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  • FDA Date: 06/17/2017

    Isotretinoin REMS

    Goals of the Isotretinoin REMS Program

    The goals of the isotretinoin risk evaluation and mitigation strategy are:

    1. To prevent fetal exposure to isotretinoin

    2. To inform prescribers, pharmacists, and patients about isotretinoin's serious risks and safe-use conditions

    REMS Elements

    • Medication Guide

    • Elements to Assure Safe Use

    • Implementation System