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Occasional Collector
Posts: 1
Registered: ‎10-30-2015
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BUD if adding to a previously prepared CSP

Due to the shortage of 250 mL bags of commercially prepared D10-1/4NS, our hospital is making our own by adding 23.4% sodium chloride to D10W 250 mL bags, and treating it as a medium risk compound.

  • If we receive an order to add heparin (either 125 units or 250 units) to D10-1/4NS, what beyond use date should we give the D10-1/4NS + heparin if we add to the previous prepared CSP? 
  • Currently we treat it as a medium-risk compound and use the original BUD assigned to D10-1/4NS.
  • Is this best practice?  Are we "allowed" to treat this as a medium risk CSP?

 

If we were to start to have D10-1/4NS prepared by an outside 503B outsourcing facility, are there rules, or guidelines, or accepted practice regarding adding sterile products to an outsourced CSP?

 

Thanks in advance