Sec. 511. Ensuring registration of foreign drug and device 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 adding at the end the following: The requirements of paragraphs
(1)and
(2)shall apply regardless of whether the drug or device undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported or offered for import into the United States. . Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall update regulations, as appropriate, to implement the amendment made by subsection (a).
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Sec. 511
Ensuring registration of foreign drug and device manufacturers
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