FDA is temporarily exercising additional enforcement discretion with respect to certain Clozapine REMS program requirements to ensure continuity of care for patients taking clozapine. FDA is aware health care professionals and patients continue to experience ongoing difficulties with the Clozapine REMS program, including issues with patient access to clozapine for patients recently discharged from an inpatient setting. To address the concern that inpatient pharmacies are only allowed to dispense a 7-days' supply of clozapine to the patient upon discharge, FDA does not intend to object if:
- Inpatient pharmacies dispense a days supply of clozapine that aligns with the patient’s monitoring frequency (e.g., weekly monitoring = 7 days' supply, twice monthly monitoring = 14 days' supply, monthly monitoring = 30 days' supply) upon discharge from an inpatient facility.
IMPORTANT REMINDER:
To avoid disruption in therapy for your patients on clozapine:
- ALL prescribers must be certified in the modified Clozapine REMS to prescribe or dispense clozapine.
- ALL pharmacies must be certified in the modified Clozapine REMS to prescribe or dispense clozapine.
- ALL patients on clozapine must be enrolled in the modified Clozapine REMS.
The Clozapine REMS full implementation was delayed due to initial concerns over patient access. The FDA and the Clozapine Product Manufacturers Group continue to work together to move towards a fully implemented Clozapine REMS.
For additional information you may also call the Clozapine REMS Contact Center at 1-888-586-0758.