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Published on Wednesday, January 4, 2023

New FDA policy expands access of mifepristone dispensing to certified retail pharmacies

Yesterday, FDA announced modifications to the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone (Mifeprex–Danco Labs) that enable pharmacies to become certified to dispense this FDA-approved drug to patients with a prescription, as long as they comply with the certification requirements. 

APhA advocated on your behalf urging FDA to level the playing field by permitting any pharmacy that chooses to dispense this product to become certified under the REMS. Among other requirements, a certified pharmacy must ensure certain processes and procedures are in place, and dispense, including by mail-order, within a specific timeframe.   

FDA’s action does not change the current restriction on patients’ access to mifepristone in states that have banned or restricted access following the Supreme Court’s recent Dobbs v Jackson decision overturning Roe v Wade. In addition, the U.S. Postal Service announced on December 23, 2022, that current law supports delivery of mifepristone and misoprostol through the mail. APhA will continue to advocate for clarifications in areas where discrepancies in authorities across state lines exist. 

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