CLEAR LABELS Act
Latest action (Jul 27, 2026) — under General Orders. Calendar No. 523.
What it does
Congressional Research Service, Jul 27, 2026Consumer 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.
Face Value
as reported to the SenateHow much of this bill its name accounts for.
- Every bill starts at100
- Areas of law−8
Amends 2 titles of the US Code (5 and 18) rather than one.
Face Value measures reach, not honesty. A big bill can be accurately named, and a low score is not an accusation — it means the contents reach further than any short title could describe. Count it yourself ↗ How this is worked out
Who lobbied on this
6 organizationsThese organizations told Congress, in their own quarterly disclosures, that they were lobbying on this bill.
- American Hospital Associationno position stated
“…S.3788, Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act, all…” filing ↗
- Amgen Inc.no position stated
“…Appropriations Act of 2026 HR 4299 Protecting Patient Access to Cancer and Complex Therapies Act H.R.7837 Most Favored Patient Act of 2026 S 3788 Clear Labels Act HR 5256 340B Access Act H.R.5526 Biosimilar Red Tape Elimination Act HR 7391 Community Health Center Drug Pricing Protection…” filing ↗
- Biotechnology Innovation Organizationno position stated
“…---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug…” filing ↗
- Consumer Healthcare Products Associationno position stated
“…S.3122 - Better FDA Act of 2025 H.R.7366 - Dietary Supplement Regulatory Uniformity Act S.3788 - CLEAR LABELS Act - Activity related to Acetaminophen use - Nonprescription Drug Product with an Additional Condition for Nonprescription Use…” filing ↗
- National Community Pharmacists Associationno position stated
“…S.3788/H.R.8269, the CLEAR LABELS…” filing ↗
- Pharmaceutical Research & Manufacturers of Americano position stated
“…Affordability and Patent Integrity Act S. 3014: Ensuring Timely Access to Generics Act of 2025 S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a…” filing ↗
Most filings say only that an organization lobbied on a bill, not which side it took — where that's the case we say so rather than guessing. Quotes are verbatim from the filing. How this is built.
Discussion
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