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Judge Says the FDA Never Explained Why Mifepristone Prescriber Certification Was Necessary
['Dorothy Brooks']
Medical Daily
The certification requirements remain in force while the agency reviews them.
The FDA removed the requirement that the drug be dispensed in person, and retained a prescriber certification requirement and a patient agreement form.
It added certification requirements for pharmacies that dispense it.
According to the court's opinion, the stated goal of the 2023 program is "to mitigate the risk of serious complications associated with mifepristone."
Prescriber and pharmacy certification remain in effect.