Endotoxins may decrease the effectiveness of a therapeutic product. More severely, bacterial endotoxins enter patients' bloodstream would cause harmful symptoms. As such, any pharmaceutical products that will enter the body, including parenteral medicines and injectable devices, must be tested for the presence of endotoxins before release to the market. The FDA and USP have recognized the validity of various approaches to using Limulus Amebocyte Lysate (LAL) for endotoxin testing.
