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Abstract:  The establishment of both a beyond-use date and the extension of a beyond-use date need to be scientifically based. What is accepted as scientific evidence is at times misleading. The pharmacist may have the right to utilize some degree of professional judgment in both establishing and extending a beyond-use date, after a review of appropriate scientific literature. Notwithstanding this scientific review, it is the concept of professional judgment that seemingly needs to be better defined. A new-found appreciation for professional judgment will bring us to the understanding that a validated stability-indicating assay is the correct manner in which to extend a beyond-use date. This article addresses and discusses the recommendations and rigor required to establish and extend a beyond-use date. The perspectives of the pharmacist and physician are explored, as well as the impact of an extended beyond-use date, or lack thereof, are discussed. The application of a set of fundamental principles will be revealed, which will lead to finite conclusions as to the necessary methodology to establish as well as extend a beyond-use date.

Related Keywords: beyond-use date, drug safety, chemical stability, drug degradation pathways, validated stability-indicating assay, high-performance liquid chromatography, HPLC, stability studies

Related Categories: STABILITIES, COMPATIBILITIES, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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