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FDA approves abortion pill distribution at pharmacies

The U.S. Food and Drug Administration has approved certified pharmacies for distribution of abortion medication to those who have a prescription, according to CNN.

Two pills called misoprostol and mifepristone, when combined, cause a medical abortion according to the FDA’s website.

“Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy through ten weeks gestation,” the website reads.

Prior to COVID-19, these drugs could only be ordered, prescribed, and dispensed by a certified health care provider. However, the FDA temporarily approved the drug mifepristone to be acquired by mail without permission/prescription from a clinic or hospital under public health orders. That rule change is now permanent.

The FDA’s website also provides detailed instructions on how to properly use the drugs to induce an abortion, advising users to seek medical assistance with a health care provider “about seven to fourteen days after taking.”

Danco Laboratories, which markets the drugs under the name Mifeprex, proudly announced the policy change on its website:

“Danco Laboratories is pleased to announce that on January 3, 2023, the FDA approved Risk Evaluation and Mitigation Strategy (REMS) modifications to the Mifepristone REMS Program,” the homepage says.

To become a certified provider or prescriber for the medication, Danco Laboratories requires applicants fill out an online form.

“At a time when people across the country are struggling to obtain abortion care services this modification is critically important to expanding access to medication abortion services,” the pharmaceutical company announced.

“[This] will provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy. Danco is proud and honored to continue the work with Mifeprex providers and the reproductive rights community that has spanned more than two decades,” the press release reads.

The drug Mifeprex was approved by the FDA for abortions in September 2000. According to Danco Laboratories, the product has been used by over four million women in the United States since its approval.

The pill blocks a hormone called progesterone, a naturally-produced hormone that prepares the lining of the uterus for a fertilized egg. The “uterus softens, breaks down and bleeding begins,” according to the drug’s manufacturer.

The drug’s 97% effectiveness rate comes with a 3% chance that “women will require surgical intervention for ongoing pregnancy, heavy bleeding,” or “incomplete expulsion.”

The company’s media release also warns that “serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifeprex use.”

The Justice Department recently cleared the U.S. Postal Service to deliver the abortion medication by mail, determining that mailing the products does not violate the Comstock Act, a federal statute from 1867 which supresses the trade and circulation of “Obscene Literature and Articles of Immoral Use.”

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