Sunday, August 2, 2009

Hazardous Drug Storage in an USP 797 Compliant Environment

Questions and Answers on USP 797

RJLG Question 17: Chapter <797> states that “hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure”. I work in a hospital with a separate negative pressure chemo room adjacent to a positive pressure ante room. We use a separate refrigerator for chemotherapy drugs and it is only accessed by staff that are involved in the preparation and distribution of these drugs. However, this refrigerator is too large to store in our negative pressure chemo room and would adversely impact our air quality. Therefore, we store this refrigerator in a separate storage room. Since the concern of volatilization of hazardous drugs is at room temperature and these drugs are refrigerated, is this an acceptable plan?

RJLG Answer 17: Hazardous drug storage in a separate negative pressure room is preferred, but not required by USP797. It sounds as if your hazardous drugs are stored separately from other inventory and access is restricted only to authorized personnel. As long as your storage is in a manner to prevent contamination and personnel exposure, your plan may be acceptable.
Hazardous drug storage must be in accordance with USP797, OSHA, and other applicable guidelines and recommendations. Your site-specific policies & procedures and hazardous drug safety plan must include conditions for storage. Also see RJLG Question 12 in this Q&A section of the website for more information.

Answer provided as a courtesty to, inc. 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, inc. is not responsible for this answer.

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

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