Why are males included in the iPLEDGE Program?
Because iPLEDGE is a restricted distribution program, one of the requirements for iPLEDGE is the reporting and data collection of sales and dispensing of isotretinoin outside of the iPLEDGE program. Therefore, the program is required for all patients in order to effectively manage the distribution of isotretinoin product at all times to all patients. • Has the 23-day lockout requirement been eliminated for Female Patients of Childbearing Potential? Yes. The 23-day lockout period has been eliminated for female patients of childbearing potential. Previously, whether a prescription was filled or not, a female patient of childbearing potential could not start the qualification process for another prescription until 23 days after the end of her 7-day prescription window. While the prescribing procedures and qualification criteria for isotretinoin will remain the same, the elimination of the 23-day lockout period will allow female patients of childbearing potential the ability to re-qualify
