FDA Temporarily Suspending Certain Clozapine REMS Program Requirements

Health care professionals continue to alert FDA about ongoing difficulties with the Clozapine REMS program, including a high call volume and long call wait times for stakeholders since launching of the program on November 15, 2021. We understand that this has caused frustration and has led to patient access issues for clozapine. FDA takes these concerns seriously. Continuity of care, patient access to clozapine, and patient safety are our highest priorities. We are working closely with the Clozapine REMS program administrators to address these challenges and avoid interruptions inpatient care.

Due to problems with implementation and the potential impact on patient care, FDA is temporarily suspending certain Clozapine REMS program requirements:

• Pharmacists may dispense clozapine without a REMS dispense authorization (RDA).
• Wholesalers may continue to ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS

Abrupt discontinuation of clozapine can result in significant complications for patient treatment. Health care professionals should use their clinical judgment with regard to prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable range.

We encourage pharmacists and prescribers to continue working with the Clozapine REMS to complete certification and patient enrollment.

If you have questions or concerns about the Clozapine REMS Program or its website, please contact FDA at [email protected], 1-855-543-3784 or 301-796-3400.