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The Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program

Get Prepared for Upcoming Changes to the Program

Effective February 15, 2021:

On July 29, 2021, FDA approved a modification to the Clozapine REMS. The modification to Clozapine REMS will go into effect on November 15, 2021. Important changes include:

  • 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.
  • Re-certification and re-enrollment can begin on August 16, 2021.
  • Pharmacies will no longer be able to use the telecommunication verification (also known as the switch system) to verify safe use conditions. The authorization to dispense will be obtained either through the contact center or online via the REMS website.
  • A new Patient Status Form will document absolute neutrophil count (ANC) monitoring for all outpatients. This form must be submitted monthly. Patient monitoring must continue per the Prescribing Information.

To re-certify and re-enroll in the Clozapine REMS, as well as for updates to the REMS, please visit: NewClozapineREMS.com. A fact sheet is included on changes to the Clozapine REMS and a new prescriber designee form is available.

APA's SMI Adviser hosted a webinar on September 29, 2021 to help physicians learn how to navigate these changes. More information and registration can be found here: Keeping Up with Clozapine REMS: A Guide to Navigating the November 15 Changes.

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