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The CLEAR LABELS Act amends the Federal Food, Drug, and Cosmetic Act to require drug manufacturers to include original manufacturer and supply chain information on drug labels. Specifically, finished drug products must identify the original manufacturer of each active pharmaceutical ingredient, the original manufacturer of the finished product, and any packer or distributor, either directly on the label or through a searchable electronic portal (barcode, QR code, or link). Active pharmaceutical ingredients must similarly identify their original manufacturer. The bill also exempts finished drug products that comply with these new labeling requirements from federal customs country-of-origin marking rules.
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