Medical Supply Chain Security Act

To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced security for the medical supply chain. 1. Short title This Act may be cited as the Medical Supply Chain Security Act 2. Medical supply chain security (a) Additional manufacturer reporting for essential medical devices Section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c (1) in subsection (a)— (A) in the matter preceding paragraph (1), by inserting or device a drug (B) in the flush matter by inserting or device drug (2) in subsection (c), by inserting and devices drugs (3) in subsection (g)— (A) in the matter preceding paragraph (1), by striking drug shortage of a drug shortage of a drug or device (B) in paragraph (1), by striking ; or (C) by redesignating paragraph (2) as paragraph (3); (D) by inserting after paragraph (1) the following: (2) expedite the review of a device subject to premarket approval under section 515 that could help mitigate or prevent such shortage; or ; and (E) in paragraph (3), as so redesignated, by striking drug shortage shortage (4) in subsection (h)— (A) by amending paragraph (2) to read as follows: (2) the term shortage ; and (B) in paragraph (3)(A), by inserting or device drug (5) by adding at the end the following: (k) Additional manufacturer reporting for essential drugs and devices 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— (1) details about— (A) all locations of production; (B) the sourcing of all component parts; (C) the sourcing of any active pharmaceutical ingredients; and (D) the use of any scarce raw materials; and (2) any other information determined by the Secretary to be relevant to the security of the supply chain of the drug or device. . (b) Provision of additional information Section 506C–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c–1 (1) in the heading, by striking drug shortages drug or device shortages (2) by striking drug shortages drug or device shortages (3) in subsection (a)— (A) in paragraph (3)(B)— (i) in clause (i), by striking section 506C(g)(1) paragraph (1) or (2) of section 506C(g) (ii) in clause (ii), by striking section 506C(g)(2) section 506C(g)(3) (B) in paragraph (5), by striking drug shortage drug or device shortage (4) in subsection (c), by striking drug shortage

Summary: Medical Supply Chain Security Act This bill requires manufacturers of essential medical devices (i.e., those that are life supporting, life-sustaining, or intended for use for a debilitating disease or condition) to notify the Food and Drug Administration (FDA) if the device is discontinued or if there is any meaningful disruption to the device's manufacturing. The bill also authorizes the FDA to expedite review of such a device to mitigate or prevent a shortage. The bill also requires the manufacturer of an essential medical device or drug to report annually to the FDA certain information, such as details about all locations of production and the sourcing of component parts or active pharmaceutical ingredients.