Drug Origin Transparency Act of 2026

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