HR3955-119

What This Bill Does

The RAPID Reserve Act creates a rolling reserve for critical drugs and active pharmaceutical ingredients. HHS must award contracts or cooperative agreements for drugs and APIs that HHS determines are critical and have vulnerable supply chains, and must publish the list. Eligible entities must maintain a six-month reserve, or another reasonable quantity set by HHS, of both the API and finished eligible drug product. The reserve must be kept in a satisfactory domestic establishment registered with FDA or in a satisfactory registered foreign establishment located in an OECD country. The establishment may be owned by the entity or by a wholesaler, distributor, or third party under contract. The reserve must be regularly replenished with recently manufactured supply so stock does not simply expire. Entities must produce the eligible drug or API at HHS direction in specified quantities and agree to transfer a portion of reserve API to another manufacturer if HHS determines more finished product is needed. The bill is aimed at drug shortages by paying manufacturers or supply-chain partners to keep usable, rotating inventories and surge capacity for selected critical medicines.

Who Benefits and How

Patients relying on critical drugs benefit from a reserve intended to reduce shortages of vulnerable medicines. Critical drug manufacturers benefit from federal contracts or cooperative agreements to maintain reserve supply and surge production. Active pharmaceutical ingredient suppliers benefit if HHS selects their products for reserve contracts. Hospitals facing shortages benefit if reserve stocks and API transfers help stabilize supply. FDA-registered domestic establishments benefit because they are preferred reserve locations.

Who Bears the Burden and How

HHS supply-chain staff must identify critical drugs and APIs, publish lists, award agreements, and direct reserve use. Eligible reserve contractors must maintain, rotate, document, and replenish six-month reserves of API and finished products. Wholesalers and distributors under contract must meet HHS reserve and transfer requirements. Federal taxpayers bear the cost of contracts or cooperative agreements for the reserve. Manufacturers receiving reserve API may need to produce additional finished drugs when HHS determines a need.

Key Provisions

• Requires HHS contracts or cooperative agreements for critical drugs and APIs with vulnerable supply chains.
• Requires HHS to publish the covered drug and API list.
• Requires a six-month or HHS-determined reserve of API and finished drug product.
• Limits reserve locations to satisfactory FDA-registered domestic establishments or OECD-country foreign establishments.
• Requires regular replenishment with recently manufactured supply.
• Directs entities to produce drugs or APIs at HHS direction and transfer reserve API when additional finished product is needed.