Directs the Secretary of Health and Human Services to contract with eligible companies to create and hold domestic reserves of critical drugs and their active pharmaceutical ingredients (APIs), strengthen U.S. production capacity, and require those companies to replenish and produce drugs on the Secretary’s direction during shortages. The Secretary must issue selection and program guidance within 180 days, report to Congress every two years after the first award, and the program is authorized $500,000,000 for fiscal year 2026.
Authorize the Secretary of Health and Human Services to award contracts or cooperative agreements to eligible entities for drugs and active pharmaceutical ingredients that the Secretary determines are critical and have vulnerable supply chains; the Secretary must publish the list of such drugs and APIs.
Require an eligible entity under a contract or cooperative agreement to maintain, in a satisfactory domestic establishment registered under section 510(b) of the Federal Food, Drug, and Cosmetic Act or a satisfactory foreign establishment registered under section 510(i) located in an OECD country, a 6-month reserve or other reasonable quantity (as determined by the Secretary) of: (i) the active pharmaceutical ingredient of the eligible drug, regularly replenished with recently manufactured supply; and (ii) the finished eligible drug product, regularly replenished with recently manufactured supply.
Require participating entities to implement production of the eligible drug or its API at the direction of the Secretary, in the quantities and under the terms specified in the contract or cooperative agreement.
Require eligible entities to enter an arrangement with the Secretary to (i) transfer a portion of the API reserve to another manufacturer if the Secretary finds additional finished product is needed and the entity cannot use its reserve to meet the need, and (ii) permit the Secretary to direct allocation of the API reserve during a public health emergency, natural disaster, or chemical, biological, radiological, or nuclear threat.
Require the Secretary, in coordination with the Commissioner of Food and Drugs, to issue guidance not later than 180 days after the date of enactment on: (A) factors for determining which drugs/APIs have vulnerable supply chains and how agreements would reduce vulnerability; (B) factors for determining entity eligibility (including commitment to quality systems, domestic manufacturing capacity, and surge capacity); and (C) requirements for award recipients (including excess manufacturing capacity, redundancy, and advanced quality systems).
Who is affected and how:
Broader effects and tradeoffs:
RAPID Reserve Act
Updated 4 days ago
Last progress June 12, 2025 (8 months ago)
Referred to the House Committee on Energy and Commerce.
Last progress June 12, 2025 (8 months ago)
Introduced on June 12, 2025 by Angela Craig