Yes, this interpretation is correct but this exemption is not applicable in Canada.
As per Section C.01.067(1) of the Food and Drug Regulations, it is required that each lot of a drug for
parenteral use be tested for the presence of pyrogens using an acceptable method and be found to be nonpyrogenic.
The Bacterial Endotoxins and Pyrogen test methods described in the United States Pharmacopoeia
(USP) and Ph. Eur. are considered acceptable methods for that purpose. For all parenteral drug products, the
Bacterial Endotoxins test should be preferred over the Pyrogen test unless the latter is demonstrated to be
justified (more appropriate) or has been approved by a review Directorate. Therefore, the specification of all
drug products for parenteral use intended for the Canadian market should include a test for Bacterial
Endotoxins or Pyrogens and the EU current “15 mL exemption” is not applicable in Canada.
The only acceptable exemptions are those provided by Section C.01.067(2) (i.e., for parenteral drug products
inherently pyrogenic or those which cannot be tested for the presence of pyrogens by either test methods). In
other words, not testing a parenteral drug product for the presence of pyrogens would be considered
acceptable only if documentation is available demonstrating that the parenteral drug product is inherently
pyrogenic or that it cannot be tested by any of the methods.
