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  • Mifeprex must be authorized by or administered under the guidance of a qualified certified healthcare professional. The FDA declared in December 2021 that the REMS must be amended by eliminating the in-person dispensing requirement. Eliminating the restriction for in-person dispensing will allow, for example, mifepristone to be dispensed by mail through certified practitioners or drugstores, in addition to in-person distribution in clinics, medical offices, and hospitals, as currently described in the Mifepristone Rems Program. When the in-person dispensing criterion was not implemented during the COVID-19 public health emergency (PHE), applicants began adopting a mail-order distribution mechanism, which is still in use today.

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