II 

117TH CONGRESS 

1ST SESSION S. 2740 

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 SENATE OF THE UNITED STATES 

SEPTEMBER 14, 2021 

Mr. BROWN (for himself and Mr. CASSIDY) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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 2021’’ or the 

2 ‘‘PREPARE Act’’. 

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 ‘‘(c) UPDATES.— 


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1 ‘‘(1) ANNUAL REVIEW.—Not less than once 

2 each year, the Secretary, after consultation with the 

3 Commissioner of Food and Drugs, the Assistant 

4 Secretary for Preparedness and Response, the Sec5 retary of Defense, Secretary of Homeland Security, 

6 and other heads of agencies, as appropriate, shall re7 view and update the list of essential generic medi8 cines required under subsection (a). 

9 ‘‘(2) RATIONALE.—In carrying out the annual 

10 review and update under paragraph (1), the Sec11 retary shall provide a rationale for each essential ge12 neric medicine added to, or removed from, the list 

13 under subsection (a). 

14 ‘‘(3) SPECIFIC POPULATIONS.—The Secretary 

15 shall consider including on the list under subsection 

16 (a), and, where appropriate, include on such list, es17 sential generic medicines that are essential to spe18 cific subpopulations, including pediatric populations, 

19 in developing the list under such subsection. 

20 ‘‘(4) THREAT ASSESSMENTS.— 

21 ‘‘(A) IN GENERAL.—The Secretary, after 

22 consultation with the Public Health Emergency 

23 Medical Countermeasures Enterprise estab24 lished under section 2811–1, shall conduct reg25 ular threat assessments, and take such assessVerDate Sep 11 2014 20:21 Sep 16, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.IS S2740

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1 ments into consideration in updating the list in 

2 accordance with paragraph (1). 

3 ‘‘(B) THREAT ASSESSMENTS CONSIDER4 ATIONS.—Each threat assessment under this 

5 paragraph shall include consideration of— 

6 ‘‘(i) the lack of existing domestic ca7 pacity of essential generic medicines; 

8 ‘‘(ii) the concentration of current sup9 ply of the essential generic medicine or ac10 tive pharmaceutical ingredients of the es11 sential generic medicine in one geo12 graphical region; 

13 ‘‘(iii) whether there are less than 2 

14 manufacturers of the essential generic 

15 medicine or active pharmaceutical ingredi16 ents of the essential generic medicine; and 

17 ‘‘(iv) the potential for increased de18 mand in a public health emergency. 

19 ‘‘(5) DIRECTOR OF THE STRATEGIC ACTIVE

20 PHARMACEUTICAL INGREDIENTS RESERVE.—The 

21 Secretary shall appoint a Director of the Strategic 

22 Active Pharmaceutical Ingredients Reserve who has 

23 experience in one or more of the following areas: 

24 supply chain management, disaster response, phar25 maceutical or active pharmaceutical ingredient develVerDate Sep 11 2014 20:21 Sep 16, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.IS S2740

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1 opment, or logistics. Such Director shall ensure a 

2 sufficient supply of the active pharmaceutical ingre3 dients and critical components necessary to manu4 facture the essential generic medicines included on 

5 the list under subsection (a) in an amount adequate 

6 to serve the needs of patients living in the United 

7 States and in the appropriate dosage forms. 

8 ‘‘(d) APPEAL PROCESS.—The Secretary shall estab9 lish a process by which stakeholders may appeal a deter10 mination by the Secretary not to include an essential ge11 neric medicine on the list under subsection (a). 

12 ‘‘(e) DEFINITIONS.—In this section: 

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

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

15 Food, Drug, and Cosmetic Act, and includes a bio16 logical product (as defined in section 351(i) of this 

17 Act). Such term includes prescription and non18 prescription drugs, or active pharmaceutical ingredi19 ents of drugs. 

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

21 term ‘essential generic medicine’ means a drug for 

22 which a generic is approved, that is medically nec23 essary to have available at all times because the 

24 drug is— 


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

2 or treat a common disease or condition, or used 

3 in a common procedure; 

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

5 treat an infectious diseases; 

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

7 public health emergency; or 

8 ‘‘(D) life-supporting, life-sustaining, or in9 tended for use in the prevention or treatment of 

10 a debilitating disease or condition.’’. 

11 SEC. 3. ESTABLISHMENT OF THE STRATEGIC ACTIVE PHAR12 MACEUTICAL INGREDIENT RESERVE. 

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

14 (42 U.S.C. 243 et seq.), as amended by section 2, is fur15 ther amended by inserting after section 319N the fol16 lowing: 

17 ‘‘SEC. 319N–1. STRATEGIC ACTIVE PHARMACEUTICAL IN18 GREDIENT RESERVE. 

19 ‘‘(a) STRATEGIC ACTIVE PHARMACEUTICAL INGRE20 DIENT RESERVE PLAN.— 

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

22 after the date of enactment of the Promoting Readi23 ness and Ensuring Proper Active pharmaceutical in24 gredient Reserves of Essential medicines Act of 

25 2021, the Secretary, in consultation with the AssistVerDate Sep 11 2014 20:21 Sep 16, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.IS S2740

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1 ant Secretary for Preparedness and Response, the 

2 Director of the Centers for Disease Control and Pre3 vention, the Commissioner of Food and Drugs, and 

4 the Director of the Biomedical Advanced Research 

5 and Development Authority, shall prepare and sub6 mit to Congress a Strategic Active Pharmaceutical 

7 Ingredient Reserve Plan (referred to in this section 

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

9 which shall be used by the Secretary in establishing 

10 and maintaining the Strategic Active Pharmaceutical 

11 Ingredient Reserve described in subsection (c). 

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

13 update the plan annually and, by not later than 

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

15 applicable committees of Congress. 

16 ‘‘(3) NATIONAL SECURITY CONSIDERATIONS.— 

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

18 ensure that any submission of the plan (includ19 ing any update to the plan) to the applicable 

20 committees of Congress is in a manner that 

21 does not compromise national security. 

22 ‘‘(B) EXEMPTION FROM DISCLOSURE.—In23 formation in the plan that, in the judgment of 

24 the Secretary, would reveal public health 

25 vulnerabilities shall be exempt from disclosure 


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

2 States Code. 

3 ‘‘(b) PLAN REQUIREMENTS.— 

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

5 subsection (a) shall— 

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

7 filling of the storage and related facilities com8 prising the Strategic Active Pharmaceutical In9 gredient Reserve described in subsection (c) (re10 ferred to in this section as the ‘Reserve’); 

11 ‘‘(B) detail the requirements for maintain12 ing the Reserve described in subsection (c), in13 cluding— 

14 ‘‘(i) storage and testing requirements, 

15 consistent with parts 210 and 211 of title 

16 21, Code of Federal Regulations, or any 

17 successor regulation; and 

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

19 the Secretary and the manufacturer of the 

20 essential generic medicine using the active 

21 pharmaceutical ingredient or key starting 

22 material; 

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

24 any interruption or reduction in imports of— 


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1 ‘‘(i) active pharmaceutical ingredients 

2 and other key starting materials that the 

3 Secretary determines are, or are likely to 

4 become, dependent upon such imports for 

5 a substantial portion of finished essential 

6 generic medicines; and 

7 ‘‘(ii) finished dosage forms of essential 

8 generic medicines for which active pharma9 ceutical ingredients and other key starting 

10 materials are not imported; 

11 ‘‘(D) include provisions to strengthen do12 mestic capacity for active pharmaceutical ingre13 dient production, storage, and conversion; and 

14 ‘‘(E) outline plans and processes for co15 ordinating and consulting, as appropriate, with 

16 the Assistant Secretary for Preparedness and 

17 Response regarding relevant issues of interest 

18 pertaining to the maintenance and stocking of 

19 the strategic national stockpile. 

20 ‘‘(2) REQUIRED COMPONENTS.— 

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

22 the following: 

23 ‘‘(i) Identification and prioritization of 

24 the essential generic medicines included on 


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1 the most recent list under section 

2 319N(a)— 

3 ‘‘(I) that the Secretary deter4 mines are essential for health care 

5 needs in the United States; and 

6 ‘‘(II) for which the Secretary de7 termines that there is the greatest 

8 need to maintain a reserve of the ac9 tive pharmaceutical ingredients and 

10 key starting materials for the essen11 tial generic medicines— 

12 ‘‘(aa) taking into account 

13 factors including the extent to 

14 which the United States is, or is 

15 at risk of becoming, dependent 

16 on foreign sources for a substan17 tial portion of the domestic need; 

18 and 

19 ‘‘(bb) giving special consid20 eration to the essential generic 

21 medicines at risk of supply inter22 ruption as a result of the factors 

23 described in section 

24 319N(c)(4)(B). 


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1 ‘‘(ii) An evaluation of the utilization 

2 levels of the essential generic medicines 

3 identified under clause (i) to inform how 

4 much of the active pharmaceutical ingredi5 ents of such medicines is required to cover 

6 the projected health care needs for one 

7 year of the United States population. 

8 ‘‘(iii) A comprehensive assessment of 

9 the essential generic medicines identified 

10 under clause (i), including the existing 

11 manufacturing bases for each such medi12 cine (including identification and location 

13 of ownership of such facilities) and wheth14 er the active pharmaceutical ingredients of 

15 such ingredients are manufactured domes16 tically or abroad, and whether finished dos17 age conversion steps for such essential ge18 neric medicines are performed domestically 

19 or abroad. 

20 ‘‘(iv) The types of facilities, equip21 ment, and technology required to appro22 priately store, track, test, and convert all 

23 forms of active pharmaceutical ingredients 

24 that are critical inputs of drugs that are 

25 essential generic medicines, preliminary 


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1 proposed locations for such public and pri2 vately owned facilities in multiple locations 

3 in the United States, the capacity required 

4 of the facilities used, and the estimated 

5 cost of acquisition and storage of the ac6 tive pharmaceutical ingredients and man7 agement and operation of the facilities. 

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

9 the establishment and ongoing mainte10 nance of the Reserve may have, including 

11 on availability and pricing of active phar12 maceutical ingredients and finished drug 

13 dosages. 

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

15 pharmaceutical ingredients held in the Re16 serve, which shall include— 

17 ‘‘(I) protocols for the method of 

18 conversion of active pharmaceutical 

19 ingredients into finished drugs, in20 cluding conversion of key starting ma21 terials into active pharmaceutical in22 gredients and distribution from the 

23 Reserve into the strategic national 

24 stockpile and other government and 


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1 commercial pharmaceutical distribu2 tion networks; and 

3 ‘‘(II) benchmarks for the Sec4 retary to initiate conversion of drug 

5 products that are essential generic 

6 medicines using the active pharma7 ceutical ingredients stored in the Re8 serve for transfer to the strategic na9 tional stockpile or other government 

10 or commercial pharmaceutical dis11 tribution networks, based on changes 

12 in the supply chain for the top essen13 tial generic medicines or a determina14 tion by the Secretary regarding a 

15 threat to public health. 

16 ‘‘(vii) A mechanism through which 

17 private sector manufacturers of active 

18 pharmaceutical ingredients or finished dos19 age forms may, through contracts with ex20 isting Reserve facilities, store and with21 draw such ingredients in the Reserve to 

22 enhance resilience and reduce shortages 

23 and disruptions in the supply chain. 

24 ‘‘(viii) A mechanism through which 

25 the Federal Government may purchase, via 


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1 manufacturing partners, reserve capacity 

2 for finished drug manufacturing to convert 

3 active pharmaceutical ingredients into fin4 ished drugs for essential generic medicines. 

5 ‘‘(B) NUMBER OF DRUGS.— 

6 ‘‘(i) IN GENERAL.—Pursuant to sub7 paragraph (A)(i), the Secretary shall en8 sure that for the first year after the date 

9 of enactment of the Promoting Readiness 

10 and Ensuring Proper Active pharma11 ceutical ingredient Reserves of Essential 

12 medicines Act of 2021, the Plan includes 

13 not less than 25 essential generic medi14 cines, and that 25 additional essential ge15 neric medicines are included in such Plan 

16 for each year thereafter until the active 

17 pharmaceutical ingredients necessary to 

18 support the full list of essential generic 

19 medicines identified under section 319N(a) 

20 are covered. 

21 ‘‘(ii) PRIORITIZATION.—The Secretary 

22 shall prioritize essential generic medicines 

23 needed immediately in the event of an 

24 emergency. 


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

2 MATERIALS.— 

3 ‘‘(A) IN GENERAL.—To the maximum ex4 tent practicable, the Plan should include a plan 

5 to ensure that, for each essential generic medi6 cine included in the Plan, the active pharma7 ceutical ingredients used in the production of 

8 such medicine that are stored in the Reserve 

9 are available in the minimum quantities as fol10 lows: 

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

12 after the date of enactment of the Pro13 moting Readiness and Ensuring Proper 

14 Active pharmaceutical ingredient Reserves 

15 of Essential medicines Act of 2021, not 

16 less than 10 percent of the total amount of 

17 such ingredients needed to produce suffi18 cient quantities of the essential generic 

19 medicines for the treatment of individuals 

20 living in the United States. 

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

22 such date of enactment, not less than 25 

23 percent of the total amount of such ingre24 dients needed to produce sufficient quan25 tities of the essential generic medicines for 


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1 the treatment of individuals living in the 

2 United States. 

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

4 such date of enactment, not less than 50 

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 ‘‘(iv) By the date that is 10 years 

11 after such date of enactment, not less than 

12 90 percent of the total amount of such in13 gredients needed to produce sufficient 

14 quantities of the essential generic medi15 cines for the treatment of individuals living 

16 in the United States. 

17 ‘‘(B) CALCULATION OF QUANTITY OF

18 API.—In calculating the quantities of active 

19 pharmaceutical ingredients needed for purposes 

20 of subparagraph (A), the Secretary shall deter21 mine the quantity of each essential generic 

22 medicine required to cover the projected health 

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

24 in the United States, based on average annual 

25 demand during the 3-year period preceding the 


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1 date of enactment of the Promoting Readiness 

2 and Ensuring Proper Active pharmaceutical in3 gredient Reserves of Essential medicines Act of 

4 2021. 

5 ‘‘(c) ADMINISTERING THE STRATEGIC ACTIVE PHAR6 MACEUTICAL INGREDIENT RESERVE.— 

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

8 pharmaceutical ingredient and key starting material 

9 that is included in the Plan, the Secretary shall 

10 place in storage, transport, track, and exchange 

11 quantities of the substance that are— 

12 ‘‘(A) produced in conformance with all 

13 quality requirements under this Act and the 

14 Federal Food, Drug, and Cosmetic Act, includ15 ing the associated regulations of such Acts; 

16 ‘‘(B) stored in compliance with— 

17 ‘‘(i) the requirements of parts 210 

18 and 211 of title 21, Code of Federal Regu19 lations, or any successor regulation; and 

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

21 Secretary and the manufacturer of the essential 

22 generic medicine using the active pharma23 ceutical ingredient or key starting material. 

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

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1 retary shall acquire active pharmaceutical ingredi2 ents and key starting materials in a manner that 

3 minimizes cost, minimizes vulnerability of the United 

4 States to severe shortages or disruptions for essen5 tial generic medicines, minimizes the impact of ac6 quisition of such ingredients and materials to the 

7 marketplace, gives preference to domestic manufac8 turers, and encourages competition in the market9 place. 

10 ‘‘(3) DRAWDOWN OF THE RESERVE.— 

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

12 distribute active pharmaceutical ingredients and 

13 key starting materials in the Reserve in order 

14 to initiate conversion of active pharmaceutical 

15 ingredients and finished dosage form, in accord16 ance with the Plan developed under subsection 

17 (b). 

18 ‘‘(B) DEVIATIONS FROM PLAN.—In distrib19 uting active pharmaceutical ingredients and key 

20 starting materials under subparagraph (A), the 

21 Secretary, in consultation with the Commis22 sioner of Food and Drugs and the Assistant 

23 Secretary for Preparedness and Response, may 

24 deviate from the Plan developed under sub25 section (b) only after certifying that the disVerDate Sep 11 2014 20:21 Sep 16, 2021 Jkt 019200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.IS S2740

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1 tribution from the Reserve is required in re2 sponse to a significant drug supply interrup3 tion. 

4 ‘‘(d) CONSULTATION.— 

5 ‘‘(1) IN GENERAL.—In carrying out this sec6 tion, the Secretary shall consult with— 

7 ‘‘(A) the Commissioner of Food and 

8 Drugs, with respect to identifying essential ge9 neric medicines; 

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

11 Medicare & Medicaid Services, with respect to 

12 determining the volume of essential generic 

13 medicines needed domestically; and 

14 ‘‘(C) the Assistant Secretary for Prepared15 ness and Response, and, as appropriate, the Di16 rector of the Centers for Disease Control and 

17 Prevention, regarding coordination with the 

18 strategic national stockpile. 

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

20 of Food and Drugs shall provide to the Secretary 

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

22 the Federal Food, Drug, and Cosmetic Act, for pur23 poses of carrying out this section. 

24 ‘‘(e) CONTRACTING.— 


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1 ‘‘(1) IN GENERAL.—In carrying out this sec2 tion, the Secretary shall— 

3 ‘‘(A) prioritize the purchase of active phar4 maceutical ingredients and other key starting 

5 materials manufactured in the United States by 

6 domestic manufacturers to the maximum extent 

7 possible; 

8 ‘‘(B) contract with domestic entities for 

9 the— 

10 ‘‘(i) distribution of active pharma11 ceutical ingredients and finished drug 

12 products; 

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

14 conversion of active pharmaceutical ingre15 dients and other key starting materials; 

16 ‘‘(iii) tracking and coordinating the 

17 storage, testing, and sale of active pharma18 ceutical ingredients and other key starting 

19 materials; 

20 ‘‘(iv) sale of active pharmaceutical in21 gredients in advance of their expiration 

22 dates; and 

23 ‘‘(v) manufacturing, including contin24 uous manufacturing as appropriate, of an 

25 active pharmaceutical ingredient or other 


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1 key starting material of an essential ge2 neric medicine that is anticipated to be in 

3 shortage, as defined by the Secretary for 

4 purposes of this section; 

5 ‘‘(C) give preference to domestic nonprofit 

6 and public-private partnerships, as appropriate; 

7 ‘‘(D) ensure geographic diversity of the 

8 physical storage of active pharmaceutical ingre9 dients and other key starting materials; 

10 ‘‘(E) support domestic manufacturers of 

11 active pharmaceuticals and other key starting 

12 materials and facilitate long-term domestic ca13 pacity for essential generic medicines in the 

14 United States; and 

15 ‘‘(F) prioritize contracts that facilitate the 

16 conversation of active pharmaceutical ingredi17 ents and other key starting materials into fin18 ished dosage form. 

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

20 this subsection shall be construed to limit the Sec21 retary’s ability to enter into other types of contracts 

22 to facilitate the implementation of this section. 

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

24 report to the applicable committees of Congress on supply 

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1 gredients for essential generic medicines, the status of the 

2 Reserve, and other relevant information in a manner that 

3 does not compromise national security. 

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

5 ‘‘(1) APPLICABLE COMMITTEES OF CON6 GRESS.—The term ‘applicable committees of Con7 gress’ means— 

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

9 Labor, and Pensions and the Committee on In10 telligence of the Senate; and 

11 ‘‘(B) the Committee on Energy and Com12 merce of the House of Representatives. 

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

14 term ‘essential generic medicine’ means a drug in15 cluded on the most current list under section 

16 319N(a). 

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

18 starting material’ means an active pharmaceutical 

19 ingredient or critical input used in the manufac20 turing of an essential generic medicine, as well as in21 gredients or components that possess unique at22 tributes essential in assessing the safety and effec23 tiveness of such essential generic medicines, includ24 ing excipients and inactive ingredients. 


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

2 are authorized to be appropriated to carry out this section 

3 such sums as may be necessary.’’. 

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

5 Section 505(j) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 355(j)) is amended by adding at the 

7 end the following: 

8 ‘‘(14) Notwithstanding any other provision of 

9 this section, the holder of an approved application 

10 under this subsection that changes the source of an 

11 active pharmaceutical ingredient of the drug that is 

12 the subject of such application to a source available 

13 through the Strategic Active Pharmaceutical Ingre14 dient Reserve established under section 319N–1 of 

15 the Public Health Service Act— 

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

17 approved application with respect to such 

18 change before changing the source; and 

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

20 change, through an update to the approved ap21 plication or other manner determined appro22 priate by the Secretary, prior to commercial 

23 distribution of the drug.’’. 


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1 SEC. 5. GAO REPORT. 

2 By not later than 18 months after the date of enact3 ment of this Act, the Comptroller General of the United 

4 States shall prepare and submit a report to Congress that 

5 includes— 

6 (1) an assessment of what is known about ac7 tive pharmaceutical ingredient manufacturing, in8 cluding— 

9 (A) the time needed to develop and imple10 ment domestic manufacturing capabilities; 

11 (B) projected costs of developing new man12 ufacturing capabilities for active pharmaceutical 

13 ingredients not currently available domestically, 

14 as of the date of the report; and 

15 (C) projected costs of expanding existing 

16 domestic capabilities and policies, as of the date 

17 of the report, that may help establish or 

18 strengthen domestic manufacturing capacity for 

19 active pharmaceutical ingredients, excipients, 

20 key starting materials, components, functional 

21 ingredients, and finished dosage manufacturing 

22 facilities; and 

23 (2) an assessment of incentives already offered 

24 or being considered for the development or improve25 ment of domestic capacity to manufacture active 


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1 pharmaceutical ingredients, their intermediates, and 

2 their excipients, including— 

3 (A) contractual arrangements for existing 

4 domestic storage and manufacturing of active 

5 pharmaceutical ingredients; 

6 (B) guaranteed contracts for initial pur7 chase and replenishment of essential generic 

8 medicines; and 

9 (C) other policies designed to help 

10 incentivize the relocation of manufacturing fa11 cilities to the United States or provide economic 

12 incentives for domestic production. 

Æ 


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