FDA Amendment to Labeling and Delivery of Prohibited Abortion Drugs in the U.S. After the Supreme Court Decision in 2012

The requirement for in-person purchases has been permanently removed, according to Danco Laboratories. Pharmacies that become certified to do so can dispense the drugs directly to someone who has a prescription from a certified prescriber. The updated information was posted Tuesday on the FDA’s website.

“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 and will provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy,” Danco said in a statement.

The medications can be taken up to 11 weeks after the last menstrual period in some states. In some states, telehealth can be used if you want to go to a state where abortion is legal.

More than half of U.S. abortions are now done with pills rather than surgery, according to the Guttmacher Institute, a research group that supports abortion rights.

The FDA is blocking the sale of abortion drugs in the US after a Justice Department legal opinion stated that federal law allows the US Postal Service to deliver the drugs.

In the wake of the Supreme Court ruling, Attorney General Merrick Garland issued a statement promising to work with the FDA and other federal agencies to protect access to such drugs, which some states have sought to ban.

The Biden administration partially implemented the change last year, announcing it would no longer enforce a long-standing requirement that women pick up the medicine in person. More retail stores will be allowed to sell the pills as long as they pass a certification process, after Tuesday’s action formally updates the drug’s labeling.

Still, the rule change’s impact has been blunted by numerous state laws limiting abortion broadly and the pills specifically. Legal experts think there will be lengthy court battles to challenge state restrictions over access to the pills.

The latest FDA label updates are requested by two drugmakers that make abortion pills. Agency rules require a company to file an application before they modify limits on drugs.

The FDA in 2000 approved mifepristone to terminate pregnancies of up to 10 weeks, when used with a second drug, misoprostol. Mifepristone is taken first to dilate the cervix and block the hormone progesterone, which is needed to sustain a pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and expel pregnancy tissue.

Bleeding is a common side effect, though serious complications are very rare. The FDA says more than 3.7 million U.S. women have used mifepristone since its approval.

Training requirements to certify prescribers can provide emergency care in the event of excessive bleeding are part of FDA-mandated safety requirements. Pharmacies that dispense the pills also need a certification.