FDA approves changes to iPLEDGE REMS to reduce burden during use of isotretinoin

In an effort to reduce the burden on patients, prescribers, and pharmacies while safely using isotretinoin, the FDA has approved changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS), according to a press release from the federal agency.

The iPLEDGE program was implemented in 2005, with the goal to mitigate the risk of embryo-fetal toxicity. As a shared system, all FDA-approved isotretinoin products are included in the program, providing a “centralized system for prescribers, pharmacies, and patients to manage patient risk, regardless of which isotretinoin product is being used,” according to the agency.

Included in these changes to the program are changes that were outlined in November 2023 notifications to isotretinoin manufacturers. The changes (listed below), will go into effect 180 days post February 9, 2026. Until this time, the FDA continues to exercise “enforcement discretion regarding pregnancy testing requirements as described in the Agency’s October 2023 update.”

A breakdown of these updates is listed below.

FDA-approved changes to iPLEDGE REMS (February 9, 2026)

Changes for patients:

If allowed by a prescriber, patients can complete pregnancy tests outside of a medical setting, such as using an at-home pregnancy test, during and after treatment. However, patients must continue to complete pre-treatment pregnancy tests in a medical setting.

Additionally, if a person who can get pregnant does not pick up their prescription in a 7-day window, a repeat pregnancy test can be done immediately without an additional waiting period, sometimes referred to as the “19-day lockout” period.

Changes for health care professionals who prescribe:

As stated above, patients can complete tests outside of a medical setting during and after treatment, but not during their pre-treatment tests. The FDA stated that “prescribers will need to establish processes and procedures to minimize misinterpretation and falsification of pregnancy tests completed by patients outside of a medical setting.”

Though the changes include the removal of the lockout period if a patient does not pick up their prescription within the 7-day window, if the patient has not received their first dose of isotretinoin, the repeat pregnancy test must be done in a medical setting.

For patients who cannot get pregnant, counseling must occur at enrollment.

“Prescribers should reinforce counseling throughout the course of treatment; however, monthly documentation of counseling in the REMS for patients who cannot get pregnant is no longer required,” the FDA stated.

Changes for pharmacies:

There is no longer a 30-day prescription window for patients who cannot get pregnant. Pharmacies may need to adapt their workflow practices to ensure that if a patient does not pick up the prescription, the authorization is reversed in the REMS and the prescription is returned to stock.

Clarifying language was added to the REMS to communicate that pharmacy staff training is required annually and records of the training completion should be maintained by the certified pharmacy’s authorized representative.

iPLEDGE update in use until changes go into effect (180 days after February 9, 2026)

At the time of this update, the FDA stated it was aware that “patients’ access to isotretinoin may be adversely impacted by reinstating the requirement that pregnancy tests be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory. To address this concern, FDA continues to exercise enforcement discretion with respect to certain requirements.” The FDA does not intend to object if prescribers:

• Assess a patient’s pregnancy status using pregnancy tests that are not performed in a CLIA-certified laboratory
• Rely on the patient to perform home pregnancy tests and report the dates and results of these tests to the prescriber during and after isotretinoin treatment

Until the 2026 changes go into effect, prescribers will “continue to be responsible for interpreting and documenting all pregnancy test results in the iPLEDGE REMS system. 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,” wrote the FDA.

Reference:

iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). FDA. Updated February 10, 2026. Accessed February 10, 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation-strategy-rems#10132023