Sec. 4122. 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 determined under section 319 of the Public Health Service Act after during surgery ; and in the flush text at the end— by inserting , or a discontinuance or an interruption in the manufacture of the active pharmaceutical ingredients of such drug, before that is likely ; and by adding at the end the following: Notification under this subsection shall include disclosure of reasons for the discontinuation or interruption, as applicable; if 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 medical devices used for preparation or administration included in the finished dosage form 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(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c(d) ) is amended by adding at the end the following: Information provided by a manufacturer to the Secretary under this section shall not be subject to disclosure under section 552 of title 5, United States Code. . 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 devices used for preparation or administration included in the finished dosage form of such a drug, shall maintain contingency and redundancy plans, as applicable, for each establishment in which such drugs or active pharmaceutical ingredients of such drugs are manufactured to help prevent or mitigate interruptions in the supply of the drug or ingredient. . 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. Such offices shall ensure timely and effective coordination regarding the reviews of such report and overseeing the alignment of any feedback regarding such report, or corrective or preventative actions, after consideration of the systematic benefits and risks to public health, patient safety, the drug supply and drug supply chain, and timely patient access to such drugs. . The amendments made by this section and section 4121 shall take effect on the date that is 180 days after the date of enactment of this Act.
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Sec. 4122
Additional manufacturer reporting requirements in response to drug shortages
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