SAFE Drugs Act of 2025

Key Points

• This bill, introduced in Congress, creates stricter rules for 'compounding pharmacies,' which are businesses that mix their own versions of medications. It limits these pharmacies from making more than 20 copies of a brand-name drug per month unless a doctor proves a patient has a specific medical need for the custom version.
• Pharmacies that ship these custom-made drugs to patients in other states more than 20 times a month would be required to send detailed reports to the government. These reports must show exactly what drugs they are making and how many they are selling each month.
• Large-scale facilities that make custom drugs more than 100 times a year would face tougher oversight. They would be required to pass a safety inspection before they can start making drugs and must be reinspected at least once every two years to ensure they are following safety standards.
• The bill changes the fees these drug-making facilities pay to the government. Instead of a flat $15,000 fee, the government would set a price based on the actual cost of performing safety inspections and monitoring the industry to keep the public safe.

Impact Analysis

Govbase has not yet run an impact analysis on this legislation.