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Advisor
Posts: 31
Registered: ‎10-03-2013
0

Re: BUD when using single dose vials to prepare syringes

Thanks Eric for you input, it is appreciated!

Visitor
Posts: 2
Registered: ‎03-27-2014
0

Re: BUD when using single dose vials to prepare syringes

At what quantity of a batch does it become medium risk?

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Expert
Posts: 1,168
Registered: ‎02-23-2010
0

Re: BUD when using single dose vials to prepare syringes

Currently, USP has not defined what a batch is in USP 797 but the definition will may appear in the next revision will be: More than one unit of a compounded sterile preparation that is intended to have uniform character and quality within specified limits, prepared in a single process, and completed during the same and limited time period. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.