[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

_______________________________________________________________________

                                 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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