Summary of S 3788: Drug Labeling Transparency Act

Purpose and Intent

This bill, the "Drug Labeling Transparency Act," aims to amend the Federal Food, Drug, and Cosmetic Act to require drug labels to include information about the original manufacturer and supply chain for the drug product.

Key Provisions

The main provisions of the bill include:

• Requiring drug labels to display the name and location of the original manufacturer of the drug product.
• Mandating the inclusion of information about the entire supply chain the drug has gone through, including any wholesalers, repackagers, or relabelers.
• Specifying that this labeling information must be prominently displayed on the primary packaging of the drug.
• Providing the FDA with authority to enforce these new labeling requirements through its existing regulatory powers.

Impact and Affected Parties

This legislation is intended to improve transparency around the origins and distribution of pharmaceutical drugs sold in the United States. The key groups that would be affected include:

• Pharmaceutical manufacturers, who would be required to update their drug labeling to comply with the new requirements.
• Wholesalers, repackagers, and relabelers in the drug supply chain, as their involvement would need to be disclosed on drug labels.
• Consumers and healthcare providers, who would have better information about the provenance of the drugs they are purchasing or administering.
• The FDA, which would take on additional oversight and enforcement responsibilities related to the new labeling rules.

Timeline and Procedure

The bill was introduced in the Senate on February 5, 2026 and has been referred to the Committee on Health, Education, Labor, and Pensions for further consideration. No additional legislative actions have been taken on the bill at this time.

If enacted, the provisions of the Drug Labeling Transparency Act would go into effect 180 days after the date of enactment, providing drug manufacturers and supply chain entities time to update their labeling and processes to comply with the new requirements.