FDA approves Plan B for 15-year-olds and up without prescription - KMSP-TV

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FDA approves Plan B for 15-year-olds and up without prescription

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The U.S. Food and Drug Administration announced Tuesday that the emergency contraceptive known as Plan B One-Step has been approved for use without a prescription for women aged 15 and older.

"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 product will now be labeled as "not for sale to those under 15 years of age" and proof of age will be required and verified before sale through an electronic prompt built into the packaging.

"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," Hamburg continued.

The move also means the emergency contraceptives will be available for purchase at retail stores with onsite pharmacies, and will likely be stocked in the family planning or female health aisles. The drug should be available for sale during any normal operating hours regardless of whether the pharmacy itself is open or not.

Plan B One-Step, a single-dose 1.5 mg levonorgestrel tablet, is intended to reduce the possibility of pregnancy following unprotected sex or the failure of another form of birth control. It must be taken within 3 days of the event to be effective; however, it will not stop an existing pregnancy and is not intended for repeated use.


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