RAPID Reserve Act
The Rolling Active Pharmaceutical Ingredient and Drug Reserve Act (RAPID Reserve Act) would task the Secretary of Health and Human Services with creating a rolling reserve program for drugs and their active pharmaceutical ingredients (APIs) that have vulnerable supply chains. The Secretary would select eligible entities to maintain at least a six-month reserve of both the API and the finished drug for these “eligible drugs,” stored in domestic facilities or in certain OECD-country facilities under contract. The program requires ongoing production of the drug and/or its API as directed by the Secretary, and includes a mechanism for transferring API reserves or directing allocation during emergencies. The act emphasizes domestic production capacity, offers guidance on eligibility and program requirements within 180 days of enactment, and provides a preference for domestic sources and facilities. It also authorizes funding ($500 million for FY 2026) and requires Congress reporting every two years on the list of eligible drugs and the program’s effectiveness.
Key Points
- 1Establishes a rolling reserve program for drugs with vulnerable supply chains, requiring six-month reserves of both API and finished products, stored in compliant domestic or OECD-registered facilities.
- 2Requires entities under contract to maintain reserves, produce drugs or APIs as directed, and enter into arrangements to transfer API or allocate reserves during emergencies or shortages.
- 3Creates a process for rapid guidance within 180 days on how to determine vulnerable supply chains, eligibility criteria for entities, and award requirements (capacity, redundancy, quality systems).
- 4Gives preference to domestic manufacturing and sourcing (where feasible) and aims to strengthen U.S. domestic surge capacity and resilience for critical drugs and APIs.
- 5Authorizes $500 million for FY 2026 and requires Congress to receive biennial reports on eligible drugs, rationale, and program effectiveness.