SAFE Drugs Act of 2026

Key Points

• This bill limits how often pharmacies can make 'copycat' versions of drugs that are already sold by major manufacturers. Pharmacies would be restricted to making these copies no more than 20 times a month unless a doctor confirms a specific patient has a unique medical need for a custom version.
• Pharmacies that ship custom-mixed drugs to patients in other states more than 20 times a month must start filing annual reports with the government. These reports must list exactly what drugs they are making and how many they produce each month.
• The bill creates stricter rules for 'large-scale' facilities that make more than 100 drug products a year. These businesses would be required to pass a safety inspection before they can start making drugs and must be reinspected at least every two years.
• To pay for these new safety checks, the bill changes the fees these facilities pay to the government. Instead of a flat $15,000 fee, the government will set a price that covers the full cost of keeping these drug-making sites safe for the public.
• These changes are designed to make sure pharmacies don't act like mass-production factories without following the same strict safety standards as large drug companies. Most of these new rules would go into effect six months after the bill becomes law.

Impact Analysis

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