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# Isotretinoin iPLEDGE REMS Modified
- URL: https://www.fdaweb.com/isotretinoin-ipledge-rems-modified/
- Published: 2026-02-10T12:00:00.000Z
- Updated: 2026-09-14T15:32:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160641

FDA has approved changes to the isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy that it says will minimize the burden on patients, prescribers, and pharmacies while maintaining the safe use of the drug. An agency [announcement](https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation-strategy-rems?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the modifications include changes listed in the 11/2023 FDA notification to isotretinoin manufacturers. The changes take effect 180 days after the 2/9 approval.

The notice says that until the changes take effect, prescribers must continue to complete the pre-treatment pregnancy tests in a medical setting before starting isotretinoin treatment.

In the notice, FDA lists important changes for patients, healthcare professionals who prescribe, and pharmacies. The changes relate primarily to completing required pregnancy tests outside of a medical setting and permitting a repeat pregnancy test immediately, without an additional waiting period, if a person who can get pregnant does not pick up a prescription within seven days.