CLEAR LABELS Act

This bill would change federal drug labeling rules so that finished drug products list the name, place of business, and unique facility identifier of the original maker of each active ingredient, the original maker of the finished drug, and any packer or distributor. Companies could provide this information through a link, barcode, QR code, or searchable online portal, but must also offer it in a package insert or on paper to anyone who asks. Labels and certificates of analysis for active pharmaceutical ingredients would have to identify their original manufacturer. The federal health agency would write rules to carry this out, taking effect at least one year after final rules are published. Drug products labeled this way would be exempt from the customs requirement to mark the country of origin.

Full text and official record on Congress.gov

Sponsors

• Richard McCormick Republican sponsor
• 2 cosponsors