By building a domestic buffer of APIs, the U.S. can reduce reliance on foreign supply chains and better guard against drug shortages, especially for medically vulnerable populations who disproportionately suffer when essential medicines are disrupted. Success will depend on equitable prioritization: if critical drugs for under-resourced communities are excluded, the policy could perpetuate disparities in medicine access.
Executive Office of the President - White House Office
A directive issued by the President that manages operations of the federal government. Executive orders have the force of law but must align with existing statutes and constitutional authority.
Who It Impacts: Federal agencies and employees, directing them on how to implement laws or carry out government functions. Executive orders can also influence businesses and individuals when they relate to issues like immigration, trade, or labor policies.
Who Is Not Impacted: Private citizens and businesses do not have to directly follow an executive order unless it leads to regulations or policies that apply to them. For example, an executive order directing federal agencies to increase renewable energy use does not mandate action from private companies, but it may influence policy shifts that eventually affect them.
Date Enacted
August 13, 2025
Last Updated
December 3, 2025
Policy Type
Healthcare Delivery, Services & Quality
Public Health
No items found.
Summary
This executive order directs HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) to stockpile a six-month supply of Active Pharmaceutical Ingredients (APIs) for approximately 26 critical drugs in a Strategic API Reserve (SAPIR), prioritizing U.S.-made ingredients. Within 90 days of the EO, the ASPR is additionally directed to develop a plan to maintain 86 essential medicines and medical countermeasures, obtaining APIs for those drugs if not already included in the list of 26 critical drugs.
Impact Analysis
Legal Challenges
N/A
Take Institutional Action
Advocate for inclusion of drugs used by underserved populations (e.g., rural, low-income, chronic-disease patients) on the SAPIR “critical drugs” list to ensure relevance to equity. Monitor which drugs are chosen, push for transparency in how the list is developed, and ensure community health needs (especially for marginalized communities) are reflected. Study and report on how API stockpiling affects drug availability and cost, especially in historically under-served patient groups.
Associated or Derivative Policies
N/A
Policy Prior to 2025
Before this order, only a small fraction (around 10%) of the APIs used in U.S. medicines were produced domestically. While there were federal strategies to identify API vulnerabilities, there was no fully operational stockpile for critical APIs.
Additional Resources
API Innovation Center: White Paper: Building a Resilient Domestic Drug Supply Chain: https://apicenter.org/press-release/white-paper-building-a-resilient-domestic-drug-supply-chain
.png)
