ABSTRACT

INTRODUCTION Endotoxin is a potent biological response modifier, with a wide range of effects including fever, shock, and death. Endotoxin contamination of parenteral medications is of particular concern because these products are administered directly into the body, bypassing the protective barriers of the skin and the intestinal wall. Consequently, endotoxin contamination of parenteral medications must be strictly controlled to prevent deleterious effects on recipients of the products. By contrast, endotoxin contamination of topical and orally administered therapies is generally not a concern because of the effectiveness of the skin and intestine wall in preventing the entry of endotoxin into the blood and other tissues.