Questions & Answers on the FDA’s Latest Decision to Allow Pharmacies to Stock and Sell the Abortion Pill Mifepristone

Part One: Is my neighborhood drug store going to become an abortion clinic?

By Dave Andrusko

Editor’s Note: Part Two of this Q&A series can be found here. Part Three can be found here.

On January 3rd of this year, the U.S. Food and Drug Administration (FDA) officially published new rules authorizing appropriately certified pharmacies to stock and distribute abortion pills to women with prescriptions from a certified prescriber.  Exactly what this means, and how it affects people in states where there are currently legal protections in place for unborn children and their mothers, are a few of the matters we sought to clarify with Dr. Randall K. O’Bannon, National Right to Life’s Director of Education and Research. Dr. O’Bannon has closely monitored the issue of chemical abortion for nearly thirty years.

Q. Does this mean that abortion pills are now available over the counter at my local pharmacy without a prescription?

A. No. While that is clearly the ultimate aim of abortion pill promoters, at this point the FDA only authorized pharmacies to dispense these under strict conditions. That pharmacy, whether a brick-and-mortar retail store or an online entity, must certify that they have a designated person to complete a Pharmacy Agreement Forman ensure pharmacy compliance. This person is to review the FDA’s prescribing information for mifepristone and is required to verify that they have, on file, a Prescriber Agreement Form from any health care provider sending them a prescription. 

Under the terms of their certification, the pharmacy is not to sell or distribute the abortion drugs to anyone who does not have a prescription from a verified certified prescriber; this rules out over-the- counter sales or even prescriptions from doctors or other medical agents unknown to the pharmacy. Drugs are to be delivered to the patient within four calendar days, with the pharmacy tracking and recording all shipments. The pharmacy is also responsible for reporting all deaths to the prescriber who is to report these to distributor.

A pharmacy which does not agree to comply with these conditions is not authorized to stock and sell these abortion pills.

Q. Weren’t pharmacies already stocking and filling prescriptions for mifepristone and misoprostol all along?  How did the FDA’s decision change things? When does this start?

A. Prior to this point, this combination of two pills was only available from the healthcare provider–the prescriber who filled out forms and agreements–and he or she got those pills directly from the FDA authorized distributor. Patients taking these pills could get them by visiting the prescriber or having him or her ship them to their homes from the prescriber’s clinic or office. Previously, abortion pills were not shipped or stocked in U.S. pharmacies.

However, at the request of the newly installed Biden administration, in May of 2021,the FDA conducted a review of REMS (Risk Evaluation and Mitigation Strategies) regulations regarding mifepristone. The REMS are rules that the FDA has put in place to ensure that certain drugs with serious safety concerns (like mifepristone) can be used in a way designed to reduce those risks. Upon completion of that review in December of 2021, the FDA announced that it was revising the REMS to drop the requirement that the drugs be dispensed in person to the patient. The FDA also said that it would no longer limit distribution to prescribers and their offices: pharmacies would now also be allowed to stock and dispense the abortion drug.

The new rules were not formally spelled out until January 3rd of 2023, when the FDA published the modified REMS and new procedures explaining how this could be done. Any pharmacy completing the certification process could legally begin filling prescriptions for abortion pills at that point. However, even for those wishing to do so, it will likely take some time for stores to train employees, set up the system, and fill out the proper paperwork.

Before this, any online pharmacy or mifepristone promoter selling pills was either doing so illegally or possibly operating under the older regulations using a previously certified prescriber to order and distribute the pills.

Q. Will my local CVS, Walgreens, or Rite Aid be stocking and filling prescriptions for the abortion pill?

A. After the FDA announced its decision, corporate offices of CVS, Walgreens, and Rite Aid all announced their intentions to comply with the certification procedure and stock and distribute the drug. As of this writing, none have claimed to have set up the program in any of its drug stores yet.  That is, none had indicated that they had trained the appropriate staff, filled out the required certification forms, set up the database of certified prescribers or set up the system for shipping and tracking deliveries of pills to patients.

It may take some time for these corporations to fully set up the system at it stores, to identify and train the appropriate employees, and some stores and staffs may not wish to take part in it. For now, the drugstore chains have said they will confine their dispensing of the drugs to stores in states where these chemical abortions are allowed by state law.

If you haven’t let the corporate offices of CVS, Walgreens, and Rite Aid know of your opposition to their plans, do so immediately. Ask that they consider whether selling abortion drugs is good business, much less an appropriate activity for a company supposedly devoted to healthcare.

But also contact your local CVS, Walgreens, or Rite Aid stores, particularly ones where you might previously have done business, and find out whether they intend to participate in the announced corporate program. Find out how they feel about turning your local store into an abortion clinic or an abortion pill outlet.  You may find that they are as troubled by the prospect as you and could use your support in fighting against the corporate policy.

Editor’s note. In Part Two, Dr. O’Bannon will explain the new chemical abortion protocol and why it may make things more dangerous for patients getting these prescriptions by telemedicine and having pharmacies shipping these pills to their homes.