On July 13, the U.S. Food and Drug Administration (FDA) approved Opill (norgestrel), the first daily oral contraceptive for use without a prescription. 

According to the FDA, the manufacturer, Laboratoire HRA Pharma, will determine the timeline for the availability and price of the product, which will be available in drug stores, convenience stores, and grocery stores, as well as online.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

According to the FDA, almost half of the 6.1 million pregnancies in the U.S. each year are unintended. The FDA stated that unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes.

The availability of Opill may help reduce the number of unintended pregnancies and their potential negative impacts.

Opill’s approval comes on the heels of the passage of House Enrolled Act 1568, which allows pharmacists who meet specific requirements to prescribe and dispense hormonal contraceptive patches and self-administered hormonal contraceptives to individuals 18 or older. Under the new law, which went into effect on July 1, prescriptions are limited to no more than two six-month periods unless the patient sees a primary care physician or provider before seeking additional prescriptions.

Read the full FDA announcement here.