New modifications are expected to be implemented to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) to reduce burdens for pharmacists, patients, and prescribers while ensuring the safe use of isotretinoin. Food and Drug Administration notes that if permitted by the prescriber, patients will be allowed to complete pregnancy testing outside of a medical setting during and after treatment. The agency also removed the 30-day prescription timeframe requirement for patients who are unable to get pregnant. Pharmacies must “reverse” REMS authorization and restock a prescription if the patient does not pick it up. In addition, pharmacy staff is required to complete annual REMS training, and a certified pharmacy’s authorized representative must maintain documentation of that training.
The modifications will go into effect on August 8, 2026 (180 days from February 9, 2026).