Sec. 2. Lengthen expiration dates to mitigate critical drug shortages
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/bill/117/s/2595/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 drug subject to notification requirements under section 506C(a) (referred to in this section as an essential drug ) shall— submit to the Secretary data and information as required by subsection (b)(1); conduct and submit the results 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 essential 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 shelf life 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 an essential drug to, by a specified date, make any labeling change regarding the expiration period that the Secretary determines to be appropriate based on the data and information required to be submitted under this section or any other data and information available to the Secretary in accordance with labeling requirements under subpart G of part 211 of title 21, Code of Federal Regulations (or any successor regulations). 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. . 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 drug manufacturer fails to submit data and information as required under section 506C–2(b)(1), fails to conduct or submit the results of 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. . Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study examining the process by which prescription drug manufacturers submit data on shelf life to the Food and Drug Administration. In carrying out this study, the Comptroller General shall consider whether manufacturers adequately test the shelf life stability of their drug products subject to section 211.166 of title 21, Code of Federal Regulations (or any successor regulations). Not later than 6 months after the date of enactment of this Act, the Secretary shall publish for notice and comment in the Federal Register updates to stability testing under section 211.166 of title 21, Code of Federal Regulations (or any successor regulations).
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- 21 USC 356c–1
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