I 
118TH CONGRESS 
1ST SESSION H. R. 6802 
To improve supply chain resiliency for critical drug products with vulnerable 
supply chains and ensure that reserves of critical drugs and active 
pharmaceutical ingredients are maintained to prevent supply disruptions 
in the event of drug shortages or public health emergencies. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 14, 2023 
Ms. CRAIG (for herself, Mr. VAN DREW, and Ms. SPANBERGER) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 
A BILL 
To improve supply chain resiliency for critical drug products 
with vulnerable supply chains and ensure that reserves 
of critical drugs and active pharmaceutical ingredients 
are maintained to prevent supply disruptions in the event 
of drug shortages or public health emergencies. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Rolling Active Pharma-
ceutical Ingredient and Drug Reserve Act’’ or the 
‘‘RAPID Reserve Act’’. 
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SEC. 2. ROLLING ACTIVE PHARMACEUTICAL INGREDIENT 
AND DRUG RESERVE. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall award contracts or cooperative agreements 
to eligible entities with respect to drugs and active phar-
maceutical ingredients of such drugs that the Secretary 
determines to be critical and to have vulnerable supply 
chains. The Secretary shall publish the list of such drugs 
and active pharmaceutical ingredients of such drugs. 
(b) REQUIREMENTS.— 
(1) IN GENERAL.—An eligible entity, pursuant 
to a contract or cooperative agreement under sub-
section (a), shall agree to— 
(A) maintain, in a satisfactory domestic es-
tablishment registered under section 510(b) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(b)) or in a satisfactory foreign es-
tablishment registered under section 510(i) of 
such Act that is located in a country that is a 
member of the Organisation for Economic Co-
operation and Development, which may be an 
establishment owned and operated by the enti-
ty, or by a wholesaler, distributor, or other 
third party under contract with the entity, a 6- 
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H6802
month reserve, or other reasonable quantity, as 
determined by the Secretary, of— 
(i) the active pharmaceutical ingre-
dient of the eligible drug specified in the 
contract or cooperative agreement, which 
reserve shall be regularly replenished with 
a recently manufactured supply of such in-
gredient; and 
(ii) the finished eligible drug product 
specified in the contract or cooperative 
agreement, which reserve shall be regularly 
replenished with a recently manufactured 
supply of such product; 
(B) implement production of the eligible 
drug or an active pharmaceutical ingredient of 
the eligible drug, at the direction of the Sec-
retary, under the terms of, and in such quan-
tities as specified in, the contract or cooperative 
agreement; and 
(C) enter into an arrangement with the 
Secretary under which the eligible entity— 
(i) agrees to transfer a portion, as de-
termined necessary, of the reserve of active 
pharmaceutical ingredient maintained pur-
suant to subparagraph (A)(i) to another 
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