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# New Clozapine REMS Requires Recertification by 11/15
- URL: https://www.fdaweb.com/new-clozapine-rems-requires-recertification-by-11-15/
- Published: 2021-11-01T12:00:00.000Z
- Updated: 2026-09-14T17:20:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150488

Beginning 11/15, new requirements under the FDA-approved [Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMTExMDEuNDgxOTkxNzEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L2RydWdzL2RydWdzYWZldHkvcG9zdG1hcmtldGRydWdzYWZldHlpbmZvcm1hdGlvbmZvcnBhdGllbnRzYW5kcHJvdmlkZXJzL3VjbTQ5Nzc5MC5odG0%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.kK%5FgY2EvH2l0Z1HPO%5Fvs4XbDs6WezGP1u17voa8ncyw/s/1255718496/br/115910946768-l?ref=fdaweb.com) become effective to require all patients, prescribers, and pharmacies to recertify and re-enroll in the new system to prevent treatment interruptions. FDA 7/29 approved modifications to the clozapine REMS and prescribers and pharmacies that have not enrolled by 11/15 will not be able to prescribe, dispense, or distribute clozapine, according to an [FDA reminder](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMTExMDEuNDgxOTkxNzEiLCJ1cmwiOiJodHRwczovL2NvbnRlbnQuZ292ZGVsaXZlcnkuY29tL2FjY291bnRzL1VTRkRBL2J1bGxldGlucy8yZjljOGZhIn0.WQUxHYLSy3QYlW5qQ7CDszW%5FtxOrhGVvRUCsXmWpdO4/s/1255718496/br/115910946768-l?ref=fdaweb.com).