Objectives: To highlight newly revised guidelines on sterile medication compounding released by the United States Pharmacopeia (USP 797) in December 2007, and the implications on immunotherapy vial preparation.
Study design and methods: A policy review.
Results: The newly revised USP chapter on sterile medication guidelines was released December 2007 and becomes effective June 2008. The revised USP 797 now has specific guidelines addressing immunotherapy vial preparation that are a significant change from the previous version. The revised guidelines should be a useful tool for clinicians who are developing and setting office mixing standards.
Conclusions/significance: Offices preparing immunotherapy vials should consider formalizing and implementing vial preparation guidelines. These guidelines should be based on expert opinion, experience, and scientific literature.