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118TH CONGRESS
1ST SESSION H. R. 2500
To amend the Federal Food, Drug, and Cosmetic Act to expand certain
authorities with respect to the recall of controlled substances to apply
with respect to all drugs, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
APRIL 6, 2023
Mr. KIM of New Jersey 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
expand certain authorities with respect to the recall of
controlled substances to apply with respect to all drugs,
and for other purposes.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Protecting Americans
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from Unsafe Drugs Act of 2023’’.
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•HR 2500 IH
SEC. 2. NOTIFICATION, NONDISTRIBUTION, AND RECALL
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OF DRUGS.
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(a) ORDER TO CEASE DISTRIBUTION
AND RE-
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CALL.—Section 569D of the Federal Food, Drug, and
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Cosmetic Act (21 U.S.C. 360bbb–8d) is amended—
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(1) in the section heading, by striking ‘‘CON-
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TROLLED SUBSTANCES’’ and inserting ‘‘DRUGS’’;
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(2) by striking ‘‘controlled substance’’ each
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place such term appears and inserting ‘‘drug’’;
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(3) in subsection (b)—
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(A) by striking ‘‘controlled substances’’
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and inserting ‘‘drugs’’; and
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(B) by inserting ‘‘of subsection (a)’’ after
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‘‘an order pursuant to paragraph (1) or an
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amended order pursuant to subparagraph (B)
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or (C) of paragraph (3)’’; and
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(4) in subsection (c), by striking ‘‘or an official
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senior to such Director’’ and inserting ‘‘or the Direc-
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tor of the Center for Biologics Evaluation and Re-
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search (or an official senior to either such Direc-
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tor)’’.
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(b) IMPORTS AND EXPORTS.—Section 801(a) of the
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a))
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is amended by striking ‘‘is a controlled substance subject
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•HR 2500 IH
to an order under section 569D’’ and inserting ‘‘is a drug
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subject to an order under section 569D’’.
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