Sec. 854. Department of Defense manufacturing authorities
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The Secretary of Defense (referred to in this section as the Secretary ) shall seek to enter into contracts for the domestic manufacture of a covered product, in the event that the Secretary determines that— there is a Department of Defense requirement for a covered product that cannot be met by other means; and the covered product is— sourced from a foreign adversary (as defined in section 8(c)(2) of the Secure and Trusted Communications Networks Act of 2019 ( 47 U.S.C. 1607(c)(2) )); included on the list of essential medicines maintained by the Food and Drug Administration pursuant to Executive Order 13944 (85 Fed. Reg. 49929); listed by the World Health Organization as an essential medicine; on the drug shortage list maintained by the Food and Drug Administration under section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e ); used by the Department of Defense but not otherwise commercially available; or affected by an emergent issue, such as a natural disaster, that hinders existing manufacturing of the product; or other circumstances exist that pose a security risk to the Armed Forces which can be addressed through such manufacture of the covered product.
The Secretary is not required to enter into a contract pursuant to subsection
(a)if the Secretary is unable to identify an entity with whom to contract for the domestic manufacture of a covered product in sufficient quality and quantity. The Secretary shall consult with the Secretary of Health and Human Services on establishing domestic facility requirements for the manufacture of covered products pursuant to the Defense Production Act of 1950 ( 50 U.S.C. 4501 et seq. ). In this section, the term covered product means a drug (as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g) )), including a biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) ), or the primary packaging, active pharmaceutical ingredient, key starting material, or component or part for such a drug or device. The authority under subsection
(a)shall take effect on October 1, 2025.
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- 85 FR 49929
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Sec. 854
Department of Defense manufacturing authorities
Fed. Reg.85 FR 49929
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