Protecting Health

Horseshoe Crabs & Bacterial 
Endotoxin Test Regulations

Testing Requirements and Regulations

In the United States, the Food and Drug Administration (FDA) regulates the manufacturing and market release of human and animal parenteral drugs, biologicals and medical devices.  Other countries have similar regulatory agencies that, like the U.S. FDA, are tasked with monitoring and therefore assuring the quality and safety of products.  The FDA reviews new drug applications or changes to already approved products.  If the product will come in contact with the blood stream or cerebrospinal fluid, the product submissions must include endotoxin testing results indicating that the product has an endotoxin content below its allowable endotoxin release limit.

The United States, European, Japanese and other Pharmacopeia publish product monographs that provide endotoxin release limits for many products.  In addition, test chapters are published that define the requirements for conducting a Bacterial Endotoxins Test (BET).  In the U.S. Pharmacopeia (USP), the BET chapter is Chapter<85> and it has been, to the extent possible, harmonized with the BET chapters in the European and Japanese Pharmcopeias.  U.S. FDA inspectors audit pharmaceutical companies based on the USP requirements. The FDA regulates LAL not because of what it does, but because of where it comes from, i.e., the blood of an animal.