FDA rule allows retail pharmacies to dispense abortion pills

Abortion pills will now be available at retail pharmacies, thanks to a rule finalized Tuesday by the Food and Drug Administration.

The rule change covers a large swath of brick-and-mortar locations, including local pharmacies and large retail chains like CVS and Walgreens, as well as mail-order pharmacies. In addition, an individual can obtain a prescription for the medications after a telehealth consultation with a healthcare professional.

The FDA ruling focuses specifically on mifepristone, which is used in a two-drug medication abortion regimen. The agency first approved the brand version of mifefpristone, Mifeprex, in 2000 and approved the generic version mifepristone tablets, 200 mg, in 2019 for ending an intrauterine pregnancy through 10 weeks gestation.

In its update yesterday, the FDA states that “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.”

Mifepristone, also known as RU-486, is made by Danco Laboratories and GenBioPro. The FDA made the move by approving the Risk Evaluation and Mitigation Strategy (REMS) modifications to the Mifepristone REMS Program. REMS is one of the FDA’s drug safety programs.

Danco Laboratories said in a statement (PDF) yesterday that “at a time when people across the country are struggling to obtain abortion care services this modification is critically important to expanding access to medication abortion services and will provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy.”

Evan Masingill, CEO of GenBioPro, said in a statement that the FDA’s decision “is a step in the right direction that is especially needed to increase access to abortion care.” Politico reported Masingill as saying the FDA’s move “will not provide equal access to all people,” citing bans on abortion enacted by some states since the Dobbs decision and that individuals can only get the pills from their prescribing physician.

The FDA’s updated recommendation comes after the Supreme Court in June overturned Roe v. Wade, the 1973 decision that provided a right to abortion. The FDA’s updated recommendation comes with instructions on just how mifepristone may be dispensed. They include:

  • Healthcare providers must fill out a Prescriber Agreement Form, a copy of which must be given to the patient along with guidance on how to use mifepristone.
  • Any risks associated with taking mifepristone must be fully explained to the patient.
  • Mail-order pharmacies must ship mifepristone using a shipping service that can track the medication.
  • Pharmacies need to ensure that mifepristone is dispensed in a timely manner.

The move follows on the heels of other efforts by the Biden administration to limit the fallout from the Supreme Court’s decision in Dobbs, including the decision last year that women would no longer have to pick up the medication in person.

The Department of Justice also issued a ruling (PDF) Monday that enables the U.S. Postal Service to deliver abortion drugs through the mail, confirming it would not be in violation of the Comstock Act in doing so.