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 re-
serve to maintain a domestic supply of active pharma-
ceutical ingredients and key starting materials needed 
for the manufacturing of essential generic medicines, and 
to build a pipeline for domestic active pharmaceutical 
ingredient production. 
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 ‘‘Promoting Readiness 
and Ensuring Proper Active Pharmaceutical Ingredient 
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Reserves of Essential Medicines Act of 2024’’ or the 
‘‘PREPARE ACT of 2024’’. 
SEC. 2. LISTING OF ESSENTIAL GENERIC MEDICINES. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 319M the following: 
‘‘SEC. 319N. LISTING OF ESSENTIAL GENERIC MEDICINES. 
‘‘(a) IN GENERAL.—The Secretary, in consultation 
with the Commissioner of Food and Drugs, the Assistant 
Secretary for Preparedness and Response, the Secretary 
of Defense, Secretary of Homeland Security, and other 
heads of agencies, as appropriate, shall establish and make 
public a list of essential generic medicines determined, in 
accordance with subsection (b), to be medically necessary 
to have available at all times. 
‘‘(b) REQUIREMENTS.— 
‘‘(1) INITIAL LIST.—The initial list of essential 
generic medicines under subsection (a) shall be the 
generic medicines included on the list of essential 
medicines, medical countermeasures, and critical in-
puts identified by the Commissioner of Food and 
Drugs as published on October 30, 2020, in accord-
ance with section 3(c) of Executive Order 13944. 
‘‘(2) UPDATES.— 
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‘‘(A) ANNUAL
REVIEW.—Not less than 
once each year, the Secretary, after consultation 
with the Commissioner of Food and Drugs, the 
Assistant Secretary for Preparedness and Re-
sponse, the Secretary of Defense, Secretary of 
Homeland Security, and other heads of agen-
cies, as appropriate, shall review and update the 
list of essential generic medicines required 
under subsection (a). 
‘‘(B) RATIONALE.—In carrying out the an-
nual review and update under subparagraph 
(A), the Secretary shall provide a rationale for 
each essential generic medicine added to, or re-
moved from, the list under subsection (a). 
‘‘(C) SPECIFIC
POPULATIONS.—The Sec-
retary shall consider including on the list under 
subsection (a), and, where appropriate, include 
on such list, essential generic medicines that 
are essential to specific subpopulations, includ-
ing pediatric populations, in developing the list 
under such subsection. 
‘‘(D) THREAT ASSESSMENTS.— 
‘‘(i) IN
GENERAL.—The Secretary, 
after consultation with the Public Health 
Emergency Medical Countermeasures En-
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terprise established under section 2811–1, 
shall conduct regular threat assessments, 
and take such assessments into consider-
ation in updating the list in accordance 
with subparagraph (A). 
‘‘(ii) THREAT ASSESSMENTS CONSID-
ERATIONS.—Each threat assessment under 
this subparagraph shall include consider-
ation of— 
‘‘(I) the lack of existing domestic 
capacity of essential generic medi-
cines; 
‘‘(II) the concentration of current 
supply of the essential generic medi-
cine or active pharmaceutical ingredi-
ents of the essential generic medicine 
in one geographical region; 
‘‘(III) whether there are less 
than 2 manufacturers of the essential 
generic medicine or active pharma-
ceutical ingredients of the essential 
generic medicine; and 
‘‘(IV) the potential for increased 
demand in a public health emergency. 
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‘‘(E) DIRECTOR OF THE STRATEGIC AC-
TIVE
PHARMACEUTICAL
INGREDIENTS
RE-
SERVE.—The Secretary shall appoint a Director 
of the Strategic Active Pharmaceutical Ingredi-
ents Reserve who has experience in one or more 
of the following areas: supply chain manage-
ment, disaster response, pharmaceutical or ac-
tive pharmaceutical ingredient development, or 
logistics. Such Director shall ensure a sufficient 
supply of the active pharmaceutical ingredients 
and critical components necessary to manufac-
ture the essential generic medicines included on 
the list under subsection (a) in an amount ade-
quate to serve the needs of patients living in the 
United States and in the appropriate dosage 
forms. 
‘‘(c) APPEAL PROCESS.—The Secretary shall estab-
lish a process by which stakeholders may appeal a deter-
mination by the Secretary not to include an essential ge-
neric medicine on the list under subsection (a). 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) DRUG.—The term ‘drug’ has the meaning 
given such term in section 201(g) of the Federal 
Food, Drug, and Cosmetic Act, and includes a bio-
logical product (as defined in section 351(i) of this 
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Act). Such term includes prescription and non-
prescription drugs, or active pharmaceutical ingredi-
ents of drugs. 
‘‘(2) ESSENTIAL
GENERIC
MEDICINE.—The 
term ‘essential generic medicine’ means a drug for 
which a generic is approved, that is medically nec-
essary to have available at all times because the 
drug is— 
‘‘(A) commonly used to prevent, mitigate, 
or treat a common disease or condition, or used 
in a common procedure; 
‘‘(B) an antibiotic or antifungal used to 
treat an infectious diseases; 
‘‘(C) necessary to prevent or mitigate a 
public health emergency; or 
‘‘(D) life-supporting, life-sustaining, or in-
tended for use in the prevention or treatment of 
a debilitating disease or condition.’’. 
SEC. 3. ESTABLISHMENT OF THE STRATEGIC ACTIVE PHAR-
MACEUTICAL INGREDIENT RESERVE. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.), as amended by section 2, is fur-
ther amended by inserting after section 319N the fol-
lowing: 
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‘‘SEC. 319N–1. STRATEGIC ACTIVE PHARMACEUTICAL IN-
GREDIENT RESERVE. 
‘‘(a) STRATEGIC ACTIVE PHARMACEUTICAL INGRE-
DIENT RESERVE PLAN.— 
‘‘(1) IN
GENERAL.—Not later than 90 days 
after the date of enactment of the Promoting Readi-
ness and Ensuring Proper Active Pharmaceutical In-
gredient Reserves of Essential Medicines Act of 
2024, the Secretary, in consultation with the Assist-
ant Secretary for Preparedness and Response, the 
Director of the Centers for Disease Control and Pre-
vention, the Commissioner of Food and Drugs, and 
the Director of the Biomedical Advanced Research 
and Development Authority, shall prepare and sub-
mit to Congress a Strategic Active Pharmaceutical 
Ingredient Reserve Plan (referred to in this section 
as the ‘Plan’) in accordance with subsection (b), 
which shall be used by the Secretary in establishing 
and maintaining the Strategic Active Pharmaceutical 
Ingredient Reserve described in subsection (c). 
‘‘(2) ANNUAL UPDATES.—The Secretary shall 
update the plan annually and, by not later than 
June 1 of each year, submit the updated plan to the 
applicable committees of Congress. 
‘‘(3) NATIONAL SECURITY CONSIDERATIONS.— 
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‘‘(A) SUBMISSIONS.—The Secretary shall 
ensure that any submission of the plan (includ-
ing any update to the plan) to the applicable 
committees of Congress is in a manner that 
does not compromise national security. 
‘‘(B) EXEMPTION FROM DISCLOSURE.—In-
formation in the plan that, in the judgment of 
the Secretary, would reveal public health 
vulnerabilities shall be exempt from disclosure 
under section 552(b)(3) of title 5, United 
States Code. 
‘‘(b) PLAN REQUIREMENTS.— 
‘‘(1) IN GENERAL.—The Plan required under 
subsection (a) shall— 
‘‘(A) detail the design, construction, and 
filling of the storage and related facilities com-
prising the Strategic Active Pharmaceutical In-
gredient Reserve described in subsection (c) (re-
ferred to in this section as the ‘Reserve’); 
‘‘(B) detail the requirements for maintain-
ing the Reserve described in subsection (c), in-
cluding— 
‘‘(i) storage and testing requirements, 
consistent with parts 210 and 211 of title 
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21, Code of Federal Regulations, or any 
successor regulation; and 
‘‘(ii) any specific criteria agreed to by 
the Secretary and the manufacturer of the 
essential generic medicine using the active 
pharmaceutical ingredient or key starting 
material; 
‘‘(C) be designed to minimize the impact of 
any interruption or reduction in imports of— 
‘‘(i) active pharmaceutical ingredients 
and other key starting materials that the 
Secretary determines are, or are likely to 
become, dependent upon such imports for 
a substantial portion of finished essential 
generic medicines; and 
‘‘(ii) finished dosage forms of essential 
generic medicines for which active pharma-
ceutical ingredients and other key starting 
materials are not imported; 
‘‘(D) include provisions to strengthen do-
mestic capacity for active pharmaceutical ingre-
dient production, storage, and conversion; and 
‘‘(E) outline plans and processes for co-
ordinating and consulting, as appropriate, with 
the Assistant Secretary for Preparedness and 
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Response regarding relevant issues of interest 
pertaining to the maintenance and stocking of 
the strategic national stockpile. 
‘‘(2) REQUIRED COMPONENTS.— 
‘‘(A) IN GENERAL.—The Plan shall include 
the following: 
‘‘(i) Identification and prioritization of 
the essential generic medicines included on 
the 
most 
recent 
list 
under 
section 
319N(a)— 
‘‘(I) that the Secretary deter-
mines are essential for health care 
needs in the United States; and 
‘‘(II) for which the Secretary de-
termines that there is the greatest 
need to maintain a reserve of the ac-
tive pharmaceutical ingredients and 
key starting materials for the essen-
tial generic medicines— 
‘‘(aa) taking into account 
factors including the extent to 
which the United States is, or is 
at risk of becoming, dependent 
on foreign sources for a substan-
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tial portion of the domestic need; 
and 
‘‘(bb) giving special consid-
eration to the essential generic 
medicines at risk of supply inter-
ruption as a result of the factors 
described 
in 
section 
319N(c)(4)(B). 
‘‘(ii) An evaluation of the utilization 
levels of the essential generic medicines 
identified under clause (i) to inform how 
much of the active pharmaceutical ingredi-
ents of such medicines is required to cover 
the projected health care needs for one 
year of the United States population. 
‘‘(iii) A comprehensive assessment of 
the essential generic medicines identified 
under clause (i), including the existing 
manufacturing bases for each such medi-
cine (including identification and location 
of ownership of such facilities) and wheth-
er the active pharmaceutical ingredients of 
such ingredients are manufactured domes-
tically or abroad, and whether finished dos-
age conversion steps for such essential ge-
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neric medicines are performed domestically 
or abroad. 
‘‘(iv) The types of facilities, equip-
ment, and technology required to appro-
priately store, track, test, and convert all 
forms of active pharmaceutical ingredients 
that are critical inputs of drugs that are 
essential generic medicines, preliminary 
proposed locations for such public and pri-
vately owned facilities in multiple locations 
in the United States, the capacity required 
of the facilities used, and the estimated 
cost of acquisition and storage of the ac-
tive pharmaceutical ingredients and man-
agement and operation of the facilities. 
‘‘(v) An evaluation of the impact that 
the establishment and ongoing mainte-
nance of the Reserve may have, including 
on availability and pricing of active phar-
maceutical ingredients and finished drug 
dosages. 
‘‘(vi) A distribution plan for the active 
pharmaceutical ingredients held in the Re-
serve, which shall include— 
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‘‘(I) protocols for the method of 
conversion of active pharmaceutical 
ingredients into finished drugs, in-
cluding conversion of key starting ma-
terials into active pharmaceutical in-
gredients and distribution from the 
Reserve into the strategic national 
stockpile and other government and 
commercial pharmaceutical distribu-
tion networks; and 
‘‘(II) benchmarks for the Sec-
retary to initiate conversion of drug 
products that are essential generic 
medicines using the active pharma-
ceutical ingredients stored in the Re-
serve for transfer to the strategic na-
tional stockpile or other government 
or commercial pharmaceutical dis-
tribution networks, based on changes 
in the supply chain for the top essen-
tial generic medicines or a determina-
tion by the Secretary regarding a 
threat to public health. 
‘‘(vii) A mechanism through which 
private sector manufacturers of active 
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pharmaceutical ingredients or finished dos-
age forms may, through contracts with ex-
isting Reserve facilities, store and with-
draw such ingredients in the Reserve to 
enhance resilience and reduce shortages 
and disruptions in the supply chain. 
‘‘(viii) A mechanism through which 
the Federal Government may purchase, via 
manufacturing partners, reserve capacity 
for finished drug manufacturing to convert 
active pharmaceutical ingredients into fin-
ished drugs for essential generic medicines. 
‘‘(B) NUMBER OF DRUGS.— 
‘‘(i) IN GENERAL.—Pursuant to sub-
paragraph (A)(i), the Secretary shall en-
sure that for the first year after the date 
of enactment of the Promoting Readiness 
and Ensuring Proper Active Pharma-
ceutical Ingredient Reserves of Essential 
Medicines Act of 2024, the Plan includes 
not less than 25 essential generic medi-
cines, and that 25 additional essential ge-
neric medicines are included in such Plan 
for each year thereafter until the active 
pharmaceutical ingredients necessary to 
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support the full list of essential generic 
medicines identified under section 319N(a) 
are covered. 
‘‘(ii) PRIORITIZATION.—The Secretary 
shall prioritize essential generic medicines 
needed immediately in the event of an 
emergency. 
‘‘(3) QUANTITIES OF APIS AND KEY STARTING 
MATERIALS.— 
‘‘(A) IN GENERAL.—To the maximum ex-
tent practicable, the Plan should include a plan 
to ensure that, for each essential generic medi-
cine included in the Plan, the active pharma-
ceutical ingredients used in the production of 
such medicine that are stored in the Reserve 
are available in the minimum quantities as fol-
lows: 
‘‘(i) By the date that is 18 months 
after the date of enactment of the Pro-
moting Readiness and Ensuring Proper 
Active Pharmaceutical Ingredient Reserves 
of Essential Medicines Act of 2024, not 
less than 10 percent of the total amount of 
such ingredients needed to produce suffi-
cient quantities of the essential generic 
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medicines for the treatment of individuals 
living in the United States. 
‘‘(ii) By the date that is 3 years after 
such date of enactment, not less than 25 
percent of the total amount of such ingre-
dients needed to produce sufficient quan-
tities of the essential generic medicines for 
the treatment of individuals living in the 
United States. 
‘‘(iii) By the date that is 5 years after 
such date of enactment, not less than 50 
percent of the total amount of such ingre-
dients needed to produce sufficient quan-
tities of the essential generic medicines for 
the treatment of individuals living in the 
United States. 
‘‘(iv) By the date that is 10 years 
after such date of enactment, not less than 
90 percent of the total amount of such in-
gredients needed to produce sufficient 
quantities of the essential generic medi-
cines for the treatment of individuals living 
in the United States. 
‘‘(B) CALCULATION
OF
QUANTITY
OF 
API.—In calculating the quantities of active 
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pharmaceutical ingredients needed for purposes 
of subparagraph (A), the Secretary shall deter-
mine the quantity of each essential generic 
medicine required to cover the projected health 
care needs, over a 1-year period, of people living 
in the United States, based on average annual 
demand during the 3-year period preceding the 
date of enactment of the Promoting Readiness 
and Ensuring Proper Active Pharmaceutical In-
gredient Reserves of Essential Medicines Act of 
2024. 
‘‘(c) ADMINISTERING THE STRATEGIC ACTIVE PHAR-
MACEUTICAL INGREDIENT RESERVE.— 
‘‘(1) IN GENERAL.—With respect to each active 
pharmaceutical ingredient and key starting material 
that is included in the Plan, the Secretary shall 
place in storage, transport, track, and exchange 
quantities of the substance that are— 
‘‘(A) produced in conformance with all 
quality requirements under this Act and the 
Federal Food, Drug, and Cosmetic Act, includ-
ing the associated regulations of such Acts; 
‘‘(B) stored in compliance with the require-
ments of parts 210 and 211 of title 21, Code 
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of Federal Regulations, or any successor regula-
tion; and 
‘‘(C) any specific criteria agreed to by the 
Secretary and the manufacturer of the essential 
generic medicine using the active pharma-
ceutical ingredient or key starting material. 
‘‘(2) REQUIREMENTS.—To the greatest extent 
practicable, in carrying out paragraph (1), the Sec-
retary shall acquire active pharmaceutical ingredi-
ents and key starting materials in a manner that 
minimizes cost, minimizes vulnerability of the United 
States to severe shortages or disruptions for essen-
tial generic medicines, minimizes the impact of ac-
quisition of such ingredients and materials to the 
marketplace, gives preference to domestic manufac-
turers, and encourages competition in the market-
place. 
‘‘(3) DRAWDOWN OF THE RESERVE.— 
‘‘(A) IN
GENERAL.—The Secretary may 
distribute active pharmaceutical ingredients and 
key starting materials in the Reserve in order 
to initiate conversion of active pharmaceutical 
ingredients and finished dosage form, in accord-
ance with the Plan developed under subsection 
(b). 
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‘‘(B) DEVIATIONS FROM PLAN.—In distrib-
uting active pharmaceutical ingredients and key 
starting materials under subparagraph (A), the 
Secretary, in consultation with the Commis-
sioner of Food and Drugs and the Assistant 
Secretary for Preparedness and Response, may 
deviate from the Plan developed under sub-
section (b) only after certifying that the dis-
tribution from the Reserve is required in re-
sponse to a significant drug supply interrup-
tion. 
‘‘(d) CONSULTATION.— 
‘‘(1) IN GENERAL.—In carrying out this sec-
tion, the Secretary shall consult with— 
‘‘(A) the Commissioner of Food and 
Drugs, with respect to identifying essential ge-
neric medicines; 
‘‘(B) the Administrator of the Centers for 
Medicare & Medicaid Services, with respect to 
determining the volume of essential generic 
medicines needed domestically; and 
‘‘(C) the Assistant Secretary for Prepared-
ness and Response, and, as appropriate, the Di-
rector of the Centers for Disease Control and 
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Prevention, regarding coordination with the 
strategic national stockpile. 
‘‘(2) REPORTING BY FDA.—The Commissioner 
of Food and Drugs shall provide to the Secretary 
the information collected under section 510(j)(3) of 
the Federal Food, Drug, and Cosmetic Act, for pur-
poses of carrying out this section. 
‘‘(e) CONTRACTING.— 
‘‘(1) IN GENERAL.—In carrying out this sec-
tion, the Secretary shall— 
‘‘(A) prioritize the purchase of active phar-
maceutical ingredients and other key starting 
materials manufactured in the United States by 
domestic manufacturers to the maximum extent 
possible; 
‘‘(B) contract with domestic entities for 
the— 
‘‘(i) distribution of active pharma-
ceutical ingredients and finished drug 
products; 
‘‘(ii) storage, withdrawal, testing, and 
conversion of active pharmaceutical ingre-
dients and other key starting materials; 
‘‘(iii) tracking and coordinating the 
storage, testing, and sale of active pharma-
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ents and other key starting materials into fin-
ished dosage form. 
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to limit the Sec-
retary’s ability to enter into other types of contracts 
to facilitate the implementation of this section. 
‘‘(f) REPORTS TO CONGRESS.—The Secretary shall 
report to the applicable committees of Congress on supply 
chain resiliency with respect to active pharmaceutical in-
gredients for essential generic medicines, the status of the 
Reserve, and other relevant information in a manner that 
does not compromise national security. 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) 
APPLICABLE
COMMITTEES
OF
CON-
GRESS.—The term ‘applicable committees of Con-
gress’ means— 
‘‘(A) the Committee on Health, Education, 
Labor, and Pensions and the Committee on In-
telligence of the Senate; and 
‘‘(B) the Committee on Energy and Com-
merce of the House of Representatives. 
‘‘(2) ESSENTIAL
GENERIC
MEDICINE.—The 
term ‘essential generic medicine’ means a drug in-
cluded on the most current list under section 
319N(a). 
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‘‘(3) KEY STARTING MATERIAL.—The term ‘key 
starting material’ means an active pharmaceutical 
ingredient or critical input used in the manufac-
turing of an essential generic medicine, as well as in-
gredients or components that possess unique at-
tributes essential in assessing the safety and effec-
tiveness of such essential generic medicines, includ-
ing excipients and inactive ingredients. 
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
such sums as may be necessary.’’. 
SEC. 4. WAIVER OF CERTAIN FDA ANDA REQUIREMENTS. 
Section 505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)) is amended by adding at the 
end the following: 
‘‘(14) Notwithstanding any other provision of 
this section, the holder of an approved application 
under this subsection that changes the source of an 
active pharmaceutical ingredient of the drug that is 
the subject of such application to a source available 
through the Strategic Active Pharmaceutical Ingre-
dient Reserve established under section 319N–1 of 
the Public Health Service Act— 
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‘‘(A) shall not be required to update the 
approved application with respect to such 
change before changing the source; and 
‘‘(B) shall inform the Secretary of the 
change, through an update to the approved ap-
plication or other manner determined appro-
priate by the Secretary, prior to commercial 
distribution of the drug.’’. 
SEC. 5. GAO REPORT. 
By not later than 18 months after the date of enact-
ment of this Act, the Comptroller General of the United 
States shall prepare and submit a report to Congress that 
includes— 
(1) an assessment of what is known about ac-
tive pharmaceutical ingredient manufacturing, in-
cluding— 
(A) the time needed to develop and imple-
ment domestic manufacturing capabilities; 
(B) projected costs of developing new man-
ufacturing capabilities for active pharmaceutical 
ingredients not currently available domestically, 
as of the date of the report; and 
(C) projected costs of expanding existing 
domestic capabilities and policies, as of the date 
of the report, that may help establish or 
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strengthen domestic manufacturing capacity for 
active pharmaceutical ingredients, excipients, 
key starting materials, components, functional 
ingredients, and finished dosage manufacturing 
facilities; and 
(2) an assessment of incentives already offered 
or being considered for the development or improve-
ment of domestic capacity to manufacture active 
pharmaceutical ingredients, their intermediates, and 
their excipients, including— 
(A) contractual arrangements for existing 
domestic storage and manufacturing of active 
pharmaceutical ingredients; 
(B) guaranteed contracts for initial pur-
chase and replenishment of essential generic 
medicines; and 
(C) 
other 
policies 
designed 
to 
help 
incentivize the relocation of manufacturing fa-
cilities to the United States or provide economic 
incentives for domestic production. 
Æ 
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