I 

118TH CONGRESS 

2D SESSION H. R. 7709 

To establish a strategic active pharmaceutical ingredient reserve to maintain 

a domestic supply of active pharmaceutical ingredients and key starting 

materials needed for the manufacturing of essential generic medicines, 

and to build a pipeline for domestic active pharmaceutical ingredient 

production. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 15, 2024 

Ms. SPANBERGER (for herself and Mr. BACON) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed 

for the manufacturing of essential generic medicines, and 

to build a pipeline for domestic active pharmaceutical 

ingredient production. 

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 ‘‘Promoting Readiness 

5 and Ensuring Proper Active Pharmaceutical Ingredient 


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1 Reserves of Essential Medicines Act of 2024’’ or the 

2 ‘‘PREPARE ACT of 2024’’. 

3 SEC. 2. LISTING OF ESSENTIAL GENERIC MEDICINES. 

4 Part B of title III of the Public Health Service Act 

5 (42 U.S.C. 243 et seq.) is amended by inserting after sec6 tion 319M the following: 

7 ‘‘SEC. 319N. LISTING OF ESSENTIAL GENERIC MEDICINES. 

8 ‘‘(a) IN GENERAL.—The Secretary, in consultation 

9 with the Commissioner of Food and Drugs, the Assistant 

10 Secretary for Preparedness and Response, the Secretary 

11 of Defense, Secretary of Homeland Security, and other 

12 heads of agencies, as appropriate, shall establish and make 

13 public a list of essential generic medicines determined, in 

14 accordance with subsection (b), to be medically necessary 

15 to have available at all times. 

16 ‘‘(b) REQUIREMENTS.— 

17 ‘‘(1) INITIAL LIST.—The initial list of essential 

18 generic medicines under subsection (a) shall be the 

19 generic medicines included on the list of essential 

20 medicines, medical countermeasures, and critical in21 puts identified by the Commissioner of Food and 

22 Drugs as published on October 30, 2020, in accord23 ance with section 3(c) of Executive Order 13944. 

24 ‘‘(2) UPDATES.— 


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1 ‘‘(A) ANNUAL REVIEW.—Not less than 

2 once each year, the Secretary, after consultation 

3 with the Commissioner of Food and Drugs, the 

4 Assistant Secretary for Preparedness and Re5 sponse, the Secretary of Defense, Secretary of 

6 Homeland Security, and other heads of agen7 cies, as appropriate, shall review and update the 

8 list of essential generic medicines required 

9 under subsection (a). 

10 ‘‘(B) RATIONALE.—In carrying out the an11 nual review and update under subparagraph 

12 (A), the Secretary shall provide a rationale for 

13 each essential generic medicine added to, or re14 moved from, the list under subsection (a). 

15 ‘‘(C) SPECIFIC POPULATIONS.—The Sec16 retary shall consider including on the list under 

17 subsection (a), and, where appropriate, include 

18 on such list, essential generic medicines that 

19 are essential to specific subpopulations, includ20 ing pediatric populations, in developing the list 

21 under such subsection. 

22 ‘‘(D) THREAT ASSESSMENTS.— 

23 ‘‘(i) IN GENERAL.—The Secretary, 

24 after consultation with the Public Health 

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1 terprise established under section 2811–1, 

2 shall conduct regular threat assessments, 

3 and take such assessments into consider4 ation in updating the list in accordance 

5 with subparagraph (A). 

6 ‘‘(ii) THREAT ASSESSMENTS CONSID7 ERATIONS.—Each threat assessment under 

8 this subparagraph shall include consider9 ation of— 

10 ‘‘(I) the lack of existing domestic 

11 capacity of essential generic medi12 cines; 

13 ‘‘(II) the concentration of current 

14 supply of the essential generic medi15 cine or active pharmaceutical ingredi16 ents of the essential generic medicine 

17 in one geographical region; 

18 ‘‘(III) whether there are less 

19 than 2 manufacturers of the essential 

20 generic medicine or active pharma21 ceutical ingredients of the essential 

22 generic medicine; and 

23 ‘‘(IV) the potential for increased 

24 demand in a public health emergency. 


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1 ‘‘(E) DIRECTOR OF THE STRATEGIC AC2 TIVE PHARMACEUTICAL INGREDIENTS RE3 SERVE.—The Secretary shall appoint a Director 

4 of the Strategic Active Pharmaceutical Ingredi5 ents Reserve who has experience in one or more 

6 of the following areas: supply chain manage7 ment, disaster response, pharmaceutical or ac8 tive pharmaceutical ingredient development, or 

9 logistics. Such Director shall ensure a sufficient 

10 supply of the active pharmaceutical ingredients 

11 and critical components necessary to manufac12 ture the essential generic medicines included on 

13 the list under subsection (a) in an amount ade14 quate to serve the needs of patients living in the 

15 United States and in the appropriate dosage 

16 forms. 

17 ‘‘(c) APPEAL PROCESS.—The Secretary shall estab18 lish a process by which stakeholders may appeal a deter19 mination by the Secretary not to include an essential ge20 neric medicine on the list under subsection (a). 

21 ‘‘(d) DEFINITIONS.—In this section: 

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

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

24 Food, Drug, and Cosmetic Act, and includes a bio25 logical product (as defined in section 351(i) of this 


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1 Act). Such term includes prescription and non2 prescription drugs, or active pharmaceutical ingredi3 ents of drugs. 

4 ‘‘(2) ESSENTIAL GENERIC MEDICINE.—The 

5 term ‘essential generic medicine’ means a drug for 

6 which a generic is approved, that is medically nec7 essary to have available at all times because the 

8 drug is— 

9 ‘‘(A) commonly used to prevent, mitigate, 

10 or treat a common disease or condition, or used 

11 in a common procedure; 

12 ‘‘(B) an antibiotic or antifungal used to 

13 treat an infectious diseases; 

14 ‘‘(C) necessary to prevent or mitigate a 

15 public health emergency; or 

16 ‘‘(D) life-supporting, life-sustaining, or in17 tended for use in the prevention or treatment of 

18 a debilitating disease or condition.’’. 

19 SEC. 3. ESTABLISHMENT OF THE STRATEGIC ACTIVE PHAR20 MACEUTICAL INGREDIENT RESERVE. 

21 Part B of title III of the Public Health Service Act 

22 (42 U.S.C. 243 et seq.), as amended by section 2, is fur23 ther amended by inserting after section 319N the fol24 lowing: 


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1 ‘‘SEC. 319N–1. STRATEGIC ACTIVE PHARMACEUTICAL IN2 GREDIENT RESERVE. 

3 ‘‘(a) STRATEGIC ACTIVE PHARMACEUTICAL INGRE4 DIENT RESERVE PLAN.— 

5 ‘‘(1) IN GENERAL.—Not later than 90 days 

6 after the date of enactment of the Promoting Readi7 ness and Ensuring Proper Active Pharmaceutical In8 gredient Reserves of Essential Medicines Act of 

9 2024, the Secretary, in consultation with the Assist10 ant Secretary for Preparedness and Response, the 

11 Director of the Centers for Disease Control and Pre12 vention, the Commissioner of Food and Drugs, and 

13 the Director of the Biomedical Advanced Research 

14 and Development Authority, shall prepare and sub15 mit to Congress a Strategic Active Pharmaceutical 

16 Ingredient Reserve Plan (referred to in this section 

17 as the ‘Plan’) in accordance with subsection (b), 

18 which shall be used by the Secretary in establishing 

19 and maintaining the Strategic Active Pharmaceutical 

20 Ingredient Reserve described in subsection (c). 

21 ‘‘(2) ANNUAL UPDATES.—The Secretary shall 

22 update the plan annually and, by not later than 

23 June 1 of each year, submit the updated plan to the 

24 applicable committees of Congress. 

25 ‘‘(3) NATIONAL SECURITY CONSIDERATIONS.— 


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1 ‘‘(A) SUBMISSIONS.—The Secretary shall 

2 ensure that any submission of the plan (includ3 ing any update to the plan) to the applicable 

4 committees of Congress is in a manner that 

5 does not compromise national security. 

6 ‘‘(B) EXEMPTION FROM DISCLOSURE.—In7 formation in the plan that, in the judgment of 

8 the Secretary, would reveal public health 

9 vulnerabilities shall be exempt from disclosure 

10 under section 552(b)(3) of title 5, United 

11 States Code. 

12 ‘‘(b) PLAN REQUIREMENTS.— 

13 ‘‘(1) IN GENERAL.—The Plan required under 

14 subsection (a) shall— 

15 ‘‘(A) detail the design, construction, and 

16 filling of the storage and related facilities com17 prising the Strategic Active Pharmaceutical In18 gredient Reserve described in subsection (c) (re19 ferred to in this section as the ‘Reserve’); 

20 ‘‘(B) detail the requirements for maintain21 ing the Reserve described in subsection (c), in22 cluding— 

23 ‘‘(i) storage and testing requirements, 

24 consistent with parts 210 and 211 of title 


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1 21, Code of Federal Regulations, or any 

2 successor regulation; and 

3 ‘‘(ii) any specific criteria agreed to by 

4 the Secretary and the manufacturer of the 

5 essential generic medicine using the active 

6 pharmaceutical ingredient or key starting 

7 material; 

8 ‘‘(C) be designed to minimize the impact of 

9 any interruption or reduction in imports of— 

10 ‘‘(i) active pharmaceutical ingredients 

11 and other key starting materials that the 

12 Secretary determines are, or are likely to 

13 become, dependent upon such imports for 

14 a substantial portion of finished essential 

15 generic medicines; and 

16 ‘‘(ii) finished dosage forms of essential 

17 generic medicines for which active pharma18 ceutical ingredients and other key starting 

19 materials are not imported; 

20 ‘‘(D) include provisions to strengthen do21 mestic capacity for active pharmaceutical ingre22 dient production, storage, and conversion; and 

23 ‘‘(E) outline plans and processes for co24 ordinating and consulting, as appropriate, with 

25 the Assistant Secretary for Preparedness and 


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1 Response regarding relevant issues of interest 

2 pertaining to the maintenance and stocking of 

3 the strategic national stockpile. 

4 ‘‘(2) REQUIRED COMPONENTS.— 

5 ‘‘(A) IN GENERAL.—The Plan shall include 

6 the following: 

7 ‘‘(i) Identification and prioritization of 

8 the essential generic medicines included on 

9 the most recent list under section 

10 319N(a)— 

11 ‘‘(I) that the Secretary deter12 mines are essential for health care 

13 needs in the United States; and 

14 ‘‘(II) for which the Secretary de15 termines that there is the greatest 

16 need to maintain a reserve of the ac17 tive pharmaceutical ingredients and 

18 key starting materials for the essen19 tial generic medicines— 

20 ‘‘(aa) taking into account 

21 factors including the extent to 

22 which the United States is, or is 

23 at risk of becoming, dependent 

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1 tial portion of the domestic need; 

2 and 

3 ‘‘(bb) giving special consid4 eration to the essential generic 

5 medicines at risk of supply inter6 ruption as a result of the factors 

7 described in section 

8 319N(c)(4)(B). 

9 ‘‘(ii) An evaluation of the utilization 

10 levels of the essential generic medicines 

11 identified under clause (i) to inform how 

12 much of the active pharmaceutical ingredi13 ents of such medicines is required to cover 

14 the projected health care needs for one 

15 year of the United States population. 

16 ‘‘(iii) A comprehensive assessment of 

17 the essential generic medicines identified 

18 under clause (i), including the existing 

19 manufacturing bases for each such medi20 cine (including identification and location 

21 of ownership of such facilities) and wheth22 er the active pharmaceutical ingredients of 

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1 neric medicines are performed domestically 

2 or abroad. 

3 ‘‘(iv) The types of facilities, equip4 ment, and technology required to appro5 priately store, track, test, and convert all 

6 forms of active pharmaceutical ingredients 

7 that are critical inputs of drugs that are 

8 essential generic medicines, preliminary 

9 proposed locations for such public and pri10 vately owned facilities in multiple locations 

11 in the United States, the capacity required 

12 of the facilities used, and the estimated 

13 cost of acquisition and storage of the ac14 tive pharmaceutical ingredients and man15 agement and operation of the facilities. 

16 ‘‘(v) An evaluation of the impact that 

17 the establishment and ongoing mainte18 nance of the Reserve may have, including 

19 on availability and pricing of active phar20 maceutical ingredients and finished drug 

21 dosages. 

22 ‘‘(vi) A distribution plan for the active 

23 pharmaceutical ingredients held in the Re24 serve, which shall include— 


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1 ‘‘(I) protocols for the method of 

2 conversion of active pharmaceutical 

3 ingredients into finished drugs, in4 cluding conversion of key starting ma5 terials into active pharmaceutical in6 gredients and distribution from the 

7 Reserve into the strategic national 

8 stockpile and other government and 

9 commercial pharmaceutical distribu10 tion networks; and 

11 ‘‘(II) benchmarks for the Sec12 retary to initiate conversion of drug 

13 products that are essential generic 

14 medicines using the active pharma15 ceutical ingredients stored in the Re16 serve for transfer to the strategic na17 tional stockpile or other government 

18 or commercial pharmaceutical dis19 tribution networks, based on changes 

20 in the supply chain for the top essen21 tial generic medicines or a determina22 tion by the Secretary regarding a 

23 threat to public health. 

24 ‘‘(vii) A mechanism through which 

25 private sector manufacturers of active 


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1 pharmaceutical ingredients or finished dos2 age forms may, through contracts with ex3 isting Reserve facilities, store and with4 draw such ingredients in the Reserve to 

5 enhance resilience and reduce shortages 

6 and disruptions in the supply chain. 

7 ‘‘(viii) A mechanism through which 

8 the Federal Government may purchase, via 

9 manufacturing partners, reserve capacity 

10 for finished drug manufacturing to convert 

11 active pharmaceutical ingredients into fin12 ished drugs for essential generic medicines. 

13 ‘‘(B) NUMBER OF DRUGS.— 

14 ‘‘(i) IN GENERAL.—Pursuant to sub15 paragraph (A)(i), the Secretary shall en16 sure that for the first year after the date 

17 of enactment of the Promoting Readiness 

18 and Ensuring Proper Active Pharma19 ceutical Ingredient Reserves of Essential 

20 Medicines Act of 2024, the Plan includes 

21 not less than 25 essential generic medi22 cines, and that 25 additional essential ge23 neric medicines are included in such Plan 

24 for each year thereafter until the active 

25 pharmaceutical ingredients necessary to 


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1 support the full list of essential generic 

2 medicines identified under section 319N(a) 

3 are covered. 

4 ‘‘(ii) PRIORITIZATION.—The Secretary 

5 shall prioritize essential generic medicines 

6 needed immediately in the event of an 

7 emergency. 

8 ‘‘(3) QUANTITIES OF APIS AND KEY STARTING

9 MATERIALS.— 

10 ‘‘(A) IN GENERAL.—To the maximum ex11 tent practicable, the Plan should include a plan 

12 to ensure that, for each essential generic medi13 cine included in the Plan, the active pharma14 ceutical ingredients used in the production of 

15 such medicine that are stored in the Reserve 

16 are available in the minimum quantities as fol17 lows: 

18 ‘‘(i) By the date that is 18 months 

19 after the date of enactment of the Pro20 moting Readiness and Ensuring Proper 

21 Active Pharmaceutical Ingredient Reserves 

22 of Essential Medicines Act of 2024, not 

23 less than 10 percent of the total amount of 

24 such ingredients needed to produce suffi25 cient quantities of the essential generic 


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1 medicines for the treatment of individuals 

2 living in the United States. 

3 ‘‘(ii) By the date that is 3 years after 

4 such date of enactment, not less than 25 

5 percent of the total amount of such ingre6 dients needed to produce sufficient quan7 tities of the essential generic medicines for 

8 the treatment of individuals living in the 

9 United States. 

10 ‘‘(iii) By the date that is 5 years after 

11 such date of enactment, not less than 50 

12 percent of the total amount of such ingre13 dients needed to produce sufficient quan14 tities of the essential generic medicines for 

15 the treatment of individuals living in the 

16 United States. 

17 ‘‘(iv) By the date that is 10 years 

18 after such date of enactment, not less than 

19 90 percent of the total amount of such in20 gredients needed to produce sufficient 

21 quantities of the essential generic medi22 cines for the treatment of individuals living 

23 in the United States. 

24 ‘‘(B) CALCULATION OF QUANTITY OF

25 API.—In calculating the quantities of active 


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1 pharmaceutical ingredients needed for purposes 

2 of subparagraph (A), the Secretary shall deter3 mine the quantity of each essential generic 

4 medicine required to cover the projected health 

5 care needs, over a 1-year period, of people living 

6 in the United States, based on average annual 

7 demand during the 3-year period preceding the 

8 date of enactment of the Promoting Readiness 

9 and Ensuring Proper Active Pharmaceutical In10 gredient Reserves of Essential Medicines Act of 

11 2024. 

12 ‘‘(c) ADMINISTERING THE STRATEGIC ACTIVE PHAR13 MACEUTICAL INGREDIENT RESERVE.— 

14 ‘‘(1) IN GENERAL.—With respect to each active 

15 pharmaceutical ingredient and key starting material 

16 that is included in the Plan, the Secretary shall 

17 place in storage, transport, track, and exchange 

18 quantities of the substance that are— 

19 ‘‘(A) produced in conformance with all 

20 quality requirements under this Act and the 

21 Federal Food, Drug, and Cosmetic Act, includ22 ing the associated regulations of such Acts; 

23 ‘‘(B) stored in compliance with the require24 ments of parts 210 and 211 of title 21, Code 


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1 of Federal Regulations, or any successor regula2 tion; and 

3 ‘‘(C) any specific criteria agreed to by the 

4 Secretary and the manufacturer of the essential 

5 generic medicine using the active pharma6 ceutical ingredient or key starting material. 

7 ‘‘(2) REQUIREMENTS.—To the greatest extent 

8 practicable, in carrying out paragraph (1), the Sec9 retary shall acquire active pharmaceutical ingredi10 ents and key starting materials in a manner that 

11 minimizes cost, minimizes vulnerability of the United 

12 States to severe shortages or disruptions for essen13 tial generic medicines, minimizes the impact of ac14 quisition of such ingredients and materials to the 

15 marketplace, gives preference to domestic manufac16 turers, and encourages competition in the market17 place. 

18 ‘‘(3) DRAWDOWN OF THE RESERVE.— 

19 ‘‘(A) IN GENERAL.—The Secretary may 

20 distribute active pharmaceutical ingredients and 

21 key starting materials in the Reserve in order 

22 to initiate conversion of active pharmaceutical 

23 ingredients and finished dosage form, in accord24 ance with the Plan developed under subsection 

25 (b). 


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1 ‘‘(B) DEVIATIONS FROM PLAN.—In distrib2 uting active pharmaceutical ingredients and key 

3 starting materials under subparagraph (A), the 

4 Secretary, in consultation with the Commis5 sioner of Food and Drugs and the Assistant 

6 Secretary for Preparedness and Response, may 

7 deviate from the Plan developed under sub8 section (b) only after certifying that the dis9 tribution from the Reserve is required in re10 sponse to a significant drug supply interrup11 tion. 

12 ‘‘(d) CONSULTATION.— 

13 ‘‘(1) IN GENERAL.—In carrying out this sec14 tion, the Secretary shall consult with— 

15 ‘‘(A) the Commissioner of Food and 

16 Drugs, with respect to identifying essential ge17 neric medicines; 

18 ‘‘(B) the Administrator of the Centers for 

19 Medicare & Medicaid Services, with respect to 

20 determining the volume of essential generic 

21 medicines needed domestically; and 

22 ‘‘(C) the Assistant Secretary for Prepared23 ness and Response, and, as appropriate, the Di24 rector of the Centers for Disease Control and 


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1 Prevention, regarding coordination with the 

2 strategic national stockpile. 

3 ‘‘(2) REPORTING BY FDA.—The Commissioner 

4 of Food and Drugs shall provide to the Secretary 

5 the information collected under section 510(j)(3) of 

6 the Federal Food, Drug, and Cosmetic Act, for pur7 poses of carrying out this section. 

8 ‘‘(e) CONTRACTING.— 

9 ‘‘(1) IN GENERAL.—In carrying out this sec10 tion, the Secretary shall— 

11 ‘‘(A) prioritize the purchase of active phar12 maceutical ingredients and other key starting 

13 materials manufactured in the United States by 

14 domestic manufacturers to the maximum extent 

15 possible; 

16 ‘‘(B) contract with domestic entities for 

17 the— 

18 ‘‘(i) distribution of active pharma19 ceutical ingredients and finished drug 

20 products; 

21 ‘‘(ii) storage, withdrawal, testing, and 

22 conversion of active pharmaceutical ingre23 dients and other key starting materials; 

24 ‘‘(iii) tracking and coordinating the 

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1 ceutical ingredients and other key starting 

2 materials; 

3 ‘‘(iv) sale of active pharmaceutical in4 gredients in advance of their expiration 

5 dates; and 

6 ‘‘(v) manufacturing, including contin7 uous manufacturing as appropriate, of an 

8 active pharmaceutical ingredient or other 

9 key starting material of an essential ge10 neric medicine that is anticipated to be in 

11 shortage, as defined by the Secretary for 

12 purposes of this section; 

13 ‘‘(C) give preference to domestic nonprofit 

14 and public-private partnerships, as appropriate; 

15 ‘‘(D) ensure geographic diversity of the 

16 physical storage of active pharmaceutical ingre17 dients and other key starting materials; 

18 ‘‘(E) support domestic manufacturers of 

19 active pharmaceuticals and other key starting 

20 materials and facilitate long-term domestic ca21 pacity for essential generic medicines in the 

22 United States; and 

23 ‘‘(F) prioritize contracts that facilitate the 

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1 ents and other key starting materials into fin2 ished dosage form. 

3 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in 

4 this subsection shall be construed to limit the Sec5 retary’s ability to enter into other types of contracts 

6 to facilitate the implementation of this section. 

7 ‘‘(f) REPORTS TO CONGRESS.—The Secretary shall 

8 report to the applicable committees of Congress on supply 

9 chain resiliency with respect to active pharmaceutical in10 gredients for essential generic medicines, the status of the 

11 Reserve, and other relevant information in a manner that 

12 does not compromise national security. 

13 ‘‘(g) DEFINITIONS.—In this section: 

14 ‘‘(1) APPLICABLE COMMITTEES OF CON15 GRESS.—The term ‘applicable committees of Con16 gress’ means— 

17 ‘‘(A) the Committee on Health, Education, 

18 Labor, and Pensions and the Committee on In19 telligence of the Senate; and 

20 ‘‘(B) the Committee on Energy and Com21 merce of the House of Representatives. 

22 ‘‘(2) ESSENTIAL GENERIC MEDICINE.—The 

23 term ‘essential generic medicine’ means a drug in24 cluded on the most current list under section 

25 319N(a). 


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1 ‘‘(3) KEY STARTING MATERIAL.—The term ‘key 

2 starting material’ means an active pharmaceutical 

3 ingredient or critical input used in the manufac4 turing of an essential generic medicine, as well as in5 gredients or components that possess unique at6 tributes essential in assessing the safety and effec7 tiveness of such essential generic medicines, includ8 ing excipients and inactive ingredients. 

9 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 

10 are authorized to be appropriated to carry out this section 

11 such sums as may be necessary.’’. 

12 SEC. 4. WAIVER OF CERTAIN FDA ANDA REQUIREMENTS. 

13 Section 505(j) of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 355(j)) is amended by adding at the 

15 end the following: 

16 ‘‘(14) Notwithstanding any other provision of 

17 this section, the holder of an approved application 

18 under this subsection that changes the source of an 

19 active pharmaceutical ingredient of the drug that is 

20 the subject of such application to a source available 

21 through the Strategic Active Pharmaceutical Ingre22 dient Reserve established under section 319N–1 of 

23 the Public Health Service Act— 


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1 ‘‘(A) shall not be required to update the 

2 approved application with respect to such 

3 change before changing the source; and 

4 ‘‘(B) shall inform the Secretary of the 

5 change, through an update to the approved ap6 plication or other manner determined appro7 priate by the Secretary, prior to commercial 

8 distribution of the drug.’’. 

9 SEC. 5. GAO REPORT. 

10 By not later than 18 months after the date of enact11 ment of this Act, the Comptroller General of the United 

12 States shall prepare and submit a report to Congress that 

13 includes— 

14 (1) an assessment of what is known about ac15 tive pharmaceutical ingredient manufacturing, in16 cluding— 

17 (A) the time needed to develop and imple18 ment domestic manufacturing capabilities; 

19 (B) projected costs of developing new man20 ufacturing capabilities for active pharmaceutical 

21 ingredients not currently available domestically, 

22 as of the date of the report; and 

23 (C) projected costs of expanding existing 

24 domestic capabilities and policies, as of the date 

25 of the report, that may help establish or 


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1 strengthen domestic manufacturing capacity for 

2 active pharmaceutical ingredients, excipients, 

3 key starting materials, components, functional 

4 ingredients, and finished dosage manufacturing 

5 facilities; and 

6 (2) an assessment of incentives already offered 

7 or being considered for the development or improve8 ment of domestic capacity to manufacture active 

9 pharmaceutical ingredients, their intermediates, and 

10 their excipients, including— 

11 (A) contractual arrangements for existing 

12 domestic storage and manufacturing of active 

13 pharmaceutical ingredients; 

14 (B) guaranteed contracts for initial pur15 chase and replenishment of essential generic 

16 medicines; and 

17 (C) other policies designed to help 

18 incentivize the relocation of manufacturing fa19 cilities to the United States or provide economic 

20 incentives for domestic production. 

Æ 


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