FDA Approves Abortion Pill for Sale by Retail Pharmacies

Alerts / January 13, 2023
Key Takeaways:
  • The FDA has finalized a rule permitting abortion pills to be sold at certified retail pharmacies.
  • Mifeprex and its approved generic can now be dispensed by certified pharmacies or by or under the supervision of a certified prescriber.

On Jan. 3, the Food and Drug Administration (FDA) finalized a rule allowing more retail pharmacies to dispense abortion pills upon completion of a certification process. The FDA finalized the changes after reviewing supplemental applications from manufacturers of the drug mifepristone requesting modification of the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. Under the modified Mifepristone REMS Program, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber. The Mifepristone REMS Program continues to require the Patient Agreement Form and certification of healthcare providers who prescribe mifepristone.

The FDA first approved mifepristone in 2000 to terminate pregnancies of up to seven weeks’ gestation and in 2016 extended this to 10 weeks’ gestation. Mifepristone blocks the hormone progesterone, which is needed for a pregnancy to continue. Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy through 10 weeks’ gestation (70 days or less since the first day of the last menstrual period).

The submitted REMS modification documents and materials are available on the FDA website linked here and more information regarding mifepristone can be found on the FDA Q&A webpage.

Authorship Credit: Amy Fouts (partner) and Claire Bass (associate)

Baker & Hostetler LLP publications are intended to inform our clients and other friends of the firm about current legal developments of general interest. They should not be construed as legal advice, and readers should not act upon the information contained in these publications without professional counsel. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you written information about our qualifications and experience.

Related Emerging Issues