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U.S. Department of Health and Human Services

About FDA

Quality Assessment of Repackaged Products

Description: 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.

Accomplishment: 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 web page.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Complete literature and field activity evaluations

3/31/3009

Completed 2/28/2009

2. Identify products and develop laboratory methods

12/31/2010

Completed 3/31/2009

3. Complete laboratory studies

9/30/2012

Completed 9/30/2010

4. Complete internal report and publications

9/30/2013

Completed 9/30/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.