In accordance with the NIH Office of Laboratory Animal Welfare, USDA Animal Care Policy #3, and the Guide for the Care and Use of Laboratory Animals (the Guide, 8th edition, p. 31), the Animal Research Committee (ARC) has established the following guidelines:
- Unless approved by the ARC, investigators are expected to use pharmaceutical-grade or veterinary grade medications, anesthetics, analgesics, euthanasia agents and experimental agents whenever they are available, even in acute procedures.
- Investigators should consider relevant animal welfare and scientific issues including safety, efficacy, and the inadvertent introduction of new variables when using non-pharmaceutical grade compounds.
- Use of non-pharmaceutical grade/veterinary grade agents must be justified in the protocol and submitted to the ARC for specific review and approval. Anesthetics, analgesics and sedatives used to treat more than momentary or slight pain or distress, and euthanasia agents, must be pharmaceutical/veterinary grade unless used as investigational agents. Examples of acceptable justification for use of non-pharmaceutical/veterinary grade investigational agents include: 1) the compound is not available in a pharmaceutical-grade preparation and comparable alternative agents available in pharmaceutical grade form cannot be used for scientific reasons; 2) it is necessary to compare data with previous experiments using the non-pharmaceutical grade substance; 3) it would be necessary to dilute the pharmaceutical grade preparation thereby compromising the pharmaceutical grade quality of the preparation; 4) the vehicle of the pharmaceutical grade preparation cannot be determined preventing use of an appropriate control.
- Cost savings alone is not an adequate justification for using non-pharmaceutical-grade compounds in animals.
- All non-pharmaceutical- and/or veterinary-grade compounds and diluents must be sterilized (eg. autoclaved or filter-sterilized using a 0.22 µm filter prior to administration) wherever this is possible without jeopardizing the activity/stability of the agent.
Approved 11/13/00; Revised 6/02, 7/28/03, 8/10/09, 8/23/10, 1/18/11, 5/23/11, 7/9/12