Monday, November 24, 2008

Q & A on usp 797: Privately Owned Physician's Office

Questions and Answers on USP 797

RJLG Question 4: We are a privately owned physicians office and do not have pharmacy or pharmacist. We have (2) RN's that are trained and certified to mix and give chemo drugs. We follow NIOSH guidelines. De we have to follow the USP797 guidelines?

RJLG Answer 4: If your institution prepares compounded sterile preparations (CSPs) which meet the definition of the specific categories described in USP797 (low-risk level, medium-risk level, high-risk level, or immediate use), including hazardous drugs as CSPs, you must comply with USP797. The standards are intended to apply to all persons who prepare CSPs and all places where CSPs are prepared including physicians offices.

Answer provided as a courtesy to 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 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 ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)

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