S. 3788

Official summary (Congressional Research Service, Reported to Senate): Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act or the CLEAR LABELS Act

This bill requires drugs and active pharmaceutical ingredients made available in the U.S. market to be labeled with the names and locations of their manufacturers.

Specifically, a finished, packaged drug product must be labeled with the name and place of business of (1) the original manufacturer (or manufacturers) of each active pharmaceutical ingredient; (2) the original manufacturer of the finished drug product; and (3) the packer or distributor, if any. This information must be printed on the product label or made available electronically. Active pharmaceutical ingredients (which are generally sold to manufacturers and researchers, not consumers) must also be labeled with the name and place of business of their original manufacturers.

Under the bill, the original manufacturer is the establishment that conducts the majority of the significant phases of manufacturing to produce the ingredient or product.

The Food and Drug Administration (FDA) has discretion to determine whether a violation of these requirements constitutes misbranding and to assess a civil fine. The FDA must consider certain factors in determining whether to assess a fine, including whether the violator was notified of their noncompliance and was provided an opportunity to correct the violation.

Finally, the FDA must coordinate with U.S. Customs and Border Protection to address any overlap between these requirements and existing requirements for imported drugs.

These provisions take effect five years after the bill is enacted.