FDA to allow pharmacies to dispense abortion pills
The new rule allows pharmacies to apply for certification to distribute the abortion medication mifepristone
January 4, 2023 6:41am
Updated: February 19, 2023 2:29pm
The U.S. Food and Drug Administration (FDA) announced on Tuesday that it will allow retail pharmacies to dispense abortion pills for the first time in the United States.
The new rule allows pharmacies to apply for certification to distribute the abortion medication mifepristone. If the applications are accepted, the pharmacies will be able to directly dispense it to patients who present a prescription. Previously, the pill was required to be dispensed in person by doctors or clinics.
The drug, known as mifepristone, was approved to use up to 10 weeks of pregnancy and is commonly prescribed to treat women who have miscarriages.
The FDA first announced that it would seek to change the way abortion pills could be accessed in December 2021, including permanently removing restrictions on mail-order shipping for abortion bills and allowing their prescription through telemedicine.
The FDA finalized the changes on Tuesday after reviewing applications from the two companies that make the drug, Danco Laboratories and GenBioPro.
"Under the Mifepristone REMS Program, as modified, Mifeprex and it's approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber," the agency said on its website on Tuesday.
The change could potentially expand access to abortions as several states seek to ban the medication following the overturn of the Roe v Wade Ruling by the Supreme Court.
“Today’s FDA announcement expands access to medications that are essential for reproductive autonomy and is a step in the right direction that is especially needed to increase access to abortion care,” GenBioPro CEO Evan Masingill told The Hill.
“The FDA determined that removal of the in-person dispensing requirement and the addition of the requirement for certification for pharmacies were necessary to minimize the burden on the healthcare delivery system … while still ensuring that the benefits of mifepristone for medical abortion outweigh the risks,” Masingill said.