Sec. 4. U.S. pharmaceutical supply chains mapping
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S . pharmaceutical supply chains mapping The Secretary of Health and Human Services (referred to in this section as 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, to— map, or otherwise visualize, the supply chains, from manufacturing of key starting materials through manufacturing of finished dosage forms and distribution, of drugs (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )) included on the Essential Medicines List under section 2; and use data analytics to identify supply chain vulnerabilities that pose a threat to public health or national security, as determined by the Secretary or the heads of other relevant Federal departments and agencies.
In carrying out subsection (a), 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; and 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 paragraph
(1)related to drugs described in subsection (a)(1). Such information should include, at a minimum— 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 active pharmaceutical ingredients and finished dosage forms of drugs described in subsection (a)(1), and the amount of such ingredients and finished dosage forms 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 the active pharmaceutical ingredients and finished dosage forms, and the amount of such materials and excipients produced at each such establishment; and any regulatory actions with respect to such drugs or the establishments manufacturing such drugs, including with respect to inspections and related regulatory activities conducted under section 704 of such Act ( 21 U.S.C. 374 ), the seizure of such a drug pursuant to section 304 of such Act ( 21 U.S.C. 334 ), any recalls of such a drug; inclusion of such a drug on the drug shortage list under section 506E of such Act ( 21 U.S.C. 356e ), or prior reports of a discontinuance or interruption in the production of such a drug under section 506C of such Act ( 21 U.S.C. 356c ). Not later than 18 months after the date of enactment of this Act, and annually thereafter, the Secretary, in consultation with the heads of agencies with which the Secretary coordinates under subsection (a), 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 subsection (a); activities of the Secretary carried out under this section to coordinate efforts as described in subsection (a), including information sharing between relevant Federal departments, agencies, and offices; the roles and responsibilities described in subsection (b)(1), 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; and the extent to which the Secretary has engaged relevant industry in such mapping.
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Sec. 4
U.S. pharmaceutical supply chains mapping
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