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Institutional Animal Care and Use Committee

Guideline #19

Use of Non-Pharmaceutical Grade Drugs in Research Animals

1. References:  United States Department of Agriculture Animal Care Resource Guide, Policy #3; National Institutes of Health, Office of Laboratory Animal Welfare, Frequently Asked Questions.

2. Purpose/Scope:  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:

3. Definitions:

3.1. Pharmaceutical Grade - Compounds or agents intended for use in human or veterinary medicine which meet the highest standards for purity and bioavailability.

3.2. 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.

4. Pharmaceutical-grade substances are expected to be used whenever they are available, even in acute/terminal procedures, to avoid toxicity or side effects that may threaten the health and welfare of the animals and/or interfere with the interpretation of research results.

5. Investigators, and the IACUC, should consider relevant animal welfare and scientific issues including safety, efficacy, and inadvertent introduction of new variables.

6. The IACUC recognizes that some substances are only available as a non-pharmaceutical grade product, and that, under certain circumstances, the use of non-pharmaceutical grade substances may be necessary to meet specific scientific and research goals.

7. Non-pharmaceutical-grade chemical compounds may only be used in animals after specific review and approval by the IACUC based on the following reasons:

7.1. Scientific necessity.

7.2. Non-availability of an acceptable veterinary or human pharmaceutical-grade product

7.3. Non-availability of an acceptable alternative pharmaceutical-grade compound.

8. Cost savings alone are not an adequate justification for using non-pharmaceutical-grade compounds in animals.

9. If the use of specific non-pharmaceutical grade drugs is necessary:

9.1. The method of preparation of the drug and the storage conditions must be described in the animal care and use protocol and approved by the IACUC (Section VI.I.2.).

9.2. Consultation with the Attending Veterinarian is strongly recommended.

10. Supersedes:  IACUC Guideline #19: The Use of Non-pharmaceutical Grade Drugs in Research Animals 07/21/2011.