Virginia: Deficiencies Associated With Compounding Sterile Preparations

Deficiencies Associated With
Compounding Sterile Preparations
Certification of the direct compounding area, buffer or clean
room, and ante room is to be performed by a qualified individual
no less than every six months and whenever the device or room
is relocated, altered, or major service to the facility is performed
(refer to Major Deficiencies 22 and 23). Every six months is interpreted
to be six months from the date of the last certification.
For example, a direct compounding area certified as ISO Class 5
on January 17, 2013, requires certification on or before July 17,
2013. The inspector will ask for documentation of at least the two
most recent certifications to ensure that the areas comply with the
appropriate ISO class.
Individuals preparing compounded sterile preparations (CSP)
must complete media-fill testing annually when preparing low and
medium-risk CSPs and semiannually when preparing high-risk level
CSPs (refer to Major Deficiencies 25a and 26). The terms “annually”
and “semiannually” as used in USP Chapter <797> are defined
to mean every 12 months and every six months, respectively. In
the event an individual fails a media-fill test, that individual may
not perform high-risk level compounding prior to retraining and
receipt of a passing media-fill test (refer to Major Deficiency 25c).
Individuals preparing low or medium-risk level CSPs must provide
documentation of passing the media-fill test within 45 days of the
failed test (refer to Major Deficiency 26a). Records associated
with annual and semiannual requirements shall be maintained in
accordance with USP standards. The records may be maintained as
an electronic image that provides an exact image of the document
that is clearly legible provided such electronic image is retrievable
and made available at the time of inspection. The inspector will
ask for documentation that each individual who prepares CSPs has
completed the required media-fill testing and retesting if required.
Compounded sterile preparations must be assigned an appropriate
beyond-use date (BUD) in compliance with USP-NF standards
(Major Deficiencies 25 and 33). In the absence of sterility testing,
the BUD for low, medium, and high-risk CSPs are:
Low Risk Medium Risk High Risk
Controlled
Room
Temperature
48 hours 30 hours 24 hours
2° to 8°C (36°
and 46°F) 14 days 9 days 3 days
-25° to -10°C
(-4° and 14°F)
or colder
45 days 45 days 45 days
If performed, sterility and endotoxin testing must comply with
USP Chapters <51> Antimicrobial Effectiveness Testing, <71>
Sterility Test, or <85> Bacterial Endotoxin Testing in addition to
USP Chapter <797> Pharmaceutical Compounding: Sterile Preparations.
The inspector will ask for documentation for sterility or
endotoxin testing.

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