UNIVERSITY of WISCONSIN-MADISON
COMPLIANCE MY UW MAP
RARC link
IACUC Overview
CALS IACUC
LSVC IACUC
SMPH IACUC
SVM IACUC
Meeting Calendar
Semiannual Inspections
Training
Pathology
Pharmacy
Program Assessment
Rodent Quarantine
Veterinary Care
Equipment Lending
Protocol Overview
What All PIs Need to Know
ARROW
ARROW Tips
Request Grant Congruence
Submit
Comply
Amend
Renew, Update
Terminate
Wildlife Waiver
RARC Documents and Forms
Animal Research Alternatives
Animal Transfer, Imports and Exports
Animal Transport
Facilities
Inspections
Species

Policies Overview
Animal User Requirements
Policies by Committee
My Profile
Login Contacts

Guidance for the Justification for the Use of Non-Pharmaceutical-Grade Compounds

See policy UW-4123, Use of Nonpharmaceutical-Grade Compounds 

Justification that is typically acceptable:

Inadequate justification:

Examples of good justifications:

  1. “Compound XXX is experimental in nature and no pharmaceutical-grade alternative is available. It is not practical or possible to generate a pharmaceutical-grade version of this novel compound.”
  2. “The commercially available pharmaceutical-grade compound form of drug YYY is not available in an appropriate concentration to meet the scientific requirements of this study, and it is not possible to alter the concentration to a useable formulation.”
  3. “Though compound ZZZ is commercially available in a pharmaceutical-grade, a non-pharmaceutical-grade preparation has been used by the laboratory since 199X. The data collected on this protocol are part of a longitudinal study that depends on comparison of new data to the results of prior studies. Once comparison of new results to previously collected data is no longer necessary, we will transition to the use of pharmaceutical-grade compounds wherever applicable.”
jump to top button
Internet Explorer is not compatible with this website.

Please use Edge, Firefox, Safari, Chrome or Opera.