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119-hr-1060119th CongressWALLET

Modern Authentication of Pharmaceuticals Act of 2025

Sponsored By: Representative Davis, Donald G. [D-NC-1]

Introduced

Summary

Require a machine-readable physical chemical identifier on every solid oral controlled-substance dose. The bill would add chemical markers that can be read by machines to authenticate pills, create a dual-track system that keeps graphic labels while adding chemical identifiers, and phase in the chemical requirement five years after enactment.

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  • Manufacturers: Drug makers would have to put a machine-readable physical chemical identifier in or on each pill that is a controlled substance and in solid oral form. The rule applies to products manufactured five years after enactment.
  • Patients and pharmacies: Each dose would carry a chemical identifier intended to authenticate the product or a dosage form, enabling machine verification of authenticity.
  • Regulators and the supply chain: The bill harmonizes definitions in the Federal Food, Drug, and Cosmetic Act and ties standards for the machine-readable data carrier to those from a widely recognized international standards development organization.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 1 benefits, 0 costs, 1 mixed.

Chemical markers count for drug checks

This bill would update how drugs can be identified and verified. Companies could use either a standard label with a machine‑readable code and human‑readable lot and expiry, or a machine‑readable chemical marker, to prove a product is real. These changes would start upon enactment and apply to manufacturers, repackagers, distributors, and pharmacies. The machine‑readable code would need to follow widely recognized standards.

Chemical tags on controlled-substance pills

If enacted, makers and repackagers of controlled‑substance pills would need a chemical tag on each dose. This would apply only to solid oral forms made on or after five years after enactment. Distributors and pharmacies would handle tagged doses and could face new checks and costs. The tags are meant to help spot fake or altered pills.

Sponsors & CoSponsors

Sponsor

Davis, Donald G. [D-NC-1]

NC • D

Cosponsors

  • Rep. Rutherford, John H. [R-FL-5]

    FL • R

    Sponsored 2/6/2025

  • Rep. Bacon, Don [R-NE-2]

    NE • R

    Sponsored 2/6/2025

  • Rep. Fitzpatrick, Brian K. [R-PA-1]

    PA • R

    Sponsored 3/11/2025

Roll Call Votes

No roll call votes available for this bill.

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