Guidance for the Justification for the Use of Non-Pharmaceutical-Grade Compounds
See policy UW-4123, Use of Nonpharmaceutical-Grade CompoundsJustification that is typically acceptable:
- Pharmaceutical-grade is not available from a veterinary or medical supplier.
- Pharmaceutical-grade is not available from a veterinary or medical supplier in the needed concentration (e.g., high concentration of penicillin to produce seizures; supersaturated solution of potassium chloride to euthanize pigs)
- Non-pharmaceutical-grade is required in order to produce data that is comparable to previous data
- Pharmaceutical-grade compounds have known unwanted effects on measured outcomes substantiated by data or published results
- Non-pharmaceutical-grade compounds produce necessary outcomes substantiated by data or published reports that are not replicated by pharmaceutical-grade compounds
- Pharmaceutical-grade compounds contain unwanted fillers/diluents/vehicles
- Pharmaceutical-grade is only available in a form not suited for chosen route of administration or the species in which the compound is to be used
Inadequate justification:
- Cost savings alone
- Administrative burden of acquiring and maintaining a DEA license
- Consideration/elimination of only one of multiple pharmaceutical-grade alternatives
Examples of good justifications:
- “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.”
- “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.”
- “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.”