FDA-Approved Generic Mifepristone Tablets, 200 mg, Are Now Available
The first FDA-approved generic mifepristone (equivalent to Mifeprex®) is now available from GenBioPro. It is used in combination with misoprostol for abortion up to 70 days gestation.
Become a Certified Pharmacy to Start Dispensing
To begin dispensing GenBioPro generic mifepristone tablets, 200 mg, you must first become a GenBioPro certified pharmacy. It’s quick and easy.
- Designate a champion who will be your authorized representative to centralize communications, provide program oversight, and manage compliance.
- Download a Pharmacy Agreement.
- Fill out the form as instructed and sign where indicated.
- Submit the signed agreement to GenBioPro by faxing it to 1-877-239-8036 or by emailing it to RxAgreements@genbiopro.com.
A GenBioPro representative will contact you directly once your certification is received and discuss next steps in the procurement process. That’s all it takes to become a GenBioPro certified pharmacy.
Mifepristone is available only under an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) program. To become a certified pharmacy and fill prescriptions for GenBioPro generic mifepristone tablets, 200 mg, a pharmacy must be able to meet the requirements of the REMS program.
Detailed Requirements for GenBioPro Certified Pharmacies
All pharmacies dispensing GenBioPro generic mifepristone tablets, 200 mg, must:
- Designate an authorized representative on behalf of the pharmacy to oversee implementation and compliance with the REMS program governing dispensing of generic mifepristone tablets, 200 mg.
- Ensure that GenBioPro generic mifepristone tablets, 200 mg, will be delivered to the patient within 4 calendar days of the date the pharmacy receives the prescription, unless otherwise approved by the prescriber.
- Record in the patient’s record the NDC and lot number of each package of GenBioPro generic mifepristone tablets, 200 mg, dispensed.
- Track and verify receipt of each shipment of GenBioPro generic mifepristone tablets, 200 mg.
- Contact the prescriber and GenBioPro immediately to report any adverse events, designating the patient by a non-identifiable reference and the recorded NDC and lot number of the dispensed GenBioPro generic mifepristone tablets, 200 mg.
- Train all relevant staff on the REMS program requirements for generic mifepristone tablets, 200 mg.
To review the FDA-Approved Mifepristone REMS program requirements, visit REMS@FDA
Mifepristone is used in combination with misoprostol to carry out an early abortion. “Early” is defined as up to 70 days from the first day of the patient’s last menstrual period.
How it is Prescribed and What Patients Should Expect
- One 200 mg generic mifepristone tablet is administered orally.
- Four 200 mcg misoprostol tablets are taken buccally 24-48 hours after ingestion of mifepristone. Two tablets are placed in each cheek pouch for 30 minutes and then any remnants are swallowed with liquid.
- The health care provider may prescribe or recommend additional medicine or prescriptions to help manage common cramps or gastrointestinal symptoms.
- Most pregnancies will be expelled within 2-24 hours after the administration of the misoprostol.
- Patients follow up with their health care provider 7 to 14 days following ingestion of the generic mifepristone tablet, 200 mg, to assess bleeding and confirm termination of pregnancy.