I 
119TH CONGRESS 
1ST SESSION H. R. 3955 
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 
JUNE 12, 2025 
Ms. CRAIG (for herself and Mr. VAN DREW) 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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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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drug manufacturer in the event that the 
Secretary determines there to be a need for 
additional finished eligible drug product 
and such eligible entity is unable to use the 
reserve of active pharmaceutical ingredient 
to manufacture a sufficient supply of such 
drug product; and 
(ii) permits the Secretary to direct al-
location of the reserve of active pharma-
ceutical ingredient so maintained in the 
event of a public health emergency, natural 
disaster, or chemical, biological, radio-
logical, or nuclear threat. 
(2) GUIDANCE.—Not later than 180 days after 
the date of enactment of this Act, the Secretary, in 
coordination with the Commissioner of Food and 
Drugs, shall issue guidance on— 
(A) the factors the Secretary will use to 
determine which eligible drugs, or active phar-
maceutical ingredient of such drugs, have vul-
nerable supply chains and how a contract or co-
operative agreement would help minimize the 
vulnerability or vulnerabilities identified; 
(B) the factors the Secretary will consider 
in determining eligibility of an entity to partici-
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pate in the program under this section, which 
shall include an entity’s commitment to quality 
systems, including strong manufacturing infra-
structure, reliable processes, and trained staff, 
as well as the entity’s commitment to domestic 
manufacturing capacity and surge capacity, as 
appropriate; and 
(C) requirements for entities receiving an 
award under this section, including the extent 
of excess manufacturing capacity the manufac-
turers will be required to generate, the amount 
of redundancy required, and requirements relat-
ing to advanced quality systems. 
(3) PREFERENCE.—In awarding contracts and 
cooperative agreements under subsection (a), the 
Secretary shall— 
(A) give preference to eligible entities that 
will— 
(i) carry out the requirements of 
paragraph (1) through one or more domes-
tic establishments registered under section 
510(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(b)) capable 
of manufacturing the eligible drug; or 
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(ii) source key starting materials or 
excipients for eligible drugs domestically or 
from a country that is a member of the 
Organisation for Economic Cooperation 
and Development; and 
(B) to the greatest extent practicable, 
award such contracts and cooperative agree-
ments in a manner that strengthens domestic 
manufacturing, resiliency, and capacity of eligi-
ble drugs and their active pharmaceutical ingre-
dients. 
(c) ADDITIONAL
CONTRACT
AND
COOPERATIVE 
AGREEMENT TERMS.— 
(1) IN GENERAL.—Each contract or cooperative 
agreement under subsection (a) shall be subject to 
such terms and conditions as the Secretary may 
specify, including terms and conditions with respect 
to procurement, maintenance, storage, testing, and 
delivery of drugs, in alignment with inventory man-
agement and other applicable best practices, under 
such contract or cooperative agreement, which may 
consider, as appropriate, costs of transporting and 
handling such drugs. 
(2) TERMS
CONCERNING
THE
ACQUISITION, 
CONSTRUCTION, ALTERATION, OR RENOVATION OF 
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ESTABLISHMENTS.—Notwithstanding section 6303 
of title 41, United States Code, the Secretary may 
award a contract or cooperative agreement under 
this section to support the acquisition, construction, 
alteration, or renovation of non-federally owned es-
tablishments— 
(A) as determined necessary to carry out 
or improve preparedness and response capa-
bility at the State and local level; or 
(B) for the production of drugs, devices, 
and supplies where the Secretary determines 
that such a contract or cooperative agreement 
is necessary to ensure sufficient amounts of 
such drugs, devices, and supplies. 
(d) REQUIREMENTS IN AWARDING CONTRACTS.—To 
the greatest extent practicable, the Secretary shall award 
contracts and cooperative agreements under this section 
in a manner that— 
(1) maximizes quality, minimizes cost, mini-
mizes vulnerability of the United States to severe 
shortages or disruptions for eligible drugs and their 
active pharmaceutical ingredients, gives preference 
to domestic manufacturers, and encourages competi-
tion in the marketplace; and 
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(2) increases domestic production surge capac-
ity and reserves of domestic-based manufacturing es-
tablishments for critical drugs and active pharma-
ceutical ingredients of such drugs. 
(e) DEFINITIONS.—In this section: 
(1) ACTIVE PHARMACEUTICAL INGREDIENT.— 
The term ‘‘active pharmaceutical ingredient’’ has the 
meaning given such term in section 744A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–41). 
(2) DRUG.—The term ‘‘drug’’ has the meaning 
given such term in section 201(g) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)). 
(3) DRUG
SHORTAGE; SHORTAGE.—The term 
‘‘drug shortage’’ or ‘‘shortage’’ has the meaning 
given such term in section 506C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356c). 
(4) ELIGIBLE DRUG.—The term ‘‘eligible drug’’ 
means a drug, as determined by the Secretary, in 
coordination with the Assistant Secretary for Pre-
paredness and Response, the Director of the Centers 
for Disease Control and Prevention, and the Com-
missioner of Food and Drugs— 
(A) that is approved under section 505(j) 
of the Federal Food, Drug, and Cosmetic Act 
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(21 U.S.C. 355(j)) or licensed under section 
351(k) of the Public Health Service Act (42 
U.S.C. 262(k)); 
(B)(i) that is reasonably likely to be re-
quired to respond to a public health emergency 
or to a chemical, biological, radiological, or nu-
clear threat; or 
(ii) the shortage of which would pose a sig-
nificant threat to the United States health care 
system or at-risk populations; and 
(C) that has a vulnerable supply chain, 
such as a geographic concentration of manufac-
turing, poor quality or safety issues, complex 
manufacturing or chemistry, or few manufac-
turers. 
(5) ELIGIBLE ENTITY.—The term ‘‘eligible enti-
ty’’ means a person that— 
(A)(i) is the holder of an approved applica-
tion under subsection (j) of section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) or subsection (k) of section 351 of 
the Public Health Service Act (42 U.S.C. 262) 
for an eligible drug; 
(ii) maintains at least one domestic estab-
lishment registered under section 510(b) of the 
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Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(b)) or one foreign establishment 
registered under section 510(i) of such Act that 
is located in a country that is a member of the 
Organisation for Economic Cooperation and 
Development that is capable of manufacturing 
the eligible drug; and 
(iii) has a strong record of good manufac-
turing practices of drugs; 
(B)(i) is a manufacturer of an active phar-
maceutical ingredient for an eligible drug, in 
partnership with an entity that meets the re-
quirements of subparagraph (A); 
(ii) maintains at least one domestic estab-
lishment registered under section 510(b) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(b)) or one foreign establishment 
registered under section 510(i) of such Act that 
is located in a country that is a member of the 
Organisation for Economic Cooperation and 
Development that is capable of manufacturing 
the active pharmaceutical ingredient; and 
(iii) has a strong record of good manufac-
turing practices of active pharmaceutical ingre-
dients; or 
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(C) is a distributor or wholesaler of an eli-
gible drug, in partnership with an entity that 
meets the requirements of subparagraph (A). 
(f) REPORTS TO CONGRESS.—Not later than 2 years 
after the date on which the first award is made under this 
section, and every 2 years thereafter, the Secretary shall 
submit a report to Congress detailing— 
(1) the list of drugs determined to be eligible 
drugs, as described in subsection (e)(2), and the ra-
tionale behind selecting each such drug; and 
(2) an update on the effectiveness of the pro-
gram under this section, in a manner that does not 
compromise national security. 
(g) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$500,000,000 for fiscal year 2026. 
Æ 
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