Program Description
As health-system pharmacists, we understand the relationship between quality
in sterile preparation compounding and patient safety. However, gaps between
ideal and actual compounding practices persist. USP <797> will close the gap on
significant variations in sterile compounding practices.
Pharmacists need guidance on important aspects of USP chapter <797> to
ensure compliance in 2006. These aspects include the training of personnel, with
didactic instruction, direct observation, and evaluation of aseptic manipulation
skills through media fill testing. Environmental sanitation and monitoring are
areas of chapter <797> of concern to many pharmacists, who need insight into
requirements for cleaning and disinfecting the work environment and monitoring
air quality for particulates and microorganisms. Requirements for documentation
and corrective action also are important.
State board of pharmacy regulations, accreditation organization standards, and
recommendations of other organizations for compounding sterile preparations
are based on USP requirements and therefore, they are in a state of flux. The Joint
Commission on Accreditation of Healthcare Organizations (JCAHO), in conjunction
with ASHP, has developed a suggested timeline for the gradual phasing in of
USP requirements. Although not required, these suggested timeframes can assist
organizations in developing an individualized action plan. Pharmacists need to
be aware of JCAHO's standards and timeline, recommendations of other organizations
(e.g., the National Institute for Occupational Safety and Health), and state
board of pharmacy regulations that impact compounding practices.
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