Sec. 2. Medical supply chain security
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/bill/116/hr/6049/ih/section-2A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) is amended— in subsection (a)— in the matter preceding paragraph (1), by inserting or device after a drug ; and in the flush matter by inserting or device after drug each place such term appears; in subsection (c), by inserting and devices after drugs ; in subsection (g)— in the matter preceding paragraph (1), by striking drug shortage of a drug and inserting shortage of a drug or device ; in paragraph (1), by striking ; or and inserting a semicolon; by redesignating paragraph
(2)as paragraph (3); by inserting after paragraph
(1)the following: expedite the review of a device subject to premarket approval under section 515 that could help mitigate or prevent such shortage; or ; and in paragraph (3), as so redesignated, by striking drug shortage and inserting shortage ; in subsection (h)— by amending paragraph
(2)to read as follows: the term shortage , with respect to a drug or device, means a period of time when the demand or projected demand for the drug or device within the United States exceeds the supply of the drug or device; and ; and in paragraph (3)(A), by inserting or device after drug ; and by adding at the end the following: Each manufacturer of a drug or device described in subsection
(a)shall provide to the Food and Drug Administration, on an annual basis, or more frequently at the request of the Secretary, information related to the manufacturing capacity of such drug or device. Such information shall include— details about— all locations of production; the sourcing of all component parts; the sourcing of any active pharmaceutical ingredients; and the use of any scarce raw materials; and any other information determined by the Secretary to be relevant to the security of the supply chain of the drug or device. . Section 506C–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c–1 ) is amended— in the heading, by striking and inserting drug shortages ; drug or device shortages by striking drug shortages each place it appears and inserting drug or device shortages ; in subsection (a)— in paragraph (3)(B)— in clause (i), by striking section 506C(g)(1) and inserting paragraph
(1)or
(2)of section 506C(g) ; and in clause (ii), by striking section 506C(g)(2) and inserting section 506C(g)(3) ; and in paragraph (5), by striking drug shortage and inserting drug or device shortage ; and in subsection (c), by striking . drug shortage or
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- 21 USC 356c–1
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