Sec. 776. Pilot program on ensuring pharmaceutical supply stability
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Not later than January 1 2024, the Secretary of Defense, acting through the Director of the Defense Logistics Agency, shall establish a pilot program to acquire, manage, and replenish a 180-day supply of at least 30 commonly used generic drugs at risk of shortage under the military health system as a result of a pharmaceutical supply chain disruption, to ensure the stability of such supply. The Secretary of Defense shall select for participation in the pilot program established under subsection
(a)not fewer than five military medical treatment facilities that are— located in the continental United States; and at the greatest risk of pharmaceutical supply chain disruption, as determined by the Secretary. In carrying out the pilot program established under subsection (a), the Secretary of Defense shall— use the systems and processes of the Direct Vendor Delivery System established by section 352 of the National Defense Authorization Act for Fiscal Year 1996 ( Public Law 104–106 ; 10 U.S.C. 2458 note); include the establishment of a vendor managed inventory approach to pharmaceutical distribution, to acquire, manage, and replenish the vendor-held supply described in subsection
(a)to prevent product expiration and shortages; and ensure guaranteed Department of Defense access to the vendor managed inventory approach specified in paragraph (2). The pilot program established under this section shall terminate on the date that is three years after the date of the enactment of this Act. Not later than 30 days after the date of the establishment of the pilot program under subsection (a), the Secretary of Defense shall submit to the Committees on Armed Services of the House of Representatives and Senate a report on the design of the pilot program. Such report shall include— a description of the military medical treatment facilities selected under subsection
(b)and the generic drugs selected for the pilot program pursuant to subsection (a); the plan for the implementation and management of the pilot program; and key performance indicators to measure the success of the pilot program in ensuring the availability of generic drugs selected for the pilot program pursuant to subsection (a). Not later than 180 days after the termination date under subsection (d), the Secretary of Defense shall submit to the Committees on Armed Services of the House of Representatives and Senate a final report on the results of the pilot program. The report shall include— measurements of key performance indicators identified in the initial report required under subsection (e); an analysis of the success of the pilot program in preventing shortages of commonly used generic drugs within the military medical treatment facilities selected under subsection (b); and recommendations for further expansions of the pilot program, including any legislative or regulatory proposals the Secretary determines would reduce supply chain risk to commonly used generic drugs under the military health system. In this section: The term generic drug means a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 231 )) that is approved pursuant to section 505(j) of such Act ( 21 U.S.C. 355(j) ). The term pharmaceutical supply chain disruption means a disruption described in the report of the Inspector General of the Department of Defense titled Evaluation of the Department of Defense’s Mitigation of Foreign Suppliers in the Pharmaceutical Supply Chain (DODIG-2021-126) and published on September 20, 2021.
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- Pub. L. 104-106
- 21 USC 231
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Sec. 776
Pilot program on ensuring pharmaceutical supply stability
Pub. L.Pub. L. 104-106
Cite21 USC 231
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