(a) Extension
The Secretary of Defense shall carry out the pilot program of the Uniformed Services University of the Health Sciences titled Assessing the Security and Quality of the U.S. Military Health System Pharmaceutical Supply Chain for a period of not less than five years beginning on the date of the enactment of this Act.
(b) Elements
The Secretary shall ensure that the pilot program under subsection (a) includes the following:
Defining the Department Essential Medicine list to consist of not more than 100 medicines that do not have patent exclusivity and are determined by the Secretary as essential for operational capabilities, predeployment, or the military health system (based on the progress of the pilot program before the date of the enactment of this Act).
To the extent practicable, harmonizing such Department Essential Medicine list with a list of defense-relevant generic drugs based on the risk management framework developed under section 860 of the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 ( Public Law 117–263 ; 10 U.S.C. 3241 note prec.).
Refreshing and expanding chemical testing data from the pilot program as carried out before the date of the enactment of this Act to include all medicines listed on the Department Essential Medicine List and creating National Drug Code-specific categorizations of high-risk, moderate-risk, or low-risk based on objective indicators for relative chemical quality and safety risk.
Adding to the objective risk-categorization framework assessment of location of manufacturing, including flagging entities in China and other countries that are not compliant with the Trade Agreements Act of 1979 ( 19 U.S.C. 2501 et seq. ) and creating National Drug Code-specific, objective categorizations of high-risk, moderate-risk, or low-risk based on independently derived indicators for true country of origin, that includes countries of concern, including China, being classified under the highest-risk category.
Making recommendations for the continuation of the scoring framework at the conclusion of the pilot program.
(c) Independent testing
The Secretary shall ensure that, in determining the true country of origin (location quality) and relative chemical quality and safety risks of medicines under the pilot program under subsection (a), the testing for such information is conducted by independent laboratories acceptable to the Uniformed Services University of the Health Sciences that—
are accredited under ISO 17025 standards;
are not registered as a Good Manufacturing Practice facility to ensure no conflicts of interest;
have experience developing and operating a published quality risk scoring framework applicable to individual National Drug Codes; and
are duly licensed and demonstrate an ability to conduct ongoing post-market surveillance through procurement of pharmaceutical products from common wholesalers, and not directly from manufacturers.