On June 10, 2013, the agency notified a United States District Court judge in New York of its intent to comply with the court’s April 5, 2013 order instructing the FDA to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions. This approval fulfills the FDA’s commitment to the court to promptly complete the review of the supplemental application for the one-pill emergency contraceptive.
Plan B One-Step will be available in store aisles rather than behind the pharmacy counter. Consumers will not need to show identification to purchase the product.
The two-pill version will continue to be available by prescription to women under the age of 17.
Plan B One-Step is intended to prevent pregnancy after known or suspected birth control failure or unprotected sex.
For more information visit www.planbonestep.com.