; and (2) by adding at the end the following: (C) Each report submitted pursuant to subparagraph (A) with respect to a drug shall— (i) include additional information as may be specified by the Secretary in regulation or guidance regarding the supply chain for such drug, such as— (I) the identity of the respective suppliers of each active pharmaceutical ingredient, active pharmaceutical ingredient intermediate, and in-process material used in such manufacture, preparation, propagation, compounding, or processing of the drug; and (II) the respective amounts of such drug that were manufactured, prepared, propagated, compounded, or processed using an active pharmaceutical ingredient, active pharmaceutical ingredient intermediate, and in-process material from each such identified supplier; and (ii) be submitted more frequently than annually, in accordance with a reporting schedule as may be specified by the Secretary in such regulation or guidance, but not more frequently than 4 times per year. (D) Any additional information specified in regulation or guidance pursuant to subparagraph (C) shall be a required element of reports under this paragraph not earlier than 6 months after the date on which such regulation or guidance is issued in final form (and in no event shall the absence of any regulation or guidance issued under subparagraph (C) affect the requirement to report as described in subparagraph (A)). . (b) Conforming amendment Section 510(j)(3)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 510(j)(3)(B) ) is amended by striking subparagraph (A) and inserting this paragraph . 512. Require drug labeling to include original manufacturer and supply chain information Section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ) is amended— (1) in paragraph (b)— (A) by striking (b) If in a package and inserting (b)(1) If in a package ; (B) by striking a label containing (1) the name and place and inserting a label containing— (A) the name and place ; (C) by striking or distributor