S. 3788 — CLEAR LABELS Act

This section requires finished drug products in package form to include on the label the name, place of business, and unique facility identifier of the original manufacturer of each active pharmaceutical ingredient and of the finished drug product, as well as of the packer or distributor, or a link, barcode, QR code, or other electronic means to access that information. It imposes parallel requirements on active pharmaceutical ingredients and directs the Secretary to issue implementing regulations that take effect no earlier than one year after publication and apply to drugs manufactured on or after that date.

This section exempts finished drug products from the country-of-origin marking requirements under the Tariff Act of 1930 if the products are marked in accordance with the country-of-origin labeling rules in section 502(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act.