Policy Title: Policy on the Use of Nonpharmaceutical-Grade Compounds in Research Animals
Purpose: To remain in compliance with positions held by the National Institutes of Health Office of Laboratory Animal Welfare (NIH-OLAW), the United States Department of Agriculture – Animal Plant Health Inspection Service (USDA-APHIS), and the 8th Edition of The Guide for the Care and Use of Laboratory Animals, this policy describes requirements regarding the use of nonpharmaceutical-grade chemicals or compounds in laboratory animals at the University of Wisconsin–Madison. This Policy applies to animals used for research and teaching purposes at UW–Madison facilities regardless of the funding source. Oral compounds used in agricultural animals are excluded from this policy.
For the purposes of this policy, a pharmaceutical-grade chemical compound is defined as any active or inactive drug, biologic (e.g., vaccine), reagent, etc. that is approved by the FDA or for which a chemical purity standard has been written or established by any recognized pharmacopeia, such as the U.S. Pharmacopeia [USP], the National Formulary [NF], the British Pharmacopoeia [BP], or the Pharmacopoeia of the Council of Europe [EP].
- Compounds to be used in living vertebrate animal subjects for investigational or clinical purposes, including in terminal studies, must either be pharmaceutical grade as defined above or meet criteria detailed in number 2 below or exclusions identified in number 3 below.
- The use of nonpharmaceutical-grade chemical compounds may be granted by the Animal Care and Use Committee (ACUC) in certain circumstances upon request by Principal Investigators (PI). Such requests must:
- be written in an animal care and use protocol submitted to the appropriate ACUC.
- include details on the scientific necessity to use a nonpharmaceutical-grade chemical compound. Cost savings alone are not an adequate justification for the use of nonpharmaceutical-grade drugs in animals. Acceptable criteria for use of nonpharmaceutical-grade compounds are:
- No pharmaceutical-grade formulation is available; if no equivalent veterinary or human drug is available for experimental use, then the highest-grade equivalent chemical (e.g., non-USP) reagent should be used and formulated aseptically and with a nontoxic vehicle as appropriate for the route of administration.
- Although an equivalent veterinary or human drug is available for experimental use, the chemical-grade reagent is required to replicate methods from previous studies because results are directly compared to those of replicated studies.
- Although an equivalent veterinary or human drug is available, the concentration or formulation is not appropriate to meet experimental requirements.
- The available human or veterinary drug does not meet the nontoxic vehicle requirements for the specified route of injection or for the proposed research species.
- include specific details on how the PI will prepare nonpharmaceutical-grade compounds for administration; if applicable, ACUC-approved standard policies and formulations may be referenced by PIs in lieu of detailed descriptions (see companion SOP).
- be approved in the protocol by the ACUC before the administration of nonpharmaceutical-grade chemical compounds to animals.
- Statements justifying the use of nonpharmaceutical-grade viruses, vaccines, fungal spores, bacteria, or other nondrugs, nonchemicals, nonreagents, and noncompounds are not required in ACUC-approved protocols. The use of novel substances in live vertebrate animals must be consistent with ACAPAC policy 2005-028 ("Novel Substances Tested in Laboratory Animals").
- The Guide for the Care and Use of Laboratory Animals, 8th ed., 2011
- OLAW/USDA/AAALAC International webinar “Use of Non-Pharmaceutical-Grade Chemicals and Other Substances in Research with Animals”
Author: H. McEntee, J. Welter, D. Jefcoat, D. Uhlrich, B. Darien, R. Stoffel, RARC Veterinary Staff
ePublication Date: 4/9/2010
History: amended 6/2012, 10/2014