This project will examine the effects of repackaging commercially available drug products from the standpoint of product chemical stability and performance in patients as determined by in vitro testing.This project was started to see if there are merits to repackagers' requests to extend the automatic expiration of unit dose repackaged products to 12 months. While the United States Pharmacopeia and some States changed this to one year, the FDA wanted to evaluate the merits scientifically. Our studies have indicated that two out of the five products evaluated did not maintain the product integrity or stability for one year. Therefore, FDA decided to stay with the six month expiration dating for unit dose repackaged products. The results have been communicated in five peer-reviewed journal articles and a book chapter. Additional information about this and other OTR projects is available on our <a href= http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm142591.htm target=”_blank”>web page</a>.1. Complete literature and field activity evaluations3/31/3009Completed2/28/20092. Identify products and develop laboratory methods12/31/2010Completed3/31/20093. Complete laboratory studies9/30/2012Completed9/30/20104. Complete internal report and publications9/30/2013Completed9/30/2010http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboardhttp://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm142591.htmDivision of Product Quality Research Programshttp://accessdata-test.fda.gov/FDATrack/track-proj?program=cder&id=CDER-OTR-Quality-Assessment-of-Repackaged-Products-ResourcesAdditional Articles Related to the Quality Assessment of Repackaged Products ਍††਍਍਍਍਍਍਍