FDA exercises additional enforcement discretion for Clozapine REMS (Updated November 2, 2022)

In an announcement dated November 2, 2022, the FDA will temporarily use their discretion with regards to enforcing (or not enforcing) an additional aspect of REMS, allowing for more flexibility with regards to the REMS program requirements.  To help ensure continuity of care from inpatient to outpatient settings, the FDA no longer objects if inpatient pharmacies dispense a supply of clozapine that aligns with the patient’s historical monitoring frequency.

For example:

  • If the patient has been on weekly monitoring, the pharmacy may dispense a 7-day supply.
  • If the patient is on every other week monitoring, the pharmacy may dispense a 14-day supply.
  • If the patient has been on monthly monitoring, the pharmacy may dispense a 30-day supply.

Additionally, the FDA continues to exercise the enforcement discretion from the November 2021 announcement, which means that the FDA does not intent to object if pharmacists dispense clozapine without a REMS dispense authorization.  See the full announcement here.

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