What does Preamble of CLEAR LABELS Act do?

This bill aims to amend the Federal Food, Drug, and Cosmetic Act The amendment requires drug labeling to include original manufacturer information The amendment also requires drug labeling to include supply chain information

What does SHORT TITLE. of CLEAR LABELS Act do?

This bill is formally titled the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act.

What does REQUIRE DRUG LABELING TO INCLUDE ORIGINAL MANUFACTURER AND of CLEAR LABELS Act do?

This section amends the Federal Food, Drug, and Cosmetic Act to require drug labeling to include original manufacturer and supply chain information. Finished drug products must bear a label with the name, place of business, and unique facility identifier of the manufacturer, packer, or distributor. Active pharmaceutical ingredients must have accompanying labels and certificates of analysis with the name, place of business, and unique facility identifier of the original manufacturer. Labeling must contain information on the original manufacturer of each active pharmaceutical ingredient and the finished drug product. Manufacturers, packers, and distributors must make information available electronically and in paper copy upon request.

What does EXEMPTION FROM CUSTOMS COUNTRY OF ORIGIN MARKING REQUIREMENT. of CLEAR LABELS Act do?

This section amends Section 304 of the Tariff Act of 1930. The amendment adds a subsection (m) regarding marking of certain finished drug products. Finished drug products marked according to section 502(b)(3)(A) of the Federal Food, Drug, and Cosmetic Act are exempt from marking requirements under subsections (a) and (b) of Section 304 of the Tariff Act of 1930.

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CLEAR LABELS Act

Last updated: 4/14/2026 · Introduced: 4/14/2026

Author: Richard McCormick (R-GA)

TL;DR (AI)

The bill mandates that drug labels include the original manufacturer's information, along with supply chain details, for both finished drug products and their active pharmaceutical ingredients.
It requires manufacturers, packers, and distributors to provide this information electronically and in paper format upon request.
Finished drug products already marked according to existing federal food and drug regulations are exempt from country of origin marking requirements under the Tariff Act of 1930.

119th Congressin committeeS. 3788(In Committee)Official page

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Other Sections

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

4 sections

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