Session Detail

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Monday, October 8, 2018  |  11:15 AM - 12:15 PM

Open to Conference Attendees Only

A paradigm for complying with revisions to USP <797> and <800>

Tonia Burnette, RA
Senior Director, Johns Hopkins Health System, Architecture and Planning
Kevin Bernhard
Planner, Johns Hopkins Health System, Architecture and Planning

When first reading the regulations for USP <800> and <797> Design Professionals and Facilities Staff can quickly become overwhelmed by the complexity, and lack of familiar terms. The regulations were written by industry experts in Pharmaceutical Compounding, and not Design or Facility Professionals, which can make deciphering their intended meaning difficult. In addition to the regulations themselves being cumbersome, determining where to get started in analyzing existing pharmacies for compliance can be daunting. Upon evaluating where pharmacies are noncompliant, you then have to balance the need to become compliant with the realities of cost, phasing, and limiting disruption to operations. In this session, the presentation team from Johns Hopkins will explain how they navigated these trials to ensure that their facilities are compliant, while weighing the desires of the end users to improve current operations, and also being responsible stewards for the institution.



1. Familiarize yourself with the Facilities sections of the revisions to USP <797> and <800> pharmaceutical regulations which take effect December 2019
2. Learn how to efficiently review your facilities for USP compliance, and develop tools to effectively analyze your current compliance
3. Identify key challenges of implementation and determine how to meet them
4. Explore how to manage user expectations, set realistic goals, align those goals with existing culture and future growth

SESSION FOCUS AREAS: = Generative Space = NOAH