(a) Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission changed · Sec. 2(b) · see the words
What the words would change: every change, in place (6)
Today's wording of each part of the law, with what would be struck out and added. Each change also gives the bill's own instruction, word for word.
…who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public. In providing such notice, the Secretary may use the assistance of health professionals who prescribed or dispensed such controlled substancesdrugs. (c) Nondelegation. An order described in subsection (a)(3) shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the…
The bill says: in the section heading, by striking "controlled substances" and inserting "drugs";
(a) Order to cease distribution and recall. (1) In general. If the Secretary determines there is a reasonable probability that a controlled substancedrug would cause serious adverse health consequences or death, the Secretary may, after providing the appropriate person with an opportunity to consult with the agency, issue an order requiring manufacturers, importers, distributors, or pharmacists, who distribute such controlled substancedrug to immediately cease distribution of such controlled substancedrug. (2) Hearing. An order under paragraph (1) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify an amendment to the order, and what actions are required by such amended order pursuant to subparagraph (3). (3) Order resolution. After an order is issued according to the process under paragraphs (1) and (2), the Secretary shall, except as provided in paragraph (4)— (A) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order; (B) continue the order ceasing distribution of the controlled substancedrug until a date specified in such order; or (C) amend the order to require a recall of the controlled substancedrug, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall. (4) Risk assessment. If the Secretary determines that the risk of recalling a controlled substancedrug presents a greater health risk than the health risk of not recalling such controlled substancedrug from use, an amended order under subparagraph (B) or (C) of paragraph (3) shall not include either a recall order for, or an order to cease distribution of, such controlled substancedrug, as applicable. (5) Action following order. Any person who is subject to an order pursuant to subparagraph (B) or (C) of paragraph (3) shall immediately cease distribution of or recall, as applicable, the controlled substancedrug and provide notification as required by such order. (b) Notice to persons affected. If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to paragraph (1) or an amended order pursuant to subparagraph (B) or (C) of paragraph (3) to provide either a notice of a recall order for, or an order to cease distribution of, such controlled substancedrug, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public. In providing such notice, the Secretary may use the assistance of health professionals who prescribed or dispensed such controlled substancedrugs. (c) Nondelegation. An order described in subsection (a)(3) shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the…
The bill says: by striking "controlled substance" each place such term appears and inserting "drug";
(b) Notice to persons affected. If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to paragraph (1) or an amended order pursuant to subparagraph (B) or (C) of paragraph (3) to provide either a notice of a recall order for, or an order to cease distribution of, such controlled substance, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public. In providing such notice, the Secretary may use the assistance of health professionals who prescribed or dispensed such controlled substancesdrugs.
The bill says: by striking "controlled substances" and inserting "drugs"; and
(b) Notice to persons affected. If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to paragraph (1) or an amended order pursuant to subparagraph (B) or (C) of paragraph (3) of subsection (a) to provide either a notice of a recall order for, or an order to cease distribution of, such controlled substance, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public. In providing such notice, the Secretary may use the assistance of health professionals who prescribed or dispensed such controlled substances.
The bill says: 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
(c) Nondelegation. An order described in subsection (a)(3) shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the Center for Drug Evaluation and Research or an official senior to such Directoror the Director of the Center for Biologics Evaluation and Research (or an official senior to either such Director).
The bill says: 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)".
The bill says: 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".
From the bill's official text on GovInfo and the U.S. Code, 2024 edition, which may not yet show changes made since.
What it does
Sourced
Protecting Americans from Unsafe Drugs Act of 2026
This bill expands the authority of the Secretary of the Department of Health and Human Services (HHS) to order the recall of controlled substances to cover all drugs.
Furthermore, the authority to issue such an order may be delegated to the Director of the Center for Drug Evaluation and Research or the Director of the Center for Biologics Evaluation and Research (or an official senior to either director), whereas currently this authority may only be delegated to the Director of the Center for Drug Evaluation and Research or an official senior to such director. (Both centers are located in the Food and Drug Administration within HHS.)
Official summary by the Congressional Research Service (Introduced in House, Mar 18, 2026).
Our plain-language breakdown, with what it means for you and the case for and against, is written once a bill starts to move.
What has happened
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Mar 18, 2026Referred to the House Committee on Energy and Commerce.House floor actions
Mar 18, 2026Introduced in HouseLibrary of Congress
Mar 18, 2026Introduced in HouseLibrary of Congress