* RJLG Question 8: We are a small home infusion pharmacy. Approximately 2% of our patient base receives chemotherapy medications (primarily 5FU). Do we need a negative pressure room if: we compound/mix in a BSC, maintain a “safety zone” around the BSC within the clean room and utilize the PhaSeal product line when compounding?
* RJLG Answer 8: The Hazardous Drugs as CSPs section of USP797 allows low volume hazardous drug compounding in a non-negative pressure buffer or clean room if two tiers of containment are used, e.g., using a closed-system transfer device (CSTD) within a biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI). This is not an exemption from training and personal protective equipment (PPE) requirements, or recommended environmental sampling.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
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Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:
Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com
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For more information about USP 797, visit the USP 797 website: www.usp797.org.
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