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Posted by / 03-Dec-2017 20:04

Usp 797 standards beyond use dating

The familiar "Expiration Date" terminology was replaced with "Beyond-use Date" (BUD).

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.

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.

(i.e.; 6 month - initial or time zero, weeks 4, 8, and months 3, 6, 8, 10, and 12).

Maintenance of a Beyond-use Date after Initial Establishment Each year, there should be a series of tests to establish the continued efficacy of the BUD for each preparation.

During stability studies, HPLC testing is used routinely to separate and quantitate the medication of interest. Method validation Sample generation is the easiest to accomplish whereas method development and validation are more difficult but achievable if given the necessary information.

In potency-over-time studies, data points are identified based on the desired length of time that the preparation will be stored before use and the ability of the data points to establish a comprehensive picture of the degradation/stability processes ongoing in the samples.

Upon subsequent storage and shipping of freshly finished CSPs, an increase in the risks of chemical degradation of ingredients, contamination from physical damage to packaging, and permeability of plastic and elastomeric packaging is expected.

In such cases, compounding personnel are responsible for considering the potential additional risks to the integrity of CSPs when assigning BUDs.

It is not for everyone, and can only be accomplished by using an analytical approach.

Pharmacists should have the unique skill set to accomplish and maintain these processes. Allen, Jr.; International Journal of Pharmaceutical Compounding, Edmond, OK Lisa D.

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