[White Paper] Facility and Engineering Controls Using USP 800 Guidelines

September 8, 2016 Bryan Prince

The implementation of United States Pharmacopeia (USP) General Chapter <800> “Hazardous Drugs—Handling in Healthcare Settings” is a major part of the evolution and “new normal” influencing the future of the independent compounding pharmacy and healthcare facilities that take effect on July 1st, 2018. Moving forward, the lab environments from which we will unpack, store, handle, compound, and dispose of hazardous drugs (HDs), will integrate design methods and engineering controls to minimize worker and environmental exposure to the HDs. The primary and secondary engineering control methods proposed and passed by the USP will be reliable process-safety controls if implemented, maintained and used properly.

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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[Infographic] Flow Chart for USP 797 and USP 800 PEC Requirements
[Infographic] Flow Chart for USP 797 and USP 800 PEC Requirements

Navigate your primary engineering control options according to USP 797 and USP 800 with this flow chart.

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