Long description: Drug/Feed classification flowchart

Appendix A is composed of the Drug/Feed classification flow chart. The purposes of this graphic flowchart are to explain the logical step-by-step approach to the classification process currently used within VDD and explain the interactions between the different classification criteria. To begin, only products intended for livestock species would be considered to go through this process. Products intended for other species are not relevant for the Feed/Drug interface. Then, the following questions are asked, in the determined order, in order to exclude a probable feed classification right from the start:

• Is the product presented in an oral dosage form or administered orally? No = not a feed
• Is the product used via forceable administration? Yes = not a feed
• Does the product contain a known medicinal ingredient? Yes = not a feed
• Does the product have a therapeutic purpose or intent of use? Yes = not a feed

In order to answer this latter question, a group of four (4) classification criteria or factors need to be considered individually and as a whole;

• the indications on the product's label (which are assessed in conjunction with the subject product's advertising, traditional uses and the scientific literature associated with it);
• the composition of the product (which is influenced by the type of ingredients and their concentration);
• the mode of action (which is supported by the scientific literature); and
• the directions for use (which may or may not be influenced by the duration and or timing of the administration)

After answering the last questions, one would be in a good position to decide upon a classification of a drug (yes answer), of a feed (no answer) or another classification type. Other possible classifications for a product intended for animal use include veterinary biologics, pesticides, disinfectants, medical devices, etc.)