Sec. 515. Reporting requirement for drug manufacturers
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Section 510(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(i) ) is amended by inserting at the end the following new paragraph: The requirements of paragraphs
(1)and
(2)shall apply to establishments within a foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of any drug, including the active pharmaceutical ingredient, that is required to be listed pursuant to subsection (j). Such requirements shall apply regardless of whether the drug or active pharmaceutical ingredient undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment or establishments outside the United States prior to being imported or offered for import into the United States. . Section 510(j)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(j)(1) ) is amended— in subparagraph (D), by striking and at the end; in subparagraph (E), by striking the period at the end and inserting ; and ; and by adding at the end the following new subparagraph: in the case of a drug contained in the applicable list, a certification that the registrant has— identified every other establishment where manufacturing is performed for the drug; and notified each known foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of the drug, including the active pharmaceutical ingredient, of the inclusion of the drug in the list and the obligation to register. . Section 510(j)(3)(A) of the Federal Food, Drug, and Cosmetic Act (as added by section 3112 of the CARES Act ( Public Law 116–136 )) is amended by striking annually and inserting once during the month of March of each year, once during the month of June of each year, once during the month of September of each year, and once during the month of December of each year .
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