Combating Counterfeit Pharmaceuticals Act of 2025
Sen. Cotton Introduces Bill to Expand Sanctions on Foreign Counterfeit Drug Traffickers
This bill is currently in the early stages of the legislative process after being sent to the Senate Committee on Banking, Housing, and Urban Affairs for review. It is considered active, but no further hearings or votes have been scheduled at this time.
Legislative Progress
While drug safety is a popular topic, the bill was just introduced and currently lacks the bipartisan support needed to move quickly through the Senate.
Key Points
- This bill expands the Fentanyl Sanctions Act to cover all counterfeit drugs and copy-cat ingredients, not just opioids. By broadening the legal definitions, the government gains new tools to go after foreign traffickers selling fake or substandard versions of real prescription medications.
From policy text
“To amend the Fentanyl Sanctions Act to address trafficking of copy-cat and counterfeit drugs and active pharmaceutical ingredients, and for other purposes.”
View in full text - The bill creates a new legal definition for "copy-cat ingredients" -- substances that are meant to look like real drug ingredients but are made using a different process or have lower purity or quality than the approved version.
- Throughout the existing law, the bill replaces the word "opioid" with "illicit drug," dramatically widening the scope of sanctions and intelligence tools that were previously limited to the fentanyl and opioid crisis.
From policy text
“by striking ``opioid trafficking'' each place it appears and inserting ``illicit drug trafficking''”
View in full text - The Director of National Intelligence gets new flexibility to delegate the job of identifying foreign drug traffickers to other officials, which could speed up the process of tracking and sanctioning bad actors.
From policy text
“by inserting ``(or a designee of the Director)'' after ``Director of National Intelligence'' each place it appears”
View in full text - The bill includes a safety valve for patients who need medicine: sanctions can be waived for drugs that are on the official government shortage list, making sure these new enforcement tools do not accidentally block access to needed medications.
From policy text
“by inserting after ``medications'' the following: ``on the current drug shortage list maintained by the Secretary of Health and Human Services under section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e)''”
View in full text
Impact Analysis
Personal Impact
Milestones
Read twice and referred to the Committee on Banking, Housing, and Urban Affairs.
Sent to a congressional committee for expert review. The committee decides whether this bill moves forward.
Introduced in Senate
The bill was officially filed and given a number. It now enters the legislative queue.
Votes
No votes have been recorded for this legislation yet.
News
No related news coverage found for this legislation yet.
Source Information
Document Type
Congressional Bill
Official Title
Combating Counterfeit Pharmaceuticals Act of 2025
Data Sources
Sponsor
Cosponsors
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