[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3810 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 3810
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
June 5, 2023
Ms. Eshoo introduced the following bill; which was referred to the
Committee on Energy and Commerce
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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
2023''.
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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