How the Clozapine REMS Elimination Impacts Clozapine Stakeholders
Prescriber
Prescribers no longer need to submit patient ANC results to the Clozapine REMS.
Pharmacy
Pharmacies no longer need to obtain a REMS Dispense Authorization (RDA) before dispensing clozapine.
Wholesalers/Distributors
Wholesalers and distributors no longer need to confirm a pharmacy’s REMS certification status before shipping clozapine.
Patients and Caregivers
If patients and caregivers have trouble obtaining clozapine from a pharmacy, they may request that the pharmacy reach out to the prescriber, or they may direct the pharmacy to visit this page or FDA’s announcement for more information.