA-7].

What is the latest detailed status?

The latest detailed status is: Referred to the Subcommittee on Health.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-30.

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Health Security Economy