FDA Rolls Back Some Requirements for Isotretinoin-Containing Treatments for Acne

The FDA announced that, with approval from a clinician, patients of reproductive age who are prescribed isotretinoin-containing treatments for acne may complete pregnancy testing at home or in other nonmedical settings during or after treatment. However, patients will need to continue to complete their pretreatment pregnancy tests in a medical setting.¹

Additionally, if a person who can get pregnant does not pick up their prescription within the 7-day window, a repeat pregnancy test may be done immediately without an additional waiting period. This update, like previous modifications made in 2023, aims to minimize the burden on patients, pharmacies, and prescribers while maintaining the safe use of isotretinoin.¹

What Is Isotretinoin and the iPLEDGE Program?

Isotretinoin—also known as Accutane (Roche), which is no longer available in the US—is a prescription medication that can treat deep and painful acne cysts and nodules. It is FDA approved for the treatment of patients aged 12 years and older, and duration of treatment can take about 6 months, but may be shorter or longer.²

Common adverse effects include dry skin, chapped lips, dry and irritated eyes, nosebleeds, sun-sensitive skin, worsening acne, and in serious cases, mood disorders (eg, depression, anxiety) and birth defects or other risks to a fetus.²

The iPLEDGE Program is designed to prevent embryo-fetal toxicity in reproductive-age users of isotretinoin. First approved as the iPLEDGE Program in 2005, then as the iPLEDGE REMS in 2010, it established a centralized system for prescribers, pharmacies, and patients to manage patient risk, regardless of which isotretinoin product is being used.¹

For those who are unable to become pregnant, prescribers must provide counseling at enrollment in the iPLEDGE program and continue to counsel patients periodically during treatment; however, documentation of the counseling is no longer required.¹

What Should Pharmacists Know About This Update?

Pharmacists should be aware that there is no longer a 30-day prescription window for patients who cannot get pregnant. In their announcement, the FDA notes that community 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.¹

In addition, 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.¹

Beyond the headline changes, pharmacists and pharmacies should be thinking about how this will affect day-to-day iPLEDGE workflow and compliance—especially around documentation, timing, and staff training. Although pregnancy testing is becoming more flexible with home/nonclinical testing allowed during and after therapy, pharmacies will still need to ensure the iPLEDGE authorization is valid at the time of dispense, that the prescription is picked up within the required window, and that any unclaimed prescriptions are promptly reversed in the REMS and returned to stock to avoid compliance issues.

Pharmacies should also prepare for increased patient questions and confusion about which tests can be done at home versus what still must happen in a medical setting, and they should confirm their internal processes for annual staff training and record retention, since the update clarifies that training is required every year and documentation must be maintained by the certified pharmacy’s authorized representative.

This update will go into effect on August 9, 2026, which is 180 days after the approval on February 9, 2026. Until then, the FDA reports that it will continue to retain enforcement discretion regarding pregnancy testing requirements.¹ In the meantime, pharmacies should prepare to operate under the new rules to ensure a smooth transition once the updated REMS requirements officially begin.

REFERENCES

1. iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). FDA. News release. February 9, 2026. Accessed February 11, 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation-strategy-rems

2. What is isotretinoin? American Academy of Dermatology Association. Accessed February 11, 2026. https://www.aad.org/public/diseases/acne/derm-treat/isotretinoin/side-effects