CLEAR LABELS Act

Rick Scott

Republican · FL · Senator

Source: Congress.gov · FEC

• Katie Boyd Britt (R-AL)Original· 2026-02-05
• Kirsten E. Gillibrand (D-NY)Original· 2026-02-05
• Ron Johnson (R-WI)Original· 2026-02-05
• Tommy Tuberville (R-AL)Original· 2026-02-05
• Ashley Moody (R-FL)· 2026-02-12
• Mike Lee (R-UT)· 2026-03-09
• Kevin Cramer (R-ND)· 2026-03-11
• James E. Risch (R-ID)· 2026-03-23
• Chuck Grassley (R-IA)· 2026-03-25
• Pete Ricketts (R-NE)· 2026-03-25
• Joni Ernst (R-IA)· 2026-04-13
• Alan Armstrong (R-OK)· 2026-07-13

Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.

2026-07-27

Source: Congress.gov

Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act or the CLEAR LABELS Act This bill requires drugs and active pharmaceutical ingredients made available in the U.S. market to be labeled with the names and locations of their manufacturers. Specifically, a finished, packaged drug product must be labeled with the name and place of business of (1) the original manufacturer (or manufacturers) of each active pharmaceutical ingredient; (2) the original manufacturer of the finished drug product; and (3) the packer or distributor, if any. This information must be printed on the product label or made available electronically. Active pharmaceutical ingredients (which are generally sold to manufacturers and researchers, not consumers) must also be labeled with the name and place of business of their original manufacturers. Under the bill, the original manufacturer is the establishment that conducts the majority of the significant phases of manufacturing to produce the ingredient or product. The Food and Drug Administration (FDA) has discretion to determine whether a violation of these requirements constitutes misbranding and to assess a civil fine. The FDA must consider certain factors in determining whether to assess a fine, including whether the violator was notified of their noncompliance and was provided an opportunity to correct the violation. Finally, the FDA must coordinate with U.S. Customs and Border Protection to address any overlap between these requirements and existing requirements for imported drugs. These provisions take effect five years after the bill is enacted.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [S. 3788 Introduced in Senate (IS)] <DOC> 119th CONGRESS 2d Session S. 3788 To amend the Federal Food, Drug, and Cosmetic Act to require drug labeling to include original manufacturer and supply chain information. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES February 5, 2026 Mr. Scott of Florida (for himself, Mrs. Gillibrand, Mr. Tuberville, Mrs. Britt, and Mr. Johnson) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions _______________________________________________________________________ A BILL To amend the Federal Food, Drug, and Cosmetic Act to require drug labeling to include original manufacturer and supply chain information. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act'' or the ``CLEAR LABELS Act''. SEC. 2. REQUIRE DRUG LABELING TO INCLUDE ORIGINAL MANUFACTURER AND SUPPLY CHAIN INFORMATION. Section 502(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(b)) is amended-- (1) by striking ``containing (1) the name and place of business of the manufacturer, packer, or distributor'' and inserting the following: ``containing-- ``(A) the name, place of business, and unique facility identifier of the manufacturer, packer, or distributor or a link, barcode, QR code, or other means to access a searchable electronic portal containing such information''; (2) in clause (A) (as so designated), by striking ``(2) an accurate'' and inserting the following: ``(B) an accurate''; (3) in clause (B) (as so designated), by striking ``count: Provided, That under clause (2) of this paragraph reasonable variations'' and inserting ``count, provided that under this clause, reasonable variations''; (4) by striking ``(b) If in a package form'' and inserting the following: ``(b)(1) If it is a finished drug product in a package form''; and (5) by adding at the end the following: ``(2) If it is an active pharmaceutical ingredient, unless any accompanying label and certificate of analysis contains the name, place of business, and unique facility identifier of the original manufacturer. ``(3)(A) If it is a finished drug product, unless its labeling contains the name, place of business, and unique facility identifier of-- ``(i) the original manufacturer of each active pharmaceutical ingredient; ``(ii) the original manufacturer of the finished drug product; and ``(iii) the packer or distributor, if any, or a link, barcode, QR code, or other means to access a searchable electronic portal containing such information. ``(B) In the case of a finished drug product for which there are multiple potential different manufacturers of the active pharmaceutical ingredient, the requirements of this subparagraph shall be satisfied if all such manufacturers of active pharmaceutical ingredients for the drug product are identified in the labeling or the searchable electronic portal. ``(4) A manufacturer, packer, or distributor required to furnish information under paragraphs (1), (2), and (3), in addition to making such information available electronically, as applicable, shall make such information available through a package insert, or in paper copy to any individual who requests such a copy. ``(5) For purposes of this subsection, the term `original manufacturer', means the single last establishment to conduct substantial manufacturing activities prior to introduction of the active pharmaceutical ingredient or finished drug product into interstate commerce. ``(6) The Secretary shall issue regulations to implement subparagraphs (2) and (3) and may provide for reasonable variations in the implementation of, or an alternative placement for, the labeling requirements under such subparagraphs, including by electronic means. Such regulations shall take…

effect on a date determined by the Secretary and not earlier than 1 year after the date of publication of the final regulations, and shall apply with respect to drugs manufactured on or after the effective date of such regulations.''. SEC. 3. EXEMPTION FROM CUSTOMS COUNTRY OF ORIGIN MARKING REQUIREMENT. Section 304 of the Tariff Act of 1930 (19 U.S.C. 1304) is amended by adding at the end the following: ``(m) Marking of Certain Finished Drug Products.--The marking requirements of subsections (a) and (b) shall not apply to articles that are finished drug products and are marked in accordance with the requirements of section 502(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(b)(2)(A)).''. <all>

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