Temporary Clozapine REMS Enforcement Discretion

FDA says it is temporarily exercising additional enforcement discretion for certain clozapine REMS requirements to ensure continuity of care for patients taking the drug. An agency notice says FDA is aware that healthcare professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with access to the drug for patients recently discharged from an inpatient setting.

The notice says FDA will not object if:

• inpatient pharmacies dispense a day’s supply of clozapine that aligns with a patient’s monitoring frequency upon discharge from an inpatient facility.

The agency is continuing the enforcement discretion announced in 11/2021 that it will not object if:

• pharmacists dispense clozapine without a REMS dispense authorization; and
• wholesalers ship clozapine to pharmacies and healthcare settings without confirming enrollment in the REMS.