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The changes in rules for pharmacies and physician offices with regard to compounded medications, sterile and non-sterile products have been occurring quickly over the past few years. In this environment the need for updated and reliable information has been great but also difficult to come by as the rules seem to shift often. The purpose of this presentation is to update the healthcare provider in regard to the primary rules involved in medical practice as well as the larger setting that these rules are derived from.

This information is derived from official documents referenced in the paper, consultation with industry experts including pharmacy and legal professionals and the personal investigations for private medical practice and consulting activities made by the author. The entire purpose of this paper is to not only consolidate the laws and rules we need to observe but also set a goal for best clinical practices for enhanced patient safety

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