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Normally accepted beyond-use dating (BUD) is provided in the USP and elsewhere in the literature.When it is believed that the standard dating of a formulation can be exceeded, and extended BUD is desired, allowance for this is provided in the USP if there is solid scientific data supporting the new limit.BUDs are best assigned on the basis of direct testing or extrapolation from reliable literature sources and other documentation (see Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding-Nonsterile Preparations ) or, if not available using the default dates provided in the chapters.The pre-administration storage duration and temperature limits specified apply in the absence of direct sterility testing results that justify different limits for specific CSPs.The Exten DATE™ Sterility Testing system provides a convenient, simple, and inexpensive answer.The revolutionary Exten DATE™ system allows hospital and clinical pharmacies to safely, accurately, and economically batch-compound CSPs between 40m L and 200m L in volume.low-, medium-, high-risk level CSPs) into two categories – Category 1 and Category 2 – based primarily on the conditions under which the preparations are made and the time within which they will be used.

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Recent concern about the quality of CSPs acquired from commercial compounding facilities by the hospital and clinical pharmacy has led to an increased interest in performing batch compounding in-house.Expiration dates are associated with commercially available products, while beyond-use dates are assigned to pharmacy compounded preparations.BUDs are defined by as the date after which a compounded preparation should not be used; determined from the date the preparation is compounded.The assay is then performed in a manner which assures the results will be accurate.Our potency assays are usually completed within 2-3 days.The USP as well as local Boards of Pharmacy are concerned that compounded prescriptions are of correct potency and purity to accomplish their intended goal without doing harm.