I 

118TH CONGRESS 

2D SESSION H. R. 6992 

To require the Secretary of Health and Human Services to establish a 

list of essential medicines, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 12, 2024 

Ms. MATSUI (for herself and Mr. BUCSHON) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To require the Secretary of Health and Human Services 

to establish a list of essential medicines, and for other 

purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Mapping America’s 

5 Pharmaceutical Supply Act’’ or the ‘‘MAPS Act’’. 

6 SEC. 2. ESSENTIAL MEDICINES LIST UPDATE. 

7 (a) IN GENERAL.—The Secretary of Health and 

8 Human Services (in this section referred to as the ‘‘Sec9 retary’’) shall establish and maintain a list of essential 

10 medicines. 


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1 (b) CRITERIA.— The list under subsection (a) shall 

2 consist of drugs and active pharmaceutical ingredients 

3 that— 

4 (1) are reasonably likely to be required to re5 spond to a public health emergency or to a chemical, 

6 biological, radiological, or nuclear threat; or 

7 (2) the shortage of which would pose a signifi8 cant threat to the United States health care system 

9 or at-risk populations. 

10 (c) SELECTION.—The Secretary shall select drugs 

11 and active pharmaceutical ingredients for inclusion on the 

12 list under subsection (a)— 

13 (1) based on the criteria specified in subsection 

14 (b); and 

15 (2) from the list of essential medicines, medical 

16 countermeasures, and critical inputs developed by 

17 the Food and Drug Administration in response to 

18 Executive Order 13944 (85 Fed. Reg. 49929) and 

19 other relevant assessments or lists. 

20 (d) PROCESS.— 

21 (1) IN GENERAL.—Before finalizing the list 

22 under subsection (a) or any update to such list, the 

23 Secretary shall— 

24 (A) publish a proposed list or update, as 

25 applicable; and 


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1 (B) provide an opportunity for public com2 ment on the proposed list or update. 

3 (2) INITIAL LIST.—The Secretary shall— 

4 (A) publish the proposed initial list under 

5 subsection (a) not later than 6 months after the 

6 date of enactment of this Act; and 

7 (B) publish the final initial list under sub8 section (a) not later than 1 year after such date 

9 of enactment. 

10 (3) REGULAR REVIEW.—The Secretary shall 

11 regularly review the list under subsection (a) to de12 termine whether any updates should be made pursu13 ant to paragraph (1). 

14 (e) RELATION TO EXECUTIVE ORDER.—The partici15 pation of the Secretary in establishing, maintaining, and 

16 updating the list under subsection (a) shall be deemed to 

17 be full satisfaction of the requirements applicable to the 

18 Secretary under section 3 of Executive Order 13944 (85 

19 Fed. Reg. 49929). 

20 SEC. 3. FEDERAL UNITED STATES PHARMACEUTICAL SUP21 PLY CHAIN MAPPING. 

22 (a) IN GENERAL.—The Secretary of Health and 

23 Human Services, in coordination with the heads of other 

24 relevant agencies, shall support efforts, including through 

25 public-private partnerships, to map the entire United 


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1 States pharmaceutical supply chain, from inception to dis2 tribution, and use data analytics to identify supply chain 

3 vulnerabilities and other national security threats. Such 

4 activities shall include, at a minimum— 

5 (1) defining agency roles in monitoring the 

6 pharmaceutical supply chain and communicating 

7 supply chain vulnerabilities; and 

8 (2) with respect to drugs and active pharma9 ceutical ingredients on the list of essential medicines 

10 under section 2(a), establishing a database that shall 

11 include— 

12 (A) the location of establishments reg13 istered under subsection (b), (c), or (i) of sec14 tion 510 of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 360) involved in the pro16 duction of— 

17 (i) the finished dosage forms of the 

18 drugs on such list; 

19 (ii) the active pharmaceutical ingredi20 ents of such drugs; or 

21 (iii) active pharmaceutical ingredients 

22 on such list; 

23 (B) the amount of such finished dosage 

24 forms and active pharmaceutical ingredients 

25 produced at each such establishment; 


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1 (C) to the extent available— 

2 (i) the location of establishments in3 volved in the production of the key starting 

4 materials and excipients used to produce 

5 the finished dosage forms and active phar6 maceutical ingredients referred to in sub7 paragraph (A); and 

8 (ii) the amount of such materials and 

9 excipients produced at each such establish10 ment; and 

11 (D) any regulatory actions with respect to 

12 the establishments referred to in subparagraph 

13 (A) or (C), including with respect to— 

14 (i) labeling requirements; 

15 (ii) registration and listing informa16 tion required to be submitted under section 

17 510 of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 360); 

19 (iii) inspections and related regulatory 

20 activities conducted under section 704 of 

21 such Act (21 U.S.C. 374); 

22 (iv) the seizure of such a drug or ac23 tive pharmaceutical ingredient pursuant to 

24 section 304 of such Act (21 U.S.C. 334); 


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1 (v) any recalls of a drug or active 

2 pharmaceutical ingredient on the list of es3 sential medicines under section 2(a), or a 

4 drug containing an active pharmaceutical 

5 ingredient on such list; 

6 (vi) inclusion of such a drug or active 

7 pharmaceutical ingredient on the drug 

8 shortage list under section 506E of such 

9 Act (21 U.S.C. 356e); or 

10 (vii) prior reports of a discontinuance 

11 or interruption in the production of such a 

12 drug or active pharmaceutical ingredient 

13 under 506C of such Act (21 U.S.C. 356c). 

14 (b) REPORT.—Not later than 18 months after the 

15 date of enactment of this Act, and annually thereafter, 

16 the Secretary of Health and Human Services, in consulta17 tion with the heads of agencies with which such Secretary 

18 coordinates under subsection (a), shall submit a report to 

19 Congress on— 

20 (1) progress on implementing subsection (a), in21 cluding any timelines for full implementation; 

22 (2) gaps in data needed for full implementation 

23 of such subsection; 


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1 (3) how the database established pursuant to 

2 subsection (a) increases Federal visibility into the 

3 pharmaceutical supply chain; 

4 (4) how Federal agencies are able to use data 

5 analytics to conduct predictive modeling of antici6 pated drug shortages or national security threats; 

7 and 

8 (5) the extent to which industry has cooperated 

9 in mapping the pharmaceutical supply chain. 

10 (c) CONFIDENTIAL COMMERCIAL INFORMATION.— 

11 The exchange of information among the Secretary of 

12 Health and Human Services and the heads of other rel13 evant agencies for purposes of carrying out this section 

14 shall not be a violation of section 1905 of title 18, United 

15 States Code. 

16 (d) CLARIFICATION.—The information in the data17 base established pursuant to subsection (a) shall not be 

18 publicly disclosed. Nothing in this subsection shall be con19 strued to relieve the Secretary of Health and Human Serv20 ices from the Secretary’s obligation to provide information 

21 to Congress. 

Æ 


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