CLEAR LABELS Act

Drug labels would name makers and facilities

If enacted, the bill would require finished drug packages to show the manufacturer's name, place of business, and a unique facility identifier or a link/QR code to a searchable online portal. It would also require API labels and certificates of analysis to name the original API maker and include its facility identifier. For finished drugs, labels would have to identify the original maker of each API, the finished-drug manufacturer, and the packer or distributor, and list all possible original API manufacturers when more than one could apply. The same information would be available online and as a paper insert or paper copy if requested. The bill would define "original manufacturer" as the single last establishment to do substantial manufacturing before the product entered interstate commerce; that definition would take effect on enactment. The FDA would write implementing regulations, which could allow reasonable label variations and would take effect no earlier than one year after the final rules are published; the rules would apply to drugs made on or after the effective date. The bill would also exempt finished drug products marked under the FD&C Act from certain Customs marking rules when imported; that exemption would take effect on enactment.