f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 9 [Entry Date] 03/01/2011 at 03:46:39 PM [Affiliation] Self [Comments] 
Comment 1: The guide states that pharmaceutical grade chemicals or substances should be used when available for studies conducted in animals to ensure that toxic or unwanted effects are not introduced into studies. I have difficulty with this suggestion. First, the assumption that toxic or unwanted effects occur to any significant extent because of the use of non-pharmaceutical grade chemicals or substances in animal studies appears unwarranted. Currently, pharmaceutical grade chemicals or substances are only rarely used in animal studies, and I am unaware of any problems associated with this practice. Is there any empirical evidence of such a problem? How frequently do such problems occur? Second, there are problems of definition. In particular, what is meant by pharmaceutical grade is unclear. This could be taken to mean that it is more desirable to crush tablet formulations of medications and inject these ip than to prepare a solution using a substance obtained from a chemical company. Clearly, this is not desirable. Finally, that a pharmaceutical grade compound is unavailable can be difficult to demonstrate depending upon the definition of pharmaceutical grade. If this is defined by compound purity or the like, then such compounds can be custom synthesized in almost all cases, but at a significant cost in time, effort and financial resources. This would is a burdensome guideline, if as seems likely to be the case the problem being addressed cannot be reliably demonstrated.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals