Sec. 6. National security risk assessment of drug, active pharmaceutical ingredient and medical device manufacturing operations
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The Secretary of Health and Human Services, in collaboration with the Secretary of Homeland Security and in consultation with stakeholders (including pharmacists, hospitals, physicians, and pharmaceutical and medical device manufacturers), shall conduct a risk assessment of national security threats arising from, or related to, the manufacture and distribution of drugs described in 506C(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c(a) ) or of any active pharmaceutical ingredients of such drugs or associated medical devices used for preparation or administration of such drugs.
Not later than 18 months after the date of enactment of this Act, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report outlining findings under such assessment and any recommended actions. The assessment and report under paragraph
(1)shall include— a review of manufacturing and distribution of drugs described in such section 506C(a), active pharmaceutical ingredients of such drugs, and associated medical devices used for preparation or administration of such drugs, that includes consideration of whether manufacturing sites and distribution systems should be considered critical infrastructure (as defined in section 1016(e) of the Critical Infrastructures Protection Act of 2001 ( 42 U.S.C. 5195c(e) )); a review of risks associated with the foreign manufacture of such drugs, ingredients, or devices; and recommendations on how to mitigate any such risks. The Secretary of Health and Human Services, in collaboration with the Secretary of Homeland Security, shall establish a standing forum to engage stakeholders, including pharmacists, hospitals, physicians, and pharmaceutical and medical device manufacturers, to mitigate risks identified through the assessment conducted under subsection (a).
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Sec. 6
National security risk assessment of drug, active pharmaceutical ingredient and medical device manufacturing operations
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