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22-Mar-2017 12:26

In communications with FDA, we’ve learned that the agency does not routinely require manufacturers to update stability and compatibility data. A vast majority of respondents (97%) feel the CMS regulation and interpretive guidelines that require strict adherence to the manufacturer’s directions for storage, stability, and beyond use dating increases waste and contributes to the drug shortage crisis when evidence-based compendia information recommends a longer beyond use dating.

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When asked how often respondents follow recommendations in national compendia, even if it differs from the manufacturer’s directions, most reported always (21%), often (28%), or sometimes (27%).Very few (7%) said they never follow compendia recommendations if they differ from the manufacturer’s directions.Respondents made it clear that one of the reasons they rely on compendia recommendations is that the manufacturer’s directions often provide insufficient information.About a quarter of respondents reported that, upon request, manufacturers never or rarely provide newer in-house data on extended beyond use dating that differs from the package insert.