Sec. 4. Improved data sharing: ensuring timely and informative notification
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/bill/117/s/2595/is/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: Any manufacturer who violates a requirement of this Act that relates to critical drugs by failing to provide timely, adequate information related to drug shortages pursuant to section 506C(a) shall be subject to a civil penalty in an amount not to exceed $50,000 per violation. . Not later than 1 year after the date of the enactment of this Act, the Secretary shall promulgate final regulations to carry out section 301(fff) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).
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Sec. 4
Improved data sharing: ensuring timely and informative notification
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