H.R. 8269

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8269 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 8269

To amend the Federal Food, Drug, and Cosmetic Act to require drug 
labeling to include original manufacturer and supply chain information.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

April 14, 2026

Mr. McCormick (for himself and Ms. DeLauro) introduced the following 
bill; which was referred to the Committee on Ways and Means, and in 
addition to the Committee on Energy and Commerce, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
of such provisions as fall within the jurisdiction of the committee 
concerned

_______________________________________________________________________

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 to read as follows:
``(b)(1) If it is a finished drug product in a package form, unless 
it bears a label 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; and
``(B) an accurate statement of the quantity of the contents 
in terms of weight, measure, or numerical count, provided that 
under this clause reasonable variations shall be permitted, and 
exemptions as to small packages shall be established, by 
regulations prescribed by the Secretary.
``(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 subparagraphs (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 paragraph, 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)(3)(A) of the Federal Food, Drug, and 
Cosmetic Act.''.
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