These guidelines describe the requirements regarding the use of drugs and other chemicals administered to laboratory animals at the University of Iowa. The use of drugs falls into one of two usage categories: therapeutic purposes or experimental use. These guidelines apply to both categories of administration. Deviation from these guidelines must be described and justified in an IACUC-approved Animal Protocol.
The use of non-pharmaceutical grade compounds in animals may be necessary and appropriate, but must be scientifically justified in an IACUC-approved Animal Protocol.
Definitions
Definitions
- Pharmaceutical grade compound: Drug, biologic, or reagent which is approved by the FDA or for which a chemical purity standard has been established by USP/NF or BP.
- Non-pharmaceutical grade compound: Any substance which does not meet the above definition of pharmaceutical grade, including:
- Analytical grade bulk chemical: ~99% purity chemical, Certificate of Analysis typically available
- Pharmaceutical grade drug compounded with non-pharmaceutical grade vehicle or other substance
- FDA – Food and Drug Administration
- USP/NF – United States Pharmacopeia/National Formulary
- BP – British Pharmacopeia
Drugs Administered for Therapeutic Purposes
- Current standards for the veterinary therapeutic care of research animals state that pharmaceutical grade medications should be used for routine medical treatment
- Examples of therapeutic purposes include:
- Sedation and anesthesia for surgery or other procedures
- Relief or treatment of disease or injury
- Pain control (analgesia)
- Euthanasia
- Drugs used for veterinary care, either as part of an IACUC-approved Animal Protocol or an OAR veterinarian-approved treatment plan, should be obtained from a veterinary supply or from a pharmaceutical supplier licensed by the FDA, if available from such sources