YourVoice.Now Summary
Transparency & AccountabilityCorporate BenefitsYour medicine label would have to name who made the drug and its ingredients — but not for five years.
Transparency & Accountability
Labels would name the maker of each active ingredient and of the finished drug, plus where each is based. Makers could post this online, and only drugs made five or more years out are covered.
Corporate Benefits
A company that leaves this off could be fined up to a quarter of a drug batch's value. The FDA picks whether to fine at all, and weighs whether the firm fixed the problem.
More about this bill
Medicine labels would have to name the company that made each active ingredient in the drug. They would also name the maker of the finished product and where those makers are based. Drugmakers could print this on the label or post it online instead. Bulk shipments of an active ingredient would also have to name their maker. The change would not reach the pharmacy for years. It covers only drugs made and packaged five years or more after the bill becomes law. Drugmakers that leave the information out could be fined up to 25 percent of the drug lot's value. The FDA would choose case by case whether to act. It could not treat a violation as a crime.
Congressional 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.
Legislative Subjects
Details
- Congress
- 119th
- Chamber
- Senate
- Status
- summarized
- Action
- Reported to Senate
- Action Date
- 2026-07-27
- Date Added
- 2026-09-09
- Source
- Congress.gov →
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