FDA Approves First-Ever Nonprescription Oral Contraceptive

The new approval will allow consumers to purchase this oral contraceptive medication without a prescription at stores and online.

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

According to a new FDA news release, this approval will allow consumers to purchase an oral (tablet form) contraceptive medication without a prescription at drug stores, convenience stores, grocery stores, and 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. “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.”

Wider availability of such a product could have positive implications for health equity as it may help reduce barriers to access by allowing individuals to obtain an oral contraceptive over-the-counter. This could potentially prevent millions of unintended pregnancies that are associated with various negative maternal and perinatal outcomes. 

Read to full FDA release.

You may also visit the Opill consumer information page on the FDA website, which includes additional background, plus important questions and answers.

Lastly, visit the NHF website for more information on the programs designed to improve health outcomes for women with bleeding disorders.

Source: FDA news release, July 13, 2023 (National Hemophilia Foundation)