Abortions pills can be dispensed at pharmacies nationwide under new FDA rules

As the first week of 2023 approaches, the U.S. Food and Drug Administration (FDA) has quietly announced new regulations regarding the dissemination of the abortion drug mifepristone. The decision has the potential to expand nationwide access to medical abortion through patients’ local pharmacies, if companies agree.

A new regulatory change, known as the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program, will allow pharmacies, from local businesses to large retailers, to receive valid Mifepristone prescriptions from accredited health care providers with face-to-face access. You will be able to fill it out without needing a dose. clinic or doctor’s office.the adjusted language Federal Agency Information Pages on Mifepristone (aka Mifeprex) Tuesday, January 3, new york times reportand also the agency Updated online FAQ about drugs and how to use them.

The pill is part of a medically safe and very common two-pill medical procedure.As Planned Parenthood explains on their website, Mifepristone blocks an individual’s progesterone production and halts gestational growth. Misoprostol then causes cramps and bleeding, clearing the uterus. It had to be administered to patients by a nurse or doctor at one medical center, and guidelines for use and care varied depending on where the tablets were received. The new FDA rule moves away from that procedural requirement to allow pregnant women to obtain prescriptions directly from pharmacies.

“Mifepristone may only be dispensed by or under the supervision of an accredited prescriber or by an accredited pharmacy under a prescription issued by an accredited prescriber,” the new rule states. read. “Accredited pharmacies should ensure that mifepristone is administered to patients in a timely manner.”

Providers must be qualified to supervise the use of medications under the Mifepristone REMS program. This is where many pay attention. Pharmacies must choose to qualify to dispense pills through a separate FDA process. As of Tuesday, major retail pharmacy chains such as Walgreens and CVS had only promised to review the updated requirements. A CVS spokesperson said it was “evaluating the requirements for dispensing drugs in states that do not restrict access to abortion drugs.”

In 2019, the FDA concurrently approved a generic version of Mifeprex and the REMS Collaborative Drug Safety Program for administering two forms of mifepristone. Two years later, based on the FDA’s review of the program’s effectiveness and health safety, the FDA removed the in-person physician appointment requirement (prioritizing the need for expanded telemedicine access) and made it permanent. Approved mailing prescription for pills.

These decisions stem from the need to address public health and safety concerns affecting individuals across the United States. use pill-based medical proceduresAccording to the FDA website, the FDA currently does not recommend individuals purchase mifepristone from online sources.

But The global Reproductive Justice Network has long found that this is the only way to receive medical abortion care at home., especially in countries where abortion is illegal. In 2022, as the threat of state abortion bans and federal repeal of abortion rights loomed over Americans, many individuals began outsourcing these needs across borders. Local Abortion Fund and Advocate for Reproductive Justice Who can provide help if the need arises in a post-Roe America? Sites and organizations like Plan C have become a frequent source of information on how people in the United States are receiving home care.

It is hoped that the new flexibility provided by the FDA’s procedural changes may eliminate this need for individuals who have access to both accredited physicians and compliant pharmacies. But there is still a gatekeeper in the true reach of the decision.