Assigning Beyond-Use Dates for Compounded Sterile Preparations: Evaluating Stability Data
September 2009 - Vol. 6 No. 9

By Lou Diorio, RPh, and Dave Thomas, RPh, MBA

 

Assigning beyond-use dates (BUDs) to compounded sterile preparations (CSPs) is a complex process, fraught with responsibility and risk. To mitigate this risk and provide the highest quality preparations to patients, one must fully understand the risk of non-sterility and then identify and carefully interpret available resources on chemical stability.

USP defines an expiration date as the date placed by the manufacturer on the container and label of a drug product designating the time frame a product is expected to remain within the approved specifications of its identity, strength, quality, and purity, if stored under the conditions defined on the package insert.1 The BUD is defined in USP as the date and time after which a preparation must not be used or transported. It is important to note that as long as administration of the preparation to the patient began prior to the BUD, the preparation can be used. BUD, in the context of USP General Chapter , is a pre-administration consideration.

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