Mifepristone, a progesterone antagonist, blocks progesterone needed for a pregnancy to continue. Mifepristone is used along with misoprostol for medication abortion or off-label for medical management of miscarriage. This two-drug regimen of mifepristone and misoprostol can safely and effectively be used in these ways, both in-person and via telehealth, and is FDA-approved for medication abortion through ten weeks gestation (70 days or less since the first day of the last menstrual period). Although it has been FDA-approved since 2000, restrictions to access have impacted mifepristone availability, especially in the pharmacy setting.
Can mifepristone currently be dispensed in a pharmacy?
Yes! A Risk Evaluation and Mitigation Strategy (REMS) program sets the guidelines and requirements for how mifepristone can be dispensed by a pharmacy. Certification and adherence to the steps in the REMS program are needed to dispense mifepristone. The original Mifepristone REMS Program was approved in 2007 for the brand name mifepristone (Mifeprex). It was updated to include generic mifepristone products in 2019. In 2021, the FDA reviewed data from the Mifepristone REMS Program and made modifications that reduce the burden on the health care delivery system while maintaining safety. The Mifepristone REMS Program was officially modified on January 3, 2023, to remove the restriction that did not allow mifepristone to be dispensed in a retail pharmacy.
The Mifepristone REMS Program requires health care providers prescribing mifepristone to be certified and to complete a Prescribed Agreement Form that is then reviewed and signed by the patient. A copy of this form must be provided to the patient along with the mifepristone Medication Guide. In the REMS, mifepristone can only be dispensed by a certified prescriber or by a certified pharmacy with a prescription issued by a certified prescriber. Pharmacies that wish to become certified must complete a Pharmacy Agreement Form. Certified pharmacies must also be able to ship mifepristone using a trackable shipping service and ensure that the mifepristone is dispensed to the patient in a timely manner.
Can every pharmacy dispense mifepristone?
Following the Dobbs v. Jackson Women’s Health Organization US Supreme Court decision in June 2022 overturning the federal constitutional right to abortion, several states have banned or restricted the use of mifepristone for medication abortion.
Individuals cannot obtain mifepristone at the pharmacy (or in any health care setting) in states that have a near-total abortion ban. At the time of this writing, 13 states have a near-total abortion ban in effect, and 15 states restrict access to medication abortion. All 15 that restrict access require mifepristone to be provided by a physician—not a pharmacy or other health care provider such as a nurse practitioner. In addition, one state (Arizona) bans the mailing of medication abortion pills to a patient.
What about FDA approval?
Mifepristone remains FDA-approved nationwide as part of the two-drug regimen for medication abortion. In November of 2022, a court case, Alliance for Hippocratic Medicine vs. FDA, was filed challenging the FDA approval of mifepristone. This court case is ongoing and the FDA does not comment on pending legislation. This court case could impact the availability and distribution of mifepristone nationwide, even in states that have legislation protecting patient access to medication abortion. The outcome of this unprecedented case could have any number of implications for FDA approval of medications.
Bottom line
Mifepristone remains FDA-approved nationwide and legal to be dispensed by pharmacists in certain states. However, individual state laws or company policy may impact a pharmacy’s ability to dispense mifepristone. With appropriate certification and compliance with the Mifepristone REMS Program, pharmacists can dispense safe and effective medication abortion.
