On December 10, 2025, Representatives Rudy Yakym (R-IN) and André Carson (D-IN) introduced the Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act of 2025, a bipartisan initiative designed to protect patients from untested, unapproved, and potentially dangerous compounded drugs.
Compounded drugs, often produced in bulk without oversight and have been linked to adverse events, including severe dosing errors and the use of unsafe ingredients sourced from unregulated foreign suppliers. This legislation seeks to strengthen patient safety and accountability through enhanced oversight and transparency.
- Clarifies “Essentially a Copy”: Any compounded drug containing the same active ingredient as an FDA-approved medication will be considered a copy unless a clinically significant change is made for an individual patient. This closes loopholes that allow evasion through minor or cosmetic alterations.
- Strengthened Oversight: 503A compounders must notify the FDA when shipping more than 20 out-of-state prescriptions containing approved active ingredients. Mandatory FDA inspections of outsourcing facilities are also required.
- Enhanced FDA Resources: Increases user fees for outsourcing facilities to fund timely and consistent FDA inspections.
Learn more here.
Last Updated on December 30, 2025 by Aimed Alliance
