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January 3, 2023regulatory actionhealthcarereproductive rightsfederal regulation

FDA modifies mifepristone REMS to allow mail-order dispensing

The FDA revised mifepristone's Risk Evaluation and Mitigation Strategy, removing the in-person dispensing requirement and allowing certified retail and mail-order pharmacies to dispense the drug. Prescribers still required certification and patients still signed agreement forms. The change triggered a fivefold increase in telehealth abortion access over two years, with 25% of all US abortions accessed via telehealth by the end of 2024. Louisiana challenged the change as violating the Administrative Procedure Act.