Importance of Justification of Non-Pharmaceutical Grade Drugs
NIH’s Office of Laboratory Animal Welfare (OLAW) and the Guide for the Care and Use of Laboratory Animals (the Guide) state that the use of pharmaceutical grade drugs/substances must be used when available to avoid toxicity or side effects from occurring. Non-pharmaceutical grade chemicals or substances must be described and justified in the animal use protocol and approved by the IACUC. Non-pharmaceutical grade compounds include analytical grade, chemical grade, bulk chemicals, reagent grade, and investigational compounds/drugs. They include those purchased from chemical companies.
To assist you, OLAW states it would be reasonable for the IACUC to review and approve the use of non-pharmaceutical grade substances in the situations itemized below:
- No equivalent veterinary or human drug is available for experimental use
- For urethane and tribromoethanol use in mice and rats, a scientific justification and a description of why pharmaceutical grade alternatives (e.g. ketamine/xylazine, isoflurane, etc.) cannot be used in a given animal model
- An equivalent veterinary or human drug is available for experimental use; however, the non-pharmaceutical grade is required to replicate methods from previous studies because results are directly compared to those of replicated studies
- The available human or veterinary drug is not concentrated enough to meet experimental requirements or the correct formulation for the route of administration
- The available human or veterinary drug contains preservatives or inactive ingredients which confound the research goals of the study
If you have any questions, please contact the IACUC Office at IACUC@wayne.edu.
Director, Research Communications