On August 13, 2025, President Trump signed the Executive Order “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve” (SAPIR). The measure directs the HHS’ Assistant Secretary for Preparedness and Response (ASPR) to take several steps to bolster national pharmaceutical preparedness and reduce dependence on foreign Active Pharmaceutical Ingredient (API) supply. While many agree the Order is a step in the right direction, it will face political and economic challenges. 

The Order states that of all APIs used in U.S. prescription drugs, only about 10% are produced domestically, leaving the nation vulnerable to supply chain disruptions. Stockpiling APIs—which have lower cost and longer shelf life than finished drugs—is seen as a cost-effective preparedness step. 

Providing a timeline for building up resilience, the Order mandates: 

  • Within 30 days: ASPR must compile a list of approximately 26 drugs deemed critical to national health and security, and conduct an accounting of existing funds, forwarding both to the Office of Management and Budget (OMB) for funding support.  
  • Within 120 days: Subject to available funding, ASPR shall prepare the existing SAPIR repository so it can begin to stockpile APIs.  
  • Within 30 days of readiness: ASPR must stock the repository with a six-month supply of APIs for the identified critical drugs, preferably sourced domestically.  
  • Within 90 days: ASPR must update its 2022 list of 86 essential medicines and submit a plan to secure a six-month API supply for those not already included in the initial 26. This plan must include proposals and cost estimates for a second SAPIR repository to be established within a year. 

The Order is likely to face some headwinds, since building up stockpiles would require appropriations from Congress. Experts also point out that scaling domestic API production may face barriers related to manufacturing capacity, cost competitiveness, regulatory hurdles and supply chain logistics. Simply designating APIs as critical and funding stockpiles may not ensure new production unless sufficient incentives and infrastructure are mobilized.