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Protecting Americans from Unsafe Drugs Act of 2026
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.
Summary
This bill amends federal law to expand the FDA's authority to order the recall and halt distribution of drugs. Currently, these recall powers apply only to controlled substances, but this bill extends them to all drugs, including prescription and over-the-counter medications. The bill also clarifies which FDA officials have authority to issue such recall orders by adding the Director of the Center for Biologics Evaluation and Research to the chain of command.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Rep. Dexter, Maxine [D-OR-3] (D-OR)
Actions (2)
- Mar 18, 2026 Referred to the House Committee on Energy and Commerce. · house
- Mar 18, 2026 Introduced in House
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
IN THE HOUSE OF REPRESENTATIVES
March 18, 2026
Ms. Dexter 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 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”. <all>
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