H.R. 6483 (117th Congress) — To clarify reporting requirements for establishments within a foreign country
Summary
H.R. 6483, a bill introduced in the House of Representatives on January 25, 2022 by Ms. Eshoo and referred to the Committee on Energy and Commerce. The bill amends 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. It amends Section 510(i) and Section 510(j)(1) of that Act.
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“H.R. 6483 (117th Congress) — To clarify reporting requirements for establishments within a foreign country.”
Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/bills-bills-117hr6483ih-bills-117hr6483ih/
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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.
1 Be it enacted by the Senate and House of Representa-
2 tives of the United States of America in Congress assembled,
3 SECTION 1. SHORT TITLE.
4 This Act may be cited as the ‘‘Improved Trans-
5 parency of Foreign Drug Manufacturing Act of 2022’’.
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1 SEC. 2. REPORTING REQUIREMENT FOR DRUG MANUFAC-
2 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 ingre-
15 dient undergoes further manufacture, preparation,
16 propagation, compounding, or processing at a sepa-
17 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;
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25 (2) in subparagraph (E), by striking the period
26 at the end and inserting ‘‘; and’’; and
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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 es-
6 tablishment where manufacturing is per-
7 formed for the drug; and
8 ‘‘(ii) notified each known foreign es-
9 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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