Pharmaceutical-Grade Compounds in Research

In compliance with Federal Animal Welfare Regulations and guidelines and standard veterinary medical practice the IACUC requires that investigators use pharmaceutical grade medications whenever they are available for anesthesia, analgesia and euthanasia. The use of non-pharmaceutical-grade chemical compounds in experimental animals under certain circumstances has been, and will continue to be, a necessary and acceptable component of biomedical research.  OLAW and the USDA have determined that their use should be based on (1) scientific necessity, (2) nonavailability of an acceptable veterinary or human pharmaceutical-grade compound, and (3) specific review and approval by the IACUC.  In reviewing proposals the IACUC will consider a number of related animal welfare and scientific issues including safety, efficacy, and the inadvertent introduction of research-complicating variables.  Cost savings alone do not adequately justify the use on non-pharmaceutical-grade chemical compounds.

By definition, “pharmaceutical grade” is a term referring to a standard or level of purity suitable for the production of medicine within the pharmaceutical community. The product must be  in excess of 99% purity with no binders, filters, dyes, or unknown substances.  To achieve this level, a product must A) be produced in a fully compliant, government approved facility, B) offer full document traceability detailing every step of the supply chain process for each batch of product produced, C) exceed product purity levels and D) meet consistent, tight specifications for each batch of product produced. To be fully considered “pharmaceutical grade”, a product should also have an active “Drug Master File” recognized by multiple governmental health or drug agencies. Lists of chemical compounds available in pharmaceutical grade can be found in either the human or veterinary PDR.