iPLEDGE REMS has changes that include action items for pharmacies, effective Nov. 15, 2026:
- Authorized Representatives should inform all trained pharmacists interacting with the iPLEDGE REMS system that they should create a personal account by calling the REMS Contact Center.
- Authorized Representatives must provide training, at enrollment and annually thereafter, to all staff involved in dispensing isotretinoin annually and maintain records of training.
- Before dispensing each prescription for Patients Who Cannot Get Pregnant, the iPLEDGE System will verify that the patient is enrolled and that the prescriber is certified in the iPLEDGE REMS. The pharmacist will now be prompted to enter the prescriber’s NPI number to verify that the prescriber is certified in the iPLEDGE REMS to obtain a Risk Management Authorization (RMA).
- Pharmacists will no longer receive a “Do Not Dispense After Date” when obtaining an RMA for a Patient Who Cannot Get Pregnant. However, if the prescription is returned to stock (not dispensed to the patient), the RMA must be reversed in the iPLEDGE system.
Pharmacies may still only dispense a maximum of a 30-day supply with a Medication Guide. Isotretinoin may only be dispensed with a new prescription (no refills) and a new RMA.
NCPA
