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Implementation for iPLEDGE REMS Modifications Delayed Until November

The U.S. Food and Drug Administration (FDA) is alerting the public about an implementation delay for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) modifications. The modifications were scheduled to go into effect August 8, 2026, but the planned implementation date has been changed to November 15, 2026, to allow additional time to test iPLEDGE REMS system updates, minimize technical issues for users of the iPLEDGE REMS platform, and help ensure patients have uninterrupted access to isotretinoin treatment.

The modifications, described in the Agency’s February 2026 update, aim to minimize the burden on patients, prescribers, and pharmacies while maintaining the safe use of isotretinoin.

Until the modifications are fully implemented, FDA will continue to exercise enforcement discretion regarding pregnancy testing requirements, as detailed in the Agency’s October 2023 update.

For up-to-date and detailed information on the iPLEDGE REMS, please visit the iPLEDGE REMS website or contact the iPLEDGE REMS Contact Center at 866-495-0654.

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