[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3788 Reported in Senate (RS)]
<DOC>
Calendar No. 523
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, Mr. Johnson, Mrs. Moody, Mr. Lee, Mr. Cramer, Mr. Risch,
Mr. Grassley, Mr. Ricketts, Ms. Ernst, and Mr. Armstrong) introduced
the following bill; which was read twice and referred to the Committee
on Health, Education, Labor, and Pensions
July 27, 2026
Reported by Mr. Cassidy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> 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''.</DELETED>
<DELETED>SEC. 2. REQUIRE DRUG LABELING TO INCLUDE ORIGINAL MANUFACTURER
AND SUPPLY CHAIN INFORMATION.</DELETED>
<DELETED> Section 502(b) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352(b)) is amended--</DELETED>
<DELETED> (1) by striking ``containing (1) the name and
place of business of the manufacturer, packer, or distributor''
and inserting the following: ``containing--</DELETED>
<DELETED> ``(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'';</DELETED>
<DELETED> (2) in clause (A) (as so designated), by striking
``(2) an accurate'' and inserting the following:</DELETED>
<DELETED> ``(B) an accurate'';</DELETED>
<DELETED> (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'';</DELETED>
<DELETED> (4) by striking ``(b) If in a package form'' and
inserting the following:</DELETED>
<DELETED> ``(b)(1) If it is a finished drug product in a package
form''; and</DELETED>
<DELETED> (5) by adding at the end the following:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(3)(A) If it is a finished drug product, unless its
labeling contains the name, place of business, and unique facility
identifier of--</DELETED>
<DELETED> ``(i) the original manufacturer of each active
pharmaceutical ingredient;</DELETED>
<DELETED> ``(ii) the original manufacturer of the finished
drug product; and</DELETED>
<DELETED> ``(iii) the packer or distributor, if
any,</DELETED>
<DELETED>or a link, barcode, QR code, or other means to access a
searchable electronic portal containing such information.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 3. EXEMPTION FROM CUSTOMS COUNTRY OF ORIGIN MARKING
REQUIREMENT.</DELETED>
<DELETED> Section 304 of the Tariff Act of 1930 (19 U.S.C. 1304) is
amended by adding at the end the following:</DELETED>
<DELETED> ``(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)).''.</DELETED>
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 LABELS TO INCLUDE ORIGINAL MANUFACTURER AND SUPPLY
CHAIN INFORMATION.
Section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353) is amended by adding at the end the following --
``(i) Original Manufacturer and Supply Chain Information.--
``(1) In general.--No person shall introduce or deliver for
introduction into interstate commerce any drug--
``(A) if it is an active pharmaceutical ingredient,
unless the label and certificate of analysis contain
the name and place of business of the original
manufacturer; or
``(B) if it is a finished drug product in a package
form, unless the label includes, either printed
directly or made available through electronic means,
the name and place of business 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.
``(2) Multiple original manufacturers.--In the case of a
finished drug product for which there are multiple different
original manufacturers of an active pharmaceutical ingredient,
the requirements of paragraph (1)(B)(i) shall be satisfied if
the label includes, either printed directly or made available
through electronic means, the name and place of business of
each applicable original manufacturer of the active
pharmaceutical ingredient for the applicable drug product lot.
``(3) Effect of noncompliance.--In the case of
noncompliance with the requirements of paragraph (1), the
Secretary shall have discretion to determine that such
noncompliance constitutes misbranding and to assess a civil
monetary penalty, as described in section 303(f)(10), except
that the Secretary may not treat a violation of this subsection
as a criminal violation.
``(4) Definition of original manufacturer.--For purposes of
this subsection, the term `original manufacturer' means the
establishment that conducts the majority of the significant
phases of manufacturing (chemical, physical, or biological
manipulation) to produce the active pharmaceutical ingredient
or the finished dosage form.''.
SEC. 3. PENALTIES.
(a) In General.--Section 303(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333(f)) is amended by adding at the end the
following:
``(10)(A) Any person who fails to comply with the requirements of
section 503(i) shall be subject to a civil monetary penalty in an
amount not to exceed 25 percent of the total value of the drug product
lot or lots involved.
``(B) In determining whether to assess a penalty under this
paragraph against a person, and the amount of such a penalty, the
Secretary shall consider--
``(i) the size of the business of such person and the
gravity of the violation;
``(ii) whether such person received written notice of the
noncompliance in advance of such proceeding and was provided an
opportunity by the Secretary to correct the violation following
such notice; and
``(iii) whether such person acted in good faith to correct
the violation following any such notice.''.
(b) Conforming Amendments.--Section 303(f)(5)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(5)(A)) is amended by
striking ``(1), (2), (3), (4), or (9)'' and inserting ``(1), (2), (3),
(4), (9), or (10)''.
SEC. 4. AGENCY COORDINATION REGARDING FDA AND CUSTOMS COUNTRY OF ORIGIN
REQUIREMENTS.
In carrying out the amendments made by this Act, the Commissioner
of Food and Drugs shall coordinate with the Commissioner of U.S.
Customs and Border Protection on efforts to address the potential
administrative burden on manufacturers of active pharmaceutical
ingredients and finished drug products related to any potential overlap
with, or duplication or conflict between, the requirements of such
amendments and section 304 of the Tariff Act of 1930 (19 U.S.C. 1304).
Such coordination may include the establishment of mechanisms to
facilitate the sharing of relevant information between the Food and
Drug Administration and U.S. Customs and Border Protection to ensure
compliance with such amendments and such section 304, and joint
rulemaking, if determined by such commissioners to be appropriate.
SEC. 5. CONFIDENTIALITY.
Nothing in the amendments made by this Act shall be construed as
authorizing the Secretary of Health and Human Services to disclose any
information that is a trade secret or confidential information subject
to section 552(b)(4) of title 5, United States Code, or section 1905 of
title 18, United States Code.
SEC. 6. EFFECTIVE DATE.
The amendments made by this Act shall apply to active
pharmaceutical ingredients and finished drug products that are
manufactured and packaged on or after the date that is 5 years after
the date of enactment of this Act.
Calendar No. 523
119th CONGRESS
2d Session
S. 3788
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to require drug
labeling to include original manufacturer and supply chain information.
_______________________________________________________________________
July 27, 2026
Reported with an amendment