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Qualified licensed health care professionals who supervise compounding and dispensing of CSPs shall ensure that the following objectives are achieved.
This chapter emphasizes the need to maintain high standards for the quality and control of processes, components, and environments; and for the skill and knowledge of personnel who prepare CSPs.
For the purposes of this chapter, CSPs include any of the following: The sections in this chapter are organized to facilitate practitioners understanding of the fundamental accuracy and quality practices of CSPs.
The basic understanding for CSTDs is that they should not be used to extend BUD.
However, does this prevent multiple entries into the bag by creating a sealed barrier between the product and the direct compounding area (DCA)? It is interesting to note that the media-fill test procedure for low-risk compounding includes transferring four 5-m L aliquots of TSA into a single 30-m L vial. A CSP prepared under low-risk conditions receives a 48 hour BUD when stored at controlled room temperature.
So if you were to prepare a single ingredient stock bag and leave it in the hood, why not give it 48 hours?
Medium-Risk Conditions— When CSPs are compounded aseptically under Low-Risk Conditions and one or more of the following conditions exists, such CSPs are at a medium risk of contamination.
The BUD after initially entering or opening (e.g., needle-punctured) multiple-dose containers is 28 days unless otherwise specified by the manufacturer.” Is a stock bag a single dose container or something else? However, some state boards have taken to treating stock bags as single dose containers, forcing pharmacies to discard unused portions within 6 hours of compounding.