The prescriber certification deadline for new Clozapine REMS Program has been extended from November 23 to December 14.
Due to ongoing implementation challenges with the new Clozapine REMS Program, FDA said it would extend the deadline to help ensure that health care professionals have sufficient time to complete this process and that patient access to clozapine is maintained.
The Food and Drug Administration sad that it was evaluating next steps regarding the December 14, 2015 pre-dispense authorization (PDA) launch.
“We will communicate the revised certification deadlines and additional information about the PDA launch as soon as possible,” FDA said.
Healthcare providers should prioritize the medical needs of their patients and, as appropriate, continue prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable ranges while the issues are being resolved by the Clozapine REMS program administrators.
Prescribers and pharmacies should continue to work with the Clozapine REMS Program administrators to resolve any issues and continue their efforts to complete certification and update patient information to meet the requirements of the program.