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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