Clozapine REMS: FDA Authorizes Enforcement Discretion to Ease Certain Requirements and Help Ensure Continuity of Care of Patients
The FDA is exercising enforcement
The implementation of the Clozapine REMS modification on November 15, 2021 resulted in high call volumes and long wait times at the Clozapine REMS Contact Center. This has created issues accessing clozapine treatment for some patients.
To ease the problems with the implementation of the Clozapine REMS and not interrupt patient treatment, requirements around wholesalers shipping and pharmacy dispensing of clozapine will temporarily not be enforced by the FDA. Patients should continue to have their absolute neutrophil count (ANC) monitored.
Patients and Caregivers
- Continue to have your blood tested for the ANC.
- Contact your healthcare provider if you are having difficulty obtaining your clozapine prescription.
- Use clinical judgment with regard to prescribing clozapine to patients with an ANC within an acceptable range.
- Continue to monitor patients ANC according to the labeled recommendations and report these values using the Patient Status Form when feasible to the Clozapine REMS program.
- Continue working with the Clozapine REMS to complete certification and patient enrollment.
- FDA does not intend to object if pharmacists dispense clozapine without obtaining a REMS dispense authorization (RDA).
- Use clinical judgment with regard to dispensing clozapine to patients with an ANC within an acceptable range.
- Continue working with the Clozapine REMS to complete certification.