FDA REMS Protocol Modification Provides a Pathway for Pharmacies to Dispense Mifepristone
On January 3, 2023, the U.S. Food and Drug Administration (FDA) modified its risk evaluation and mitigation strategy (REMS) program (“Mifepristone REMS Program”) to provide a process for pharmacies to become certified to dispense Mifepristone, a drug that blocks the progesterone hormone that is needed for a pregnancy to continue.1 When Mifepristone is used with another medication, Misoprostol, it can be used to end a pregnancy through 10 weeks gestation.
Pharmacies that dispense Mifepristone must be certified by the manufacturers of the medication. The pharmacy certification process is the implementation of a REMS modification announced by the FDA on December 16, 2021, which formally removed an in-person dispensing requirement after a relaxation of this requirement due to the COVID-19 public health emergency but added a pharmacy certification requirement. The Mifepristone REMS Program has the following requirements, effective January 3, 2023:
- Mifepristone must be prescribed by a health care provider that meets certain qualifications and is certified under the Mifepristone REMS Program.
- In order to become certified to prescribe Mifepristone, health care providers must complete a Prescriber Agreement Form.2
- The Patient Agreement Form must be reviewed with and signed by the patient and the health care provider, and the risks of the Mifepristone treatment regimen must be fully explained to the patient before Mifepristone is prescribed.
- The patient must be provided with a copy of the Patient Agreement Form and Mifepristone Medication Guide (FDA-approved information for patients).
- Mifepristone may only be dispensed by or under the supervision of a certified prescriber, or by a certified pharmacy on a prescription issued by a certified prescriber.
- To become certified to dispense Mifepristone, pharmacies must complete a Pharmacy Agreement Form.3 Copies of the agreements for both the name brand and generic version of the medication are available here.
- Certified pharmacies must verify the prescriber is certified by confirming their completed Prescriber Agreement Form was received with the prescription or is on file with the pharmacy.
- Certified pharmacies must be able to ship Mifepristone using a shipping service that provides tracking and verification services.
- Certified pharmacies must maintain required patient, dispensing, shipping and NDC records.
- Certified pharmacies must maintain policies and procedures regarding the Program and services provided.
- Certified pharmacies must train all relevant staff on the Mifepristone REMS Program requirements.
- Certified pharmacies must ensure Mifepristone is dispensed to the patient within four calendar days after the prescription was received by the certified pharmacy.4
- Certified pharmacies must confirm with the prescriber the appropriateness of dispensing Mifepristone for patients who will receive the drug more than four calendar days after the date the pharmacy receives the prescription and must document the prescriber’s decision.
While it’s only been a little over a year since the FDA added the pharmacy certification requirement to the Mifepristone REMS Program, the landscape has shifted considerably in the last several months with the U.S. Supreme Court’s June 24, 2022, ruling in Dobbs v. Jackson Women’s Health Organization. Without a constitutional right to abortion, pharmacy providers have been analyzing state laws and federal guidance to determine how best to meet patient needs. This FDA-approved certification process will ease some of that burden on pharmacy providers and provide an avenue for them to dispense Mifepristone within the parameters of the REMS Program. However, for pharmacies that deliver medications across state lines, choice of law issues remain. Mail order pharmacy providers that do business in several states still need to consider both the federal and state laws and guidance in how they approach the dispensing of Mifepristone. We will continue to monitor federal and state law changes post-Dobbs.
If you have any questions, please contact your Quarles & Brady attorney or:
- Jaya White: (312) 715-5242 / email@example.com
- Katie Lavigne: (612) 224-3759 / firstname.lastname@example.org
1 U.S. Food And Drug Administration, Mifeprex (Mifepristone) information.
2 U.S. Food And Drug Administration, Mifepristone Materials.
4 U.S. Food And Drug Administration, Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation; Questions and Answers on Mifepristone