date of enactment of the Promoting Readiness 
and Ensuring Proper Active Pharmaceutical In-
gredient Reserves of Essential Medicines Act of 
2021. 
‘‘(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— 
‘‘(i) the requirements of parts 210 
and 211 of title 21, Code of Federal Regu-
lations, or any successor regulation; 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-
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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). 
‘‘(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-
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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 
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.— 
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‘‘(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-
ceutical ingredients and other key starting 
materials; 
‘‘(iv) sale of active pharmaceutical in-
gredients in advance of their expiration 
dates; and 
‘‘(v) manufacturing, including contin-
uous manufacturing as appropriate, of an 
active pharmaceutical ingredient or other 
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key starting material of an essential ge-
neric medicine that is anticipated to be in 
shortage, as defined by the Secretary for 
purposes of this section; 
‘‘(C) give preference to domestic nonprofit 
and public-private partnerships, as appropriate; 
‘‘(D) ensure geographic diversity of the 
physical storage of active pharmaceutical ingre-
dients and other key starting materials; 
‘‘(E) support domestic manufacturers of 
active pharmaceuticals and other key starting 
materials and facilitate long-term domestic ca-
pacity for essential generic medicines in the 
United States; and 
‘‘(F) prioritize contracts that facilitate the 
conversation of active pharmaceutical ingredi-
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-
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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). 
‘‘(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. 
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‘‘(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— 
‘‘(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.’’. 
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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 
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 
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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 incentiv-
ize the relocation of manufacturing facilities to 
the United States or provide economic incen-
tives for domestic production. 
Æ 
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