Sec. 3112. Additional manufacturer reporting requirements in response to drug shortages
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Subsection
(a)of section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) is amended— in paragraph (1)(C), by inserting 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 after during surgery ; and in the flush text at the end— by inserting , or a permanent discontinuance in the manufacture of an active pharmaceutical ingredient or an interruption in the manufacture of the 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, before and the reasons ; and by adding at the end the following: Notification under this subsection shall include disclosure of reasons for the discontinuation or interruption, and if applicable, an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation or interruption, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known 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 or interruption; the expected duration of the interruption; and such other information as the Secretary may require. . Section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) is amended by adding at the end the following: Each manufacturer of a drug described in subsection
(a)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 704(a)(4). . Section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e ) is amended by adding at the end the following: Not later than 180 days after the date of enactment of this subsection, and every 90 days thereafter, the Secretary shall transmit a report regarding the drugs of the current drug shortage list under this section to the Administrator of the Centers for Medicare & Medicaid Services. . Section 704(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(b) ) is amended— by redesignating paragraphs
(1)and
(2)and subparagraphs
(A)and (B); by striking
(b)Upon completion and inserting (b)(1) Upon completion ; and by adding at the end the following: In carrying out this subsection with respect to any establishment manufacturing a drug approved under subsection
(c)or
(j)of section 505 for which a notification has been submitted in accordance with section 506C is, or has been in the last 5 years, listed on the drug shortage list under section 506E, or that is described in section 505(j)(11)(A), a copy of the report shall be sent promptly to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages. . Section 510(j) of the Federal Food, Drug, Cosmetic Act ( 21 U.S.C. 360(j) ) is amended— by redesignating paragraphs
(3)and
(4)as paragraphs
(4)and (5), respectively; and by inserting after paragraph
(2)the following: Each person who registers with the Secretary under this section with regard to a drug shall report annually to the Secretary 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 format as determined by the Secretary. The Secretary may require that information required to be reported under this paragraph be submitted at the time a public health emergency is declared by the Secretary under section 319 of the Public Health Service Act. By order of the Secretary, certain biological products or categories of biological products regulated under section 351 of the Public Health Service Act may be exempt from some or all of the reporting requirements under subparagraph (A), if the Secretary determines that applying such reporting requirements to such biological products or categories of biological products is not necessary to protect the public health. . Nothing in the amendments made by this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code. The amendments made by this section and section 3111 shall take effect on the date that is 180 days after the date of enactment of this Act.
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Sec. 3112
Additional manufacturer reporting requirements in response to drug shortages
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