Combating Counterfeit Pharmaceuticals Act of 2025

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.
• 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.
• 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.
• 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.