Changes to clozapine dispensing; REMS to be eliminated

NCPA April 17, 2025

Pharmacies registered in the Clozapine Risk Evaluation and Mitigation Strategy (REMS) program were recently notified that the Food and Drug Administration no longer expects them to participate in the REMS program or check blood tests prior to dispensing. According to reporting from the American Association of Psychiatric Pharmacists, a new medication guide for clozapine is in the works and expected to be approved by FDA in June to coincide with the official elimination of the Clozapine REMS program.

This change allows patients to have clozapine prescriptions filled at the pharmacy of their choice rather than being limited to pharmacies that chose to participate in the REMS program in the past. Pharmacy owners and staff should be prepared to fill prescriptions for clozapine for new or existing patients who previously obtained the medication elsewhere. For more information, visit the FDA website.

NCPA