Mifeprex and generic mifepristone tablets 200 mg are provided under a single Risk Evaluation and Mitigation System (REMS) strategy, known as the Mifepristone REMS Program. This program specifies the requirements that mifepristone must meet for medical termination of pregnancy. 10 weeks pregnant. Mifepristone Under the REMS program, mifepristone must be dispensed by or under the supervision of a certified physician or at a certified pharmacy when prescribed by a certified physician. The Mifepristone REMS program can dispense mifepristone in person or by mail.
(mifepristone) and generic Mifepristone 200 mg tablets (Co-mifepristone) are approved for use in combination with misoprostol to terminate an intrauterine pregnancy up to the 10th week of pregnancy (within 70 days from the first day of the patient’s last pregnancy). menstrual period). The FDA first approved Mifeprex in 2000, and in 2019 approved a generic version of Mifeprex, mifepristone 200 mg tablets.
Mifepristone must be prescribed by a qualified and certified health care provider under the Mifepristone REMS Program. To be certified to prescribe mifepristone, your healthcare provider must complete a prescriber consent form. A patient consent form must be reviewed and signed by the patient and healthcare provider, and the risks associated with the mifepristone treatment regimen must be fully explained to the patient before prescribing mifepristone. Patients must be provided with a copy of the patient consent form and mifepristone prescribing information (FDA-approved patient information). Mifepristone may be dispensed only by or under the supervision of a licensed physician or at a certified pharmacy with a prescription issued by a licensed physician. To obtain a certificate of dispensing mifepristone, you must fill out a pharmacy contract form at the pharmacy. Certified pharmacies must be able to ship mifepristone using a shipping service that provides tracking information. Certified pharmacies must ensure that mifepristone is administered to patients in a timely manner.
