Upcoming Changes to the Mifepristone REMS Program: Implications for Pharmacy Practice

Mifepristone REMS Change

Pharmacists in the community setting may soon have the opportunity to ease access to medication abortion in the United States. In the coming months, mifepristone (Mifeprex) is anticipated to have an updated Risk Evaluation and Mitigation Strategy (REMS) Program that allows dispensing through local brick-and-mortar and mail-order pharmacies. This change will integrate pharmacists into abortion care and bring them to the forefront of the national discussion about reproductive rights. Staying up to date on new regulations and their legal implications is paramount for successfully navigating this new role pharmacists can play in reproductive health and providing the best patient care.


Mifepristone (Mifeprex) and misoprostol (Cytotec) are used together for medication abortion, or drug-induced interuterine pregnancy termination. Since 2000, this medication combination has provided pregnant patients with a safe, noninvasive means to end an unwanted but otherwise uncomplicated pregnancy. Patients first take mifepristone, followed by misoprostol in 24 to 48 hours. While misoprostol is dispensed at the prescriber’s office or a local pharmacy, there have historically been strict dispensing regulations on mifepristone.

In order to access medication abortion, patients must first make an appointment with a reproductive healthcare provider to ensure that there are no contraindications to this method of pregnancy termination. Prior to the coronavirus-19 pandemic, the prescriber of mifepristone was the only individual allowed to dispense this medication. Patients were required to be physically present with the prescriber to obtain mifepristone. Appointments to receive this medication often occur after the initial pregnancy screenings, and barriers to abortion such as intimidation by protestors and geographical proximity to clinics severely limited patient access to this service. 

During the coronavirus pandemic, enforcement of the in-person dispensing requirement has been relaxed with the condition that adherence to all other requirements included in the Patient Agreement Form be maintained, allowing for the utilization of mail to dispense mifepristone, either mailed to the patient from the clinic or a partner mail-order pharmacy. This temporary change has not only allowed greater access to medication abortion, but has led to increased calls for the permanent modification of the REMS Program associated with mifepristone.

More information on medication abortion can be found here.

Forthcoming FDA Update to the Mifepristone REMS Program

The success of the pandemic-spurred dispense by mail model emboldened advocacy for adjusting the provisions associated with mifepristone. Though no formal announcement was made, the FDA’s question and answer webpage on mifepristone was updated on December 16, 2021 to include upcoming changes. After a comprehensive review of the safety data collected through mifepristone’s REMS Program, the FDA indicated that an updated REMS is appropriate and should include pharmacy dispensing of this medication. 

While this change brings a groundbreaking transformation to safe abortion access in the United States, there are limitations on its timely implementation into pharmacy practice. Customary with the FDA’s policies for updating REMS requirements, REMS modification notification letters have been sent to the manufacturers of Mifeprex and generic mifepristone. The manufacturers, Danco Laboratories and GenBioPro, will draft an updated REMS Program and submit it to the FDA for approval. Once approved, the modifications to the REMS Program will be in effect. Pharmacies will need to be certified to dispense mifepristone.

This change will only affect the dispensing aspect of mifepristone use. The requirements associated with the safe prescribing of this medication will likely remain the same.

How to Prepare for Changes to Pharmacy Practice 

Though the details of the updated REMS Program are not yet public, there are steps that pharmacists can take in order to prepare for this change.

  • Become familiar with the websites for Mifeprex and mifepristone from Danco Laboratories and GenBioPro. The current process for prescribers to certify to prescribe and dispense this product, the Prescriber Agreement Form, is relatively straightforward. It is likely that the certification process for pharmacies will be similar.

  • Complete a continuing pharmacy education program on medication abortion to get acquainted with the adverse events, contraindications, counseling points, and follow up requirements associated with mifepristone and misoprostol.

  • Develop pharmacy policies regarding the dispensing of this medication. If a pharmacist on staff is not willing to verify and dispense a mifepristone prescription, there should be reasonable alternatives in place to ensure patient access to this medication.

  • Identify local resources for patients. In states where abortion restrictions are in place, it is incredibly important to stay up to date on the options that patients have for safe and effective reproductive care. 


Pharmacists have been and continue to be the most accessible healthcare providers to patients. With the upcoming modification to mifepristone’s REMS Program, pharmacists can play a larger role in patients’ reproductive health. Commitment to lifelong learning is an essential component of effective pharmacy practice. Regardless of personal beliefs, we as healthcare providers have a responsibility to practice in an educated way that is respectful of our patients’ autonomy and right to care within the law.


MuscatAbout the Author


Jacqueline Muscat is a pharmacy student in the Class of 2023 at University of Michigan College of Pharmacy.

Society of Family Planning Annual Meeting Highlights

SFP Annual Meeting Highlights Quyen NguyenThe Society of Family Planning (SFP) annual meeting was held virtually on October 1st and 2nd this year with well over one thousand attendees. For those who are not familiar with SFP, it is a community of like-minded people including clinicians, academics, residents, fellows, and students who share the same interest for family planning. SFP values diversity, equity, and the science behind abortion and contraception for everyone. I had the privilege of attending the meeting as part of an APPE rotation with Dr. Sally Rafie at Birth Control Pharmacist.

There were some highlights at the meeting:

Health Disparities Among Asian Americans and Pacific Islanders

On the days of the meeting, the opening plenary was presented by a group of panelists from across the country on the history that led to health disparities among Asian American and Pacific Islanders (AAPIs) and how future generations of healthcare providers, researchers can help address this gap. My favorite part of this presentation was listening to the vulnerability of the children of immigrants, through the lens of the panelists, regarding their experience about sexual reproductive health, and how much of a taboo topic it is to talk with their parents or even healthcare providers. Coming from a family of immigrants, this presentation hit home and how much it resonated with me professionally and personally. It was, as if, they were telling my story, and I am positive many fellow AAPIs feel the same way. To tell you the least, this plenary made me feel seen and inspired me to advocate for equitable health care among fellow Asian American, Native Hawaiian and Pacific Islanders (AANHPIs) as an aspired ambulatory care pharmacist. As of now, the panelists are continuing to conduct more research to help AANHPIs in the near future regarding access to health care.

Impact of the Pandemic on Access to Care

The pandemic has changed the climate of healthcare delivery here in the United States. It was a challenge for patients, especially women and BIPOC, to visit their doctor’s office for appointments such as getting their birth control shot. Health care disparities also increased in women during the pandemic, and contraceptive visits have declined as well.

Evidence reviewed by Dr. Nguyen at the CDC and colleagues showed that the use of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) in four studies with self-injection and provider-injection groups resulted in no differences in pregnancies and side effects, along with higher continuation rate in the self-administered DMPA-SC at 12 months, therefore DMPA-SC should be offered to patients to increase access to reproductive care.

Another group of panelists presented on the impact of tear gas used by law enforcement and reproductive health following the racial justice protests in 2020. What they found was 100% of the participants in their research had health problems due to tear gas, alarmingly, 54.5% had changes to menstrual health such as increased bleeding, cramping, and unusual spotting.

Innovations in Abortion Care

 The closing plenary was nothing short of relatable to what is going on in the country at the moment; the panelists presented on self-managed medication abortion in the United States among providers, patients, and seekers. Due to strict state laws regarding abortion and increased distances to abortion clinics, a telemedicine service was used to deliver medication abortion saw an increase of more than 40% within the last two years and it resulted in 96% of successful abortion and only 1% resulted in any serious adverse events.  Unrelated to this study, but if pharmacies are able to dispense medication abortion, pharmacists get to use their expertise to help ease the anxiety and panic patients are facing who want an abortion but cannot access care.

Apart from disseminating information about family planning, there were presentations on how to use oral hormonal contraceptives in other health conditions. Additionally, there was a plethora of presentations on relevant topics such as how to counsel transgender and nonbinary patients on emergency contraceptives, anti-Black racism in obstetrics and gynecology, and many more.

Movie Screening & Discussion

To close out the annual meeting, and in my opinion, one of the many amazing things that happened at this meeting was the community screening of HBO Max’s Unpregnant. This movie depicts the struggles of two girls who are minors and cannot find an abortion clinic in their state that would provide care without parental consent and how religion plays a role in hindering an abortion. So, they had to drive from Kansas to New Mexico with hardly any resources to get to the clinic.

I hope this article sparks some interests and encourages you to play a part in advocating for reproductive justice.

For more information about the Society of Family Planning, visit https://www.societyfp.org/.

About the Author

Quyen Nguyen Headshot

Quyen Nguyen, PharmD Candidate 2022, is currently attending St. John Fisher College Wegmans School of Pharmacy in Rochester, New York. She is a member of APhA and the Treasurer for Club for Advancing Interprofessional Practice and Education (CAIPE). In this role, she collaborates with other healthcare professional students to help underserved patients in her community.