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Occasional Contributor
Posts: 10
Registered: ‎07-31-2012

BUD question

I am new to USP 797 procedures and I am having a difficult time differentiating the different risk levels. Please clarify on:

 

1. 2 Lovenox single dose syringe transferred by squirting the drug into an empty syringe to make larger doses e.g 180mg. If this is made in a clean environment, do you consider this low or medium risk? I feel that it should be medium because it is not truly a closed system and contains no preservative, is this correct?

 

2. Folic acid multidose vial batch compounded into multiple syringes. Contains a preservative. Low risk? Can you clarify when batch preparation is considered low vs medium risk?

 

3. Do you consider an ampule an open system, in which case, any compounded product utilizing an ampule, should that be considered medium to high risk?

 

4. High risk compounding specifically includes open system transfers. Please clarify what constitutes an open system - irrigation bottles?