I 
117TH CONGRESS 
1ST SESSION H. R. 5388 
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 
SEPTEMBER 27, 2021 
Ms. SPANBERGER (for herself and Mr. MCKINLEY) 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 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
Reserves of Essential Medicines Act of 2021’’ or the 
‘‘PREPARE ACT of 2021’’. 
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. 
‘‘(c) UPDATES.— 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(1) 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 Response, the Sec-
retary of Defense, Secretary of Homeland Security, 
and other heads of agencies, as appropriate, shall re-
view and update the list of essential generic medi-
cines required under subsection (a). 
‘‘(2) RATIONALE.—In carrying out the annual 
review and update under paragraph (1), the Sec-
retary shall provide a rationale for each essential ge-
neric medicine added to, or removed from, the list 
under subsection (a). 
‘‘(3) SPECIFIC
POPULATIONS.—The Secretary 
shall consider including on the list under subsection 
(a), and, where appropriate, include on such list, es-
sential generic medicines that are essential to spe-
cific subpopulations, including pediatric populations, 
in developing the list under such subsection. 
‘‘(4) THREAT ASSESSMENTS.— 
‘‘(A) IN GENERAL.—The Secretary, after 
consultation with the Public Health Emergency 
Medical Countermeasures Enterprise estab-
lished under section 2811–1, shall conduct reg-
ular threat assessments, and take such assess-
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
ments into consideration in updating the list in 
accordance with paragraph (1). 
‘‘(B) THREAT
ASSESSMENTS
CONSIDER-
ATIONS.—Each threat assessment under this 
paragraph shall include consideration of— 
‘‘(i) the lack of existing domestic ca-
pacity of essential generic medicines; 
‘‘(ii) the concentration of current sup-
ply of the essential generic medicine or ac-
tive pharmaceutical ingredients of the es-
sential generic medicine in one geo-
graphical region; 
‘‘(iii) whether there are less than 2 
manufacturers of the essential generic 
medicine or active pharmaceutical ingredi-
ents of the essential generic medicine; and 
‘‘(iv) the potential for increased de-
mand in a public health emergency. 
‘‘(5) DIRECTOR
OF
THE
STRATEGIC
ACTIVE 
PHARMACEUTICAL
INGREDIENTS
RESERVE.—The 
Secretary shall appoint a Director of the Strategic 
Active Pharmaceutical Ingredients Reserve who has 
experience in one or more of the following areas: 
supply chain management, disaster response, phar-
maceutical or active pharmaceutical ingredient devel-
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
opment, or logistics. Such Director shall ensure a 
sufficient supply of the active pharmaceutical ingre-
dients and critical components necessary to manu-
facture the essential generic medicines included on 
the list under subsection (a) in an amount adequate 
to serve the needs of patients living in the United 
States and in the appropriate dosage forms. 
‘‘(d) 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). 
‘‘(e) 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 
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— 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(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: 
‘‘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 
2021, the Secretary, in consultation with the Assist-
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
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.— 
‘‘(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 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
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 
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— 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(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 
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 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
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-
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). 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(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-
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 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
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— 
‘‘(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 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
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 
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 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
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 2021, 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 
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. 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(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 2021, not 
less than 10 percent of the total amount of 
such ingredients needed to produce suffi-
cient quantities of the essential generic 
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 
VerDate Sep 11 2014 
22:32 Sep 29, 2021
Jkt 019200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H5388.IH
H5388
pamtmann on DSKBC07HB2PROD with BILLS