Drug Origin Transparency Act of 2026

Increased Supply Chain Transparency: The bill requires reports to include the identity of suppliers for each active pharmaceutical ingredient, intermediate, and in-process material (Section 2(a)(1)(C)(i)(I)). This provides more detail on who is supplying the components of drugs.

Detailed Manufacturing Data: Reports must include the specific amounts of drugs manufactured using materials from each identified supplier (Section 2(a)(1)(C)(i)(II)).

More Frequent Information: Reporting requirements may change from an annual schedule to a more frequent schedule, specified by the Secretary, but not more than 4 times per year (Section 2(a)(1)(C)(ii)).

Enhanced Labeling Information: Drugs and active pharmaceutical ingredients may be required to bear labels containing the name, place of business, and unique facility identifier of the original manufacturer (Section 3(1)(A)(B)(2)(A)).

Comprehensive Manufacturer Identification: Labels may be required to include the name and place of business of the original manufacturer of each active pharmaceutical ingredient, any different manufacturers, and the packer or distributor (Section 3(1)(d)(1)).

Increased Regulatory Burden: The Secretary of the government is granted the authority to specify additional information through regulation or guidance regarding the drug supply chain (Section 2(a)(1)(C)(i)).

Mandatory Labeling Changes: The bill introduces requirements for drug labeling to include specific information about original manufacturers and the supply chain, though the Secretary may allow for variations or electronic placement (Section 3(1)(A)(B)(2)(C) and Section 3(1)(d)(2)).