Sec. 3. 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 the matter preceding paragraph (1), by inserting or its active pharmaceutical ingredients after a drug ; and in the flush text at the end— by inserting or its active pharmaceutical ingredients before that is likely ; or its active pharmaceutical ingredients after that drug ; and by adding at the end the following: Notification under this subsection shall include full disclosure of the problems resulting in the shortage, the source of the active pharmaceutical ingredient, associated medical devices used for preparation or administration included in the finished dosage form, any alternative sources for the active pharmaceutical ingredient that are known or contacted by manufacturer, information concerning the extent of the shortage, the expected duration of the shortage, the expected impact to distribution and availability in pharmacies, 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 associated medical devices used for preparation or administration included in the finished dosage form of such a drug, shall report in such manufacturer's annual establishment registration and product listing under subsections
(b)and
(j)of section 510 the specific facilities in which such drug or ingredient is manufactured and contingency and redundancy plans to help ensure uninterrupted supply of the drug or ingredient. Additional manufacturer reporting requirements under this section shall be maintained by the Secretary in a confidential and internal manner for use by the agency to help ensure continued supply of such drugs. . Not later than one year after the date of enactment of this Act, the Secretary shall develop and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives legislative and regulatory recommendations for consumer notification in the case of a drug shortage, discontinuance, or interruption of the manufacture of a drug described in section 506C(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c(a) ), including recommendations for notification to patients and physicians, pharmacists, and other practitioners authorized under applicable State law to prescribe or dispense drugs. 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 that is described in 506C(a) or 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 2 shall take effect on the date that is 180 days after the date of enactment of this Act.
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Sec. 3
Additional manufacturer reporting requirements in response to drug shortages
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