Expiration dating of repackaged medications

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Since most drug products are repackaged at the time of dispensing by a pharmacist, unless they are readily available in unit-of-use form from the manufacturer, it is imperative to consider the stability of these products once they are opened and repackaged in a different container closure system.Even though, according to most patients store their drugs inside the medicine cabinet, which is typically located in the family bathroom, where humidity is a serious concern.Hence, considering all the potential issues involved with the dispensing process and during storage (e.g., environmental exposure, type of repackaging container, frequent opening of the package, direct contact with the patient and pharmacy personnel), the recommended one-year beyond-use date for a repackaged product is perhaps not too stringent.In other words, the beyond-use date or the pharmacy expiration date limits the time during which a drug may be used or retained by a patient after it is dispensed.A draft guidance document, “Expiration Dating of Unit-Dose Repackaged Drugs,” issued by FDA in 2005 contains similar if not identical provisions.

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