Beginning February 24, 2025, FDA does not expect prescribers, pharmacies, and patients to participate in the REMS program for clozapine or to report results of ANC blood tests before pharmacies dispense clozapine.

What is the Clozapine REMS?

The Clozapine REMS (Risk Evaluation and Mitigation Strategy) is a safety program required by the Food and Drug Administration (FDA) to manage the risk of severe neutropenia associated with clozapine treatment.

Severe neutropenia (absolute neutrophil count (ANC) less than 500/µL), can lead to serious and fatal infections.
Patient Information
To receive treatment, a patient must be enrolled in the Clozapine REMS program by a certified doctor.
Enrollment Information
Pharmacy
Pharmacies must be certified in the Clozapine REMS to receive and dispense clozapine.

If you are the designated authorized representative of a pharmacy, you can certify below.

Certify Pharmacy
Prescriber
Healthcare Providers must be certified in the Clozapine REMS to prescribe clozapine for outpatient use.

If you are a clozapine prescriber, you can certify below.

Certify Prescriber