Sec. 2. FDA increased demand reporting with respect to drugs
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/bill/116/s/3781/is/section-2·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ), as amended by the CARES Act ( Public Law 116–136 ), is further amended— in subsections (c), (e), (f), (g), and (j), by inserting or
(k)after subsection
(a)each place such term appears; and by adding at the end the following: The manufacturer of a drug described in subsection
(a)or a biological product subject to subsection (i)(3) shall notify the Secretary, in accordance with paragraph (2), of any— increase in demand for the drug that the manufacturer likely will be unable to meet; or export restrictions or other limitations imposed, on or after the date of enactment of the PART Act , on manufacturing or shipment of the drug or any of its active pharmaceutical ingredients by the country in which such drug or any such ingredient is manufactured. A notice required under paragraph
(1)shall be submitted to the Secretary as soon as practicable but not later than 5 calendar days after the manufacturer becomes aware of the issue requiring notification under such paragraph. A manufacturer of a drug who submits a notification to the Secretary under paragraph
(1)shall notify the Secretary after the issue giving rise to such notification has been resolved or when the manufacturer is able to meet demand. .
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