ENSURING REGISTRATION OF FOREIGN DRUG AND DEVICE MANUFACTURERS.

SEC. 2511. ENSURING REGISTRATION OF FOREIGN DRUG AND DEVICE MANUFACTURERS.(a) Registration of Certain Foreign Establishments.—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:136 STAT. 5804 “(5) 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.” . (b) Updating Regulations.—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).