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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.
- Soon after the ruling, major pharmacies put a limit on purchases or deliveries of Plan B and other emergency contraceptive pills.
- "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 Corp (NYSE:CVS) and Walgreens Boots Alliance Inc (NASDAQ:WBA) said they were reviewing the updated REMS "drug safety program certification requirements for mifepristone to determine the requirements.
- Photo via Wikimedia Commons
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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