I 

117TH CONGRESS 

2D SESSION H. R. 6483 

To amend the Federal Food, Drug, and Cosmetic Act to clarify reporting 

requirements for establishments within a foreign country engaged in 

the manufacture, preparation, propagation, compounding, or processing 

of an active pharmaceutical ingredient, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 25, 2022 

Ms. ESHOO introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

clarify reporting requirements for establishments within 

a foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of an active pharmaceutical ingredient, 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 ‘‘Improved Trans5 parency of Foreign Drug Manufacturing Act of 2022’’. 


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1 SEC. 2. REPORTING REQUIREMENT FOR DRUG MANUFAC2 TURERS. 

3 (a) ESTABLISHMENTS IN A FOREIGN COUNTRY.— 

4 Section 510(i) of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 360(i)) is amended by inserting at the end 

6 the following: 

7 ‘‘(5) The requirements of paragraphs (1) and 

8 (2) shall apply to establishments within a foreign 

9 country engaged in the manufacture, preparation, 

10 propagation, compounding, or processing of any 

11 drug, including the active pharmaceutical ingredient, 

12 that is required to be listed pursuant to subsection 

13 (j). Such requirements shall apply regardless of 

14 whether the drug or active pharmaceutical ingre15 dient undergoes further manufacture, preparation, 

16 propagation, compounding, or processing at a sepa17 rate establishment or establishments outside the 

18 United States prior to being imported or offered for 

19 import into the United States.’’. 

20 (b) LISTING OF DRUGS.—Section 510(j)(1) of the 

21 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

22 360(j)(1)) is amended— 

23 (1) in subparagraph (D), by striking ‘‘and’’ at 

24 the end; 

25 (2) in subparagraph (E), by striking the period 

26 at the end and inserting ‘‘; and’’; and 


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•HR 6483 IH

1 (3) by adding at the end the following: 

2 ‘‘(F) in the case of a drug contained in the 

3 applicable list, a certification that the registrant 

4 has— 

5 ‘‘(i) identified every other known es6 tablishment where manufacturing is per7 formed for the drug; and 

8 ‘‘(ii) notified each known foreign es9 tablishment engaged in the manufacture, 

10 preparation, propagation, compounding, or 

11 processing of the drug, including the active 

12 pharmaceutical ingredient, of the inclusion 

13 of the drug in the list and the obligation 

14 to register.’’. 

15 (c) QUARTERLY REPORTING ON AMOUNT OF DRUGS

16 MANUFACTURED.—Section 510(j)(3)(A) of the Federal 

17 Food, Drug, and Cosmetic Act (as added by section 3112 

18 of the CARES Act (Public Law 116–136)) is amended 

19 by striking ‘‘annually’’ and inserting ‘‘once during the 

20 month of March of each year, once during the month of 

21 June of each year, once during the month of September 

22 of each year, and once during the month of December of 

23 each year’’. 

Æ 


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