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Determination of Risk for Sterile Preparations

Author(s):  Freedman ben-Horin Shimon, Rousso Tamaro

Issue:  Jan/Feb 2014 - Volume 18, Number 1
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Abstract:  A quick and reliable system is described to quantify risk assessment for compounded sterile pharmaceuticals, which are “compounded in anticipation” for hospitals and clinics, having shelf lives assessed on documented literature and other criteria. These shelf lives are well in excess of the recommendations of the United States Pharmacopeia without placing patients at risk due to inadequate safety, quality, or efficacy.

Related Keywords: Shimon Freedman ben-Horin, Bpharm, MRPharmS, PhD, Tamaro Rousso, BPharm, MSc, compounded sterile preparations, risk assessment, compounded in anticipation, sterile compounding, United States Pharmacopeia, USP, scoring system

Related Categories: STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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