CLEAR LABELS Act

This bill proposes amendments to the Federal Food, Drug, and Cosmetic Act to significantly increase transparency regarding the origin and manufacturing of pharmaceutical products. Its primary goal is to ensure consumers and healthcare providers have access to detailed supply chain information for both active pharmaceutical ingredients (APIs) and finished drug products. Specifically, the legislation requires drug labeling to include the name, place of business, and unique facility identifier of the original manufacturer for each API and the finished drug product itself. This information can be directly printed on the label or made accessible through a scannable link, barcode, or QR code leading to an electronic portal. If a finished drug product uses multiple API manufacturers, all must be identified. Furthermore, the bill mandates that this detailed manufacturing information also be available through a package insert or in paper copy upon individual request. It defines "original manufacturer" as the last establishment to conduct substantial manufacturing activities before a product enters interstate commerce. Finally, the bill exempts finished drug products that comply with these new labeling requirements from existing customs country of origin marking rules and directs the Secretary to issue implementing regulations.