FDA Allows Certified Retail Pharmacies to Dispense Mifepristone

The Food and Drug Administration (FDA) has modified the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program allowing certified retail pharmacies to dispense the progestin antagonist for medical termination of pregnancy through 10 weeks gestation (70 days or less since the first day of the last menstrual period). 

Prior to this update, mifepristone was only available through certain health care settings, specifically clinics, medical offices, and hospitals. During the COVID-19 pandemic, the FDA allowed dispensing mifepristone through mail order pharmacies when the dispensing was done under the supervision of a certified prescriber, thereby exercising enforcement discretion with respect to the in-person dispensing requirement. Subsequently, the Agency conducted a review of available data and determined that the REMS for mifepristone should be changed.

The modified Mifepristone REMS Program removes the in-person dispensing requirement and adds a requirement that pharmacies that dispense the drug be certified. Mifepristone may now be dispensed by or under the supervision of a certified prescriber, or by a certified pharmacy on a prescription issued by a certified prescriber. In order to become certified to prescribe or dispense mifepristone, health care providers and pharmacies must complete a Prescriber/Pharmacy Agreement Form.

Commenting on the FDA announcement, Iffath Abbasi Hoskins, MD, FACOG, president of the American College of Obstetricians and Gynecologists (ACOG), said: “Today’s announcement that the FDA will officially remove the in-person dispensing requirement for mifepristone for reproductive health indications represents an important step forward in securing access to medication abortion. ACOG has advocated for many years for the in-person dispensing requirement to be removed from the risk evaluation and mitigation strategy (REMS) for mifepristone. There is no clinical evidence that in-person dispensing improves the safety of this medication or patient outcomes; instead, this requirement unnecessarily restricted patient access to a safe and effective medication.”

References

1. Information about mifepristone for medical termination of pregnancy through ten weeks gestation. News release. US Food and Drug Administration. Accessed January 4, 2023. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation.
2. ACOG releases statement on FDA announcement regarding changes to restrictions on provision of mifepristone. News release. The American College of Obstetricians and Gynecologists. Accessed January 4, 2023. https://www.acog.org/news/news-releases/2023/01/statement-fda-announcement-regarding-changes-to-restrictions-on-provision-of-mifepristone.