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# FDA Changing Isotretinoin iPLEDGE REMS Requirements
- URL: https://www.fdaweb.com/fda-changing-isotretinoin-ipledge-rems-requirements/
- Published: 2021-10-12T12:00:00.000Z
- Updated: 2026-09-14T17:18:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150344

FDA has approved a modification to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin effective 12/13\. An agency [notice](https://content.govdelivery.com/accounts/USFDA/bulletins/2f71058?ref=fdaweb.com) says that for healthcare providers, REMS patient risk categories will be reduced from three to two — patients who can get pregnant and patients who cannot get pregnant. There also are changes affecting pharmacies and patients. An FDA question-and-answer post on iPLEDGE is [here](https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-ipledge-rems/?utm%5Fmedium=email&utm%5Fsource=govdelivery).