Sec. 501. Improving notification procedures in case of increased demand for critical drugs
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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 drugs by striking subsections (a), (b), and (c), and inserting the following: A manufacturer of a covered drug 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 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 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 the reasons for such discontinuance, interruption, or other circumstance, if known.
Notification under this subsection with respect to a covered drug shall include— 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; 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); the expected duration of the interruption; 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 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 if compliance with paragraph
(1)or
(2)is not possible, as soon as practicable. 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. ; in subsection (g), in the matter preceding paragraph (1), by striking drug described in subsection
(a)and inserting covered drug ; and in subsection (j), by striking drug described in subsection
(a)and inserting covered drug . 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: the term covered drug means a drug that is intended for human use and 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; is not a radio pharmaceutical drug product or any other product as designated by the Secretary; and 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); .
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Sec. 501
Improving notification procedures in case of increased demand for critical drugs
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