H.R. 7980

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7980 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 7980

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.

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IN THE HOUSE OF REPRESENTATIVES

March 18, 2026

Ms. Dexter introduced the following bill; which was referred to the 
Committee on Energy and Commerce

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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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Protecting Americans from Unsafe 
Drugs Act of 2026''.

SEC. 2. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF DRUGS.

(a) Order To Cease Distribution and Recall.--Section 569D of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8d) is amended--
(1) in the section heading, by striking ``controlled 
substances'' and inserting ``drugs'';
(2) by striking ``controlled substance'' each place such 
term appears and inserting ``drug'';
(3) in subsection (b)--
(A) by striking ``controlled substances'' and 
inserting ``drugs''; and
(B) by inserting ``of subsection (a)'' after ``an 
order pursuant to paragraph (1) or an amended order 
pursuant to subparagraph (B) or (C) of paragraph (3)''; 
and
(4) in subsection (c), by striking ``or an official senior 
to such Director'' and inserting ``or the Director of the 
Center for Biologics Evaluation and Research (or an official 
senior to either such Director)''.
(b) Imports and Exports.--Section 801(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381(a)) is amended by striking ``is a 
controlled substance subject to an order under section 569D'' and 
inserting ``is a drug subject to an order under section 569D''.
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