Drug Origin Transparency Act of 2026

New drug origin reporting and labeling

If enacted, drug makers and API suppliers would have to include detailed supply‑chain information in reports to the Food and Drug Administration. Reports would have to name each supplier of every active pharmaceutical ingredient (API), API intermediate, and in‑process material, and state how much of the drug was made using material from each supplier. Reports would be filed more often than once a year under a schedule set by the Secretary, but not more than four times per year, and new report items would not become required earlier than six months after final guidance or regulation; the absence of guidance would not excuse reporting. If enacted, drug and API labels and any API certificate of analysis would have to show the original manufacturer’s name, place of business, and a unique facility identifier, though the Secretary could allow alternative placement or electronic labeling. These changes would raise compliance and labeling costs for manufacturers and distributors while increasing transparency for regulators and consumers.