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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.

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