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# FDA Approves Clozapine REMS Changes
- URL: https://www.fdaweb.com/fda-approves-clozapine-rems-changes/
- Published: 2021-07-29T12:00:00.000Z
- Updated: 2026-09-14T17:08:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149823

FDA approved a modification to the clozapine REMS (risk evaluation and mitigation strategy) 7/29 to become effective 11/15\. An agency [notice](https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-clozapine?ref=fdaweb.com) says FDA continues to work with the Clozapine Product Manufacturing Group to ensure that patients relying on clozapine have continued access to the medication and appropriate management of associated risks. The notice lists important REMS changes as: 

- all prescribers and pharmacies must be recertified by 11/15 or they will not be able to prescribe/dispense clozapine;
- prescribers must re-enroll their patients who will continue clozapine by 11/15;
- recertification and re-enrollment can begin 8/16;
- pharmacies will no longer be able to use telecommunication verification (switch system) to verify safe use conditions; and
- a new patient status form will document absolute neutrophil count monitoring for all outpatients on a form that must be submitted monthly.

 FDA also updated its Information on Clozapine [sheet](https://www.fda.gov/drugs/drug-safety-and-availability/clozapine-risk-evaluation-and-mitigation-strategy-rems-requirements-will-change-november-15-2021?ref=fdaweb.com) with the REMS changes and a question-and-answer [document](https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/frequently-asked-questions-clozapine-rems-modification?ref=fdaweb.com).