Clozapine REMS Re-Certification – Drug Information Update

Remember to re-certify in the Clozapine REMS by November 15, 2021!

If your email program has trouble displaying this email, view it as a web page. 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 REMS that will go into effect on November 15, 2021. 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 are not re-enrolled by that day will no longer be able to receive clozapine. The Clozapine Product Manufacturers' Group (CPMG) and FDA continue to work to ensure that patients relying on clozapine have continued access to the medication and appropriate management of associated risks. To re-certify, please see the Important Program Update at www.clozapinerems.com. Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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