CLEAR LABELS Act

This bill proposes amendments to the Federal Food, Drug, and Cosmetic Act, significantly enhancing transparency requirements for drug labeling. It mandates that finished drug products and active pharmaceutical ingredients (APIs) include detailed information about their manufacturing origins.

Specifically, labels for finished drug products must identify the original manufacturer of each active pharmaceutical ingredient, the original manufacturer of the finished drug product itself, and any packer or distributor. This information can be provided directly on the label or through a scannable code linking to an electronic portal.

The legislation defines "original manufacturer" as the last entity performing substantial manufacturing before the product enters interstate commerce. Furthermore, it requires that this supply chain information, while accessible electronically, also be available via a package insert or paper copy upon request.

Finally, the bill provides an exemption from existing customs country of origin marking requirements for finished drug products that comply with these new, comprehensive FDA labeling standards.