US FDA Approve Sale of Abortion Pills at Retail Pharmacies

HEALTHCARE

Despite the fact that more US states are attempting to ban medication abortion, the Food and Drug Administration (FDA) of the United States has stated that retail pharmacies will be able to offer abortion pills for the first time in the country.

The US FDA said that, under the Mifepristone REMS Program and the approved generic medication, can be dispensed by some certified pharmacies or under the supervision of a certified prescriber.

As President Joe Biden’s administration grapples with how to best protect abortion rights after they were severely curtailed last year by the Supreme Court’s decision to overturn the landmark Roe v. Wade ruling and the subsequent state bans, the regulatory change may potentially expand abortion access.

After reviewing the supplemental applications submitted by Danco Laboratories and GenBioPro, the two US manufacturers of the drug, the agency approved the modifications.

With one of the two companies that make the abortion pill Mifepristone, pharmacies can start applying for certification to distribute it. If they are successful, pharmacies will be able to dispense it directly to patients upon receiving a prescription from a certified prescriber.

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When it announced that it would relax some risk evaluation and mitigation strategies, or REMS, on the pill, which had been in place since the agency approved it in 2000 and were temporarily lifted in 2021 due to the COVID-19 pandemic, the FDA had first stated that it would be making those changes in December 2021.

The pill has a long history of being safe and effective, according to abortion rights advocates, and there is no danger of addiction or overdose. Women can purchase them to induce abortion without a prescription in several nations, including India and Mexico.