I 

118TH CONGRESS 

1ST SESSION H. R. 6112 

To establish postmarket reporting requirements for pharmaceuticals, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 26, 2023 

Mr. WALTZ introduced the following bill; which was referred to the Committee 

on Energy and Commerce, and in addition to the Committee on Ways 

and Means, for a period to be subsequently determined by the Speaker, 

in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To establish postmarket reporting requirements for 

pharmaceuticals, 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 ‘‘Further Strengthening 

5 America’s Supply Chain and National Security Act’’. 


ssavage on DSKBC07HB2PROD with BILLS
2 

•HR 6112 IH

1 SEC. 2. MODIFICATION OF RULES OF ORIGIN FOR PHARMA2 CEUTICAL PRODUCTS. 

3 (a) TRADE AGREEMENTS.—Section 308(4)(B) of the 

4 Trade Agreements Act of 1979 (19 U.S.C. 2518(4)(B)) 

5 is amended— 

6 (1) in clause (i), by striking ‘‘instrumentality, 

7 or’’ and inserting ‘‘instrumentality,’’; 

8 (2) in clause (ii), by inserting ‘‘, other than an 

9 active pharmaceutical ingredient,’’ after ‘‘part of 

10 materials’’; and 

11 (3) by striking the period at the end and insert12 ing ‘‘, or (iii) in the case of an article which consists 

13 of an active pharmaceutical ingredient, the pharma14 ceutical ingredient is wholly the growth, product, or 

15 manufacture of that country or instrumentality.’’. 

16 (b) FEDERAL ACQUISITION REGULATION.—Not later 

17 than 180 days after the date of the enactment of this Act, 

18 the President shall prescribe regulations to update sec19 tions 52.225–5 and 25.003 of title 48, Code of Federal 

20 Regulations (or successor regulations) to be consistent 

21 with rules of origin determinations for active pharma22 ceutical ingredients made under section 308(4)(B) of the 

23 Trade Agreements Act of 1979 (19 U.S.C. 2518(4)(B)), 

24 as amended by subsection (a). 


ssavage on DSKBC07HB2PROD with BILLS
3 

•HR 6112 IH

1 SEC. 3. POSTMARKET REPORTING REQUIREMENTS FOR 

2 PHARMACEUTICALS. 

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

4 Human Services, acting through the Commissioner of 

5 Food and Drugs, shall ensure that each holder of an ap6 proved application under section 505 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 355) or under section 

8 351 of the Public Health Service Act (42 U.S.C. 262) an9 nually submit, as part of the postmarket annual report 

10 required by the Secretary under section 314.81(b)(2) of 

11 title 21, Code of Federal Regulations (or any successor 

12 regulation), the following information: 

13 (1) The names and addresses of the sources of 

14 active and inactive ingredients of the drug. 

15 (2) For each active and inactive ingredient of 

16 the drug, the percentage of the aggregate amount of 

17 such ingredient used in the manufacture of the drug 

18 during the reporting period that is from each of the 

19 sources identified under paragraph (1). 

20 (b) DISCLOSURE OF INFORMATION.—The Secretary 

21 of Health and Human Services shall— 

22 (1) annually provide the information reported in 

23 paragraphs (1) and (2) of subsection (a) to the Sec24 retary of Defense for purposes of understanding the 

25 dependency on foreign manufacturers of drugs used 

26 by members of the Armed Forces; and 


ssavage on DSKBC07HB2PROD with BILLS
4 

•HR 6112 IH

1 (2) publish the information reported under such 

2 paragraphs on a publicly available internet website 

3 of the Federal Government in a single, aggregate 

4 form, without disclosing proprietary information. 

5 SEC. 4. ADDITIONAL RISK FACTORS FOR CONSIDERATION 

6 DURING INSPECTIONS OF DRUG AND DEVICE 

7 ESTABLISHMENTS. 

8 Section 510(h)(4) of the Federal Food, Drug, and 

9 Cosmetic Act (21 U.S.C. 360(h)(4)) is amended— 

10 (1) by redesignating subparagraph (G) as sub11 paragraph (J); and 

12 (2) by inserting after subparagraph (F) the fol13 lowing: 

14 ‘‘(G) Whether the establishment has been 

15 inspected by an entity that carries out inspec16 tions on behalf of a foreign government deter17 mined to be a foreign adversary under section 

18 7.4 of title 15, Code of Federal Regulations (or 

19 successor regulations). 

20 ‘‘(H) The particular drugs or devices (with 

21 a focus on drugs and devices included on the 

22 list of essential medicines pursuant to section 

23 3(c) of Executive Order 13944 (85 Fed. Reg. 

24 49929)) manufactured, prepared, propagated, 

25 compounded, or processed in the establishment, 


ssavage on DSKBC07HB2PROD with BILLS
5 

•HR 6112 IH

1 with particular attention to the number of other 

2 establishments globally that also manufacture, 

3 prepare, propagate, compound, or process the 

4 same drug or device from which the United 

5 States sources such drug or device. 

6 ‘‘(I) Whether the establishment is located 

7 in a country with a history or 1 or more pre8 vious instances of exporting illicit drugs or pre9 cursor chemicals to the United States, as deter10 mined by the Secretary by reference to the most 

11 recent report submitted to Congress pursuant 

12 to section 489 of the Foreign Assistance Act of 

13 1961.’’. 

Æ 


ssavage on DSKBC07HB2PROD with BILLS