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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 isotretinoin2. To inform prescribers, pharmacists, and patients about isotretinoin's serious risks and safe-use conditions
• Medication Guide• Elements to Assure Safe Use• Implementation System