Removal of REMS Contributes to Access of Mifepristone

The FDA’s removal of the Risk Evaluation and Mitigation Strategy (REMS) requirement for in-person dispensing of mifepristone (Mifeprex) was associated with a significant increase in access to the drug in pharmacies, according to JAMA.¹ More specifically, however, a majority of prescriptions for mifepristone were filled through mail-order pharmacies and telehealth prescribers.

“The FDA in January 2023 permanently removed rules requiring patients to obtain mifepristone—the first of 2 drugs used in medication abortion—in person at a clinic or hospital,” according to a Medical Xpress article written by the University of Southern California.² “That change meant in-store and mail-order pharmacies could provide the drug when it was prescribed by a certified provider, a shift expected to broaden access nationwide.”

This regulatory shift, which modified the longstanding REMS, was designed to broaden access by allowing certified retail and mail-order pharmacies to dispense the medication when prescribed by a certified provider.^1-3

According to the JAMA study, the impact was immediate and substantial, particularly for pharmacists navigating a post-Roe environment.¹

READ MORE: Federal Judge Temporarily Upholds Access to Abortion Medication

Pharmacy’s Role in Expanding Mifepristone Access

The study reveals that monthly mifepristone prescriptions filled at pharmacies jumped from a mean of 17.9 to over 2730 following the policy change. Mail-order pharmacies have become the primary channel for this growth, accounting for nearly 98% of fills in the post-policy period. This shift is particularly pronounced in the 27 states and Washington, DC, where abortion remains legal and telehealth is permitted.^1,2

In these regions, in-store pharmacies handled less than 2% of the volume, with independent pharmacies significantly outperforming national chains. However, in the 11 states where abortion is legal but telehealth is restricted, retail pharmacies have filled a critical gap, accounting for approximately 61% of prescription fills.

For pharmacists, as the FDA states, this evolution necessitates a deep understanding of the mifepristone REMS program, which mandates that the drug only be dispensed by certified pharmacies for prescriptions from certified providers. To participate, pharmacies must complete a specific pharmacy agreement form, ensure timely dispensing, and utilize shipping services that provide tracking information.³

Furthermore, the FDA limits the use of mifepristone for medical termination to 70 days of gestation or fewer. Although clinical research suggests high patient accuracy in self-eligibility assessment, pharmacists remain essential for contraindication screening and managing the shipment tracking required under the REMS.^3,4

The Heated Political Climate

This expansion of access occurs against a backdrop of extreme legal and jurisdictional volatility. Since the Supreme Court overturned Roe v. Wade, the Center for Reproductive Rights notes that states have divided into a spectrum ranging from expanded access to fully illegal.⁵

Pharmacists now operate within a complex patchwork of laws, including 18 states with telemedicine bans and 14 states where abortion is entirely prohibited and enforced with criminal penalties.

In some hostile jurisdictions like Louisiana, officials have taken the unprecedented step of scheduling mifepristone as a controlled substance, significantly increasing compliance risks and potential criminal exposure for health professionals. Even as a federal judge recently upheld access to the medication by deferring to the FDA’s scientific expertise over judicial interference, the court mandated a safety review update within 6 months, signaling that the current regulatory status is not indefinite.⁴

Navigating this landscape also involves managing divergent corporate policies and political pressure. Although major chains like CVS and Walgreens have announced they will offer the drug in certain legal jurisdictions, others, such as Costco, have declined to carry it. Meanwhile, proposed federal legislation seeks to revoke FDA approval for abortion entirely, while retaining it mainly for Cushing syndrome.^2,4

This would force pharmacists to manage the same molecule under 2 separate legal frameworks, depending on its indicated use. As pharmacists navigate these technical, legal, and digital hurdles—from certification paperwork to the occasional complexities of accessing secure medical information in a fractured digital landscape—the pharmacy’s role in reproductive health continues to undergo a high-stakes evolution.^4,5

“Study findings suggest that removing in-person dispensing requirements may increase access in states with telehealth restrictions through retail and mail-order pharmacies,” concluded authors of the current study.¹ “Efforts to identify and address barriers in the implementation of mifepristone dispensing at retail pharmacies in states without a total ban are needed.”

READ MORE: Women’s Health Resource Center

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REFERENCES

1. Scannell C, Kakani P, Myerson R, et al. Changes in mifepristone use at pharmacies after removal of the FDA in-person dispensing requirement. JAMA. April 13, 2026. doi:10.1001/jama.2026.3419

2. Despite FDA rule change, few retail pharmacies dispense mifepristone. Medical Xpress. April 13, 2026. Accessed April 16, 2026. https://medicalxpress.com/news/2026-04-fda-retail-pharmacies-mifepristone.html

3. Information about mifepristone for medical termination of pregnancy through ten weeks gestation. FDA. January 17, 2025. Accessed April 16, 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation

4. Nowosielski B. Federal judge temporarily upholds access to abortion medication. Drug Topics. April 9, 2026. Accessed April 16, 2026. https://www.drugtopics.com/view/federal-judge-temporarily-upholds-access-to-abortion-medication

5. After Roe fell: U.S. abortion laws by state. Center for Reproductive Rights. March 2026. Accessed April 16, 2026. https://reproductiverights.org/maps/abortion-laws-by-state/