(B) provide an opportunity for public com-
ment on the proposed list or update. 
(2) INITIAL LIST.—The Secretary shall— 
(A) publish the proposed initial list under 
subsection (a) not later than 6 months after the 
date of enactment of this Act; and 
(B) publish the final initial list under sub-
section (a) not later than 1 year after such date 
of enactment. 
(3) REGULAR
REVIEW.—The Secretary shall 
regularly review the list under subsection (a) to de-
termine whether any updates should be made pursu-
ant to paragraph (1). 
(e) RELATION TO EXECUTIVE ORDER.—The partici-
pation of the Secretary in establishing, maintaining, and 
updating the list under subsection (a) shall be deemed to 
be full satisfaction of the requirements applicable to the 
Secretary under section 3 of Executive Order 13944 (85 
Fed. Reg. 49929). 
SEC. 3. FEDERAL UNITED STATES PHARMACEUTICAL SUP-
PLY CHAIN MAPPING. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, in coordination with the heads of other 
relevant agencies, shall support efforts, including through 
public-private partnerships, to map the entire United 
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States pharmaceutical supply chain, from inception to dis-
tribution, and use data analytics to identify supply chain 
vulnerabilities and other national security threats. Such 
activities shall include, at a minimum— 
(1) defining agency roles in monitoring the 
pharmaceutical supply chain and communicating 
supply chain vulnerabilities; and 
(2) with respect to drugs and active pharma-
ceutical ingredients on the list of essential medicines 
under section 2(a), establishing a database that shall 
include— 
(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-
duction of— 
(i) the finished dosage forms of the 
drugs on such list; 
(ii) the active pharmaceutical ingredi-
ents of such drugs; or 
(iii) active pharmaceutical ingredients 
on such list; 
(B) the amount of such finished dosage 
forms and active pharmaceutical ingredients 
produced at each such establishment; 
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(C) to the extent available— 
(i) the location of establishments in-
volved in the production of the key starting 
materials and excipients used to produce 
the finished dosage forms and active phar-
maceutical ingredients referred to in sub-
paragraph (A); and 
(ii) the amount of such materials and 
excipients produced at each such establish-
ment; and 
(D) any regulatory actions with respect to 
the establishments referred to in subparagraph 
(A) or (C), including with respect to— 
(i) labeling requirements; 
(ii) registration and listing informa-
tion required to be submitted under section 
510 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360); 
(iii) inspections and related regulatory 
activities conducted under section 704 of 
such Act (21 U.S.C. 374); 
(iv) the seizure of such a drug or ac-
tive pharmaceutical ingredient pursuant to 
section 304 of such Act (21 U.S.C. 334); 
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(v) any recalls of a drug or active 
pharmaceutical ingredient on the list of es-
sential medicines under section 2(a), or a 
drug containing an active pharmaceutical 
ingredient on such list; 
(vi) inclusion of such a drug or active 
pharmaceutical ingredient on the drug 
shortage list under section 506E of such 
Act (21 U.S.C. 356e); or 
(vii) prior reports of a discontinuance 
or interruption in the production of such a 
drug or active pharmaceutical ingredient 
under 506C of such Act (21 U.S.C. 356c). 
(b) REPORT.—Not later than 18 months after the 
date of enactment of this Act, and annually thereafter, 
the Secretary of Health and Human Services, in consulta-
tion with the heads of agencies with which such Secretary 
coordinates under subsection (a), shall submit a report to 
Congress on— 
(1) progress on implementing subsection (a), in-
cluding any timelines for full implementation; 
(2) gaps in data needed for full implementation 
of such subsection; 
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(3) how the database established pursuant to 
subsection (a) increases Federal visibility into the 
pharmaceutical supply chain; 
(4) how Federal agencies are able to use data 
analytics to conduct predictive modeling of antici-
pated drug shortages or national security threats; 
and 
(5) the extent to which industry has cooperated 
in mapping the pharmaceutical supply chain. 
(c) CONFIDENTIAL COMMERCIAL INFORMATION.— 
The exchange of information among the Secretary of 
Health and Human Services and the heads of other rel-
evant agencies for purposes of carrying out this section 
shall not be a violation of section 1905 of title 18, United 
States Code. 
(d) CLARIFICATION.—The information in the data-
base established pursuant to subsection (a) shall not be 
publicly disclosed. Nothing in this subsection shall be con-
strued to relieve the Secretary of Health and Human Serv-
ices from the Secretary’s obligation to provide information 
to Congress. 
Æ 
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