Drug Origin Transparency Act of 2026

This bill aims to significantly enhance transparency within the drug supply chain by amending the Federal Food, Drug, and Cosmetic Act. It introduces new requirements for drug manufacturers to provide more detailed and frequent reports to the Secretary regarding their manufacturing processes.

Specifically, these reports must include the identity of suppliers for active pharmaceutical ingredients (APIs), API intermediates, and in-process materials, along with the respective amounts of drugs produced using materials from each supplier. The Secretary may specify these additional details through regulation or guidance, and reports will be submitted more frequently than annually, up to four times per year.

Furthermore, the bill mandates expanded drug labeling requirements to provide consumers and stakeholders with crucial origin information. Drug labels, including those for active pharmaceutical ingredients, must now clearly state the name, place of business, and unique facility identifier of the original manufacturer.

Beyond the original manufacturer, the bill also requires labeling to include the name and place of business of

• the original manufacturer of each active pharmaceutical ingredient
• each subsequent manufacturer
• and any packer or distributor

. The Secretary retains authority to allow for reasonable variations in the implementation of these new labeling and reporting requirements, including alternative placements for information, such as electronic means.