H.R. 8269 — CLEAR LABELS Act

This section requires labeling of finished drug products and active pharmaceutical ingredients (APIs) to disclose supply chain information, including the name, place of business, and unique facility identifier of specified entities or a link, barcode, QR code, or other means to access a searchable electronic portal with such information. Specifically, it requires (1) packaged finished drug products to identify the manufacturer, packer, or distributor; (2) APIs' accompanying labels and certificates of analysis to identify the original manufacturer (i.e., the last establishment conducting substantial manufacturing activities prior to interstate commerce); and (3) finished drug product labeling to identify the original manufacturer of each API (or all potential API manufacturers, if multiple), the original manufacturer of the finished product, and the packer or distributor. Manufacturers, packers, or distributors must also provide this information via package insert or paper copy upon request; the Secretary of Health and Human Services must issue implementing regulations for API and finished product requirements, effective no earlier than one year after final rule publication and applying to drugs manufactured thereafter.

This section exempts finished drug products marked in accordance with labeling requirements of the Federal Food, Drug, and Cosmetic Act (i.e., including the name and place of business of the manufacturer, packer, or distributor) from imported merchandise country-of-origin marking requirements. (Thus, such products need not bear an additional customs-required mark indicating their country of manufacture.)