21 U.S.C. 356cchangedby S. 2665 Sec. 2(a)
The bill says: in the section heading, by striking "Discontinuance or interruption in the production of life-saving drugs" and inserting "Notification of issues affecting domestic supply of critical drugs";
Bill text · Current law (21 U.S.C. 356c)
21 U.S.C. 356cchangedby S. 2665 Sec. 2(a)
(a) Notification required.—(1) In general.— A manufacturer of a covered drug shall notify the Secretary, in accordance with subsection (b), of—(A)(i) a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the supply of such drug in the United States;(ii) a permanent discontinuance in the manufacture of an active pharmaceutical ingredient of such drug, or an interruption in the manufacture of an active pharmaceutical ingredient of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug; or(iii) any other circumstance, such as an increase in demand or export restriction, that is likely to leave the manufacturer unable to meet demand for the drug without a meaningful shortfall or delay; and(B) the reasons for such discontinuance, interruption, or other circumstance, if known.(2) Contents.— Notification under this subsection with respect to a covered drug shall include—(A) with respect to the reasons for the discontinuation, interruption, or other circumstance described in paragraph (1)(A)(iii), if an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation, interruption, or other circumstance, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known to the manufacturer;(B) whether any associated device used for preparation or administration included in the drug is a reason for, or a risk factor in, such discontinuation, interruption, or other circumstance described in paragraph (1)(A)(iii);(C) the expected duration of the interruption; and(D) such other information as the Secretary may require.(b) Timing.— A notice required under subsection (a) shall be submitted to the Secretary—(1) at least 6 months prior to the date of the discontinuance or interruption;(2) in the case of such a notice with respect to a circumstance described in subsection (a)(1)(A)(iii), as soon as practicable, or not later than 10 business days after the onset of the circumstance; or(3) if compliance with paragraph (1) or (2) is not possible, as soon as practicable.(c) Distribution.— To the maximum extent practicable, the Secretary shall distribute, through such means as the Secretary determines appropriate, information on the discontinuance or interruption of the manufacture of, or other circumstance described in subsection (a)(1)(A)(iii) that is likely to lead to a shortage or meaningful disruption in the supply of, covered drugs to appropriate organizations, including physician, health provider, and patient organizations, as described in section 506E.
The bill says: by striking subsections (a), (b), and (c), and inserting the following:
Bill text · Current law (21 U.S.C. 356c)
21 U.S.C. 356c(g)changedby S. 2665 Sec. 2(a)
(g) Expedited inspections and reviews. If, based on notifications described in subsection (a) or any other relevant information, the Secretary concludes that there is, or is likely to be, a drug shortage of a drug described in subsection (a)covered drug, the Secretary shall, as appropriate— (1) prioritize and expedite the review of a supplement to a new drug application submitted under section 355(b) of this title, an abbreviated new drug application submitted under section 355(j) of…
The bill says: in subsection (g), in the matter preceding paragraph (1), by striking "drug described in subsection (a)" and inserting "covered drug"; and
Bill text · Current law (21 U.S.C. 356c)
21 U.S.C. 356c(j)changedby S. 2665 Sec. 2(a)
(j) Risk management plans. Each manufacturer of a drug described in subsection (a)covered drug or of any active pharmaceutical ingredient or any associated medical device used for preparation or administration included in the drug, shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the drug, as applicable, for each establishment in which such drug or active pharmaceutical ingredient of such drug is manufactured. A risk management plan under this section shall be subject to inspection and copying by the Secretary pursuant to an inspection or a request under section 374(a)(4) of this title.
The bill says: in subsection (j), by striking "drug described in subsection (a)" and inserting "covered drug".
Bill text · Current law (21 U.S.C. 356c)
21 U.S.C. 356c(h)rewrittenby S. 2665 Sec. 2(b)
(1) the term covered drug means a drug that is intended for human use and that—(A) is—(i) life-supporting;(ii) life-sustaining; or(iii) intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the Secretary under section 319 of the Public Health Service Act;(B) is not a radio pharmaceutical drug product or any other product as designated by the Secretary; and(C) is not a biological product (as defined in section 351(i) of the Public Health Service Act), unless otherwise provided by the Secretary in the regulations promulgated under subsection (i);
The bill says: Paragraph (1) of section 506C(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(h)) is amended to read as follows:
Bill text · Current law (21 U.S.C. 356c)
21 U.S.C. 360(j)(3)(A)changedby S. 2665 Sec. 3(1)
(3)(A) Each person who registers with the Secretary under this section with regard to a drug shall report annually to the Secretaryto the Secretary, once during the month of March each year and once during the month of September each year, on the amount of each drug listed under paragraph (1) that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. Such information may be required to be submitted in an electronic…
The bill says: by striking "annually to the Secretary" in the first sentence and inserting "to the Secretary, once during the month of March each year and once during the month of September each year,";
Bill text · Current law (21 U.S.C. 360)
21 U.S.C. 360(j)(3)(A)changedby S. 2665 Sec. 3(2)
The bill says: by inserting ", and the legal names of, and any additional information the Secretary may require, regarding suppliers of active pharmaceutical ingredients and intermediate and in-process materials such person used for the manufacture, preparation, propagation, compounding, or processing of such drug, and the amount of such drug manufactured, prepared, propagated, compounded, or processed using each such active pharmaceutical ingredient or intermediate or in-process material sourced from each such supplier" before the period at the end of the first sentence; and
Bill text · Current law (21 U.S.C. 360)
21 U.S.C. 360(j)(3)(A)addedby S. 2665 Sec. 3(3)
The bill says: by inserting after the first sentence the following: "In addition to the reporting required under the preceding sentence, each person who registers with the Secretary under this section with regard to a drug may voluntarily report on the information described in the preceding sentence, at such other times as the Secretary may specify.".
Bill text · Current law (21 U.S.C. 360)