pharmaphorum January 4, 2023
Retail pharmacies in the US will be able to dispense mifepristone-based therapies to end pregnancies after the FDA introduced changes to its regulatory framework for the products.
A change to the risk evaluation and mitigation strategy (REMS) for mifepristone – sold as Mifeprex by Danco Labs and also available as a generic – means that it no longer needs to be dispensed in person by a healthcare provider at a registered clinic.
The FDA’s new approach means it can now be collected in-pharmacy or through mail-order, removing one obstacle to more widespread access, although it is still only available with a prescription.
It makes permanent a temporary suspension of the in-person requirement implemented during COVID-19. Pharmacies will have to apply...
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