An Update on USP 797

Dan Doyle, Grumman/Butkus

USP 797 is a new chapter in the 2004 United States Pharmacopeia/National Formulary entitled "USP/NF Tests and Assays Chapter 797, Pharmaceutical compounding - Sterile Preparations." The intent of USP 797 is to "prevent harm and fatality to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, large content error in the strength of correct ingredients, and incorrect ingredients in compounded sterile preparations." The Environmental Quality and Control section covers the specific requirements of the physical environment, such as air quality, surface materials and space configuration. This presentation focuses on some of the requirements related to the ventilation systems and the potential enforcement by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Health Fee Advisory Board (HFAB), and various state healthcare compliance agencies.

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