S 3788 119th Congress
CLEAR LABELS Act
A bill to amend the Federal Food, Drug, and Cosmetic Act to require drug labeling to include original manufacturer and supply chain information.
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Bill journey
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Introduction Congress.gov
Introduced
Introduced in the Senate.
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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Introduced in Senate
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Introduced in Senate
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Committee on Health, Education, Labor, and Pensions. Hearings held.
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Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
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Reported to Senate
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View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the Senate. | Congress.gov | |
| Official actionRead twice and referred to the Committee on Health, Education, Labor, and Pensions. | No additional detail supplied.IntroReferral · Senate | Congress.gov | |
| Official actionIntroduced in Senate | No additional detail supplied.IntroReferral · Library of Congress · Code 10000 | Congress.gov | |
| Text versionIntroduced in Senate | A dated text-version record is available. | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Hearings held. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionPlaced on Senate Legislative Calendar under General Orders. Calendar No. 523. | No additional detail supplied.Calendars · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Library of Congress · Code 14000 | Congress.gov | |
| Text versionReported to Senate | A dated text-version record is available. | Congress.gov |
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Congressional Research Service
CRS summary
Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act or the CLEAR LABELS ActThis 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.
Official documents
Text versions
- Reported to SenateJul 27, 2026
- Introduced in SenateFeb 5, 2026