Innovations-Magazine-Nov-Dec-2024 - 13

ASSOCIATION NEWS
Section 3: Inspection Observations
1. Did compounding personnel
entering the compounding area
perform the appropriate handwashing
procedures in compliance
with USP <797> standards?
2. Did compounding personnel
follow appropriate garbing
procedures in compliance with
USP <797> standards?
3. Are compounding personnel
observed using the appropriate
aseptic technique that ensures the
quality and environment of the
CSP, and that the environment is
maintained in compliance with
USP <797> standards?
13%
21%
23%
87%
79%
77%
Live observations during inspections provide critical insights into whether pharmacy personnel
are following proper aseptic procedures. Hand hygiene, garbing, and aseptic technique are
all vital for maintaining the sterility of CSPs. While most pharmacies meet these standards,
there is room for improvement. For example, 23% of pharmacies inspected by NABP were
observed failing to maintain aseptic technique, potentially compromising the CSP environment.
Regulators should focus on improving compliance in these areas through regular inspections,
feedback, and educational efforts with licensees.
Adherence to USP Chapter <797> is crucial for producing highquality,
safe, sterile compounded medications. Regulators must
continue to support pharmacies in meeting these standards through
audits, education, and resources.
NOV/DEC 2024 | 11
Innovations-Magazine-Nov-Dec-2024

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