Preparing for USP 797 and 800—No Time to Rest
Navigating and complying with the new USP 800 standards and proposed USP 797 standards is complex, time-consuming, and often expensive. The December 1, 2019, deadline for compliance may seem far off; but hospitals must act now because it will be a long, difficult road to compliance. These new standards provide additional infrastructure requirements, which many organizations will struggle to meet given limitations involving time, costs, and understanding of compliance elements related to facility design, engineering controls and architecture. The deadline allows very little time to plan for the design and construction necessary to achieve compliance.
This presentation will provide healthcare facility managers and pharmacists with a better understanding of the changes, potential impacts, and next steps so informed decisions regarding operations and budgets can be made.
- USP 797 and 800 regulations – what has changed and strategies for compliance.
- State of the industry and current trends.
- Measures to protect the environment during construction in a compounding pharmacy.
- Environmental monitoring – sampling, interpretation and corrective action plans.
- Case studies illustrating the importance of pressurization and how differential pressure is used as a barrier for contamination.