To the Editor — In reviewing OLAW’s response to the Protocol Review scenario presented in the June 2018 issue of Lab Animal1, I noted a direct contradiction to previous advice regarding Veterinary Verification and Consultation (VVC) review of changes from pharmaceutical to non-pharmaceutical compounds issued by OLAW in their August 21, 2014 webinar entitled, “Significant Changes to Animal Activities.”

Specifically, in Dr. Brown’s response to the scenario presented in the column she states, “Neither the change to a non-pharmaceutical grade version nor to an outdated drug qualify as acceptable practices for an IACUC to include in its VVC policy”. Yet in the OLAW webinar transcript2, it states:

Q10: Can the IACUC have a policy allowing the change from a pharmaceutical grade substance to a non-pharmaceutical-grade substance?

A10: Yes, the IACUC may develop an institutional policy regarding the use of non-pharmaceutical-grade substances. OLAW FAQ F4 states, OLAW and USDA agree that pharmaceutical-grade chemicals and other substances, when available, must be used… However, it is frequently necessary to use investigational compounds, veterinarian- or pharmacy-compounded drugs, and / or Schedule I controlled substances to meet scientific and research goals… The IACUC may use a variety of administrative methods to review and approve the use of such non-pharmaceutical grade agents. For example, the IACUC may establish acceptable scientific criteria for use of these agents within the institution, rather than on a case-by-case basis. Change from a pharmaceutical-grade to non-pharmaceutical-grade substance according to an IACUC-approved policy may be administratively handled by veterinary verification and consultation as per NOT-OD-14-126, paragraph 2a., change in experimental substances.

Given that researchers frequently have legitimate reasons to switch from pharmaceutical to non-pharmaceutical grade compounds and given the strong interest in the use of VVC, I feel that clarification regarding these contradictory statements should be provided.