PERSPECTIVE FDA Withdraws LAL Test Guideline

On June 22, 2011, the U.S. Food and Drug Administration (FDA) withdrew the “Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-product Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices,” which was issued in 1987. Elements of the Guideline continue to impact current methods because they can be found in other references relied on by the industry. As such, to those of us who helped write it, its retirement is like the passage of a venerated patriarch who lives on through his descendents. This discussion will cover how important aspects of the LAL Guideline influence standards of practice today.