Pharmaceutical-Grade Compounds in Research

USDA Policy 3 states - Investigators are expected to use pharmaceutical-grade medications whenever they are available, even in acute procedures.  Non-pharmaceutical-grade chemical compounds should only be used in regulated animals after specific review and approval by the IACUC for reasons such as scientific necessity or non-availability of an accepted veterinary or human pharmaceutical-grade product.  Cost savings alone are not an adequately justification for using non-pharmaceutical-grade compounds in animals.  

Pharmaceutical Grade - meets pharmaceutical standards.  There are several criteria by which pharmaceutical grade is judged.  The product must be in excess of 99% purity with no binders, filters, dyes, or unknown substances.  Lists of chemical compounds available in pharmaceutical grade can be found in either the human or veterinary PDR. 

PHS policy is quite specific on the use of non-pharmaceutical drugs

http://grants.nih.gov/grants/OLAW/references/lab_animal2003v32n9_wolff.htm

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3. Are the scientists at our institution allowed to use non-pharmaceutical-grade chemical compounds in physiological preparations involving laboratory animals? Please clarify whether this is an allowable practice and whether it makes a difference if the compounds are used in survival versus nonsurvival experiments.

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 preparing and reviewing proposals to use non-pharmaceutical-grade products, investigators and IACUCs should consider a number of related animal welfare and scientific issues including safety, efficacy, and the inadvertent introduction of research-complicating variables. Although one can assume that issues such as sterility, pyrogenicity, stability, pharmacokinetics, and quality control have been addressed during the course of producing pharmaceutical-grade drugs, one cannot say the same for substances produced in the research laboratory using non-pharmaceutical-grade chemical compounds. Cost savings alone do not adequately justify the use of non-pharmaceutical-grade compounds in animals. Although the potential animal welfare consequences of complications are less evident in nonsurvival studies, the scientific issues remain the same. The principles and need for professional judgment just outlined still apply.