FDA Approves First Over-the-Counter Birth Control Pill

Norgestrel is scheduled to hit shelves in early 2024.

Close-up of young woman's hand holding birth control pills

Updated on July 14, 2023.

On July 13, 2023, the U.S. Food and Drug Administration approved the first oral birth control for over-the-counter (OTC) sale. Norgestrel (Opill) is expected to be available in stores and online starting in early 2024 for people of all ages.

“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,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research said 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.”

How norgestrel works

Norgestrel is a progestin-only tablet, sometimes referred to as a “mini” pill because it doesn’t contain estrogen. Pills that combine progestin and estrogen are popular options in the U.S. but can’t be taken with certain medical conditions. Progestin-only pills are generally considered to have fewer safety issues and not as many potential side effects.

Norgestrel is meant to be taken each day, at around the same time. It is not intended to be used with other hormonal birth control—such as an intrauterine device (IUD) or vaginal ring—and doesn’t prevent sexually transmitted diseases. People with a history of cancer should speak with a healthcare provider (HCP) before using the drug.

Previous to norgestrel’s approval, more than two dozen states put laws into place allowing pharmacists to dispense hormonal birth control over the counter—with a condition. Medication can be obtained directly from a qualified pharmacist rather than having to visit an HCP, but a prescription is still required. Norgestrel’s wide availability will likely eliminate the need for this process.

Support for OTC birth control

The American College of Obstetricians and Gynecologists (ACOG), the premier professional association for OBGYNs in the U.S., supports OTC hormonal contraception with no age restrictions. In its 2019 committee opinion, ACOG noted that procuring a prescription is often an obstacle to contraception use. OTC birth control, however, removes that obstacle, improving accessibility and potentially preventing unintended pregnancies, of which there are an estimated 3 million in the U.S. each year. People with unintended pregnancies are less likely to receive early prenatal care and have a higher risk of preterm delivery, which is linked to health and developmental issues in babies and children.

Surveys indicate OTC birth control enjoys public support, as well. To support their 2019 opinion, ACOG cited a national survey of about 2,000 women ages 18 to 44 years old, 62 percent of whom were “strongly” or “somewhat” in its favor. About 37 percent said they were likely to use OTC birth control themselves, too.

Another survey of over 5,000 women published by the Kaiser Family Foundation in 2022 found even stronger support for the idea, with 77 percent favoring OTC birth control if they knew it was safe. Part of the FDA’s norgestrel approval involved obtaining proof that the pill could be taken safely and effectively, without instructions from a healthcare provider.

The importance of continued health screenings

It’s worth keeping in mind that many people access contraceptive prescriptions during regular visits to HCPs. During these visits, it’s common to receive essential preventive care aside from birth control, such as Pap smears, blood pressure checks, vaccinations, and physical exams. 

If you choose to take OTC medications, it’s critical to continue these appointments, which can protect you from illness, identify medical conditions, catch certain issues before they become serious problems, and help you maintain overall good health. Be sure to maintain regularly scheduled wellness appointments with your provider.

Article sources open article sources

U.S. Food and Drug Administration. FDA Approves First Nonprescription Daily Oral Contraceptive. July 13, 2023.
The American College of Obstetricians and Gynecologists. Progestin-Only Hormonal Birth Control: Pill and Injection. Last reviewed August 2022.
The Guttmacher Institute. Pharmacist-Prescribed Contraceptives. Page last reviewed Feb 1, 2023.
Jenna Milliner-Waddell. How to Get Your Birth Control Online. The Strategist: New York Magazine. March 16, 2021.
American Society of Health System Pharmacists. Pharmacists Can Now Prescribe Hormonal Birth Control in 20 States. Page last reviewed Dec 5, 2022. 
The American College of Obstetricians and Gynecologists. Over-the-Counter Access to Hormonal Contraception. Page last reviewed October 2019. 
Long M, Fredriksen B, Ranji U, et al. Interest in Using Over-the-Counter Oral Contraceptive Pills. Kaiser Family Foundation. November 3, 2022. 
California State Board of Pharmacy. Self-Administered Hormonal Contraception Protocol for Pharmacists. 2023.

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