The FDA announced on April 30, 2013, that it approved Teva's application to market Plan B One-Step for use without a prescription by women 15 years of age and older. Currently Plan B and other products like it are sold behind pharmacy counters. Individuals must prove they are 17 or older to purchase the emergency contraception without a prescription. The approval of Teva’s application for Plan B One-Step does not affect the age requirements or prescription status of other generics of emergency contraceptives.
Plan B One-Step 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.” It will also have a code in its label that will prompt the seller to ask for the age of the purchaser. The product will be available in local pharmacies and will be for sale during the retailer’s normal operating hours whether the pharmacy is open or not.
A federal judge's order in April of this year gave the agency 30 days to make the pill available to all girls and women without a prescription, regardless of age. The FDA says the new packaging has nothing to do with that decision. Pharmacists should stay informed on this hot topic to be able to accurately answer any patient concerns or questions about the changes.
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