iPLEDGE

Following sustained advocacy by the American Academy of Dermatology Association, the FDA approved significant modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program. These changes reduce administrative burdens while maintaining patient safety.

The changes will take effect in mid-August 2026 (180 days after approval). Until then, the FDA is exercising enforcement discretion as described below.

What is changing

At-home pregnancy testing permitted (during and after treatment)

• Prescribers may allow patients to complete pregnancy tests at home during and after isotretinoin treatment.

• Prescribers must establish processes and procedures to minimize the risk of misinterpretation or falsification of at-home test results.

• Accurate documentation of results is required.

Pre-treatment pregnancy tests still required in a medical setting

• All pregnancy tests performed before initiating isotretinoin must be completed in a medical setting (such as a prescriber’s office or clinic laboratory).

• This ensures the patient is not pregnant prior to starting therapy.

Removal of the 19-day lockout (7-day window missed)

• If a patient who can get pregnant does not obtain their prescription within the 7-day window, a repeat pregnancy test may be performed immediately.

• No additional waiting period is required.

• If the patient has not yet received their first dose, the repeat test must be completed in a medical setting.

Monthly counseling documentation removed

• Patients who cannot get pregnant must be counseled at enrollment.

• Monthly documentation of counseling is no longer required.

CLIA-certified laboratory requirement relaxed

• Pregnancy tests are no longer required to be performed in a CLIA-certified laboratory.

• However, pre-treatment pregnancy tests must still occur in a medical setting.

Enforcement discretion (through mid-August 2026)

Until the changes formally take effect:

• The FDA will allow prescribers to use pregnancy tests not performed in CLIA-certified laboratories.

• Patients may complete and report at-home pregnancy tests during and after treatment.

• Prescribers must have procedures in place to ensure accurate documentation of at-home results.

What remains unchanged

• The iPLEDGE REMS continues to require enrollment of prescribers, pharmacies, and patients.

• Patients must comply with REMS requirements based on their risk category.

• The goal of preventing fetal exposure to isotretinoin remains unchanged.

FAQs

When visiting the iPLEDGE REMS website, what should Prescribers and Designees do to comply?

Update your account: Ensure your identity is verified and your password is current.. You will need your Date of Personal Significance (DOPS).

• Prescribers: Log in to iPLEDGE REMS using your National Provider Identifier (NPI) and DOPS. Your NPI can be verified online via the National Plan and Provider Enumeration System.

• Designees: Log in using the prescriber’s username and DOPS to access the system. Update patient categories for existing patients. Review current patients on the “Manage Patients” screen and confirm each patient’s risk category:

  • Patients who can get pregnant must follow all Risk Evaluation and Mitigation Strategy (REMS) guidelines to prevent pregnancy during isotretinoin treatment.

  • Patients who cannot get pregnant must be counseled at enrollment; monthly counseling documentation is no longer required.

  • Any patient without a confirmed patient category cannot receive a prescription.

Complete new patient enrollment: Enrollment can be completed electronically or via a downloadable paper form. This includes risk categorization, registration, and signed informed consent.

• In-office: Consent may be signed electronically in the office on the iPLEDGE REMS website or a paper copy may be downloaded from the web site, signed by the patient. Prescriber must indicate via a checkbox that the signed paper consent has been completed, and the consent form should be kept in the patient’s medical record.

• Telehealth: If the Prescriber chooses to complete the informed consent(s) process electronically, the patient will be able to electronically sign remotely. During the enrollment process, the “Type It” option will send the patient a link, via e-mail or text, to log into the iPLEDGE REMS web site to sign electronically. Ensure the telehealth visits comply with current federal, state, and Medicare telehealth laws.

What does the current iPledge REMS program require?

• Electronic enrollment is required for all patients and includes patient risk categorization and program registration.

• Informed consent must be completed at enrollment. Consent may be completed electronically through the iPLEDGE REMS website or via a downloadable paper form that is signed and retained in the patient’s medical record.

• Pre-treatment pregnancy tests must be completed in a medical setting before initiating isotretinoin therapy.

• During and after treatment, prescribers may allow at-home pregnancy testing, provided processes are established to ensure accurate documentation and minimize the risk of misinterpretation or falsification of results.

• If a patient who can get pregnant does not obtain their prescription within the 7-day window, a repeat pregnancy test may be performed immediately without an additional waiting period.

• Patients who cannot get pregnant must be counseled at enrollment; monthly counseling documentation is no longer required.

• Patients have access to their iPLEDGE profile online to review program requirements and complete required actions.

• Prescribers must ensure the patient’s risk category is accurately documented before a prescription can be authorized.

• Educational materials and current program requirements are available through the iPLEDGE REMS website or by contacting the iPLEDGE REMS Contact Center at 866-495-0654.

For complete details visit the FDA page on iPLEDGE.

How is electronic enrollment completed?

• Prescribers must log in to the iPLEDGE REMS website using their National Provider Identifier (NPI) and Date of Personal Significance (DOPS).

  • Prescribers should review their profile information upon login to ensure their credentials and identifiers are accurate and up to date.

• First-time users will need to complete identity verification and establish or confirm their DOPS before accessing the system.

• Designees (such as office staff) must log in using the prescriber’s username and DOPS, in accordance with iPLEDGE REMS account access requirements.

Are there exemptions?

Patients with serious medical reasons, including non-pregnant individuals, may request expedited access to isotretinoin when clinically appropriate. For patients who can get pregnant and miss their 7-day prescription pickup window, a repeat pregnancy test may be performed immediately without any additional waiting period. Prescribers must complete and document this process according to the Prescriber Isotretinoin Educational Kit (PDF) ensuring that all REMS requirements for patient safety are met.

Questions or feedback?

For questions or to provide feedback on issues with the iPLEDGE program, please contact us.

All new materials can be downloaded or ordered by visiting ipledgeprogram.com.

For complete information on iPLEDGE REMS requirements and to learn more about the new QR code for patients, please visit the iPLEDGE REMS website or contact the iPLEDGE REMS Contact Center at 866-495-0654.

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