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Unit-dose repackaging

This article was originally published in The Tan Sheet

Executive Summary

FDA's six-month expiration date limitation for repackaged unit-dose drugs places registered and inspected repackaging firms "at a disadvantage" compared to drugstores, hospitals and nursing home facilities that repackage unit-dose drugs using a one-year expiration date pursuant to USP standards, Palm Harbor, Fla.-based Peiser & Associates says in recent citizen petition. Filed on behalf of several repackaging firms, petition asserts "hospitals and clinics who utilize outside packaging services prefer to receive at least a one-year expiration date" and urges FDA to enforce USP standards. Agency compliance policy guide states enforcement action will not be initiated solely on the basis of a repackaging firm's failure to have stability studies supporting expiration dates as long as dates do not exceed six months...

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