The Food and Drug Administration finalized a new regulation on Jan. 3 that allows retail pharmacies, including mail-order companies and large chains, to provide over-the-counter abortion pills.
These include mifepristone, a medication that blocks the progesterone hormone needed for pregnancy development. Used alongside misoprostol, mifepristone induces an abortion within the first 10 weeks of gestation.
Until the recent FDA approval, which seeks to make the drug more accessible, the medication could only be provided by licensed doctors and clinics and a few mail-order pharmacies. Now, pharmacies can complete a certification process to sell mifepristone to patients with a valid prescription.
Duke pharmacies, however, currently do not dispense mifepristone as they are awaiting “additional state level regulations that may apply to pharmacy dispensing of mifepristone,” according to Gene Rhea, associate chief pharmacy officer of retail and specialty pharmacy services in Duke's Medical Center’s department of pharmacy.
Duke Health does have access to misoprostol and the recent FDA regulation will not change this availability, Rhea wrote in an email to The Chronicle.
He explained that the North Carolina Board of Pharmacy “often provides interpretation and guidance of state level statutes that apply to pharmacies, which may differ or be more restrictive than federal regulations.” Once the board provides guidance, Duke Health will have more information, according to Rhea.
Many state laws limiting abortion and abortion medication may make pharmacies wary and affect users’ access to the pills across the country. In North Carolina, the state’s “informed consent” abortion law requires a doctor to be present when a patient takes their first pill.
Jay Campbell, executive director of the NC Pharmacy Board, told the News & Observer that the state law “doesn’t prevent pharmacies from becoming certified to dispense mifepristone.”
What is more unclear, however, is whether the law will require patients who pick up their prescription from the pharmacy to go to their doctor’s office to be observed while taking the pill.
Beverly Gray, a Duke OB-GYN, told the N&O that “it’s just unclear whether this is good news for North Carolina.”
If the patient must be observed, then the new regulations might not make abortion pills more accessible. Gray told the N&O that she fears the complicated abortion laws could deter pharmacies from stocking mifepristone in the state.
Rhea wrote that Duke Health is “committed to equitable access to FDA approved medications.”
Walgreens and CVS have announced they intend to become certified to sell mifepristone in states where abortion remains legal, but have not further specified in which states they will do so. Pharmacies have misinterpreted North Carolina’s abortion laws before, including Walmart, which recently rescinded its policy that limited access to misoprostol.
Anisha Reddy contributed reporting.
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Alison Korn is a Pratt senior and enterprise advisor of The Chronicle's 119th volume.