Justification of Non-Pharmaceutical Grade Drugs

Regulations state that pharmaceutical grade drugs (e.g., those purchased from a pharmacy or pharmaceutical company) must be used with animals whenever possible.  If non-pharmaceutical grade drugs or compounds (e.g., those purchased from a chemical company, like Sigma or Caymen Chemical) are used, their use must be justified. Question 7 in the “Are You Using” section of the IACUC protocol requires you to list all non-pharmaceutical grade drugs and compounds that will be used in animals.  The subsequent checkboxes are also required and provide potential justifications for their use:

  • No equivalent pharmaceutical grade drug is available
  • An equivalent pharmaceutical grade drug is available, but non-pharmaceutical grade is required to replicated previous studies
  • The available pharmaceutical grade version is not in the correct concentration or formulation
  • The available pharmaceutical grade version contains preservatives that may confound the research
  • Scientific justification

Scientific justification should include references, where possible, or data to scientifically justify all the specific uses for the non-pharmaceutical grade drug(s). 

If you have any questions regarding the use of non-pharmaceutical grade drugs, please contact the IACUC Office (IACUC@wayne.edu).

Contact info

Julie O'Connor

Director, Research Communications
Phone: 313-577-8845
Email: julie.oconnor@wayne.edu