The Use of Non-pharmaceutical Grade Drugs in Research Animals
The KSU Institutional Animal Care and Use Committee (IACUC) Guideline for use of non-pharmaceutical grade drugs closely mirrors the current USDA AWA Policy #3 on use of non-pharmaceutical grade drugs. The IACUC provisions are as follows:
- Pharmaceutical Grade - Compounds or agents intended for use in human or veterinary medicine which meet the highest standards for purity and bioavailability.
- Non-Pharmaceutical Grade (Chemical Grade) - Compounds or agents which may be chemically identical to their pharmaceutical grade counterparts, but do not conform to recognized standards for purity and bioavailability.
- Investigators are expected to use pharmaceutical-grade medications whenever they are available, even in acute/terminal procedures.
- Investigators and IACUCs should consider relevant animal welfare and scientific issues including safety, efficacy, and the inadvertent introduction of new variables.
- The IACUC acknowledges that, under certain circumstances, the use of non-pharmaceutical grade chemical compounds in experimental animals may be a necessary and acceptable component of biomedical research.
- Non-pharmaceutical-grade chemical compounds should only be used in animals after specific review and approval by the IACUC based on the following reasons:
- Scientific necessity
- Non-availability of an acceptable veterinary or human pharmaceutical-grade product
- Cost savings alone are not an adequate justification for using non-pharmaceutical-grade compounds in animals.
- If the use of specific non-pharmaceutical grade drugs is necessary:
- The method of preparation of the drug and the storage conditions must be described in the animal use protocol and approved by the IACUC (Section VI.I.6.).
- Consultation with the Attending Veterinarian is strongly recommended.
USDA AWA Policy#3 -
NIH OLAW FAQ - http://grants.nih.gov/grants/olaw/faqs.htm#useandmgmt_4
LAST REVIEWED AND ADOPTED BY THE IACUC: July 21, 2011