We are pleased that you wish to become a provider of Mifeprex*(mifepristone).
Because of the risks of serious complications, Mifeprex is available only through a restricted program called the MIFEPREX Risk Evaluation and Mitigation Strategy (REMS) Program.
Notable Requirements of the Mifeprex REMS Program include the following:
- Prescribers must be certified with the program by completing the Prescriber Agreement and Account Setup Form (PDF).
- Patients must sign a Patient Agreement Form (PDF).
- Mifeprex must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber.
For complete information on the Mifeprex REMS Program, please go to mifepristone REMS Program at FDA.
Become a Certified Mifeprex Provider
Healthcare providers who wish to prescribe Mifeprex must be specially certified. To become specially certified to prescribe Mifeprex, healthcare providers must:
- Review the Prescribing Information (PDF) for Mifeprex.
- Complete and sign the Prescriber Agreement and Account Setup Form (PDF)
- Fax the Account Setup Form to the Distributor (page 2 of the Prescriber Agreement Form)
Your account information will be kept strictly confidential. If you oversee more than one office facility, you will need to list each facility on your order form prior to shipping the first order. If you have any questions regarding account setup or ordering Mifeprex, please call 1-877-432-7596.
The distributor will call to finalize your account setup and take your first order. This is a one-time only process; subsequent orders may be phoned in. Once your account has been established, you will usually receive your order within 24 hours. You may request to return product you purchased from the distributor if the product is >30 days of its expiration date and the product is either in its original package or a blistered tablet is found to be chipped, broken or missing.
Patient information materials, including Medication Guides and chart-sized Patient Agreement Forms, will be provided together with your order of Mifeprex. If you would like additional patient information materials you may download them by clicking here . You can also order additional materials to be sent directly to your office by downloading the Reimbursement Information and Additional Materials Order Form (PDF) and faxing it to the distributor.
Qualifications and Guidelines for Mifeprex Providers
Mifeprex must be provided by or under the supervision of a healthcare provider who prescribes and meets the following qualifications:
- Ability to assess the duration of pregnancy accurately.
- Ability to diagnose ectopic pregnancies.
- Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
- Has read and understood the Prescribing Information(PDF) for Mifeprex.
In addition to having these qualifications, you also agree to follow these guidelines for use:
- Review the Patient Agreement Form with the patient and fully explain the risks of the Mifeprex treatment regimen. Answer any questions the patient may have prior to receiving Mifeprex.
- Sign and obtain the patient’s signature on the Patient Agreement Form(PDF).
- Provide the patient with a copy of the Patient Agreement Form (PDF) and the Medication Guide(PDF).
- Place the signed Patient Agreement Form in the patient’s medical record.
- Record the serial number from each package of Mifeprex in each patient’s record.
- Report any deaths to Danco Laboratories, identifying the patient by a non-identifiable reference and the serial number from each package of Mifeprex.