Strengthening the Resilience of America's Pharmaceutical Supply Chain through Stockpiling Critical Pharmaceutical Ingredients
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The Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), established during the Trump administration in 2020 to stockpile essential APIs (active pharmaceutical ingredients), is currently being actively filled and expanded as of August 2025. This expansion is being driven by a new Executive Order signed by Donald J. Trump on August 13, 2025.
The order directs the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services to:
- Develop a list of approximately 26 critical drugs vital to U.S. health and security.
- Obtain and maintain a six-month supply of APIs for these drugs in the SAPIR, with a preference for domestically manufactured APIs.
- Update the previous 2022 list of 86 essential medicines and propose plans to stockpile APIs for these medicines.
- Explore opening a second SAPIR repository to enhance pharmaceutical supply chain resilience.
Regarding the Biden administration's approach, available data indicates that former President Trump criticized the Biden administration for leaving the SAPIR "nearly empty," suggesting limited active stockpiling had occurred under Biden. The recent 2025 Executive Order by Trump aims to accelerate filling the SAPIR with a clear preference for sourcing APIs domestically to reduce reliance on foreign manufacturing.
No specific new Biden administration initiatives are mentioned in these search results regarding direct steps to ensure domestic sources for essential medicines and their precursors. However, the Trump 2025 Executive Order appears to build on and revive efforts originally begun in the Trump administration, focusing heavily on domestic production and onshoring APIs to safeguard against global supply chain disruptions.
Stockpiling APIs is advantageous as they are generally lower-cost and have longer shelf lives than the finished drug products they make. Nearly two in five prescription finished drug products are made in the U.S., but only about 10 percent of the Active Pharmaceutical Ingredients (APIs) by volume for the finished drug products used in the U.S. are made domestically.
In summary:
| Aspect | Status / Details (as of August 2025) | |------------------------------------|--------------------------------------------------------------------| | SAPIR Status | Being filled with 6 months’ supply of critical APIs | | Management | ASPR tasked with API stockpiling and repository readiness | | Domestic sourcing preference | Strong emphasis on acquiring APIs from U.S. manufacturers | | Expansion plans | Proposal for a second SAPIR repository underway | | Biden administration involvement | Criticized by Trump for limited activity; no detailed Biden plans noted in sources |
- Enhancing the health-and-wellness sector, the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) under the Department of Health and Human Services is being actively filled with critical APIs, focusing on a six-month supply and a preference for domestic production to reduce reliance on foreign manufacturing.
- To support the financial sustainability of the health sector, the Trump 2025 Executive Order aims to build on earlier initiatives by strengthening domestic production of Active Pharmaceutical Ingredients (APIs), favoring onshoring, and promoting stockpiling, as APIs are cost-effective and have longer shelf lives than finished drug products.
