Sec. 503. Reporting on use of new authorities and requirements with respect to drug shortages
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Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ) shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on— the extent to which the Secretary has implemented the authorities and requirements under sections 506C(g), 506C(j), 506E(d), 510(j)(3), and 704(b)(2) ( 21 U.S.C. 356c(g) , 356c(j), 356e(d), 360(j)(3), 374(b)(2)) of the Federal Food, Drug, and Cosmetic Act, as amended by section 3111 and 3112 of the Coronavirus Aid, Relief, and Economic Security Act ( Public Law 116–136 ), including— specific examples of uses of such authorities and requirements; and an assessment of the extent to which such authorities and requirements have helped mitigate drug shortages; and the status of the guidance documents that the Secretary intends to issue with respect to reporting and risk management plan requirements applicable to manufacturers of drugs and active pharmaceutical ingredients, pursuant to the amendments made to section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) by subsections
(a)and
(b)of section 3112 of the Coronavirus Aid, Relief, and Economic Security Act ( Public Law 116–136 ).
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Sec. 503
Reporting on use of new authorities and requirements with respect to drug shortages
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