Innovations-Magazine-Nov-Dec-2024 - 10

ASSOCIATION NEWS
Aggregate Data From NABP Compounding Pharmacy
Inspections Show Common Safety Concerns
Navigating Nonsterile Compounding Compliance
After years of development, revised compounding standards from United States Pharmacopeia
(USP) became effective on November 1, 2023. USP Chapter <795> focuses on nonsterile
compounding, with updates aimed at improving quality, safety, and consistency. These
voluntary standards provide clear guidelines on personnel, equipment, training, and
documentation, ensuring that patients receive medications that are safe and free from
contaminants. The information presented here highlights data from observations by NABP
inspectors from November 2023 to August 2024, showing how some pharmacies are meeting
requirements and others are still experiencing gaps in compliance, despite the USP chapters
being in effect for nearly a year.
Section 1: Designated Persons
Does the pharmacy have a designated person(s) who
meets the requirements in USP <795> standards?
Section 2: Training and Competency
Has the pharmacy created and implemented a training
program that aligns with USP <795> standards?
21%
42%
79%
58%
The updated USP Chapter <795> includes a
requirement for a " designated person " who is
responsible for overseeing compounding activities
and ensuring compliance. While the majority
of pharmacies inspected by NABP have met
this requirement, 21% are either unaware of or
have yet to assign someone to this role. For some
pharmacies, this may stem from confusion over
new terminology. For patient safety, it is essential
for all pharmacies, regardless of size, to designate
a qualified individual(s), as this person ensures
adherence to protocols and therefore reduces the
likelihood of contamination.
Training programs are fundamental for ensuring that
staff are knowledgeable about nonsterile compounding
procedures. However, 42% of pharmacies inspected
by NABP are still behind in this area. Proper training
covers compounding techniques, garbing, cleaning
protocols, safety protocols, and documentation of
training and competency assessment, reducing the risk
of errors that could impact patient safety. Pharmacies
with comprehensive training programs are better
equipped to maintain high standards of care. Given the
significant percentage of pharmacies without adequate
training documented, regulators should emphasize
the need for continuous education during inspections.
Training may have been completed, but there may not
be a documented assessment on file.
8 | NOV/DEC 2024

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