The U.S. Food and Drug Administration today announced it has approved Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.
The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, a security tag will be placed on all product cartons to prevent theft.
The product, by Teva Women's Health, will be available in retail outlets with an onsite pharmacy. It can be sold during the retailer’s normal operating hours whether the pharmacy is open or not.
Plan B One-Step is an emergency contraceptive intended to reduce the possibility of pregnancy after unprotected sexual intercourse – if another form of birth control (e.g., condom) was not used or failed. Plan B One-Step is a single-dose pill (1.5 mg tablet) that is most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within three days after unprotected sexual intercourse.
Plan B One-Step will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus.
“Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” said FDA Commissioner Margaret A. Hamburg, M.D. “The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease."
Read more from the U.S. Food and Drug Administration.
PHOTO: Yana Paskova/The New York Times