FDA working with manufacturers to resolve challenges with the Clozapine REMS Program
Due to ongoing implementation challenges with the new Clozapine REMS Program, FDA is extending the November 23, 2015 prescriber certification deadline and the December 14, 2015 pharmacy certification deadline to help ensure that health care professionals have sufficient time to complete this process and that patient access to clozapine is maintained. We are also carefully 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.
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.
Posted on the FDA website on 19 November 2015