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# FDA Changes Mifepristone REMS
- URL: https://www.fdaweb.com/fda-changes-mifepristone-rems/
- Published: 2023-01-04T12:00:00.000Z
- Updated: 2026-09-14T18:10:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153459

FDA has modified the mifepristone REMS program to allow Mifeprex (commonly referred to as an abortion drug) and its approved generic to be dispensed by certified pharmacies or by or under the supervision of a certified prescriber. An agency question-and-answer [notice](https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation?ref=fdaweb.com) says the change was made in response to supplemental applications, as amended, submitted by the applicant for Mifeprex and the approved generic tablets to remove the in-person dispensing requirement and add pharmacy certification. The supplemental applications were submitted after FDA sent 12/16/21 REMS modification notifications to the applicants.

The notice says the REMS modification was not in response to the Supreme Court’s 2022 decision in *Dobbs v. Jackson Women’s Health* that overturned the *Roe v Wade* precedent. Rather, it says, the 2021 REMS review that led to the change was related to the litigation in *Chelius v. Becerra* that involved the single, shared system REMS for Mifeprex and its generic. A stay in that litigation was granted 5/7/21 and under that stay and in conjunction with regular periodic assessments of the REMS, the agency reviewed the REMS in 2021 and approved the supplemental applications 1/3.