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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Rolling Active Pharma5 ceutical Ingredient and Drug Reserve Act’’ or the 

6 ‘‘RAPID Reserve Act’’. 

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1 SEC. 2. ROLLING ACTIVE PHARMACEUTICAL INGREDIENT 

2 AND DRUG RESERVE. 

3 (a) IN GENERAL.—The Secretary of Health and 

4 Human Services (referred to in this section as the ‘‘Sec5 retary’’) shall award contracts or cooperative agreements 

6 to eligible entities with respect to drugs and active phar7 maceutical ingredients of such drugs that the Secretary 

8 determines to be critical and to have vulnerable supply 

9 chains. The Secretary shall publish the list of such drugs 

10 and active pharmaceutical ingredients of such drugs. 

11 (b) REQUIREMENTS.— 

12 (1) IN GENERAL.—An eligible entity, pursuant 

13 to a contract or cooperative agreement under sub14 section (a), shall agree to— 

15 (A) maintain, in a satisfactory domestic es16 tablishment registered under section 510(b) of 

17 the Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 360(b)) or in a satisfactory foreign es19 tablishment registered under section 510(i) of 

20 such Act that is located in a country that is a 

21 member of the Organisation for Economic Co22 operation and Development, which may be an 

23 establishment owned and operated by the enti24 ty, or by a wholesaler, distributor, or other 

25 third party under contract with the entity, a 6- 

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1 month reserve, or other reasonable quantity, as 

2 determined by the Secretary, of— 

3 (i) the active pharmaceutical ingre4 dient of the eligible drug specified in the 

5 contract or cooperative agreement, which 

6 reserve shall be regularly replenished with 

7 a recently manufactured supply of such in8 gredient; and 

9 (ii) the finished eligible drug product 

10 specified in the contract or cooperative 

11 agreement, which reserve shall be regularly 

12 replenished with a recently manufactured 

13 supply of such product; 

14 (B) implement production of the eligible 

15 drug or an active pharmaceutical ingredient of 

16 the eligible drug, at the direction of the Sec17 retary, under the terms of, and in such quan18 tities as specified in, the contract or cooperative 

19 agreement; and 

20 (C) enter into an arrangement with the 

21 Secretary under which the eligible entity— 

22 (i) agrees to transfer a portion, as de23 termined necessary, of the reserve of active 

24 pharmaceutical ingredient maintained pur25 suant to subparagraph (A)(i) to another 

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1 drug manufacturer in the event that the 

2 Secretary determines there to be a need for 

3 additional finished eligible drug product 

4 and such eligible entity is unable to use the 

5 reserve of active pharmaceutical ingredient 

6 to manufacture a sufficient supply of such 

7 drug product; and 

8 (ii) permits the Secretary to direct al9 location of the reserve of active pharma10 ceutical ingredient so maintained in the 

11 event of a public health emergency or 

12 chemical, biological, radiological, or nuclear 

13 threat. 

14 (2) GUIDANCE.—Not later than 180 days after 

15 the date of enactment of this Act, the Secretary, in 

16 coordination with the Commissioner of Food and 

17 Drugs, shall issue guidance on— 

18 (A) the factors the Secretary will use to 

19 determine which eligible drugs, or active phar20 maceutical ingredient of such drugs, have vul21 nerable supply chains and how a contract or co22 operative agreement would help minimize the 

23 vulnerability or vulnerabilities identified; 

24 (B) the factors the Secretary will consider 

25 in determining eligibility of an entity to particiVerDate Sep 11 2014 06:31 Jan 03, 2024 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6802.IH H6802
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1 pate in the program under this section, which 

2 shall include an entity’s commitment to quality 

3 systems, including strong manufacturing infra4 structure, reliable processes, and trained staff, 

5 as well as the entity’s commitment to domestic 

6 manufacturing capacity and surge capacity, as 

7 appropriate; and 

8 (C) requirements for entities receiving an 

9 award under this section, including the extent 

10 of excess manufacturing capacity the manufac11 turers will be required to generate, the amount 

12 of redundancy required, and requirements relat13 ing to advanced quality systems. 

14 (3) PREFERENCE.—In awarding contracts and 

15 cooperative agreements under subsection (a), the 

16 Secretary shall give preference to eligible entities 

17 that will carry out the requirements of paragraph 

18 (1) through one or more domestic establishments 

19 registered under section 510(b) of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 360(b)) capable 

21 of manufacturing the eligible drug. To the greatest 

22 extent practicable, the Secretary shall award con23 tracts and cooperative agreements with manufactur24 ers in a manner that strengthens domestic manufacVerDate Sep 11 2014 06:31 Jan 03, 2024 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6802.IH H6802
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1 turing, resiliency, and capacity of eligible drugs and 

2 their active pharmaceutical ingredients. 

3 (c) ADDITIONAL CONTRACT AND COOPERATIVE

4 AGREEMENT TERMS.— 

5 (1) IN GENERAL.—Each contract or cooperative 

6 agreement under subsection (a) shall be subject to 

7 such terms and conditions as the Secretary may 

8 specify, including terms and conditions with respect 

9 to procurement, maintenance, storage, testing, and 

10 delivery of drugs, in alignment with inventory man11 agement and other applicable best practices, under 

12 such contract or cooperative agreement, which may 

13 consider, as appropriate, costs of transporting and 

14 handling such drugs. 

15 (2) TERMS CONCERNING THE ACQUISITION, 

16 CONSTRUCTION, ALTERATION, OR RENOVATION OF

17 ESTABLISHMENTS.—Notwithstanding section 6303 

18 of title 41, United States Code, the Secretary may 

19 award a contract or cooperative agreement under 

20 this section to support the acquisition, construction, 

21 alteration, or renovation of non-federally owned es22 tablishments— 

23 (A) as determined necessary to carry out 

24 or improve preparedness and response capa25 bility at the State and local level; or 

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1 (B) for the production of drugs, devices, 

2 and supplies where the Secretary determines 

3 that such a contract or cooperative agreement 

4 is necessary to ensure sufficient amounts of 

5 such drugs, devices, and supplies. 

6 (d) REQUIREMENTS IN AWARDING CONTRACTS.—To 

7 the greatest extent practicable, the Secretary shall award 

8 contracts and cooperative agreements under this section 

9 in a manner that— 

10 (1) maximizes quality, minimizes cost, mini11 mizes vulnerability of the United States to severe 

12 shortages or disruptions for eligible drugs and their 

13 active pharmaceutical ingredients, gives preference 

14 to domestic manufacturers, and encourages competi15 tion in the marketplace; and 

16 (2) increases domestic production surge capac17 ity and reserves of domestic-based manufacturing es18 tablishments for critical drugs and active pharma19 ceutical ingredients of such drugs. 

20 (e) DEFINITIONS.—In this section: 

21 (1) ACTIVE PHARMACEUTICAL INGREDIENT.— 

22 The term ‘‘active pharmaceutical ingredient’’ has the 

23 meaning given such term in section 744A of the 

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

25 379j–41). 

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1 (2) DRUG.—The term ‘‘drug’’ has the meaning 

2 given such term in section 201(g) of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)). 

4 (3) DRUG SHORTAGE; SHORTAGE.—The term 

5 ‘‘drug shortage’’ or ‘‘shortage’’ has the meaning 

6 given such term in section 506C of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 356c). 

8 (4) ELIGIBLE DRUG.—The term ‘‘eligible drug’’ 

9 means a drug, as determined by the Secretary, in 

10 coordination with the Assistant Secretary for Pre11 paredness and Response, the Director of the Centers 

12 for Disease Control and Prevention, and the Com13 missioner of Food and Drugs— 

14 (A) that is approved under section 505(j) 

15 of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 355(j)) or licensed under section 

17 351(k) of the Public Health Service Act (42 

18 U.S.C. 262(k)); 

19 (B)(i) that is reasonably likely to be re20 quired to respond to a public health emergency 

21 or to a chemical, biological, radiological, or nu22 clear threat; or 

23 (ii) the shortage of which would pose a sig24 nificant threat to the United States health care 

25 system or at-risk populations; and 

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1 (C) that has a vulnerable supply chain, 

2 such as a geographic concentration of manufac3 turing, poor quality or safety issues, complex 

4 manufacturing or chemistry, or few manufac5 turers. 

6 (5) ELIGIBLE ENTITY.—The term ‘‘eligible enti7 ty’’ means a person that— 

8 (A)(i) is the holder of an approved applica9 tion under subsection (j) of section 505 of the 

10 Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 355) or subsection (k) of section 351 of 

12 the Public Health Service Act (42 U.S.C. 262) 

13 for an eligible drug; 

14 (ii) maintains at least one domestic estab15 lishment registered under section 510(b) of the 

16 Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 360(b)) or one foreign establishment 

18 registered under section 510(i) of such Act that 

19 is located in a country that is a member of the 

20 Organisation for Economic Cooperation and 

21 Development that is capable of manufacturing 

22 the eligible drug; and 

23 (iii) has a strong record of good manufac24 turing practices of drugs; 

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1 (B)(i) is a manufacturer of an active phar2 maceutical ingredient for an eligible drug, in 

3 partnership with an entity that meets the re4 quirements of subparagraph (A); 

5 (ii) maintains at least one domestic estab6 lishment registered under section 510(b) of the 

7 Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 360(b)) or one foreign establishment 

9 registered under section 510(i) of such Act that 

10 is located in a country that is a member of the 

11 Organisation for Economic Cooperation and 

12 Development that is capable of manufacturing 

13 the active pharmaceutical ingredient; and 

14 (iii) has a strong record of good manufac15 turing practices of active pharmaceutical ingre16 dients; or 

17 (C) is a distributor or wholesaler of an eli18 gible drug, in partnership with an entity that 

19 meets the requirements of subparagraph (A). 

20 (f) REPORTS TO CONGRESS.—Not later than 2 years 

21 after the date on which the first award is made under this 

22 section, and every 2 years thereafter, the Secretary shall 

23 submit a report to Congress detailing— 

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1 (1) the list of drugs determined to be eligible 

2 drugs, as described in subsection (e)(2), and the ra3 tionale behind selecting each such drug; and 

4 (2) an update on the effectiveness of the pro5 gram under this section, in a manner that does not 

6 compromise national security. 

7 (g) AUTHORIZATION OF APPROPRIATIONS.—To carry 

8 out this section, there is authorized to be appropriated 

9 $500,000,000 for fiscal year 2024. 

10 SEC. 3. GAO REPORT. 

11 Not later than 18 months after the date of enactment 

12 of this Act, the Comptroller General of the United States 

13 shall— 

14 (1) examine, such as through a survey or other 

15 means, excess or underutilized domestic manufac16 turing capacity for critical drugs and active pharma17 ceutical ingredients of such drugs, including capacity 

18 to manufacture different dosage forms, such as oral 

19 tablets and sterile injectable drugs, and the capacity 

20 to manufacture drugs with various characteristics, 

21 such as cytotoxic drugs and drugs requiring 

22 lyophilization; and 

23 (2) prepare and submit a report to the Com24 mittee on Homeland Security and Governmental Af25 fairs and the Committee on Health, Education, 

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1 Labor, and Pensions of the Senate and the Com2 mittee on Homeland Security and the Committee on 

3 Energy and Commerce of the House of Representa4 tives that— 

5 (A) includes— 

6 (i) the results of the survey under 

7 paragraph (1); 

8 (ii) an assessment of projected costs 

9 of utilizing and expanding existing domes10 tic manufacturing capabilities and policies, 

11 as of the date of the report, that may help 

12 establish or strengthen domestic manufac13 turing capacity for key starting materials, 

14 excipients, active pharmaceutical ingredi15 ents, and finished dosage manufacturing 

16 establishments; and 

17 (iii) an evaluation of policies designed 

18 to invest in advanced domestic manufac19 turing capabilities and capacity for critical 

20 active pharmaceutical ingredients and drug 

21 products; and 

22 (B) shall be publicly available in an unclas23 sified form, but may include a classified annex 

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1 containing any information that the Comp2 troller General determines to be sensitive. 

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