The Rolling Active Pharmaceutical Ingredient and Drug Reserve Act, or RAPID Reserve Act, seeks to bolster the resilience of critical drug supply chains and ensure the availability of essential medications. It empowers the Secretary of Health and Human Services (HHS) to enter into contracts or cooperative agreements with eligible entities to maintain reserves of drugs and their active pharmaceutical ingredients (APIs) that are deemed critical and have vulnerable supply chains. The Secretary is tasked with publishing a list of these identified critical drugs and APIs. Participating entities are required to maintain a minimum 6-month reserve of both the API and the finished drug product, ensuring these reserves are regularly replenished with recently manufactured supplies. They must also agree to implement production at the Secretary's direction and permit the transfer or allocation of API reserves to other manufacturers or for use during public health emergencies. The Secretary will issue guidance on factors for determining vulnerable supply chains, entity eligibility, and requirements for award recipients, including commitments to quality systems and surge capacity . In awarding these contracts, the Secretary will give preference to entities that utilize domestic manufacturing establishments or source key starting materials domestically or from Organisation for Economic Co-operation and Development (OECD) countries. The program emphasizes strengthening domestic manufacturing, resiliency, and capacity to minimize the United States' vulnerability to severe drug shortages. To carry out this initiative, $500,000,000 is authorized for appropriation for fiscal year 2026.
The Rolling Active Pharmaceutical Ingredient and Drug Reserve Act, or RAPID Reserve Act, seeks to bolster the resilience of critical drug supply chains and ensure the availability of essential medications. It empowers the Secretary of Health and Human Services (HHS) to enter into contracts or cooperative agreements with eligible entities to maintain reserves of drugs and their active pharmaceutical ingredients (APIs) that are deemed critical and have vulnerable supply chains. The Secretary is tasked with publishing a list of these identified critical drugs and APIs. Participating entities are required to maintain a minimum 6-month reserve of both the API and the finished drug product, ensuring these reserves are regularly replenished with recently manufactured supplies. They must also agree to implement production at the Secretary's direction and permit the transfer or allocation of API reserves to other manufacturers or for use during public health emergencies. The Secretary will issue guidance on factors for determining vulnerable supply chains, entity eligibility, and requirements for award recipients, including commitments to quality systems and surge capacity . In awarding these contracts, the Secretary will give preference to entities that utilize domestic manufacturing establishments or source key starting materials domestically or from Organisation for Economic Co-operation and Development (OECD) countries. The program emphasizes strengthening domestic manufacturing, resiliency, and capacity to minimize the United States' vulnerability to severe drug shortages. To carry out this initiative, $500,000,000 is authorized for appropriation for fiscal year 2026.