White House directs HHS to rebuild strategic API stockpile and identify 26 critical medicines

An August 13 executive order instructs federal health officials to list approximately 26 “especially critical” drugs and begin stockpiling six months of their active pharmaceutical ingredients in the Strategic Active Pharmaceutical Ingredients Reserve.

Date: August 25, 2025

Summary

The White House directed the Department of Health and Human Services to prioritize a strategic stockpile of active pharmaceutical ingredients for especially critical medicines. The Assistant Secretary for Preparedness and Response will create a list of about 26 critical drugs, begin stockpiling their ingredients in the national reserve, and prepare plans for a second storage site. Funding will come from repurposed dollars coordinated with the Office of Management and Budget.

What happened

An August 13 Executive Order on pharmaceutical supply chain resilience instructs ASPR to compile a list of approximately 26 drugs that are “especially critical” to national health and security.
Within 90 days after finalizing that list, ASPR must begin stockpiling the drugs’ active pharmaceutical ingredients (APIs) in the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR).
Subject to available funds, ASPR is to obtain a six-month supply of APIs for the critical drugs, with a preference for domestically manufactured APIs where possible.
ASPR must also develop plans for a second SAPIR repository in the United States.

Funding and oversight

ASPR will provide an accounting of existing, available funds that can be used to open or expand SAPIR and to maintain the six-month API supply.
The package, including the critical-drugs list and funding details, goes to OMB, which will help repurpose available funds to carry out the effort.

Timeline and responsibilities

List of critical medicines: ASPR compiles the list and consults with FDA, the Assistant to the President for Economic Policy (APEP), the Assistant to the President and Homeland Security Advisor (APHSA), and other agencies.
Stockpiling start: Within 90 days of the list, begin filling SAPIR with APIs for those drugs.
Essential medicines update: Within 90 days, ASPR will update the essential medicines list and develop a stockpile plan for those products.
Ongoing supply: Maintain a six-month API supply for medicines on the updated essential list that are not already covered by the 26-drug critical list.
Second site plan: Within one year, submit a proposal and cost estimate to open a second SAPIR repository in the US.

Context

SAPIR was created by executive order in 2020. The new order states the reserve is “nearly empty.”
The administration says it does not plan to finalize or implement prior drug shortage policies drafted under the previous administration.
The White House has stated goals to increase domestic pharmaceutical production. Related actions include tariff threats to encourage onshoring and FDA policies intended to streamline manufacturing clearances for companies moving production to the US.

Related development

The executive order coincided with an HHS announcement highlighting On Demand Pharmaceuticals, an ASPR-funded company, and its centralized production and repackaging facility and modular manufacturing unit.

Key numbers and dates

26: Approximate number of drugs to be named “especially critical.”
6 months: Target API supply per drug for SAPIR, subject to available funds.
90 days: Start stockpiling after the list is finalized.
90 days: Update the essential medicines list and plan for stockpiling.
1 year: Proposal and cost estimate for a second SAPIR repository.
2020: Year SAPIR was created.

What to watch next

Publication of the 26-drug critical list and the updated essential medicines list.
OMB funding decisions to repurpose dollars for purchasing and storage.
Initial API purchases toward the six-month target and any domestic sourcing moves.
The plan and timeline for establishing a second SAPIR site.

Source: US Strategic Reserve Bulking Up: New Order Focuses On API Stockpile

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