H.R. 8339

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8339 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 8339

To amend the Federal Food, Drug, and Cosmetic Act to enhance drug 
manufacturing amount information reporting, and for other purposes.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

April 16, 2026

Ms. Matsui (for herself, Mr. Crenshaw, Ms. Schrier, and Mrs. Hinson) 
introduced the following bill; which was referred to the Committee on 
Energy and Commerce

_______________________________________________________________________

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to enhance drug 
manufacturing amount information reporting, and for other purposes.

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 ``Drug Origin Transparency Act of 
2026''.

SEC. 2. ENHANCED DRUG MANUFACTURING AMOUNT INFORMATION REPORTING.

(a) In General.--Section 510(j)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(j)(3)) is amended--
(1) in subparagraph (A), by adding ``or (2)'' after 
``paragraph (1)''; and
(2) by adding at the end the following:
``(C) Each report submitted pursuant to subparagraph (A) 
with respect to a drug shall--
``(i) include additional information as may be 
specified by the Secretary in regulation or guidance 
regarding the supply chain for such drug, such as--
``(I) the identity of the respective 
suppliers of each active pharmaceutical 
ingredient, active pharmaceutical ingredient 
intermediate, and in-process material used in 
such manufacture, preparation, propagation, 
compounding, or processing of the drug; and
``(II) the respective amounts of such drug 
that were manufactured, prepared, propagated, 
compounded, or processed using an active 
pharmaceutical ingredient, active 
pharmaceutical ingredient intermediate, and in-
process material from each such identified 
supplier; and
``(ii) be submitted more frequently than annually, 
in accordance with a reporting schedule as may be 
specified by the Secretary in such regulation or 
guidance, but not more frequently than 4 times per 
year.
``(D) Any additional information specified in regulation or 
guidance pursuant to subparagraph (C) shall be a required 
element of reports under this paragraph not earlier than 6 
months after the date on which such regulation or guidance is 
issued in final form (and in no event shall the absence of any 
regulation or guidance issued under subparagraph (C) affect the 
requirement to report as described in subparagraph (A)).''.
(b) Conforming Amendment.--Section 510(j)(3)(B) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 510(j)(3)(B)) is amended by 
striking ``subparagraph (A)'' and inserting ``this paragraph''.

SEC. 3. REQUIRE DRUG LABELING TO INCLUDE ORIGINAL MANUFACTURER AND 
SUPPLY CHAIN INFORMATION.

Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
352) is amended--
(1) in paragraph (b)--
(A) by striking ``(b) If in a package'' and 
inserting ``(b)(1) If in a package'';
(B) by striking ``a label containing (1) the name 
and place'' and inserting ``a label containing--
``(A) the name and place'';
(C) by striking ``or distributor; and (2) an 
accurate statement'' and inserting ``or distributor; 
and
``(B) an accurate statement'';
(D) by striking ``under clause (2) of this 
paragraph'' and inserting ``under this clause''; and
(E) by inserting at the end the following:
``(2)(A) Subject to clause (C), if it is a drug, including 
an active pharmaceutical ingredient, unless it bears a label 
containing the name and place of business, and unique facility 
identifier of the original manufacturer of such drug or active 
pharmaceutical ingredient, except that the Secretary may 
provide, by regulation, for reasonable variations in the 
implementation of such labeling requirements.
``(B) Subject to clause (C), if it is a drug that is an 
active pharmaceutical ingredient, unless any accompanying 
certificate of analysis contains the name and place of 
business, and unique facility identifier of the original 
manufacturer of the active pharmaceutical ingredient.
``(C) The Secretary may provide, by regulation, for 
reasonable variations in the implementation of labeling 
requirements specified in this subparagraph.''; and
(2) by inserting after paragraph (c) the following:
``(d)(1) Subject to subparagraph (2), if it is a drug, including an 
active pharmaceutical ingredient, unless it bears labeling containing 
the name and place of business of--
``(A) the original manufacturer of each active 
pharmaceutical ingredient;
``(B) each manufacturer, if different from the original 
manufacturer; and
``(C) the packer or distributor, if any.
``(2) The Secretary may provide, by regulation, for reasonable 
variations or an alternative placement for the labeling requirements 
specified in subparagraph (1), including by electronic means.''.
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