S.Amdt. 6601

SA 6601, submitted by Mr. Scott of Florida, proposes the Clear Labels Act. This amendment aims to change the Federal Food, Drug, and Cosmetic Act and the Tariff Act of 1930 to update how drugs are labeled and tracked.

The purpose of this amendment is to:

• Require drug labeling to include the name, place of business, and unique facility identifier of the manufacturer, packer, or distributor. This information can be provided directly on the label or through a barcode, QR code, or link to an electronic portal.

• Ensure finished drug products list the original manufacturer of the finished product, the original manufacturer of each active pharmaceutical ingredient, and any packer or distributor.

• Require that this information be made available in paper copy or via a package insert for any individual who requests it, in addition to electronic access.

• Define the original manufacturer as the last establishment to do substantial manufacturing activities before the drug or active pharmaceutical ingredient enters interstate commerce.

• Direct the Secretary to create regulations to implement these requirements, which cannot take effect until at least 1 year after the final regulations are published.

• Exempt finished drug products from certain customs country of origin marking requirements if they follow the new labeling rules.