Questions and Answers on USP 797
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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?
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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
USP797.org website for more information.
Answer provided as a courtesty to usp797.org, 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 usp797.org, inc. 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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