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Senior Member
Posts: 5
Registered: ‎06-30-2011

usp 797 and radiopharmaceuticals

Eric,

 

With respect to radiopharmaceuticals with 12 hr or less BUD, the chapter doesn't mandate an anteroom as long as you utilize an ISO 5 LFWB in a segregated compounding area that is ISO 8 or better.  The radionuclides are eluted from generators residing in a separate area that is better than ISO 8. Our Board recognizes this but since the references in "Personnel Cleansing and Garbing" require garbing in an anteroom, our Board takes that as meaning an anteroom is mandatory.  What are your thoughts on this?  Thanks!!

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

Re: usp 797 and radiopharmaceuticals

Frank,

 

I can appreciate how the board of pharmacy views the expectation for an ante area since personnel needs to be gowned when working with the low-risk level CSP with 12 hour BUD.  As a radiopharmacy, how do you manage the tagging of WBCs?  This CSP is considered a medium-risk or possibly hihg-risk level CSP which would require you to have both a dedicated area for this compounding and buffer area, which would require an ante area.  Thanks.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
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Senior Member
Posts: 5
Registered: ‎06-30-2011

Re: usp 797 and radiopharmaceuticals

Yes Eric, they do tag WBCs so in that case an anteroom would be in order.  Don't thing the BOP is really considering that since the inspectors know little about radiopharmacy.  Thanks for the input!!