A new executive order (EO) signed on Aug. 13 targets the domestic production of essential medications and identifies supply chain vulnerabilities through the Strategic Active Pharmaceutical Ingredient Reserve (SAPIR).
The EO directs the Administration for Strategic Preparedness and Response (ASPR) to develop a list of 26 medications critical to national health and security within 30 days and to ready the repository to receive them within 120 days. ASPR plans to purchase six months’ supply of API for drugs designated as critical.
“ASHP applauds this executive order to enhance the security of our nation’s drug supply chains and reduce our dependence on API from foreign sources that may present a national security risk,” said Tom Kraus, ASHP vice president of government relations. “Creating an API stockpile is a step in the right direction to provide domestic manufacturers and compounders with access to essential ingredients in the event of a drug shortage or supply chain disruption.”
The EO also instructs ASPR to utilize the existing critical medications list to identify additional APIs, particularly those that can be sourced domestically, that should be included in the SAPIR repository.
ASHP has repeatedly raised concerns regarding national security risks associated with threats to API access.
“Pharmacists must be engaged in development of the API stockpile and other supply chain efforts to ensure appropriate ingredients are included,” Kraus added.
As implementation of the EO progresses, ASHP will work with the administration to ensure that the SAPIR repository is built with pharmacists’ expertise and input. ASHP also continues to advocate with both federal agencies and Congress for adoption of other supply chain solutions.
