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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.”
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