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09/01/2021
Update: New Clozapine REMS Coming November 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.
Click here for complete information on the updated requirements (PDF).
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