On February 9, 2026, the FDA approved modifications to the Risk Evaluation and Mitigation Strategy (REMS) program for the safe use of isotretinoin. The REMS program has undergone various changes since its initial inception in 2005. The shared program (brand and generic applicants) is designed to mitigate the risk of fetal toxicity from isotretinoin. The current changes were outlined in a November 2023 FDA notification letter to isotretinoin manufacturers and made “to minimize burden on patients, prescribers, and pharmacies while maintaining the safe use of isotretinoin.”
The February 9, 2026 approval triggers a 180-day time period after which the changes will officially go into effect. The FDA says that it will continue to use enforcement discretion as outlined in its October 2023 update, which basically means that the FDA will continue to exercise the same level of enforcement discretion until the expiration of the 180-day period identified above.
Changes for patients include the ability to perform home pregnancy tests during and after treatment. However, before treatment begins, a pregnancy test must be completed in a medical setting. Also, there is a 7-day window after the pregnancy test during which the patient must pick up their prescription. Previously, if the prescription was not picked up during the 7-day window, there was a 19-day lock-out, or waiting period, imposed before a patient could get their prescription drug following another pregnancy test. Under the modified program, “if a person who can get pregnant does not pick up their prescription within the 7-day window, a repeat pregnancy test may be done immediately without an additional waiting period.” The pregnancy test may be a home test unless the patient is initiating therapy for the first time, in which case the test must be performed in a medical setting.
There are additional changes for medical providers and pharmacies that are outlined in the iPLEDGE modifications, which can be reviewed here. While the changes will go into effect 180 days from the official February 2026 approval date, most providers and patients are already utilizing the modified provisions of the program.
