What does Preamble of Protecting Americans from Unsafe Drugs Act of 2026 do?

This bill proposes to amend the Federal Food, Drug, and Cosmetic Act. The proposed amendment aims to expand authorities related to drug recalls. Specifically, the expansion would apply recall authorities currently used for controlled substances to all drugs.

What does SHORT TITLE. of Protecting Americans from Unsafe Drugs Act of 2026 do?

This bill is formally titled Protecting Americans from Unsafe Drugs Act of 2026.

What does NOTIFICATION, NONDISTRIBUTION, AND RECALL OF DRUGS. of Protecting Americans from Unsafe Drugs Act of 2026 do?

This section amends Section 569D of the Federal Food, Drug, and Cosmetic Act to broaden its scope from 'controlled substances' to 'drugs'. The changes include modifying the section heading, replacing instances of 'controlled substance' with 'drug', and clarifying the application of orders. Subsection (c) of Section 569D is amended to include the Director of the Center for Biologics Evaluation and Research. Section 801(a) of the Federal Food, Drug, and Cosmetic Act is also amended to replace 'controlled substance' with 'drug' in relation to orders under Section 569D.

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Protecting Americans from Unsafe Drugs Act of 2026

Last updated: 3/18/2026 · Introduced: 3/18/2026

Author: Maxine Dexter (D-OR)

TL;DR (AI)

This bill expands the Food and Drug Administration's authority to issue orders for drug recalls to encompass all drugs, not just controlled substances.
The bill modifies existing regulations to broaden the scope of notification, nondistribution, and recall orders to apply to a wider range of drugs.
The Director of the Center for Biologics Evaluation and Research is now included in the authority to issue these orders.

119th Congressin committeeOfficial page

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Other Sections

Includes provisions on preamble, short title., and 1 more.

3 sections

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