Issue Date: March 18, 2026
Issued by: Center for Veterinary Medicine
Topic(s): Investigation & Enforcement, Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Status: Final
Pyrogen and Endotoxins Testing: Questions and Answers: Guidance for Industry
This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter <85> “Bacterial Endotoxins Test”, USP Chapter <161> “Medical Devices ‒ Bacterial Endotoxin and Pyrogen Tests”, and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72). These three documents describe the fundamental principles of the gel clot, photometric, and kinetic test methods, and recommend that appropriate components and finished products be tested for the presence of pyrogens and endotoxins.
Download the Guidance Document
