FDA Won’t Enforce Certain REMS Requirements for Clozapine

The FDA said it will temporarily allow inpatient pharmacies to dispense up to a 30-day supply of clozapine to patients discharged from an inpatient facility, although the Risk Evaluation and Mitigation Strategy (REMS) for the drug currently limits the supply to seven days.

An antipsychotic drug used to treat schizophrenia, clozapine is also FDA-approved to lower the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.

The FDA said it is making the temporary change to address difficulties in timely access to the drug after an inpatient stay.

The agency also said it will continue to exercise enforcement discretion announced in November 2021 and will not object to pharmacists dispensing clozapine without a REMS authorization and wholesalers shipping clozapine to pharmacies and healthcare settings without confirming enrollment in the REMS.