With guidelines changing, some helpful tips for compounding pharmacies on endotoxin testing requirements
The time is quickly approaching for the revised USP <795> and <797> chapters to be effective for compounding pharmacies. You may be asking what changes you must make to ensure compliance with these new regulations regarding quality control testing. Or what does this mean in terms of adherence to endotoxin testing requirements, or why do I even need to test for endotoxins. We already perform sterility testing, isn’t that enough? The answer to your questions and more will be explained below.
Compounded sterile preparations (CSPs) are currently categorized as low, medium, and high risk but the designations will change to Category 1, 2 and 3. Along with a new naming convention, the factors used to determine which CSPs belong in each category will also be new and exciting. The first order of business will be to assess what category your product will be in when these changes go into effect to ensure full compliance with QC testing requirements. Depending on what you are compounding, the category could stay the same. If your product now needs to be tested for endotoxins, you might have some questions and concerns about how to do this and why it is even needed. Read more >