; and (B) the term manufacturer means a person who is engaged in any of the activities listed in clause (A). . 515. Reporting requirement for drug manufacturers (a) Establishments in a foreign country 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: (5) 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. . (b) Listing of drugs Section 510(j)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(j)(1) ) is amended— (1) in subparagraph (D), by striking and at the end; (2) in subparagraph (E), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following new subparagraph: (F) in the case of a drug contained in the applicable list, a certification that the registrant has— (i) identified every other establishment where manufacturing is performed for the drug