CLEAR LABELS Act

New drug labeling for manufacturers

If enacted, this bill would require API labels and certificates to show the original manufacturer's name and place of business. It would require finished drug package labels to show the original manufacturer of each API, the finished-product manufacturer, and the packer or distributor, or make that information available electronically. The bill defines "original manufacturer" as the place that does most of the key manufacturing steps. These rules would apply to products made and packaged five years after enactment. Failure to comply would be misbranding and could bring civil penalties up to 25% of the lot's total value; criminal penalties would not apply for the labeling violation. The bill would also direct FDA and Customs to coordinate implementation and would preserve trade-secret confidentiality.