CLEAR LABELS Act

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3788 Introduced in Senate (IS)]

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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)).''.
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