FDA and Medical Abortions

On January 3, 2023, the FDA amended its Risk Evaluation and Mitigation Strategies program for mifepristone to allow pharmacies to carry the prescription abortion medication mifepristone. Mifepristone is used along with misoprostol in the medical abortion process to end an intrauterine pregnancy through ten (10) weeks gestation. Prior to this change in FDA policy, mifepristone could only be dispensed by clinics, doctors and certain mail-order pharmacies if the patient saw the prescribing provider in person.

Under the new FDA policy, retail pharmacies may dispense mifepristone if the pharmacy agrees to the FDA’s rules for dispensing the medication. Specifically, pursuant to the rules, health care providers must complete a Prescriber Agreement Form and a Patient Agreement Form (signed by and provided to the patient), wherein the risks are fully explained and reviewed by the patient. The patient must also be provided with the mifepristone Medication Guide (FDA-approved information for patients). Furthermore, mifepristone must be dispensed under the supervision of a certified prescriber, or a certified pharmacy on a prescription issued by a certified prescriber; and the pharmacy dispensing mifepristone must be certified as well (i.e. must have completed a Pharmacy Agreement Form); and finally, if the pharmacy is shipping mifepristone, it must use a shipping service that provides tracking information, and it must ensure that the patient receives the medication in a timely manner. See, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation