FDA allows pharmacies to dispense mifepristone

The FDA finalized changes to its dispensing requirements for mifepristone to allow certified pharmacies to provide the abortifacient to patients, according to updated postmarket drug safety information.

Specifically, the FDA removed the in-person dispensing requirement, which limited the dispensing of mifepristone to clinics, medical offices and hospitals.

With the update, mifepristone can be dispensed by a certified prescriber or by a certified pharmacy filling a prescription from a certified prescriber. Prescribers who can diagnose ectopic pregnancies and ensure emergency care can become certified by filling out an agreement form. Pharmacies can become certified if they can track shipments of mifepristone and ensure patients receive their prescription in a timely manner, according to the FDA’s information on mifepristone use for medical abortion through 10 weeks’ gestation.

Previously, the FDA had temporarily lifted the in-person dispensing requirement for mifepristone due to safety concerns during the COVID-19 pandemic.

“Allowing for brick-and-mortar pharmacies to join mail-order pharmacies in dispensing mifepristone for reproductive health indications will further improve access for patients,” Iffath Abbasi Hoskins, MD, FACOG, ACOG president, said in a statement. “ACOG has long advocated that mifepristone be made available in retail pharmacies, just like other prescription drugs, to allow more patients access to abortion care without clinically unnecessary hurdles. This change will empower patients who choose medication abortion to have the option of going to a pharmacy for immediate care rather than waiting for a mail order, if that is right for them.”

References:

• ACOG releases statement on FDA announcement regarding changes to restrictions on provision of mifepristone. Published Jan. 3, 2023. Accessed Jan. 4, 2023.
• FDA. Questions and answers on mifepristone for medical termination of pregnancy through ten weeks gestation. fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation. Updated Jan. 3, 2023. Accessed Jan. 4, 2023.