The FDA is aware that in recent days, technical difficulties with the new Clozapine REMS websitedisclaimer icon 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.

We are also aware that there is confusion about the new Clozapine REMS Program requirements. Clozapine manufacturers are working to answer these questions and have posted additional information that is available by clicking on the “Important Program Update” button on the Clozapine REMS websitedisclaimer icon homepage.

If you have questions or concerns about the Clozapine REMS Program or its website please contact FDA at druginfo@fda.hhs.gov, 1-855-543-3784 or 301-796-3400.

 

Posted on the FDA website on 20 October 2015