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SAFE Drugs Act of 2026: New Regulations for Compounding Pharmacies

This act strengthens oversight of custom-made drugs to ensure they are not just mass-produced copies of existing medicines. It aims to protect patients by requiring stricter inspections and reporting for facilities that make drugs in large quantities.
Key points
Limits pharmacies from making more than 20 copies of commercially available drugs per month.
Requires pharmacies to report drugs sent to patients living in different states.
Mandates safety inspections for large-scale drug facilities before they start operating and every two years thereafter.
Adjusts registration fees to better fund government activities that ensure drug safety.
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Status: Introduced
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Additional Information
Print number: 119_S_3794
Sponsor: Sen. Banks, Jim [R-IN]
Process start date: 2026-02-05