Sec. 531. Improving notification procedures in case of increased demand for critical essential medicines
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Section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) is amended— in the section heading, by striking and inserting Discontinuance or interruption in the production of life-saving drugs ; Notification of issues affecting domestic supply of critical essential medicines by striking subsections (a), (b), and (c), and inserting the following: A manufacturer of a critical essential medicine shall notify the Secretary, in accordance with subsection (b), of— 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; a permanent discontinuance in the manufacture of an active pharmaceutical ingredient, an excipient, or any other input in the final dosage form of such drug or an interruption in the manufacture of the active pharmaceutical ingredient, an excipient, or any other input in the final dosage form of such drug of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug; an increased demand (other than an anticipated seasonal surge) for such drug or an active pharmaceutical ingredient, an excipient, or any other input in the final dosage form of such drug that is likely to lead to a shortage of the drug or the active pharmaceutical ingredient, an excipient, or any other input in the final dosage form of such drug; and the reasons for such discontinuance, interruption, or increased demand.
Notification under this subsection with respect to a critical essential medicine shall include— with respect to the reasons for the discontinuation, interruption, or increased demand referred to in paragraph (1)(C), if an active pharmaceutical ingredient, an excipient, or any other input in the final dosage form of such drug is a reason for, or risk factor in, such discontinuation, interruption, or increased demand, the source of the active pharmaceutical ingredient, excipient, or other input and any alternative sources for the an active pharmaceutical ingredient, an excipient, or any other input by the manufacturer; 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 increased demand; the expected duration of the interruption or increased demand; and such other information as the Secretary may require.
A notice required under subsection
(a)shall be submitted to the Secretary— at least 6 months prior to the date of the discontinuance or interruption; in the case of such a notice with respect to increased demand for a critical essential medicine, not later than 30 days after the submission of the initial notification under paragraph (2); or if compliance with subparagraph
(A)or
(B)is not possible, as soon as practicable. In the case a notification required under subsection
(a)with respect to increased demand for a critical essential medicine, the manufacturer of the drug involved shall submit to the Secretary an initial notification not later than 48 hours after the date on which there has been increased demand for the critical essential medicine for a period of at least 6 consecutive weeks. To the maximum extent practicable, the Secretary shall distribute, through such means as the Secretary deems appropriate, information on the discontinuance or interruption of the manufacture of, or the increased demand for, critical essential medicines to appropriate organizations, including physician, health provider, and patient organizations, as described in section 506E. ; in subsection (g), in the matter preceding paragraph (1), by striking drug described in subsection
(a)and inserting critical essential medicine ; and in subsection (j), by striking drug described in subsection
(a)and inserting critical essential medicine . Section 506C(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c(h) ) is amended— by redesignating paragraphs (1), (2), and
(3)as paragraphs (2), (3), and (4), respectively; in paragraph (2)(A) (as so redesignated), by striking and that is subject to section 503(b)(1) and inserting , including a drug that is not subject to section 503(b)(1) ; and by inserting before paragraph
(2)(as so redesignated) the following: the term critical essential medicine means a drug that— is— life-supporting; life-sustaining; or 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; and is not a radio pharmaceutical drug product or any other product as designated by the Secretary; . Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue final regulations to implement the amendments made by subsections
(a)and (b). The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue guidance on the requirements for notifications required to be submitted under section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ), as amended by subsections
(a)and (b), with respect to increased demand for critical essential medicines (as defined in such section 506C). Such guidance shall specifically address— the ways in which manufacturers of critical essential medicines can improve demand predictability; what information manufacturers of critical essential medicines should send to the Secretary; and what communications from the manufacturer the Secretary would request with respect to increases in demand following such notifications. In developing such guidance, the Secretary shall consult with relevant stakeholders, including manufacturers of critical essential medicines and local, State, or Federal public health officials. The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue— draft guidance under paragraph
(1)not later than 120 days after the date of the enactment of this Act; and final guidance under such paragraph not later than 180 days after the date of the enactment of this Act.
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Sec. 531
Improving notification procedures in case of increased demand for critical essential medicines
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