Administrative terminology.

CFR · 2024-01-01 · US · Title 9

The following administrative words and phrases shall mean: (1) An identifiable reporter; (2) An identifiable animal; (3) An identifiable biologic product; and (4) One or more adverse events. (1) A product's intended use shall be determined through an objective standard and not a subjective one, and would be dependent on factors such as representations, claims (either oral or written), packaging, labeling, or appearance. (2) The term (i) Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which are similar in function to biological products in that they act, or are intended to act, through the stimulation, supplementation, enhancement, or modulation of the immune system or immune response; or (ii) Substances, at any stage of production, shipment, distribution, or (iii) Substances, at any stage of production, shipment, distribution, or sale, which resemble or are represented as biological products intended for use in the treatment of animals through appearance, packaging, labeling, claims (either oral or written), representations, or through any other means. (3) The term

official document · source cfr-2024 · id 9:§ 101.2