FDA Withdraws 1987 Guideline for Endotoxin Testing
August 9, 2011 - As anticipated, effective 12 July 2011, the U.S. Food and Drug Administration (FDA) has withdrawn the "Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-product Test for Human and Animal Parenteral Drugs, Biological Products, and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" that was issued in 1987 and its subsequent 1991 amendment, "Interim Guidance for Human and Veterinary Drug Products and Biologicals, Kinetic LAL Techniques."
The FDA now refers drug manufacturers to the United States Pharmacopeia (USP) General Chapter <85> Bacterial Endotoxins Test (BET), which provides information on the performance and acceptance criteria for endotoxin testing.
To learn what this means for your endotoxin testing, click here.
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