What does Preamble of Drug Origin Transparency Act of 2026 do?

This bill, formally titled 'To amend the Federal Food, Drug, and Cosmetic Act to enhance drug manufacturing amount information reporting, and for other purposes,' aims to modify the Federal Food, Drug, and Cosmetic Act. The bill seeks to enhance drug manufacturing amount information reporting.

What does SHORT TITLE. of Drug Origin Transparency Act of 2026 do?

This bill is formally titled the Drug Origin Transparency Act of 2026

What does ENHANCED DRUG MANUFACTURING AMOUNT INFORMATION REPORTING. of Drug Origin Transparency Act of 2026 do?

This section amends Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act. It requires reports submitted under subparagraph (A) to include additional supply chain information. This information includes the identity of suppliers for active pharmaceutical ingredients, intermediates, and in-process materials. Reports must also include the amounts of drug manufactured using materials from each supplier. The frequency of these reports can be specified by the Secretary, but not more than four times per year. The Secretary can specify additional required information through regulation or guidance. Any new requirements will take effect six months after the final form of the regulation or guidance is issued. The requirement to report as described in subparagraph (A) will not be affected by the absence of regulation or guidance. Section 510(j)(3)(B) is amended to refer to 'this paragraph'.

What does REQUIRE DRUG LABELING TO INCLUDE ORIGINAL MANUFACTURER AND of Drug Origin Transparency Act of 2026 do?

This section amends the Federal Food, Drug, and Cosmetic Act to require drug labeling to include the original manufacturer and supply chain information. The labeling must include the name and place of business, and unique facility identifier of the original manufacturer of the drug or active pharmaceutical ingredient. The Secretary may provide reasonable variations in the implementation of labeling requirements.

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Drug Origin Transparency Act of 2026

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

Author: Doris Matsui (D-CA)

TL;DR (AI)

The bill mandates enhanced reporting of drug manufacturing information, including supplier details and material amounts, to the Food and Drug Administration.
Drug labels will be required to display the original manufacturer's name, location, and facility identifier, along with supply chain information.
The FDA Secretary has the authority to specify the frequency of reporting and additional information requirements through regulation or guidance.

119th Congressin committeeOfficial page

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Other Sections

Includes provisions on preamble, short title., and 2 more.

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