FDA Modifies Mifepristone REMS Program, Establishes Certification Process for Pharmacies - JD Supra
FDA has modified the Mifepristone REMS program, requiring pharmacies to undergo a new certification process to dispense the medication.
Aforeworn detected this change in the Pharmacy & Controlled Substances space on September 2, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. All pharmacies dispensing Mifepristone, including independent, retail chain, compounding, and long-term-care pharmacies. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Not specified in the source.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmacy & Controlled Substances continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
Introduction of a certification process for pharmacies to dispense Mifepristone under the revised REMS program.
Who it affects
All pharmacies dispensing Mifepristone, including independent, retail chain, compounding, and long-term-care pharmacies.
What you must do
Pharmacies must complete the new certification process to continue dispensing Mifepristone.
Deadline
Not specified in the source.
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