A Review of USP's Updates to chapter <797>
March 1, 2007
In summary the publication of USP Chapter <797> provides pharmacy's first required and legally enforcebale compounding standard of practise. A number of state boards of pharmacy changed their regulations as a result, and JCAHO informed its accredited organizations that compliance, via a gap anlaysis and an action plan was required. You find the current changes to Chapter <797> on the USP web site. It is anticipated that the next official version USP Chapter <797> will be published in 2007. The revisions to USP Chapter<797> allow the contribution from primary airflow such as C.A.I. (compounding aseptic isolator) and C.A.C.I. (compounding aseptic containment isolator) to meet the Iso Class 5 air cleanliness required. The article was written by Eric S. Kastango,MBA,RPh.,FASHP and published in Pharmacy Purchasing & Products, Vol.3 No.5.