Headlines, confusion, and ongoing debate have surrounded the status of Plan B and other emergency contraception products. Many other countries have approved levonorgestrel to be sold OTC without age restrictions; however, restrictions continue to be enforced in the United States.1.Grimes D.A. Switching emergency contraception to over-the-counter status.N Engl J Med. 2002; 347: 846-849Crossref PubMed Scopus (39) Google Scholar In 2011, Teva, the manufacturer of Plan B One-Step (levonorgestrel), applied for OTC status without age restrictions and was denied.2.Belluck P. Judge strikes down age limits on morning-after pill.www.nytimes. com/2013/04/06/health/judge-orders-fda-tomake-morning-after-pill-available-over-thecounter-for-all-ages.html?pagewanted=allDate: 2013Google Scholar Despite this setback, recent events show a trend toward increasing access. April 5, 2013. A federal judge ordered FDA to remove age and sale restrictions on levonorgestrel-based products. This was in response to a lawsuit requesting expanded access so that all women could purchase the products without a prescription. The judge called for FDA to take action within 30 days of the ruing.2.Belluck P. Judge strikes down age limits on morning-after pill.www.nytimes. com/2013/04/06/health/judge-orders-fda-tomake-morning-after-pill-available-over-thecounter-for-all-ages.html?pagewanted=allDate: 2013Google Scholar■Plan B One-Step (levonorgestrel) has been approved to be sold without a prescription to women 15 years or older.■The product will be sold OTC and can be purchased by patients after showing a valid form of identification. ■Plan B One-Step (levonorgestrel) has been approved to be sold without a prescription to women 15 years or older.■The product will be sold OTC and can be purchased by patients after showing a valid form of identification. April 30, 2013. FDA announced approval of Plan B One-Step without a prescription for women 15 years or older. This approval applies to an amended application submitted by Teva and was not related to the judge’s ruling. Therefore, this approval applies to Plan B One-Step only.3.Food and Drug AdministrationFDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older.www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350230.htmDate: 2013Google Scholar May 1, 2013. The Justice Department filed a notice of appeal on the judge’s ruling, but FDA’s approval of Plan B One-Step is not affected by the appeal.4.Brusk S. Carter C.J. Justice Department appeals morning-after pill ruling.www.cnn.com/2013/05/01/health/morning-after-pill/index.htmlDate: 2013Google Scholar As of May 13, 2013, Plan B One-Step has been approved to be sold without a prescription to women 15 years or older. The product will be coded to prompt the cashier to verify the buyer’s age with a form of identification such as a driver’s license, passport, or birth certificate. The labeling will state: "Not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified." To obtain approval, Teva submitted study data showing that women 15 years or older demonstrated an understanding that emergency contraception is not for routine use and does not prevent against sexually transmitted infections (STIs).3.Food and Drug AdministrationFDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older.www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350230.htmDate: 2013Google Scholar A simulation study of women aged 11 years to 17 years showed that 91.5% were able to use emergency contraception appropriately based on the product label.5.Raine T.R. Ricciotti N. Sokoloff A. et al.An over-the-counter simulation study of a singletablet emergency contraceptive in young females.Obstet Gynecol. 2012; 119: 772-779Crossref PubMed Scopus (14) Google Scholar FDA also completed a postmarketing analysis of adverse events in patients aged 15 years to 17 years. Serious adverse events were reported in three cases only. Based on these findings, FDA concluded that no evidence of safety concerns existed for use of levonorgestrel in this population.6.Food and Drug AdministrationPediatric postmarketing adverse event review.www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM288775.pdfDate: 2013Google Scholar One concern raised about increasing access to emergency contraception is that it will lead to decreased use of other methods (e.g., condoms), thereby increasing pregnancy rates and STIs. A trial randomized participants to (1) a group that received Plan B to keep at home or (2) a group that would need to go through the standard process for obtaining emergency contraception. Similar pregnancy rates were seen in both groups, and no difference in incidence of STIs was observed.7.Raymond E.G. Stewart F. Weaver M. et al.Impact of increased access to emergency contraceptive pills: a randomized controlled trial.Obstet Gynecol. 2006; 108: 1098-1106Crossref PubMed Scopus (82) Google Scholar Emergency contraception will become available OTC to women 15 years or older and possibly to women of all ages, pending the court’s decision. After Teva repackages Plan B One-Step, it will move from behind the counter to the OTC aisles, where patients can purchase it with or without pharmacist consultation.