WINTER 2025 I HEALTH SYSTEM • INFUSION
44
ABBY ROTH, FOUNDER/MICROBIOLOGIST AT PURE MICROBOLOGY
QUESTION & ANSWER
Q. What’s the best starting point for aligning with
the current USP <797> (2024)?
Begin with a formal gap assessment against the current
<797> requirements. If your organization hasn’t done this
yet, it is way behind other sterile compounding pharmacies.
Be ruthlessly objective. Observe real work practices and
compare them to your SOPs; what’s on paper often diverges
from daily practice. Prioritize high-risk findings (e.g., personnel
practices, engineering controls, viable sampling trends) before
lower-risk issues.
Q. What personnel competency elements do
inspectors and surveyors expect for USP <797>?
Obviously, initial and ongoing didactic training and the
chapter defined hand hygiene and garbing competency and
aseptic manipulation competency are going to be of interest.
The table to the right highlights the required elements.
Inspectors and surveyors are increasingly focusing on training
and competency assessments for surface sampling and colony-
forming unit (CFU) enumeration. These are critical activities
that often benefit from outsourced training unless internal staff
have been formally trained by a subject matter expert (SME)
using a train-the-trainer model. Competency assessments may
be obtained from external vendors or developed internally.
Q. For USP <800>, where do organizations most
often struggle?
One of the most common areas of noncompliance is
developing a compounding workflow that fully aligns with USP
<800> requirements. Sterile HD compounding is inherently
deliberate and must be approached with patience and respect
for the process. While patient care is always a priority, staff
safety must not be compromised.
When evaluating your HD sterile compounding process,
ensure the following:
• A new pair of outer sterile gloves is donned at the start of
each preparation.
• Hands remain inside the containment primary engineering
control (C-PEC) until the compounded sterile preparation
(CSP) is complete and decontaminated.
• Each CSP is decontaminated before being removed from
the C-PEC.
USP <797> &
RESOURCES, COMPLIANCE,
INITIAL COMPETENCY
REQUIREMENTS
Garbing & Hand Hygiene Competency
• Three Times
• Must Pass Consecutively
Includes:
• Visual Observation
• GFT
Aseptic Manipulation Competency
Replicates Not Specified
Includes:
• Media-Fill
• GFT
• Surface Sampling
ONGOING COMPETENCY
REQUIREMENTS
Garbing & Hand Hygiene Competency
• One Time
Includes:
• Visual Observation
• GFT
Aseptic Manipulation Competency
Replicates Not Specified
Includes:
• Media-Fill
• GFT
• Surface Sampling