Impact of newly revised sterile medication compounding guidelines USP (797) on allergy vial preparation

Abstract

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.