FDA Expands Access to Abortion Pills in Retail Pharmacies

After long deliberation, the FDA has expanded access to abortion pills, allowing retail pharmacies to distribute the medication.

By Veronica Salib

January 04, 2023 – In a step towards widening access, the FDA made a regulatory change, allowing the abortion pill, mifepristone, to be distributed by retail pharmacies with a valid prescription. Mifepristone is one of two medications taken during a medication abortion. Approved in 2000, this drug is meant to begin pregnancy termination within the first 70 days of gestation. The medication is delivered as a 200mg oral pill. Within two days of the initial dose, patients will also be directed to take an 800 mcg oral misoprostol tablet.

Early considerations of this regulatory change began in 2021, before any definitive changes in abortion rights. After reviewing the Risk Evaluation and Mitigation Strategy (REMS) information in 2021, the FDA found that it could loosen some of the restrictions on mifepristone without compromising patient safety.

Under these new regulations, any provider who is certified under the Mifepristone REMS Program is eligible to prescribe the medication. Certifications can be obtained by completing the Prescriber Agreement Form.

The most significant regulatory change allows patients to fill prescriptions at any certified pharmacy. A Pharmacy Agreement Form must be completed and reviewed to become a certified pharmacy. For the first time since its FDA approval in 2000, mifepristone can be delivered directly to a patient’s door by shipping services through a certified pharmacy. Under these new regulations, pharmacies take on the responsibility of ensuring that medication is dispensed promptly.

Access to reproductive care has been a highly polarizing and deliberated issue in healthcare, becoming even more complicated after the United States Supreme Court overturned Roe v. Wade in June of 2022. Since then, healthcare providers and public health organizations have been exploring expanding access to reproductive care while ensuring patient safety and confidentiality.

This new regulatory change marks a significant win for providers, patients, and organizations advocating for expanded access to reproductive healthcare. Many anticipate that these regulatory alterations—in line with reproductive healthcare policies of major healthcare organizations such as the AMA—could improve patient outcomes, alleviate anxieties, and allow for safe, equitable reproductive care. Despite these new regulatory changes, the FDA cautions against ordering mifepristone online, warning patients that they may encounter fraudulent pharmacies and endanger their well-being. A prescription from a certified medical practitioner is necessary to ensure patient safety. Clinicians and pharmacists are encouraged to review potential side effects of the medication with patients and provide counseling as needed.