Executive Order

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

AI Summary: This is a policy document: an executive order signed by the President addressing the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). This regulation aims to enhance domestic pharmaceutical supply chain resilience by directing the Office of the Assistant Secretary for Preparedness and Response (ASPR) to develop and implement a strategy for stockpiling Active Pharmaceutical Ingredients (APIs) for critical medicines. The order requires ASPR to identify approximately 26 critical drugs and obtain a 6-month supply of their APIs, with a preference for domestically manufactured ingredients. Within 90 days, ASPR must update its list of essential medicines and create a comprehensive plan to obtain, store, and maintain API supplies, which will include exploring the possibility of establishing a second SAPIR repository within one year. The regulation acknowledges the current low domestic production of APIs (only about 10 percent of API volume for U.S. finished drug products are made in the United States) and seeks to address supply chain vulnerabilities by encouraging domestic API production and creating a strategic reserve of essential pharmaceutical components.