Monday, February 18, 2013

Virginia: Compounding Sterile Preparations

Compounding Sterile Preparations
Virginia Board of Pharmacy Regulation 18VAC110-20-321
states compounding of both sterile and nonsterile drug products
shall be performed in accordance with United States Pharmacopeia-
National Formulary (USP-NF) compounding standards and
§54.1-3410.2 of the Code of Virginia. While pharmacists often
associate sterile compounding requirements with USP Chapter
<797> Pharmaceutical Compounding: Sterile Preparations, it is
important not to overlook the requirements in USP Chapters <1>
Injections, <51> Antimicrobial Effectiveness Testing, <71> Sterility
Test, and <85> Bacterial Endotoxin Testing.
At the December 12, 2012 Board meeting, the Board addressed
several issues in Guidance Document 110-9 Pharmacy Inspection
Deficiency Monetary Penalty Guide, related to compliance with
USP-NF standards regarding the compounding of sterile preparations.
Modifications, including changes for when an inspector
should cite a deficiency, were made to Major Deficiencies 20, 21,
22, 24, 25, 26, and 33, and Minor Deficiencies 30, 31, and 32. To
access Guidance Document 110-9, visit

Source found here

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