Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve

The order directs the Office of the Assistant Secretary for Preparedness and Response (ASPR) within HHS to develop a list of approximately 26 especially critical drugs and identify available funds to finance the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) within 30 days. ASPR must then ready the existing SAPIR repository to receive APIs within 120 days, and obtain a six-month supply of APIs for those critical drugs — with a preference for domestically manufactured APIs — placing them in the repository within 30 days of the facility being certified ready. OMB is directed to help HHS repurpose available funds for these activities.

Separately, within 90 days ASPR must update its 2022 list of 86 essential medicines and provide a broader plan to obtain, store, and maintain a six-month supply of APIs for all drugs on that list. That plan must also include a proposal and cost estimate for opening a second SAPIR repository somewhere in the United States within one year of the order. Implementation is subject to the availability of appropriations throughout.

Federal health preparedness officials at ASPR and HHS who must execute the procurement and storage plan; OMB, which is tasked with facilitating fund repurposing; domestic API manufacturers who may benefit from a preference for U.S.-made ingredients in government purchases; and ultimately American patients whose access to critical medicines depends on supply-chain resilience.

If the SAPIR is successfully filled, the U.S. government would hold a six-month buffer of pharmaceutical building blocks for its most critical medicines, reducing dependence on foreign suppliers during a health emergency, trade disruption, or geopolitical crisis. Domestic API manufacturers could see increased federal demand.

Implementation unfolds in three overlapping tracks. First, ASPR identifies critical drugs and available funding within 30 days, then readies the repository within 120 days, then places APIs inside within 30 days of certification — creating a sequential chain where funding identification gates everything downstream. Simultaneously, a 90-day track requires ASPR to update the broader essential medicines list and propose a second repository. OMB plays a facilitating role for fund repurposing. No new appropriation is created; all actions are explicitly contingent on funds availability, giving OMB leverage over pace and scope.