FPGEE for National Association of Boards of Pharmacy (NABP) Practice Exam 2025 - Free NABP Practice Questions and Study Guide

Bacterial endotoxin testing is required for all high-risk sterile preparations administered by injection because it helps ensure that the preparation is free of bacterial endotoxins, which can cause severe inflammatory reactions or even septic shock when introduced into the bloodstream. Endotoxins are components of the outer membrane of certain bacteria and can be very harmful if they contaminate injectable formulations. This testing is crucial for patient safety and is a standard requirement in sterile compounding practices to maintain the quality and safety of the products being administered.

Toxicity testing, while important in certain contexts, is specifically focused on the potential harmful effects of the drug itself rather than the presence of contaminants. Stability testing assesses how long a compound maintains its effectiveness but does not directly address harmful contaminants. Purity testing evaluates whether a compound is free from impurities, but it does not specifically assess bacterial endotoxin levels. Thus, bacterial endotoxin testing directly aligns with the safety needs associated with high-risk sterile preparations for injection.