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UPDATE: Justice Dept. to Appeal Plan B Order

Plan B One-Step will be available without prescription for women aged 15 and older.

Update | May 2 9:30 a.m.: The Obama administration will appeal the court order lifting age limits on purchasing 'Plan B.' The Justice Department's appeal could mean that only Plan B One-Step would be available over the counter until the case is settled. 

Original Story | May 1 4:00 p.m.: The Food and Drug Administration announced Tuesday that for the first time, the so-called "morning after pill" will be available without prescription for women aged 15 and older.

The FDA's announcement applies only to Plan B One-Step, one of the three emergency contraceptive drugs currently available on the market, and aims to eliminate barriers to securing emergency contraception.

"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," said Hamburg.

The federal agency in concert with the drug's manufacturer Teva Women's Health Inc also described provisions for labeling, age verification and theft control.

Plan B One-Step must carry the label, "not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified." Security tags on product cartons will prevent theft, according to the FDA, and although the product will mostly be sold in stores with on-site pharmacies, sale does not require that the pharmacy be open. Instead, checkout clerks will be prompted to verify the buyer's age.

In December 2011, Teva had previously sought approval from the FDA to make Plan B available to all women, but the regulatory agency did not approve. 

Plan B One-Step reduces the possibility of pregnancy after unprotected sexual intercourse or if a form of birth control fails, but the single-dose pill can only be taken within three days of sexual intercourse in order to be effective.

The two other emergency contraceptive drugs sold in the United States -- Plan B and ella -- are not affected by the FDA's new over-the-counter status for Plan B One-Step. Plan B requires a prescription for women under age 17 while ella requires a prescription for women of all ages.

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