Virginia Board of Pharmacy FAQ on Compounding

Sterile Compounding FAQs
Pursuant to Virginia Code §54.1-3410.2 and Regulation
18VAC110-20-321, both sterile and nonsterile compounding
must be performed in compliance with USP-NF standards.
The following frequently asked questions (FAQs) and
answers are provided to assist pharmacists and pharmacy
technicians in their understanding of requirements regarding sterile compounding. Guidance documents referred
to in these FAQs are available at www.dhp.virginia.gov/
Pharmacy/pharmacy_guidelines.htm.
1. Where may information regarding USP-NF standards
for compounding be located?
A subscription to the current version of USP on Compounding: A Guide for the Compounding Practitioner may
be purchased at www.usp.org/store/products-services/
usp-compounding. This guide provides access to all
compounding-related general chapters from the USPNF and is updated with the release of each new USP-NF
edition and supplement. The latest edition, USP 36-NF
31, published on November 1, 2012, becomes official
May 1, 2013.


2. Does the law require compliance only with Chapter 797?
No, the law requires compliance with all applicable
chapters within USP-NF. Regarding sterile compounding, pharmacists should pay particularly close attention
to General Chapters <1> Injections, <51> Antimicrobial Effectiveness Testing, <71> Sterility Testing, <85>
Bacterial Endotoxin Testing, and <797> Pharmaceutical
Compounding–Sterile Preparations.
3. In the absence of sterility testing, what beyond
use dates (BUDs) must be used?
When sterility testing has not been performed, the assigned BUD must not exceed the following allowances:
Controlled
Room
Temperature
Refrigerator Freezer
Low-risk 48 hours 14 days 45 days
Medium-risk 30 hours 9 days 45 days
High-risk 24 hours 3 days 45 days
4. Is it appropriate to assign a BUD of 90 days in the
absence of sterility testing if there is literature indicating the stability of the drug is ensured for 90 days?
No, it is inappropriate and a violation of law to assign
a BUD which exceeds the USP default BUDs in the
absence of sterility testing. Drug stability should not be
confused with drug sterility.
5. What is skip lot testing and may skip lot testing be
used to perform sterility testing of compounded sterile
products?
Skip lot testing is a process that only tests a fraction of
the drugs compounded. It is not appropriate for sterility
testing. It may only be used for ensuring consistency
and drug strength (potency). Because skip lot testing is
complex and requires a robust program, it may not be
possible for a pharmacy to properly implement. Information regarding skip lot testing may be accessed at www
.itl.nist.gov/div898/handbook/pmc/section2/pmc27.htm.
6. How often must the primary engineering control, eg,
laminar airflow workbench, and secondary engineering control, eg, ante and buffer rooms, be certified?
Certification of the primary and secondary engineering
controls shall be performed no less than every six months
and whenever the device or room is relocated, altered, or
major service to the facility is performed. The certification must be performed no later than the last day of the
sixth month, following the previous certification.
Note: This guidance reflects a change to Major Deficiencies 22 and 23 in Guidance Document 110-9, which was
amended at the March 2013 full Board meeting.

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