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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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FDA Approves iPLEDGE REMS Modification
FDA approved modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) to minimize burden on patients, prescribers, and pharmacies while maintaining the safe use of isotretinoin.
The modifications approved include changes outlined in the November 2023 FDA notification to isotretinoin manufacturers. These modifications to the REMS will go into effect 180 days after the February 9, 2026 approval. Until that time, FDA continues to exercise enforcement discretion regarding pregnancy testing requirements as described in the Agency’s October 2023 update.
Prescribers must continue to complete the pre-treatment pregnancy tests in a medical setting prior to starting isotretinoin treatment.
Important changes for patients:
- If permitted by a prescriber, patients may complete pregnancy tests outside of a medical setting (e.g. at-home pregnancy tests) during and after treatment. However, patients will need to continue to complete their pre-treatment pregnancy tests in a medical setting.
- 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.
Important changes for health care professionals who prescribe:
- Prescribers may opt to allow patients to complete pregnancy tests outside of a medical setting (e.g. at-home pregnancy tests) during and after treatment. However, patients must continue to complete their pre-treatment pregnancy tests in a medical setting. Prescribers will need to establish processes and procedures to minimize misinterpretation and falsification of pregnancy tests completed by patients outside of a medical setting.
- 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. If the patient has not received their first dose of isotretinoin, the repeat pregnancy test must be done in a medical setting.
- Patients who cannot get pregnant must be counseled 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.
Important 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.
For complete information on the new iPLEDGE REMS requirements, please visit the iPLEDGE REMS website or contact the iPLEDGE REMS Contact Center at 866-495-0654.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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