REMS@FDA Clozapine Risk Evaluation and Mitigation Strategy (REMS) requirements will change on November 15, 2021

REMS@FDA - Clozapine Risk Evaluation and Mitigation Strategy (REMS) requirements will change on November 15, 2021 On July 29, 2021, FDA approved a modification to the Clozapine Risk Evaluation and Mitigation Strategy (REMS). Beginning November 15, 2021 new requirements will go into effect. Key changes include: Pharmacies will no longer be able to use the telecommunication verification (the switch system) to verify safe use conditions for clozapine. The authorization to dispense clozapine can be obtained either through the contact center or online via the REMS website. Pharmacists will have to go to www.clozapineREMS.com or call the Clozapine Call Center (888-586-0758) to verify information and obtain a REMS dispense authorization to dispense clozapine New Patient Status Form to document monitoring for all outpatients. This form must be submitted monthly. Patient monitoring must still continue per the Prescribing Information. All prescribers and pharmacies must be re-certified by November 15, 2021 or they will no longer be able to prescribe/dispense clozapine. Prescribers must re-enroll their patients who will continue clozapine by November 15, 2021. Patients who ae not re-enrolled by that date will no longer be able to receive clozapine. Re-certification and re-enrollment can begin on August 16, 2021. To re-certify and re-enroll in the Clozapine REMS please see the Important Program Update at www.clozapineREMS.com For more information on the changes to the clozapine REMS that takes effect on November 15,2021 please see the updated CDER Statement, CDER Questions and Answers and the Clozapine REMS website Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA