The Drug Origin Transparency Act of 2026 requires pharmaceutical manufacturers to provide detailed information about their drug supply chains to the FDA. Specifically, companies must report the identities and amounts of active pharmaceutical ingredients and other materials sourced from different suppliers, with reports submitted up to four times per year instead of just annually. Additionally, drug labels and certificates of analysis must display the names, locations, and facility identifiers of original manufacturers and any subsequent manufacturers or distributors involved in the supply chain. The FDA has six months after issuing final regulations to require companies to comply with these new reporting and labeling requirements, and the agency may allow reasonable variations in how companies implement these rules. This legislation aims to give regulators and consumers greater visibility into where drug ingredients come from and how medicines move through the supply chain.
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