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Frequent Advisor
Posts: 75
Registered: ‎12-15-2010
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Accepted Solution

Seeking references from robust studies

I am desperate for references from good scientific studies that show a comparison between compounding in a clean room vs. compounding outside of a clean room.  I am aware of one study from Am J Health-Syst Pharm (66) Nov 15, 2009.  I am dealing with old-school administrators who claim that we could make sterile products in their garage as long as we followed aseptic technique.  They are demanding to see the science behind all of the regulations.  I may have to make my case tomorrow.  Any help you can give me is very much appreciated.  Thank you, Maureen

Expert
Posts: 1,142
Registered: ‎02-23-2010
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Re: Seeking references from robust studies

Maureen,

 

This is so much bull**bleep**! They need to get real. There are no double-blinded randomized studies showing whether USP 797 is real.  The published science isn't strong but it is difficult to study.  All we need to do is look at the number of reported incidences.  Not sure how many more patients we need to kill before we get it.    The science is that it is the law in Ohio and CMS requires compliance.  And NO, you can't make IVs consistently in garage and not have problems.  What part of USP 797 are they contesting?  I've attached some resources to help you.  Time to look for a new job if you are getting this type of pushback from your support system.  Send me an email to eric.kastango@clinicaliq.com and I will send additional articles.  Good luck. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.