Norgestrel (Opill), a daily, progestin-only oral contraceptive sold without a prescription, is now available for use in the United States. It was first approved in 1973 as a prescription drug.

At their May 2023 joint meeting, the Food and Drug Administration's Nonprescription Drugs Advisory Committee and Obstetrics, Reproductive and Urologic Drugs Advisory Committee unanimously recommended Opill for over-the-counter use. The committees agreed that the drug's labeling sufficiently provides information to consumers that they should not use Opill if they have a history of breast cancer, have abnormal vaginal bleeding with an undiagnosed cause, or are using other hormonal contraceptives. The committees also agreed that the vast majority of consumers will be able to read, understand, and follow these recommendations.

As with the prescription form of norgestrel, the most common adverse effects of Opill treatment are irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, and bloating.

Nurses who work with populations who might be likely to use this over-the-counter birth control pill (especially adolescents and those who have limited financial resources or are without health insurance) should emphasize that it must be taken daily for effectiveness. It is not emergency contraception and does not prevent pregnancy after unprotected sex. Like other oral contraceptives, it does not protect against HIV, AIDS, or other sexually transmitted diseases.

For the FDA News Release regarding norgestrel's approval, go to http://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescri.