EFFECTIVE June 13, 2025, FDA HAS OFFICIALLY ELIMINATED THE CLOZAPINE REMS, AND ALL REMS OPERATIONS HAVE CEASED.

Although the risk of severe neutropenia with clozapine still exists, FDA has determined that the Clozapine REMS is no longer necessary to ensure the benefits of the medicine outweigh that risk. Eliminating the REMS is expected to decrease the burden on the health care delivery system and improve access to clozapine.
FDA still recommends that prescribers monitor patients’ ANC according to the monitoring frequencies described in the prescribing information. Information about severe neutropenia remains in the prescribing information for all clozapine medicines, including in the existing Boxed Warnings, and ANC monitoring frequencies are unchanged.
Determination of the appropriateness for a patient to receive clozapine shall solely reside with the prescriber.

How the Clozapine REMS Elimination Impacts Clozapine Stakeholders

Prescriber
Prescribers no longer need to submit patient ANC results to the Clozapine REMS.

Pharmacy
Pharmacies no longer need to obtain a REMS Dispense Authorization (RDA) before dispensing clozapine.

Wholesalers/Distributors
Wholesalers and distributors no longer need to confirm a pharmacy’s REMS certification status before shipping clozapine.

Patients and Caregivers
If patients and caregivers have trouble obtaining clozapine from a pharmacy, they may request that the pharmacy reach out to the prescriber, or they may direct the pharmacy to visit this page or FDA’s announcement for more information.