Pharmacist FAQsFrequently Asked Questions for Pharmacists on Clozapine REMS System
WEDNESDAY, NOVEMBER 2, 2022 FDA TEMPORARILY EXERCISING ENFORCEMENT DISCRETION WITH RESPECT TO CERTAIN CLOZAPINE REMS PROGRAM REQUIREMENTS TO ENSURE CONTINUITY OF CARE FOR PATIENTS TAKING CLOZAPINE. The U.S. Food and Drug Administration’s (FDA or Agency) Intergovernmental Affairs (IGA) team would like to share with you the following important update on clozapine REMS enforcement discretion: FDA is temporarily exercising additional enforcement discretion with respect to certain Clozapine REMS program requirements to ensure continuity of care for patients taking clozapine. FDA is aware health care professionals and patients continue to experience ongoing difficulties with the Clozapine REMS program, including issues with patient access to clozapine for patients recently discharged from an inpatient setting. To address the concern that inpatient pharmacies are only allowed to dispense a 7-days’ supply of clozapine to the patient upon discharge, FDA does not intend to object if:
FDA continues to exercise the enforcement discretion announced in November 2021, including that FDA does not intend to object if:
Abrupt discontinuation of clozapine can result in significant complications for patient treatment. Health care professionals should use their clinical judgment with regard to prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable range. FDA’s Intergovernmental Affairs (IGA) staff is here to assist state/local/territorial/tribal officials, including the national associations representing them, on FDA policy-related matters. If you have questions related to this update please contact FDA’s IGA team at IGA@fda.hhs.gov.
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