Following the FDA's iPLEDGE REMS communication, the program changes on November 15, 2026. Here's what dermatology NPs and PAs who prescribe isotretinoin need to know.
Pre-Treatment Pregnancy Tests Must Be in a Medical Setting
For patients who can get pregnant, all required pre-dose tests must be completed in a medical setting (prescriber's office, clinic, or laboratory). The screening test is obtained when the decision is made to prescribe, and the confirmatory test should follow at least 30 days later.
Home Testing Allowed After the First Dose
Monthly pregnancy tests are still required before each prescription. Once a patient has taken their first dose, prescribers may optionally allow testing outside a medical setting. If you do, your practice must have procedures to obtain results that minimize misinterpretation and falsification, and the prescriber or designee must verify and document a negative result before writing each prescription.
The 19-Day Lockout Is Removed
If a patient who can get pregnant misses the first 7-day prescription window, there's no more 19-day lockout. Instead, they need a repeat confirmatory test in a medical setting, with no waiting period.
Counseling for Patients Who Cannot Get Pregnant
Counseling documentation in the iPLEDGE system moves from monthly to enrollment only, though reinforcing key points throughout treatment is still recommended. The Fact Sheet has been replaced by the new Guide for Patients Who Cannot Get Pregnant, and the 30-day supply maximum still applies.
Other Updates
- Patient category definitions have been updated, and only a prescriber can change a patient's category.
- The Pregnancy Registry Healthcare Provider Guide and Pregnancy Registry Patient Guide are being added to the REMS materials.
- Contraception counseling materials now include more information on emergency contraception.
Source: iPLEDGE REMS Program. Refer to the current iPLEDGE REMS materials for complete program requirements.
