[White Paper] USP 800 Gap Analysis, A Business Perspective

March 16, 2017 Bryan Prince

There are quite a few articles and great resources for developing and conducting a comprehensive Gap Analysis around the compliance details defined in the United States Pharmacopeia (USP) chapter <800>. Despite the title of this article we do not intend on simply repeating those articles, instead we want to address details for performing a gap analysis focused on the business side of the compliance equation. USP 800 is going to financially impact your pharmacy’s future business model so this article will focus on five important details that define the "why" for considering the capital investment. In this article we will offer up some examples that show how the gap analysis is a simple and effective analytical process that can help you understand if the capital investment is advantageous. It is difficult to design a "one size fits all" hazardous drug handling compliant facility without taking into consideration your pharmacy's specific business model, but towards the end of this article we will propose a financial model based on some generic assumptions to put capital investment into business perspective.

About the Author

Bryan Prince, MBA is the owner and lead consultant at Lab·Red Pharmacy Consultants. His early career in containment technology allowed him access to pharmaceutical labs around the U.S. where he gleaned extensive knowledge of chemical handling technique and safety strategies. In 2012 he started visiting compounding pharmacies to observe workflow habits and share his knowledge, which led to writing articles for the International Journal of Pharmaceutical Compounding (IJPC). Bryan has been invited to speak at conferences on “Quality, Safety, and Workflow in the Compounding Pharmacy” for the American College of Apothecaries and PCCA. Most recently he has spoken on "Facility and Engineering Controls Using USP 800 Guidelines" for the ACA and IACP. He is also a contributor to the ACHC’s USP 800 education conferences and webinars.

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