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  • Stuart Jeffery

FDA approves over-the-counter sale of abortion pills in the US

It means the pills can be sold by certified pharmacies without a prescription being needed.

The United States Federal Drug Agency has updated its rules for the sale of Mifepristone abortion pills, allowing them to be sold directly by certified pharmacies to patients, without needing a prescription from a doctor. This move follows the Supreme Court ruling on June 24th 2022 that overturned Roe v. Wade (1973).


On December 16 2021, the FDA modified its abortion medication protocols by allowing Mifepristone to be mailed to patients, including those that made telehealth appointments, rather than requiring the medication to be collected in-person. Although this requirement had temporarily been suspended due to COVID-19, it was made permanent after a scientific review deemed it unnecessary.


Under the updated rules, issued on January 3rd 2022, pharmacies that have been certified to sell Mifepristone by one of its manufacturers can now sell the medication directly to patients.


The FDA originally approved the medication in 2000, allowing it to be taken in the first 70 days of the pregnancy. However, safety concerns meant that there was a strict regimen that clinics had to follow in order to be able to sell the medication to patients.


Some FDA safety regulations still remain in place, including requiring the patient to sign a Patient Agreement Form and for the pharmacy to fully explain the medication and it side-effects, which commonly includes bleeding, to the patient.


Given the Supreme Court ruling in Dobbs v. Jackson Women’s Health Organization (2022), it is unclear how state legislators will respond to the FDA decision, but it is likely that there will be some challenges to it in the coming years.


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