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Who is an Authorized Representative? In general, an authorized representative for a pharmacy: – Coordinates the activities required in the Clozapine REMS Program – Establishes and implements processes and procedures to ensure compliance with the safe-use conditions required in the Clozapine REMS Program Speci ic duties of an authorized representative are noted in the section, “What is the role of the pharmacy authorized representative in the Clozapine REMS Program?” Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers For a pharmacy with a single location, the authorized representative may be a: – Pharmacy Manager, or – Staff Pharmacist If your pharmacy has more than one pharmacy location and your organization would like to coordinate staff training and implement processes for all the pharmacies clozaril in your organization, the authorized representative may be a: – Director of Pharmacy Services, or – Corporate Executive overseeing Pharmacy Services What is a Predispense Authorization (PDA)? Before clozapine can be dispensed to a patient by a pharmacy dispensing clozapine to patients treated on an outpatient or chronic basis, including, but not limited to, retail drug-stores, ambulatory care pharmacies, and pharmacies dispensing to long-term care, rehabilitation facilities and prison systems, the pharmacy must obtain a PDA each time from the Clozapine REMS Program .

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