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, prepara-
tion, propagation, compounding, or processing of an ac-
tive pharmaceutical ingredient, and for other purposes. 
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 ‘‘Improved Trans-
parency of Foreign Drug Manufacturing Act of 2022’’. 
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SEC. 2. REPORTING REQUIREMENT FOR DRUG MANUFAC-
TURERS. 
(a) ESTABLISHMENTS IN A FOREIGN COUNTRY.— 
Section 510(i) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360(i)) is amended by inserting at the end 
the following: 
‘‘(5) The requirements of paragraphs (1) and 
(2) shall apply to establishments within a foreign 
country engaged in the manufacture, preparation, 
propagation, compounding, or processing of any 
drug, including the active pharmaceutical ingredient, 
that is required to be listed pursuant to subsection 
(j). Such requirements shall apply regardless of 
whether the drug or active pharmaceutical ingre-
dient undergoes further manufacture, preparation, 
propagation, compounding, or processing at a sepa-
rate establishment or establishments outside the 
United States prior to being imported or offered for 
import into the United States.’’. 
(b) LISTING OF DRUGS.—Section 510(j)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360(j)(1)) is amended— 
(1) in subparagraph (D), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (E), by striking the period 
at the end and inserting ‘‘; and’’; and 
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(3) by adding at the end the following: 
‘‘(F) in the case of a drug contained in the 
applicable list, a certification that the registrant 
has— 
‘‘(i) identified every other known es-
tablishment where manufacturing is per-
formed for the drug; and 
‘‘(ii) notified each known foreign es-
tablishment engaged in the manufacture, 
preparation, propagation, compounding, or 
processing of the drug, including the active 
pharmaceutical ingredient, of the inclusion 
of the drug in the list and the obligation 
to register.’’. 
(c) QUARTERLY REPORTING ON AMOUNT OF DRUGS 
MANUFACTURED.—Section 510(j)(3)(A) of the Federal 
Food, Drug, and Cosmetic Act (as added by section 3112 
of the CARES Act (Public Law 116–136)) is amended 
by striking ‘‘annually’’ and inserting ‘‘once during the 
month of March of each year, once during the month of 
June of each year, once during the month of September 
of each year, and once during the month of December of 
each year’’. 
Æ 
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