PRIA Logo™
119-s-3134119th CongressWALLET

Combating Counterfeit Pharmaceuticals Act of 2025

Sponsored By: Senator Cotton, Tom [R-AR]

Introduced

Summary

Broadens sanctions to cover counterfeit drugs and copy‑cat ingredients. It would expand the Fentanyl Sanctions Act into a wider tool against illicit drugs, add a patient waiver for prescription shortages, and give the Director of National Intelligence more flexibility to use intelligence against traffickers.

Show full summary
  • Patients and families: Would create a waiver process so people can access prescription medicines that are on the drug shortage list maintained by the Secretary of Health and Human Services under section 506E of the Food, Drug, and Cosmetic Act.
  • Intelligence and enforcement agencies: Would let the Director of National Intelligence delegate identification of foreign drug traffickers and reconfigure the intelligence program on the use of intelligence resources to give more operational flexibility in illicit drug efforts.
  • Traffickers, counterfeiters, and regulators: Expands definitions and replaces references to "opioids" with "illicit drugs," explicitly covering counterfeit drugs and defined "copy‑cat ingredients," and makes technical and reporting changes across the statute.

Personalized for You

How does this bill affect your finances?

Personalize government policy and PRIA will tell you what this bill means for your household, plus every other piece of legislation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.

Free to download

Bill Overview

Analyzed Economic Effects

3 provisions identified: 3 benefits, 0 costs, 0 mixed.

Waivers for drugs on shortage list

If enacted, the bill would let agencies grant waivers to allow access to prescription medicines on the HHS drug shortage list. If your medicine is on that list, this could help you get it during an active shortage. The change would take effect upon enactment.

Broader enforcement against illicit drugs

If enacted, the bill would broaden the Fentanyl Sanctions Act to cover “illicit drugs,” not just opioids. It would rename and reconfigure the intelligence‑use provisions and let the Director of National Intelligence use a designee for certain identification and briefing duties. These changes would take effect upon enactment and expand enforcement and reporting tools.

Stronger rules on counterfeit drugs

If enacted, the bill would add “counterfeit drugs” and “copy‑cat ingredients” to the sanctions law. It would define copy‑cat ingredients as substances meant to mimic approved prescription drug ingredients or made by a different process or at lower purity. Agencies would have clearer authority to block or punish fake or low‑quality drug ingredients. The change would take effect upon enactment.

Sponsors & CoSponsors

Sponsor

Cotton, Tom [R-AR]

AR • R

Cosponsors

  • Sen. Ricketts, Pete [R-NE]

    NE • R

    Sponsored 11/6/2025

Roll Call Votes

No roll call votes available for this bill.

View on Congress.gov
Back to Legislation