119th Congress Health
S. 3788: CLEAR LABELS Act
Reported
- Introduced (completed)
- Passed Senate (not reached)
- Passed House (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
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.
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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.
Written by the Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- Katie Britt R-ALOriginal
- Kirsten Gillibrand D-NYOriginal
- Ron Johnson R-WIOriginal
- Tommy Tuberville R-ALOriginal
- Ashley Moody R-FL
- Mike Lee R-UT
- Kevin Cramer R-ND
- James Risch R-ID
- Charles Grassley R-IA
- Pete Ricketts R-NE
- Joni Ernst R-IA
- Alan Armstrong R-OK
Who scored on this bill
- 1Rick Scott SponsorDrew cross-party cosponsors, introduced, reported3 events+26
See all scorers and every scoring event
Introductions and cosponsorships count toward weekly caps and show no points.
Other bills by Rick Scott
- S. 1383: SAVE America Act
- S. 2314: SHARKED Act of 2025
- S.J.Res. 102: Disapproving the action of the District of Columbia Council in approving the D.C. Income and Franchise Tax Conformity and Revision Temporary Amendment Act of 2025
- S. 673: Miccosukee Reserved Area Amendments Act
- S. 310: Disaster Contract Improvement Act
- S. 2367: CHECKPOINT Act
History
- Introduced in the Senate by Rick Scott.
Show the full action history (6 actions)
- Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.
- Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Committee on Health, Education, Labor, and Pensions. Hearings held.
- Introduced in Senate
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.