Stability profiles of drug products extended beyond labeled expiration dates

Authors

  • Robbe C. Lyon,

    Corresponding author
    1. Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, HFD-941, White Oak, Life Sciences Building 64, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002
    • Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, HFD-941, White Oak, Life Sciences Building 64, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002. Telephone: 301-796-0019; Fax: 301-796-9816
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  • Jeb S. Taylor,

    1. Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, HFD-941, White Oak, Life Sciences Building 64, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002
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  • Donna A. Porter,

    1. Division of Field Science, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, Rockville, Maryland 20857
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  • Hullahalli R. Prasanna,

    1. Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, HFD-941, White Oak, Life Sciences Building 64, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002
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  • Ajaz S. Hussain

    1. Vice President & Global Head of Biopharmaceutical Development, Sandoz, 506 Carnegie Center, Princeton, New Jersey 08540
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Abstract

The American Medical Association has questioned whether expiration dating markedly underestimates the actual shelf life of drug products. Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. This program probably contains the most extensive source of pharmaceutical stability data extant. This report summarizes extended stability profiles for 122 different drug products (3005 different lots). The drug products were categorized into five groups based on incidence of initial extension failures and termination failures (extended lot eventually failed upon re-testing). Based on testing and stability assessment, 88% of the lots were extended at least 1 year beyond their original expiration date for an average extension of 66 months, but the additional stability period was highly variable. The SLEP data supports the assertion that many drug products, if properly stored, can be extended past the expiration date. Due to the lot-to-lot variability, the stability and quality of extended drug products can only be assured by periodic testing and systematic evaluation of each lot. © 2006 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 95: 1549–1560, 2006

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