Sec. 1083. Mapping America's Pharmaceutical Supply

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This section may be cited as the or the Mapping America's Pharmaceutical Supply Act . MAPS Act The Secretary, in coordination with the heads of other relevant Federal departments and agencies, shall ensure coordination of efforts of the Department of Health and Human Services, including through public-private partnerships, as appropriate, to— map, or otherwise visualize, the supply chains, from manufacturing of key starting materials through manufacturing of finished dosage forms and distribution, of drugs and biological products, including the active ingredients of those drugs and biological products, that are— directly related to responding to chemical, biological, radiological, or nuclear threats and incidents covered by the National Response Framework; or of greatest priority for providing health care and identified as being at high risk of shortage; and use data analytics to identify supply chain vulnerabilities that pose a threat to national security, as determined by the Secretary or the heads of other relevant Federal departments and agencies.

In carrying out paragraph (1), the Secretary shall— describe the roles and responsibilities of agencies and offices within the Department of Health and Human Services related to monitoring such supply chains and assessing any related vulnerabilities; facilitate the exchange of information between Federal departments, agencies, and offices, as appropriate and necessary to enable such agencies and offices to carry out roles and responsibilities described in subparagraph

(A)related to drugs and biological products described in paragraph (1)(A), which may include— the location of establishments registered under subsection (b), (c), or

(i)of section 510 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360 ) involved in the production of drugs and biological products, including the active ingredients of those drugs and biological products, described in paragraph (1)(A), and to the extent available, the amount of each such drug and biological product, including the active ingredients of those drugs and biological products, produced at each such establishment; to the extent available and as appropriate, the location of establishments so registered involved in the production of the key starting materials and excipients needed to produce each drug and biological product, including the active ingredients of those drugs and biological products, and the amount of such materials and excipients produced at each such establishment; and any applicable regulatory actions with respect to each such drug and biological product, or the establishments manufacturing such drugs and biological products, including with respect to— inspections and related regulatory activities conducted under section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 ); seizures pursuant to section 304 of such Act ( 21 U.S.C. 334 ); any recalls issued; drugs or biological products that are, at the time of the determination, or that were at a previous time, included on the drug shortage list consistent with section 506E of such Act ( 21 U.S.C. 356e ); and discontinuances or interruptions in the production of such drugs or biological products under 506C of such Act ( 21 U.S.C. 355d ). Not later than 18 months after the date of enactment of this Act, and annually thereafter, the Secretary, in consultation with the heads of departments and agencies with which the Secretary coordinates under paragraph (1), shall submit a report to the relevant committees of Congress on— the current status of efforts to map and analyze pharmaceutical supply chains, as described in paragraph (1); activities of the Secretary carried out under this subsection to coordinate efforts as described in paragraph (1), including information sharing between relevant Federal departments, agencies, and offices; the roles and responsibilities described in paragraph (2)(A), including the identification of any gaps, data limitations, or areas of unnecessary duplication between such roles and responsibilities; the extent to which Federal agencies use data analytics to conduct predictive modeling of anticipated drug shortages or risks associated with supply chain vulnerabilities that pose a threat to national security; the extent to which the Secretary has engaged relevant industry in such mapping; the drugs and biological products, including the active ingredients of those drugs and biological products, described in paragraph (1)(A) that rely on, for more than 50 percent of production, a high-risk foreign supplier or foreign entity of concern (as defined in section 9901(8) of the William M.

(Mac)Thornberry National Defense Authorization Act for Fiscal Year 2021 ( 15 U.S.C. 4651(8) )); the drugs and biological products, including the active ingredients of those drugs and biological products, described in paragraph (1)(A) that are sourced from foreign establishments for more than 50 percent of production, including drugs manufactured domestically from active pharmaceutical ingredients sourced from foreign establishments for more than 50 percent of production; the current domestic manufacturing capabilities for drugs and biological products, including the active ingredients of those drugs and biological products, described in paragraph (1)(A), including the key starting materials and excipients of such drugs, biological products, and ingredients, and whether such capabilities utilize advanced manufacturing technologies; and any public health or national security risks, including cybersecurity threats and critical infrastructure designations, with respect to the supply chains of drugs and biological products, including the active ingredients of those drugs and biological products, described in paragraph (1)(A). Not later than 180 days after the date of enactment of this Act, and every 180 days thereafter, the Secretary of Defense shall submit to the relevant committees of Congress a report that lists all drugs purchased by the Department of Defense during the 180-day period preceding the date of the report— that contain key starting materials, excipients, or active pharmaceutical ingredients sourced from the People’s Republic of China; or for which the finished drug product was manufactured in the People’s Republic of China. In this section: The term advanced manufacturing has the meaning given the term advanced and continuous pharmaceutical manufacturing in section 3016(h) of the 21st Century Cures Act ( 21 U.S.C. 399h(h) ). The term biological product has the meaning given such term in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) ). The term cybersecurity threat has the meaning given such term in section 2200 of the Homeland Security Act of 2002 ( 6 U.S.C. 650 ). The term drug has the meaning given such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g) ). The term relevant committees of Congress means— the Committee on Armed Services and the Committee on Health, Education, Labor, and Pensions of the Senate; and the Committee on Armed Services and the Committee on Energy and Commerce of the House of Representatives. The term Secretary , except as otherwise specified, means the Secretary of Health and Human Services. The exchange of information among the Secretary and the heads of other relevant Federal departments and agencies for purposes of carrying out subsection

(b)shall not be a violation of section 1905 of title 18, United States Code. This section shall not be construed to affect the status, if any, of such information as trade secret or confidential commercial information for purposes of section 301(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331(j) ), section 552 of title 5, United States Code, or section 1905 of title 18, United States Code. The Secretary shall ensure that robust cybersecurity measures are in place to prevent inappropriate access to, or unauthorized disclosure of, the information identified, exchanged, or disclosed under subsection (b).

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