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The FDA will allow pharmacies to offer abortion pills, mifepristone, in the U.S. Pharmacies must complete a form for certification to distribute the abortion pills.
“Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber,” the agency said.
If successful, the pharmacies can dispense it directly to patients upon receiving a prescription from a certified prescriber.
Mifeprex was approved in 2000 with restrictions to assure its safe use. Mifeprex was deemed to have, in effect, an approved REMS under the FDA Amendments Act of 2007.
In 2019, when FDA approved the generic version of Mifeprex, the agency approved a single, shared system REMS for mifepristone products (known as the Mifepristone REMS Program).
Under the Mifepristone REMS Program, mifepristone may be dispensed in person or by mail.
Reuters reported that the regulatory change would potentially expand abortion access after they were sharply curtailed by the Supreme Court’s decision to overturn the landmark Roe v Wade ruling.
“Today’s news is a step in the right direction for health equity,” Planned Parenthood President Alexis McGill Johnson said in a statement.
A spokesperson for CVS Health CorpCVS and Walgreens Boots Alliance IncWBA said they were reviewing the updated REMS “drug safety program certification requirements for mifepristone to determine the requirements.
