Drug Origin Transparency Act of 2026
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Summary
The bill amends the Federal Food, Drug, and Cosmetic Act to expand required drug manufacturing reports submitted under section 510(j). Reports would need to identify suppliers of active pharmaceutical ingredients and in-process materials and the amounts of drug produced from each supplier, with the Secretary of Health and Human Services specifying details by regulation and reports due up to four times per year. The bill also requires drug labels, including those for active pharmaceutical ingredients, to show the name, place of business, and unique facility identifier of the original manufacturer, subject to regulatory variations.
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