The U.S. Food and Drug Administration approved a modification to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program, which goes into effect on December 13, 2021. The REMS administrator has changed, and the current “switch” pharmacy management system is being removed as a method to verify authorization to dispense isotretinoin. Pharmacists will no longer use the switch system to obtain a pre-dispense authorization, known as a risk management authorization (RMA). All pharmacists must obtain an RMA prior to dispensing isotretinoin by visiting the iPLEDGE REMS website or calling the iPLEDGE REMS Contact Center at 866.495.0654.
Pharmacies will not be able to obtain an RMA number to dispense isotretinoin between December 11-12, 2021. Isotretinoin manufacturers anticipate the phone and internet systems for the modified iPLEDGE will be available on December 13, 2021.
