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# FDA Requiring Less Burdensome Isotretinoin REMS
- URL: https://www.fdaweb.com/fda-requiring-less-burdensome-isotretinoin-rems/
- Published: 2023-12-11T12:00:00.000Z
- Updated: 2026-09-14T14:18:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155963

FDA has notified isotretinoin manufacturers that they must modify their iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) to minimize the burden on patients, pharmacies, and prescribers. According to a [letter](https://www.fda.gov/media/174325/download?attachment&ref=fdaweb.com) sent to registered iPLEDGE REMS sponsors, drug manufacturers have six months to make the following changes:

- Remove the requirement that pregnancy tests be performed in a specially certified laboratory.
- Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests.
- Remove the waiting period requirement (also referred to as the “19-day lockout”) for patients if they do not obtain isotretinoin within the first 7-day prescription window.
- Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes (and associated data collection) for each pregnancy.
- Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment.

In deciding to make the changes, FDA says it evaluated the iPLEDGE REMS and considered advice from a [March Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee meeting](https://www.fda.gov/advisory-committees/advisory-committee-calendar/march-28-29-2023-joint-meeting-drug-safety-and-risk-management-advisory-committee-and-dermatologic?ref=fdaweb.com). “FDA has considered the impact of these changes, collectively, and determined the modifications will minimize burden for health care providers, patients, and pharmacists while continuing to ensure the benefits outweigh the risk of embryo-fetal toxicity (life-threatening severe birth defects),” it says.