CLEAR LABELS Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require drug labeling to include original manufacturer and supply chain information. It also exempts certain finished drug products from customs country of origin marking requirements.

Sec. 2, Require drug labeling to include original manufacturer and supply chain information: This section revises labeling requirements for finished drug products and active pharmaceutical ingredients (APIs). For finished drug products in a package, the label must include the name, place of business, and unique facility identifier of the manufacturer, packer, or distributor, or a link or code to access an electronic portal with that information, plus an accurate statement of quantity. For APIs, any accompanying label and certificate of analysis must include the name, place of business, and unique facility identifier of the original manufacturer. For finished drug products, labeling must include the name, place of business, and unique facility identifier of the original manufacturer of each API, the original manufacturer of the finished product, and the packer or distributor, or a link or code to an electronic portal. If there are multiple potential API manufacturers, all must be identified. Required information must also be available via package insert or paper copy upon request. The term 'original manufacturer' means the last establishment to conduct substantial manufacturing activities before interstate commerce. The Secretary must issue regulations to implement these requirements, effective no earlier than one year after publication of final regulations, applying to drugs manufactured on or after that effective date.

Sec. 3, Exemption from customs country of origin marking requirement: This section amends the Tariff Act of 1930 to exempt finished drug products from customs country of origin marking requirements if they are marked in accordance with the new labeling requirements under section 502(b)(3)(A) of the Federal Food, Drug, and Cosmetic Act.