After a regulatory change by the FDA, retail pharmacies are now given the green light to sell abortion pills in the U.S.
Previously, Mifepristone was distributed through a few mail-order pharmacies or through doctors and clinics. Patients will still need a prescription from a certified health care provider.
According to a review conducted by the FDA in 2021, the FDA determined that the available data and information support modification of the REMS to reduce burden on the health care delivery system and to ensure the benefits of the product outweigh the risks. The Mifepristone REMS Program was modified on Jan. 3, 2023. Under the Mifepristone REMS Program:
- Mifepristone must be prescribed by a health care provider that meets certain qualifications and is certified under the Mifepristone REMS Program.
- In order to become certified to prescribe mifepristone, health care providers must complete a Prescriber Agreement Form.
- The Patient Agreement Form must be reviewed with and signed by the patient and the health care provider, and the risks of the mifepristone treatment regimen must be fully explained to the patient before mifepristone is prescribed.
- The patient must be provided with a copy of the Patient Agreement Form and mifepristone Medication Guide (FDA-approved information for patients).
- Mifepristone may only be dispensed by or under the supervision of a certified prescriber, or by a certified pharmacy on a prescription issued by a certified prescriber.
- To become certified to dispense mifepristone, pharmacies must complete a Pharmacy Agreement Form.
- Certified pharmacies must be able to ship mifepristone using a shipping service that provides tracking information.
- Certified pharmacies must ensure mifepristone is dispensed to the patient in a timely manner.