1-May-13 12:00 PM  CST

FDA Approves Plan B One-Step Emergency Contraceptive Pill

The Food and Drug Administration (FDA) announced yesterday that it has approved an amended application for Teva’s Plan B One-Step (levonorgestrel) emergency contraceptive pill for women 15 years of age or older.  

 

Pharmacy technicians should note the following concerning the stock and sale of the new approved drug: 

 

  • The Plan B One-Step emergency contraceptive pill will be labeled not for sale to those under 15 years of age and also marked ‘proof of age required,’ not for sale where age cannot be verified. 

 

  • The emergency contraceptive pill will be packaged with a product code.  This product code will prompt a cashier to verify a customer’s age and also request their age at the time of purchase.  A security tag will also be placed on the drugs product carton as well. 

 

  • Plan B is a single dose drug that will come in a 1.5 mg tablet. 

 

Pharmacy technicians should also note that Plan B One-Step will be sold in the family planning aisle or where female health products are sold.  The emergency contraceptive pill will be sold at stores that have an onsite pharmacy.  Plan B One-Step will be available during a stores normal operating hours and also available even if the pharmacy is not open.   

FDA Commissioner Margaret A. Hamburg, M.D., recently commented on Plan B One-Step.  “Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States.”  The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease,” said Hamburg. 

 

Pharmacy technicians will be ‘in the know’ with this latest news from NPTA. 


Sources: 

Jefferson, Erica.  “FDA Approves Plan B One-Step Emergency Contraceptive Without a Prescription for women 15 Years of Age or Older.”  FDA.  Web.  30 Apr 2013.


For additional information on this article, please contact:
 
Jennifer S. O'Reilly
 
Source: NPTAnews  
http://www.pharmacytechnician.org

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