I 
119TH CONGRESS 
1ST SESSION H. R. 4191 
To improve coordination of Federal efforts to identify and mitigate health 
and national security risks through maintaining a list of essential medi-
cines, conducting a risk assessment of essential medicine supply chains, 
and creating a monitoring system to map essential medicine supply 
chains using data analytics. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 26, 2025 
Ms. MATSUI (for herself and Mr. CRENSHAW) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To improve coordination of Federal efforts to identify and 
mitigate health and national security risks through main-
taining a list of essential medicines, conducting a risk 
assessment of essential medicine supply chains, and cre-
ating a monitoring system to map essential medicine 
supply chains using data analytics. 
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 ‘‘Mapping America’s 
Pharmaceutical Supply Act’’ or the ‘‘MAPS Act’’. 
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SEC. 2. ESSENTIAL MEDICINES LIST. 
(a) IN GENERAL.—The Secretary, in coordination 
with the heads of other relevant Federal departments and 
agencies and in consultation with, as appropriate, stake-
holders who have relevant expertise, shall update and 
maintain a list of essential medicines (referred to in this 
Act as the ‘‘Essential Medicines List’’), initially developed 
in response to Executive Order 13944 (85 Fed. Reg. 
49929), to include active pharmaceutical ingredients and 
drugs— 
(1) that are directly related to responding to 
chemical, biological, radiological, or nuclear threats 
and incidents covered by the National Response 
Framework; 
(2) of greatest priority for providing health care 
and identified as being at high risk of shortage; or 
(3) the shortage of which would have an ad-
verse health outcome on patients with chronic condi-
tions. 
(b) UPDATES TO LIST.—The Secretary shall review 
the Essential Medicines List regularly, on a timeframe 
that the Secretary determines necessary and appropriate, 
and not less frequently than every 2 years; and shall up-
date the Essential Medicines List as necessary based on 
the findings of such review. 
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(c) COMPILATION OF INITIAL LIST.—The Secretary 
shall complete the first updates to the Essential Medicines 
List required pursuant to subsection (a) not later than 
180 days after the date of enactment of this Act. 
(d) PUBLICATION
OF LIST.—The Secretary shall 
publish the Essential Medicines List promptly after each 
update pursuant to subsection (b) or (c). 
SEC. 3. ESSENTIAL MEDICINES RISK ASSESSMENT. 
(a) IN GENERAL.—The Secretary, in consultation 
with the heads of other relevant departments and agen-
cies, shall conduct a comprehensive risk assessment of the 
supply chains for active pharmaceutical ingredients and 
drugs included on the Essential Medicines List described 
in section 2. 
(b) CONTENTS OF ESSENTIAL MEDICINES RISK AS-
SESSMENT.—At a minimum, the risk assessment under 
subsection (a) shall identify, to the extent available— 
(1) key starting materials and excipients used 
in manufacturing the active pharmaceutical ingredi-
ents and drugs on the Essential Medicines List; 
(2) the active pharmaceutical ingredients and 
drugs on the Essential Medicines List that rely on 
a foreign supplier for more than 50 percent of pro-
duction; 
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(3) the active pharmaceutical ingredients and 
drugs on the Essential Medicines List that are 
sourced exclusively or primarily from a single sup-
plier, including drugs manufactured domestically 
from active pharmaceutical ingredients sourced ex-
clusively or primarily from a single supplier; 
(4) current domestic manufacturing capabilities 
for active pharmaceutical ingredients and drugs on 
the Essential Medicines List, including the key 
starting materials and excipients of such ingredients 
and drugs, and any cost-effective manufacturing 
technologies, including advanced manufacturing; 
(5) public health and national security risks, in-
cluding cybersecurity threats and critical infrastruc-
ture designations specific to the supply chains of ac-
tive pharmaceutical ingredients and drugs included 
on the Essential Medicines List; 
(6) any deficiencies, lack of authorities, or limi-
tations in policy or process that reduce the ability of 
the Federal Government to address any identified 
public health or national security risks related to 
supply chains for active pharmaceutical ingredients 
and drugs included on the Essential Medicines List; 
and 
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(7) how the Federal Government will mitigate 
such national security risks, including through the 
use of authorities under the Defense Production Act 
of 1950 (50 U.S.C. 4501 et seq.). 
(c) REPORT ON ASSESSMENT.— 
(1) SUBMISSION OF REPORT.—Not later than 
180 days after the date of enactment of this Act, 
and annually thereafter, the Secretary, in consulta-
tion with the heads of relevant Federal departments 
and agencies consulted under subsection (a), shall 
submit a report with the findings under subsection 
(b) to the relevant Committees of Congress. 
SEC. 4. U.S. PHARMACEUTICAL SUPPLY CHAINS MAPPING. 
(a) PHARMACEUTICAL SUPPLY CHAIN MAPPING.— 
The Secretary of Health and Human Services (referred 
to in this section as the ‘‘Secretary’’), in coordination with 
the heads of other relevant Federal departments and agen-
cies, shall ensure coordination of efforts of the Depart-
ment of Health and Human Services, including through 
public-private partnerships, to— 
(1) map, or otherwise visualize, the supply 
chains, from manufacturing of key starting mate-
rials through manufacturing of finished dosage 
forms and distribution, of drugs (as defined in sec-
tion 201 of the Federal Food, Drug, and Cosmetic 
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Act (21 U.S.C. 321)) included on the Essential 
Medicines List under section 2; and 
(2) use data analytics to identify supply chain 
vulnerabilities that pose a threat to public health or 
national security, as determined by the Secretary or 
the heads of other relevant Federal departments and 
agencies. 
(b) REQUIREMENTS.—In carrying out subsection (a), 
the Secretary shall— 
(1) describe the roles and responsibilities of 
agencies and offices within the Department of 
Health and Human Services related to monitoring 
such supply chains and assessing any related 
vulnerabilities; and 
(2) facilitate the exchange of information be-
tween Federal departments, agencies, and offices, as 
appropriate and necessary to enable such agencies 
and offices to carry out roles and responsibilities de-
scribed in paragraph (1) related to drugs described 
in subsection (a)(1). Such information should in-
clude, at a minimum— 
(A) the location of establishments reg-
istered under subsection (b), (c), or (i) of sec-
tion 510 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360) involved in the pro-
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duction of active pharmaceutical ingredients 
and finished dosage forms of drugs described in 
subsection (a)(1), and the amount of such in-
gredients and finished dosage forms produced 
at each such establishment; 
(B) to the extent available and as appro-
priate, the location of establishments so reg-
istered involved in the production of the key 
starting materials and excipients needed to 
produce the active pharmaceutical ingredients 
and finished dosage forms, and the amount of 
such materials and excipients produced at each 
such establishment; and 
(C) any regulatory actions with respect to 
such drugs or the establishments manufac-
turing such drugs, including with respect to in-
spections and related regulatory activities con-
ducted under section 704 of such Act (21 
U.S.C. 374), the seizure of such a drug pursu-
ant to section 304 of such Act (21 U.S.C. 334), 
any recalls of such a drug; inclusion of such a 
drug on the drug shortage list under section 
506E of such Act (21 U.S.C. 356e), or prior re-
ports of a discontinuance or interruption in the 
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production of such a drug under section 506C 
of such Act (21 U.S.C. 356c). 
(c) REPORT.—Not later than 18 months after the 
date of enactment of this Act, and annually thereafter, 
the Secretary, in consultation with the heads of agencies 
with which the Secretary coordinates under subsection (a), 
shall submit a report to the relevant committees of Con-
gress on— 
(1) the current status of efforts to map and 
analyze pharmaceutical supply chains, as described 
in subsection (a); 
(2) activities of the Secretary carried out under 
this section to coordinate efforts as described in sub-
section (a), including information sharing between 
relevant Federal departments, agencies, and offices; 
(3) the roles and responsibilities described in 
subsection (b)(1), including the identification of any 
gaps, data limitations, or areas of unnecessary dupli-
cation between such roles and responsibilities; 
(4) the extent to which Federal agencies use 
data analytics to conduct predictive modeling of an-
ticipated drug shortages or risks associated with 
supply chain vulnerabilities that pose a threat to na-
tional security; and 
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(5) the extent to which the Secretary has en-
gaged relevant industry in such mapping. 
SEC. 5. DEFINITIONS. 
In this Act: 
(1) ADVANCED
MANUFACTURING.—The term 
‘‘advanced manufacturing’’ has the meaning given 
the term ‘‘advanced and continuous pharmaceutical 
manufacturing’’ in section 3016(h) of the 21st Cen-
tury Cures Act (21 U.S.C. 399h(h)). 
(2) CYBERSECURITY THREAT.—The term ‘‘cy-
bersecurity threat’’ has the meaning given such term 
in section 2200 of the Homeland Security Act of 
2002 (6 U.S.C. 650). 
(3) DRUG.—The term ‘‘drug’’ has the meaning 
given such term in section 201(g) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)). 
(4) SECRETARY.—The term ‘‘Secretary’’, except 
as otherwise specified, means the Secretary of 
Health and Human Services. 
SEC. 6. ADDITIONAL PROVISIONS. 
(a) CLARIFICATION.—The participation of the Sec-
retary in developing and updating the list of essential 
medicines under section 2 shall be deemed to be full satis-
faction of the requirements applicable to such Secretary 
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under section 3 of Executive Order 13944 (85 Fed. Reg. 
49929). 
(b) CONFIDENTIAL COMMERCIAL INFORMATION.— 
The exchange of information among the Secretary and the 
heads of other relevant Federal departments and agencies 
for purposes of carrying out sections 3 and 4 shall not 
be a violation of section 1905 of title 18, United States 
Code. This section shall not be construed to affect the sta-
tus, if any, of such information as trade secret or confiden-
tial commercial information for purposes of section 301(j) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331(j)), section 552 of title 5, United States Code, or sec-
tion 1905 of title 18, United States Code. 
(c) CYBERSECURITY
MEASURES.—The Secretary 
shall ensure that robust cybersecurity measures are in 
place to prevent inappropriate access to, or unauthorized 
disclosure of, the information identified, exchanged, or dis-
closed under sections 3 and 4. 
Æ 
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