Sec. 3. Discontinuance or interruption in production
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Section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) is amended by adding at the end the following: This section shall apply with respect to an active pharmaceutical ingredient in a drug described in subsection
(a)in the same manner and to the same extent as this section applies with respect to a drug described in subsection (a), except that subsection
(i)shall not apply with respect to active pharmaceutical ingredients. . Not later than 24 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final guidance on implementing the amendment made by paragraph (1). The guidance required by subparagraph
(A)shall specify— the form and manner of the disclosures required by the amendment made by paragraph (1); and the details that need to be included in such disclosures. Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ), as amended by section 2(b), is further amended by adding at the end the following: The failure of a manufacturer of a drug described in section 506C(a) or an active pharmaceutical ingredient of such a drug, without a reasonable basis as determined by the Secretary, to notify the Secretary of a permanent discontinuance or an interruption, and the reasons for such discontinuance or interruption, as required by section 506C. . The amendments made by subsections
(a)and
(b)apply beginning on the date that is 180 days after the date of enactment of this Act.
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