Sec. 887. Requirement to procure domestically produced generic drugs
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Subchapter II of chapter 385 of title 10, United States Code, is amended by adding at the end the following new section: The head of a military service or Department of Defense agency or field activity may not enter into a contract for the procurement of generic drugs specified on the list in subsection (c), unless the generic drugs— are manufactured in the United States; and use active pharmaceutical ingredients and key starting materials sourced from— the United States; or a foreign country or instrumentality designated under subsection
(b)of section 301 of the Trade Agreements Act of 1979 ( 19 U.S.C. 2511 ) for purposes of the waiver authority under subsection
(a)of that section. Subsection
(a)does not apply to the head of military service or Department of Defense agency or field activity if the head determines that satisfactory quality and sufficient quantity of a generic drug described in subsection
(a)cannot be procured in sufficient quantities to meet military needs or as and when needed at United States market prices. The Secretary of Defense shall notify Congress not less than 15 days after the Department exercises a waiver under paragraph (1). Not later than October 1, 2025, the Secretary of Defense shall develop and maintain a list of defense-relevant generic drugs, based on the risk management framework developed under section 860 of the James National Defense Authorization Act for Fiscal Year 2023 ( Public Law 117–347 ; 10 U.S.C. note prec. 3241). In this section: The term active pharmaceutical ingredient has the meaning given such term in section 744A(2) of the Federal Food, Drug, and Cosmetic Act. The term generic drug means a drug approved under subsection (b)(2) or
(j)of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or licensed under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ). The term key starting material means a raw material, an intermediate, or an active pharmaceutical ingredient that is used in the production of an active pharmaceutical ingredient and that is incorporated as a significant structural fragment into the structure of the active pharmaceutical ingredient. . The table of sections at the beginning of such subchapter is amended by inserting after the item relating to section 4662 the following new item: 4865. Requirement to procure domestically produced generic drugs. . The amendments made by this section shall take effect on October 1, 2025.
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Sec. 887
Requirement to procure domestically produced generic drugs
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