Glossarium

The use of a drug product (that has a DIN):

- in a different dosage than what is approved on the label; - with a greater or lesser frequency of administration than what is approved on the label; - for a different indication (ie., different disease or condition) that was stated on the label; - for a longer or shorter duration of treatment than what is indicated on the label; - by different routes of administration (e.g. oral versus injectable); - in a different species than what is indicated on the label (e.g. a drug approved in cattle administered to sheep); - in a different age group; in a different stage of the animal's production cycle (e.g. dried out cows versus lactating dairy cows); - in a different dosage form (e.g. a tablet may be crushed into powder and incorporated into a gel i.e., by ““Compounding””); - that has been approved for human use, to treat an animal; - in a medicated feed outside of Medicated Ingredient Brochure (MIB) listing; - in a different formulation e.g. two drugs being mixed in the same syringe i.e., by ““Compounding””;

The use of drug product ( with no DIN) - the use of unapproved drugs (no DIN) in animals - the use of bulk pharmaceutical substances (with no DIN), also called Active Pharmaceutical Ingredients (APIs), which have been formulated by compounding or administered as is“. Health Canada

Actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labelling. This includes, but is not limited to: - use in species not listed in the labelling - use for indications (disease or other conditions) not listed in the labelling - use at dosage levels, frequencies, or routes of administration other than those stated in the labelling - deviation from the labeled withdrawal time based on these different uses. CVMA (PUGS 2008)