S. 3788 · On the floor · Health

CLEAR LABELS Act

What it does

Requires finished drug products to display the name and location of each active pharmaceutical ingredient's original manufacturer on the label or electronically.
Requires finished drug products to display the name and location of the finished drug's original manufacturer, and any packer or distributor, on the label or electronically.
Requires active pharmaceutical ingredients to be labeled with the name and location of their original manufacturers.
Grants the FDA discretion to assess civil fines for violations and requires the FDA to consider whether a violator was notified and given opportunity to correct noncompliance before imposing penalties.

Official summary

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…

Latest action

Jul 27, 2026: Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.

Committee: Senate Health, Education, Labor, and Pensions