Sec. 2. Lengthen expiration dates to mitigate critical drug shortages
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/bill/118/s/2586/is/section-2A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506C–1 ( 21 U.S.C. 356c–1 ) the following: A manufacturer of a life-saving drug shall— submit to the Secretary data and information as required by subsection (b)(1); conduct and submit the results, data, and information of any studies required under subsection (b)(2); and make any labeling change described in subsection
(c)by the date specified by the Secretary pursuant to such subsection. The Secretary may issue an order requiring the manufacturer of any life-saving drug to submit, in such manner as the Secretary may prescribe, data and information from any stage of development of the drug that are adequate to assess the stability of the drug to determine the longest supported expiration date. If the data and information required pursuant to an order issued under paragraph
(1)are not available or are insufficient, the Secretary may require the manufacturer of the drug to— conduct studies adequate to provide the data and information in accordance with section 211.166 of title 21, Code of Federal Regulations (or any successor regulations); and submit to the Secretary the results, data, and information generated by such studies when available. The Secretary may issue an order requiring the manufacturer of a life-saving drug to, by a specified date, make any labeling change regarding the expiration date that the Secretary determines to be appropriate based on the data and information required to be submitted under this section in accordance with labeling requirements under subparts F and G of part 211 of title 21, Code of Federal Regulations (or any successor regulations) or any other data and information available to the Secretary. Nothing in 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. In this section, the term life-saving drug means a drug described in section 506C(a). . Section 303(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333(b) ) is amended by adding at the end the following: If a manufacturer fails to submit data and information as required under section 506C–2(b)(1), fails to conduct or submit the results, data, and information generated by studies as required under section 506C–2(b)(3), or fails to make a labeling change as required under section 506C–2(c), such manufacturer shall be liable to the United States for a civil penalty in an amount not to exceed $10,000 for each such violation. If a violation described in subparagraph
(A)is not corrected within the 30-day period following notification by the Secretary of a violation described in subparagraph (A), the manufacturer shall, in addition to any penalty under subparagraph (A), be subject to a civil monetary penalty of not more than $10,000 for each day of the violation after such period until the violation is corrected. .
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- 21 USC 356c–1
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