Sec. 850. REPORT AND UPDATED GUIDANCE ON CONTINUED RISK MANAGEMENT FOR PHARMACEUTICAL SUPPLY CHAINS OF DEPARTMENT OF DEFENSE
357 words·~2 min read·
/statute-compilations/comps-18280/sec-850A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 850 REPORT AND UPDATED GUIDANCE ON CONTINUED RISK MANAGEMENT FOR PHARMACEUTICAL SUPPLY CHAINS OF DEPARTMENT OF DEFENSE ###
(a)In General Not later than two years after the date of the enactment of this Act, the Under Secretary of Defense for Acquisition and Sustainment shall— ####
(1)submit to the Committees on Armed Services of the Senate and the House of Representatives a report on— #####
(A)existing information streams within the Federal Government, if any, for excipients and key starting materials for final drug products that may be used to assess the reliance by the Department of Defense on high-risk foreign suppliers analyzed in the report required under section 860(a) of the National Defense Authorization Act for Fiscal Year 2023 (Public Law 117–263; 136 Stat. 2734; 10 U.S.C. 3241 note prec.); #####
(B)active pharmaceutical ingredients, final drug products, and respective excipients and key starting materials analyzed in such report that are manufactured in a high-risk foreign country, as determined by the Secretary of Defense; #####
(C)any limitations on the ability of the Secretary to— ######
(i)obtain or analyze the information identified under subparagraphs
(A)and (B); ######
(ii)monitor the temperature of active pharmaceutical ingredients, final drug products, and respective excipients and key starting materials throughout the supply chain of the Department; and ######
(iii)use data analytics to monitor vulnerabilities in the pharmaceutical supply chain of the Department; #####
(D)how the Secretary plans to address the limitations identified under subparagraph (C); and #####
(E)any recommendations of the Secretary to address those limitations; and ####
(2)update risk management guidance developed by the Under Secretary under section 860(a)(1) of the National Defense Authorization Act for Fiscal Year 2023 (Public Law 117–263; 10 U.S.C. 3241 note prec.) to include any relevant findings identified in paragraph (1). ###
(b)FDA Determinations For the purposes of this section, the excipients and key starting materials for final drug products shall be such excipients and key starting materials as determined by the Food and Drug Administration or under regulations issued by the Food and Drug Administration. ## Subtitle E Prohibitions and Limitations on Procurement
Connectionstraces to 2
Traces to 2 documents
1 reference not yet in our index
- 136 Stat. 2734
Citation graph
cites case law
Sec. 850
REPORT AND UPDATED GUIDANCE ON CONTINUED RISK MANAGEMENT FOR PHARMACEUTICAL SUPPLY CHAINS OF DEPARTMENT OF DEFENSE
Stat.136 Stat. 2734
Cites 3Cited by 0 across 0 sources