FDA’s New Requirements for Clozapine

Due to potentially life-threatening neutropenia that may occur with clozapine the FDA has determined that the prescribing and dispensing of clozapine—for schizophrenia—will be more strictly monitored. It has replaced 6 individual registries with a shared risk evaluation and mitigation strategy (REMS) program. The FDA stated that this change is “expected to reduce the burden and possible confusion related to having separate registries for individual clozapine medicines.”

Starting October 12 of this year, both prescribers and pharmacies will have to be certified in the Clozapine REMS program. Starting December 14, a predispense authorization (PDA) from the REMS program will be required for outpatient pharmacies. Inpatients pharmacies will not be required to get a PDA. Current clozapine patients will be transferred to the REMS program automatically.

To read an article about the changes, click here.




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