FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA to Release Modified Clozapine REMS in February

Jan. 28, 2019

The FDA has made modifications to its Clozapine REMS program requirements that will become active on February 28.

Prescribers and pharmacies must be certified by that date or they will no longer be able to prescribe or dispense the antipsychotic drug, the agency said. Inpatient prescribers, however, won’t need to be certified if they are prescribing for patients already in the program.

Pharmacies may no longer enroll patients in the Clozapine REMS program once the modifications go into effect. Only the prescriber or prescriber designee will be allowed to complete enrollment of patients, the agency said.

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