1. K-State home
  2. »Research Compliance
  3. »IACUC
  4. »Policy
  5. »Guidelines
  6. »Guideline #19

Institutional Animal Care and Use Committee

Guideline #19

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:

  • Definitions:
    • 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.

Reference:

USDA AWA Policy#3 -

http://www.aphis.usda.gov/animal_welfare/downloads/policy/policy3.pdf

NIH OLAW FAQ - http://grants.nih.gov/grants/olaw/faqs.htm#useandmgmt_4

LAST REVIEWED AND ADOPTED BY THE IACUC: July 21, 2011