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Clozapine REMS Program Paused After Problems With Re-Certification

 
• By Brenda Sandburg

US FDA says pharmacists may dispense the antipsychotic without a REMS authorization and wholesalers may continue to ship it during temporary suspension of REMS. A high call volume and long wait times have impacted patient access since the modified REMS launched on 15 November.

Clozapine form
FDA temporarily suspends requirements of clozapine REMS program • Source: Alamy

The US Food and Drug Administration has temporarily suspended requirements of the modified Clozapine Risk Evaluation and Mitigation Strategy so pharmacists can dispense the antipsychotic without a REMS dispense authorization and wholesalers may continue to ship it to pharmacies and health care settings without confirming enrollment in the program.

The agency announced on 19 November that it had been alerted by health care professionals of difficulties, including a high call volume and long call wait times, since the...

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