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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4635 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 4635

 To require a report and updated guidance on continued risk management 
       for pharmaceutical supply chains of Department of Defense.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              July 8, 2024

 Mr. Peters (for himself and Ms. Ernst) introduced the following bill; 
  which was read twice and referred to the Committee on Armed Services

_______________________________________________________________________

                                 A BILL

 
 To require a report and updated guidance on continued risk management 
       for pharmaceutical supply chains of Department of Defense.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pharmaceutical Risk Assessment and 
Mitigation Act of 2024''.

SEC. 2. 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 regarding--
                    (A) existing information streams within the Federal 
                Government, if any, for excipients and key starting 
                materials of drugs 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 James M. Inhofe National Defense 
                Authorization Act for Fiscal Year 2023 (Public Law 117-
                263; 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 is produced by 
                each manufacturer 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); and
                            (ii) 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 James M. Inhofe 
        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.--The Department of Defense shall rely upon 
determinations of excipients and key starting materials for final drug 
products that are made by the Food and Drug Administration (FDA) or 
that align with FDA regulations.
                                 <all>
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