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USP 797: Insights and Resources for Small and Rural Hospitals

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Compounding Sterile Preparations, 3rd Ed., co-edited by Clyde Buchanan
Improve safety, quality and compliance with the help of new guidelines and standards.

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  E. Clyde Buchanan has over 30 years experience in hospital and health system pharmacy and now shares his expertise with pharmacists and pharmacy technicians across the nation . . . teaching people how to meet the newest USP Chapter 797 compliance standards.

USP Chapter <797>: Pharmaceutical Compounding – Sterile Preparations
is a national standard that applies to: All persons who prepare, store or transport IV admixtures or other compounded sterile preparations (CSPs) in hospitals and all other health care facilities where CSPs are prepared.

Sterile Compounding - High Risk Sterile Compounding - Medium Risk Sterile Compounding - Low Risk
High Risk
Medium Risk
Low Risk

What is the first task to comply with USP Chapter <797> Pharmaceutical Compounding - Sterile Preparations? 
Before doing anything else, pharmacists must determine the risk levels of compounding being done in their institutions.  If pharmacy or any other department is doing high risk compounding, added safeguards are required in training programs, compliance testing, end-preparation testing, environmental monitoring and buffer room.  Pharmacy is probably the only department that can be equipped to do all three risk levels of compounding. Other departments should limit their activities to immediate-use compounding.  For more information on categorizing the risks of contamination and inaccurate sterile pharmaceutical compounding, contact Mr. Buchanan. USP Chapter 797 consulting and pharmacy facility planning services available.