FDA Finalizes Updated REMS for Mifepristone

January 05, 2023 9:10 AM | Becca Liebers (Administrator)

Abortion Is Essential Health Care
FDA Finalizes Updated REMS for Mifepristone

Yesterday, the FDA finalized the updated risk evaluation and mitigation strategy (REMS) for mifepristone for reproductive health indications, permanently removing the in-person dispensing requirement against which ACOG has long advocated and, for the first time, allowing brick-and-mortar pharmacies to join mail-order pharmacies in dispensing mifepristone.

In a statement, ACOG President Iffath Abbasi Hoskins, MD, FACOG, said, “Since 2020, continued usage of mifepristone for abortion care without the in-person dispensing requirement has been shown to be safe and effective, and the official change to the REMS means that clinicians now have concrete peace of mind that this regulation which has proven to be unnecessary has been removed.” Read the full statement.

ACOG will update all relevant guidance documents and resources about mifepristone for reproductive health indications.

Powered by Wild Apricot Membership Software