News
Important Changes to the iPLEDGE® REMS Take Effect November 15, 2026
The iPLEDGE REMS Sponsors have announced changes to the iPLEDGE REMS that take effect on November 15, 2026. The changes affect pregnancy testing, patient categories, the 19-day lockout, counseling documentation, and REMS educational materials. SDPA members who prescribe isotretinoin should review the updates below and adjust their practice workflows before the effective date.
Pregnancy Testing Before the First Dose
All pregnancy testing required before a patient takes their first dose of isotretinoin for a course of treatment must be done in a medical setting, such as a prescriber’s office, clinic, or laboratory.
- Screening test: The first pregnancy test must be done in a medical setting. The prescriber obtains it when the decision is made to prescribe isotretinoin.
- Confirmatory test: The second pregnancy test must also be done in a medical setting.
Timing: The two tests should be at least 30 days apart.
Monthly Pregnancy Testing During Treatment
Patients who can get pregnant must have a pregnancy test every month, before they receive each prescription.
- After the patient has taken their first dose for a course of treatment, prescribers may allow home pregnancy testing.
- Prescribers who allow testing outside a medical setting must set up and follow procedures for getting results from the patient, and for minimizing misinterpretation and falsification.
- The prescriber or a designee must verify and document a negative result before the prescriber writes each prescription.
Patient Categories
The patient category definitions have been updated. Only a prescriber can change a patient’s category.
Removal of the 19-Day Lockout
The 19-day lockout is being removed. It currently applies when a patient who can get pregnant doesn’t obtain isotretinoin within the first 7-day prescription window. Instead, the patient must complete a repeat confirmatory test in a medical setting before starting treatment. There is no waiting period for this repeat test.
Counseling Documentation for Patients Who Cannot Get Pregnant
For patients who cannot get pregnant, prescribers will document counseling in the iPLEDGE system only at enrollment, not monthly.
- Prescribers are encouraged to reinforce key counseling points throughout treatment.
- The Fact Sheet has been removed from the REMS. Prescribers should use the new Guide for Patients Who Cannot Get Pregnant for counseling.
- Prescriptions are still limited to a maximum 30-day supply.
New and Updated REMS Materials
- The Pregnancy Registry Healthcare Provider Guide and the Pregnancy Registry Patient Guide are being added to the REMS materials.
- The REMS educational materials will include updated contraception counseling information, with more detail on emergency contraception.
Learn More
For full program details and updated materials, visit the iPLEDGE REMS website at www.ipledgeprogram.com.
This update is shared on behalf of the iPLEDGE REMS Sponsors.
