CLEAR LABELS Act
The source supplies the latest action, but no lifecycle stage.
Latest action (27 Jul 2026): Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.
What this bill does
The CLEAR LABELS Act (S. 3788) would amend the Federal Food, Drug, and Cosmetic Act to require additional disclosures on drug labels about where the product and its ingredients were made. Active pharmaceutical ingredients would need to identify the "original manufacturer" on the label and certificate of analysis. Finished drug products would need to disclose, either printed on the label or made available electronically, the original manufacturers of each active ingredient, the original manufacturer of the finished product, and any packer or distributor. "Original manufacturer" is defined as the establishment performing the majority of significant manufacturing steps. Noncompliance could be treated as misbranding, subject to a civil penalty of up to 25% of the value of the affected drug lot, but not as a criminal violation.
The bill affects pharmaceutical manufacturers, packers, and distributors, who would face new labeling and disclosure obligations and potential financial penalties for noncompliance. It also directs the FDA to coordinate with U.S. Customs and Border Protection to avoid conflicts with existing country-of-origin marking rules, and it protects trade secrets and confidential business information from required disclosure. The changes would not take effect until five years after enactment, applying only to drugs manufactured after that date.
The bill was introduced in February 2026 and referred to the Senate Committee on Health, Education, Labor, and Pensions. On July 22, 2026, the committee ordered it reported favorably with an amendment in the nature of a substitute, meaning the original text was replaced with a revised version. It next would go to the full Senate for consideration; further votes in the Senate and House would be required before it could become law.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
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 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.
Timeline
27 Jul 2026
Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.
Common questions
- What does S. 3788 do?
- The CLEAR LABELS Act (S. 3788) would amend the Federal Food, Drug, and Cosmetic Act to require additional disclosures on drug labels about where the product and its ingredients were made. Active pharmaceutical ingredients would need to identify the "original manufacturer" on the label and certificate of analysis. Finished drug products would need to disclose, either printed on the label or made available electronically, the original manufacturers of each active ingredient, the original manufacturer of the finished product, and any packer or distributor. "Original manufacturer" is defined as the establishment performing the majority of significant manufacturing steps. Noncompliance could be treated as misbranding, subject to a civil penalty of up to 25% of the value of the affected drug lot, but not as a criminal violation. The bill affects pharmaceutical manufacturers, packers, and distributors, who would face new labeling and disclosure obligations and potential financial penalties for noncompliance. It also directs the FDA to coordinate with U.S. Customs and Border Protection to avoid conflicts with existing country-of-origin marking rules, and it protects trade secrets and confidential business information from required disclosure. The changes would not take effect until five years after enactment, applying only to drugs manufactured after that date. The bill was introduced in February 2026 and referred to the Senate Committee on Health, Education, Labor, and Pensions. On July 22, 2026, the committee ordered it reported favorably with an amendment in the nature of a substitute, meaning the original text was replaced with a revised version. It next would go to the full Senate for consideration; further votes in the Senate and House would be required before it could become law.
- Has S. 3788 become law?
- The source does not supply a confirmed lifecycle stage for S. 3788. Check the latest action and official source below.
- Who sponsored S. 3788?
- S. 3788 was sponsored by Sen. Scott, Rick [R-FL] (R-FL), with 12 cosponsors.
- What's the latest action on S. 3788?
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 523. (27 Jul 2026).
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