[Congressional Record Volume 172, Number 113 (Monday, July 13, 2026)]
[Senate]
[Pages S3794-S3795]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 6601. Mr. SCOTT of Florida submitted an amendment intended to be 
proposed by him to the bill S. 4784, to authorize appropriations for 
fiscal year

[[Page S3795]]

2027 for military activities of the Department of Defense, for military 
construction, and for defense activities of the Department of Energy, 
to prescribe military personnel strengths for such fiscal year, and for 
other purposes; which was ordered to lie on the table; as follows:

       At the appropriate place in subtitle G of title X, insert 
     the following:

     SEC. __. CLEAR LABELS ACT.

       (a) 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.''.
       (b) 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) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 352(b)(2)).''.
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