Navigating the New Requirements for Handling Hazardous Drugs in the Community Oncology Setting

Fellowship Paper

Compliance Regulations

Nina K. Chavez MBA, SPHR, FACMPE
This paper explores the breadth and scope of the recently finalized USP <800> chapter and the impact that mandatory compliance will deliver to community oncology practices regarding the handling of hazardous drugs. The research methodology used in the paper comprised a literature review and close reading of USP <800> combined with original research and analysis of historical versus projected inventory and financial data from a representative community oncology practice. The research revealed the vast changes many practices will quickly need to make in order to meet compliance standards; the changes promise to affect not only personnel handling of hazardous drugs but also structural operational policies and procedures, human resources concerns, and consequential financial hardships that may prove to be too burdensome for smaller practices. Analysis of the research and collected data revealed that community oncology practices can meet the challenge of compliance with USP <800> through proactive measures detailed within the paper. Waiting for the 2018 compliance deadline or waiting on details regarding jurisdictional enforcement should not be fall back options; all community oncology practices are expected to comply with the finalized hazardous drug rules in order to provide the safe environment necessary to successfully protect employees and serve patient communities.
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About the Author

Nina K. Chavez MBA, SPHR, FACMPE

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