FDA REMS Update
On January 3rd, 2023, the FDA released updated Risk Evaluation and Mitigation Strategies (REMS) for Mifepristone, opening a pathway for pharmacies in all settings, including brick-and-mortar retail pharmacies, to become certified to dispense Mifepristone. Through this process, eligible clinicians who fill out a Prescriber Agreement Form will be able to prescribe Mifepristone to patients. Pharmacies that seek to dispense Mifepristone can complete and submit a Pharmacy Agreement Form to the drug sponsors, which will begin the process for that pharmacy to purchase Mifepristone and fill patient prescriptions from Certified Prescribers. Through Certified Prescribers and Pharmacies, patients will be able to more efficiently access this safe, FDA-approved medication.
Updated FDA REMS Pharmacy Certification Process for Mifepristone
In order for a pharmacy to dispense Mifepristone, it must be geographically located in a state where medication abortion is legal and fill out and be prepared to comply with the terms identified in the Pharmacy Agreement Form provided by either Danco or GenBioPro. Once completed, the form should be submitted to the respective company. Representatives from Danco or GenBioPro will contact the pharmacy to discuss details for purchase of the medication.
Notably, under the updated REMS for Mifepristone, each Certified Pharmacy must verify that the prescriber is certified in the Mifepristone REMS Program. Certified Pharmacies can satisfy this requirement by confirming that a completed Prescriber Agreement Form from either Danco or GenBioPro is on file with the pharmacy for the relevant prescriber upon receipt of a Mifepristone prescription.
Qualifications for a Pharmacy to Dispense Mifepristone
The Pharmacy Agreement Form outlines requirements for pharmacies seeking to dispense Mifepristone. These requirements are:
- A pharmacy will select an authorized representative to carry out and oversee the certification, implementation, and compliance of the Mifepristone REMS. Note: Hospital pharmacies, and pharmacies in clinics that are already considered certified pharmacies do not need to complete this certification.
- Certification will only apply the individual pharmacy that files. To be certified pharmacies must attest to the following items:
- Each location of my pharmacy that will dispense mifepristone is able to receive Prescriber Agreement Forms by email and fax.
- Each location of my pharmacy that will dispense mifepristone is able to ship mifepristone using a shipping service that provides tracking information.
- I have read and understood the Prescribing Information for mifepristone. The Prescribing Information is available on the drug sponsors page.
- Each location of my pharmacy that will dispense mifepristone will put processes and procedures in place to ensure the following requirements are completed. I also understand that if my pharmacy does not complete these requirements, the distributor may stop accepting mifepristone orders.
- Verify that the prescriber is certified in the Mifepristone REMS Program, by confirming their completed Prescriber Agreement Form was received with the prescription or is on file with the pharmacy.
- Dispense mifepristone such that it is delivered to the patient within 4 calendar days of the date the pharmacy receives the prescription, except as provided in the following bullet.
- Confirm with the prescriber the appropriateness of dispensing mifepristone for patients who will receive the drug more than 4 calendar days after the date the pharmacy receives the prescription and document the prescriber’s decision.
- Record in the patient’s record the NDC and lot number from each package of mifepristone dispensed.
- Track and verify receipt of each shipment of mifepristone.
- Dispense mifepristone in its package as supplied by Danco Laboratories, LLC, or GenBioPro, Inc.
- Report any patient deaths to the prescriber, including the NDC and lot number from the package of mifepristone dispensed to the patient, and remind the prescriber of their obligation to report the deaths to Danco Laboratories, LLC and GenBioPro, Inc. Notify Danco and GenBioPro that your pharmacy submitted a report of death to the prescriber, including the name and contact information for the prescriber and the NDC and lot number of the dispensed product. Danco LLC (Mifeprex)
- Not distribute, transfer, loan or sell mifepristone except to certified prescribers or other locations of the pharmacy.
- Not distribute, transfer, loan or sell mifepristone except to certified prescribers or other locations of the pharmacy.
- Maintain the identity of mifepristone patients and prescribers as confidential and protected from disclosure except to the extent necessary for dispensing under this REMS or as necessary for payment and/or insurance.
- Train all relevant staff on the Mifepristone REMS Program requirements.
- Comply with audits carried out by the Mifepristone Sponsors or a third party acting on behalf of the Mifepristone Sponsors to ensure that all processes and procedures are in place and are being followed.
How to become a Certified Prescriber for Mifepristone
Any provider seeking to become Certified Prescriber for Mifepristone will complete a Prescriber Agreement Form with Danco or GenBioPro. The prescriber will then share that form with each Certified Pharmacy where they submit a Mifepristone prescription. Note: Prescriber Agreement Forms do not need to be submitted to Danco or GenBioPro.
To be a Certified Prescriber and complete the Prescriber Agreement Form, you must meet the following qualifications and guidelines.
Qualifications
Guidelines
Resources
Questions about the Pharmacy Agreement Form or the Prescriber Agreement Form?
Email Danco
Email GenBioPro