Drug Information Update-FDA alerts prescribers and pharmacists to continue clozapine prescribing and dispensing if they encounter online Clozapine REMS certification issues

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

Program launched October 12, 2015; technical issues resolved as of October 16, 2015

The FDA is aware that in recent days, technical difficulties with the new Clozapine REMS website have prevented some pharmacies and prescribers from completing their required online Clozapine REMS certification. This has resulted in patient access issues in some cases. The clozapine manufacturers, who are the REMS program administrators, have notified FDA that these technical issues have been resolved as of October 16, 2015. If prescribers and pharmacists continue to experience any issues, they should use clinical judgment and consider the best interests of the patient. Continue prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable ranges while the issues are being resolved.

Prescribers and authorized representatives for pharmacies who encountered certification difficulties should resume the online certification process. Pharmacists at chain pharmacies will be receiving additional communication from their authorized representative.   

Prescribers or pharmacists who continue to encounter technical issues with the Clozapine REMS Program should contact the Clozapine REMS Contact Center at 1-844-267-8678; Monday – Friday, 8am – 10pm EDT.

For more information please visit: Clozapine Rems