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119-hr-8339119th CongressWALLET

Drug Origin Transparency Act of 2026

Sponsored By: Representative Matsui, Doris O. [D-CA-7]

Introduced

Summary

Require full disclosure of a drug's origins and suppliers. This bill would require manufacturers to report supplier identities and the amounts of drug made using each supplier's materials, file reports more than once a year but no more than 4 times a year, and put original API manufacturer names and facility identifiers on labels with possible electronic options.

Show full summary
  • Manufacturers and API suppliers would have to list each supplier of active pharmaceutical ingredients, intermediates, and in-process materials and report how much of the drug used materials from each supplier. New reporting elements set by the Secretary would become required no earlier than 6 months after final rules.
  • Labels would need to show the original manufacturer of each active pharmaceutical ingredient, each manufacturer if different, and the packer or distributor, plus unique facility identifiers. The Secretary could allow reasonable variations or alternative placement including electronic labeling.
  • Clinicians, pharmacies, and regulators would get clearer origin and supplier information on reports and labels to help trace ingredient sources and review certificates of analysis.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 0 benefits, 0 costs, 2 mixed.

Drug origin labels for manufacturers

If enacted, the bill would require drug labels to show the name and place of business and a unique facility identifier for the original manufacturer of a drug or each active pharmaceutical ingredient (API). For APIs, the original manufacturer's name, place of business, and facility identifier could instead appear on the certificate of analysis. Labels for drugs containing APIs would also need the name and place of business of each manufacturer (if different) and the packer or distributor, if any. The Secretary could allow reasonable variations or alternative placement of this information, including by electronic means.

New drug supply reporting rules

If enacted, this bill would require companies that file drug manufacturing reports to identify the supplier of every active pharmaceutical ingredient (API), API intermediate, and in-process material used to make a drug. Reports would also show how much of a drug was made using materials from each supplier. The Secretary would set a reporting schedule that is more frequent than once a year but no more than four times per year. The Secretary could add more required items by rule, but any new items would not be required until six months after final rules are issued; lack of final rules would not remove the basic reporting duty.

Sponsors & CoSponsors

Sponsor

Matsui, Doris O. [D-CA-7]

CA • D

Cosponsors

  • Rep. Crenshaw, Dan [R-TX-2]

    TX • R

    Sponsored 4/16/2026

  • Rep. Schrier, Kim [D-WA-8]

    WA • D

    Sponsored 4/16/2026

  • Rep. Hinson, Ashley [R-IA-2]

    IA • R

    Sponsored 4/16/2026

Roll Call Votes

No roll call votes available for this bill.

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