Sec. 512. Require drug labeling to include original manufacturer and supply chain information
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Section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ) is amended— in paragraph (b)— by striking
(b)If in a package and inserting (b)(1) If in a package ; by striking a label containing
(1)the name and place and inserting a label containing— the name and place ; by striking or distributor; and
(2)an accurate statement and inserting or distributor; and an accurate statement ; by striking under clause
(2)of this paragraph and inserting under this clause ; and by inserting at the end the following: Subject to clause (C), if it is a drug, including an active pharmaceutical ingredient, unless it bears a label containing the name and place of business, and unique facility identifier of the original manufacturer of such drug or active pharmaceutical ingredient, except that the Secretary may provide, by regulation, for reasonable variations in the implementation of such labeling requirements. Subject to clause (C), if it is a drug that is an active pharmaceutical ingredient, unless any accompanying certificate of analysis contains the name and place of business, and unique facility identifier of the original manufacturer of the active pharmaceutical ingredient. The Secretary may provide, by regulation, for reasonable variations in the implementation of labeling requirements specified in this subparagraph. ; and by inserting after paragraph
(c)the following: Subject to subparagraph (2), if it is a drug, including an active pharmaceutical ingredient, unless it bears labeling containing the name and place of business of— the original manufacturer of each active pharmaceutical ingredient; each manufacturer, if different from the original manufacturer; and the packer or distributor, if any. The Secretary may provide, by regulation, for reasonable variations or an alternative placement for the labeling requirements specified in subparagraph (1), including by electronic means. .
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Sec. 512
Require drug labeling to include original manufacturer and supply chain information
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