What does Preamble of Securing America’s Drug Supply from Communist China Act do?

This bill aims to require regulatory review of pharmaceutical products originating from Chinese entities. The bill's stated purpose is to require regulatory review and includes 'other purposes' not detailed in this section.

What does SHORT TITLE. of Securing America’s Drug Supply from Communist China Act do?

This Act is formally titled the "Securing America's Drug Supply from Communist China Act".

What does REGULATORY REVIEW OF PHARMACEUTICAL PRODUCTS FROM CHINESE of Securing America’s Drug Supply from Communist China Act do?

This section defines terms related to pharmaceutical products from Chinese entities, including 'Chinese entity,' 'drug application,' and 'PRC-, CCP-, or PLA-affiliated entity'. The Secretary of Health and Human Services must review drug applications submitted on or after the enactment of this Act by sponsors that are Chinese entities or entities licensing products from Chinese entities, to determine if they are PRC-, CCP-, or PLA-affiliated. Drug applications will not be approved if the sponsor is determined to be a PRC-, CCP-, or PLA-affiliated entity. The Secretary must also review drug applications submitted before enactment, specifically between January 1, 2016, and the date of enactment. Section 801 of the Federal Food, Drug, and Cosmetic Act is amended to refuse import of drugs sponsored or held by PRC-, CCP-, or PLA-affiliated entities. Sponsors or holders of approved applications determined to be PRC-, CCP-, or PLA-affiliated entities may demonstrate they are no longer affiliated or sell the approved application within 180 days. The Commissioner of U.S. Customs and Border Protection may waive import refusal requirements if it would create or exacerbate a drug shortage.

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Securing America’s Drug Supply from Communist China Act

Last updated: 4/16/2026 · Introduced: 4/16/2026

Author: Tom Cotton (R-AR)

TL;DR (AI)

This bill mandates reviews of pharmaceutical drug applications from Chinese entities or those licensing from them, to assess potential affiliations with the Chinese government.
Drug applications associated with entities linked to the People's Republic of China, Chinese Communist Party, or People's Liberation Army will be denied approval.
The bill prohibits the import of drugs sponsored or held by affiliated entities, with potential waivers from Customs and Border Protection to prevent drug shortages.

119th Congressin committeeOfficial page

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

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