The FDA held an Advisory Committee meeting on November 19, 2024.
The Clozapine REMS will continue to operate normally under Enforcement Discretion until the REMS receives guidance from the FDA or an approval of a modification for the REMS.

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