Mifeprex (mifepristone) and its generic mifepristone tablets 200 mg (collectively mifepristone) is a misoprostol-based regimen up to 10 weeks of gestation (up to 70 days after the first day of the patient’s last menstrual period). approved to terminate intrauterine pregnancies. The FDA approved him first Mifeprex in 2000, and in 2019 he approved his Mifepristone tablets 200 mg, the generic version of Mifeprex.
Risk Evaluation and Mitigation Strategy (REMS) Information
Mifeprex and its generic Mifepristone Tablets 200 mg are available under a single shared system risk assessment and mitigation strategy (REMS) known as the Mifepristone REMS program. Up to 10 weeks of gestation.
Under the Mifepristone REMS program, Mifepristone must be dispensed by or under the supervision of a licensed prescriber or by a licensed pharmacy on prescriptions issued by a licensed prescriber. In the Mifepristone REMS program, Mifepristone can be dispensed in person or by mail.
Mifeprex was approved in 2000 with restrictions to ensure safe use. Mifeprex was deemed to have validly an approved REMS under the Food and Drug Administration Amendments Act of 2007. Medical abortion of an intrauterine pregnancy up to 70 days of gestation (known as the Mifepristone REMS program).
In 2021, after reviewing the Mifepristone REMS program, FDA will use available data and information to help reduce the burden on the healthcare delivery system and ensure that the benefits of the product outweigh the risks. Decided to support the change. The mifepristone REMS program changed on January 3, 2023. Under the Mifepristone REMS program:
- Mifepristone must meet certain eligibility and be prescribed by a qualified healthcare provider under the Mifepristone REMS program.
- To be eligible to prescribe mifepristone, a healthcare provider must complete a prescriber consent form.
- The Patient Consent Form should be reviewed and signed by the patient and healthcare provider and should fully inform the patient of the risks of the mifepristone treatment regimen before prescribing mifepristone.
- Patients should be provided with a copy of the Patient Consent Form and a Mifepristone Medication Guide (FDA-approved information for patients).
- Mifepristone may be dispensed by or under the supervision of a licensed prescriber or by a licensed pharmacy under a prescription issued by a licensed prescriber.
- To be authorized to dispense mifepristone, pharmacies must complete a pharmacy agreement.
- Licensed pharmacies must be able to ship mifepristone using a shipping service that provides tracking information.
- Licensed pharmacies must ensure that mifepristone is administered to patients in a timely manner.
For more information, see Q&A on Mifepristone for abortion up to 10 weeks of gestation.
FDA does not recommend buying Mifepristone online
Mifepristone prescribed under the REMS program is dispensed by your healthcare provider (or someone under your healthcare provider’s supervision) or by the pharmacy where your healthcare provider submitted the prescription. will be You can ask your healthcare provider if they are certified in the Mifepristone REMS program (or if they work under the supervision of someone who is certified). The FDA does not recommend purchasing mifepristone outside of the Mifepristone REMS program. For example, buying online or personally shipping from a foreign country. When a person does so, they are circumventing important safeguards specifically designed to protect their health. It has been reviewed and is subject to FDA-regulated manufacturing controls, including inspections of manufacturing facilities. In general, prescription drugs purchased from foreign sources are not FDA-approved versions. The FDA has no regulatory oversight over prescription drugs outside the legal U.S. pharmaceutical supply chain. Therefore, FDA cannot guarantee the safety, efficacy, or quality of these drugs.
For more information on how to safely buy medicines, visit BeSafeRx: Your Source for Online Pharmacy Information.
Labeling and regulatory history from Drugs@FDA
Mifepristone tablet 200mg