The Virginia Society of Health-System Pharmacists would like to indicate there appears to be a discrepancy between the monetary penalty guide and the USP guidance for compounding.  The penalty guideline items are: 

25d. Documentation that a person who failed a media-fill test or gloved fingertip test has performed compounding of Category 3 CSPs after receipt of the failed test result and prior to retraining and receipt of passing media-fill and gloved fingertip test 

26a. Documentation that a person who failed a media-fill test or gloved fingertip test has performed compounding of Category 1 and Category 2 CSPs after receipt of the failed test result and prior to retraining and receipt of passing media-fill and gloved fingertip test 

The relevant USP <797> FAQ item is below:

FAQ #53. If compounding personnel fail media-fill testing or gloved fingertip and thumb sampling, are they required to stop compounding until corrective action and reevaluation have been completed? General Chapter <797> chapter does not require compounding personnel to cease compounding, however, the facility must evaluate the cause of failure and determine appropriate corrective actions. The results of the evaluation and corrective action must be documented, and the documentation must be maintained to provide a record and long-term assessment of personnel competency. General Chapter <797> describes gloved fingertip and thumb sampling and media-fill testing in Sections 2.2 Demonstrating Competency in Garbing and Hand Hygiene and 2.3 Competency Testing in Aseptic Manipulation, and required documentation in 20. Documentation.

VSHP would like to ensure our members are aligning expectations with the Board of Pharmacy and USP and would appreciate clarity on this discordance. 

Thank you for this opportunity.

The Virginia Society of Health-System Pharmacists