OAR 603-012-0210: Definitions

In addition to the definitions set forth in ORS 596.095, the following shall apply: (1) “Animal remedy” means any product used to prevent, inhibit, cure, enhance, or protect the health or well-being of animals, but does not include food, surgical instruments, or accessories. A product will be deemed to be used to prevent, inhibit, cure, enhance, or protect the health or well-being of animals if it contains labeling indicating that it is intended for such use. (2) "Autogenous biologic" means a product that meets the requirements in 9 CFR §113.113 (January 1, 2025 edition). (3) “Feed” has the meaning given that term in ORS 633.006. (4) “Food” means a nutritionally adequate feed for animals other than humans; by specific formula is compounded to be fed as the sole ration and is capable of maintaining life and/or promoting production without any additional substance being consumed except water or forage. (5) “Labeling” means all labels and other written or graphic materials in print or electronic form, (a) upon a product or any of its containers for wrappers, or (b) accompanying or promoting such product. (6) “Manufacturer” means any person whose name appears on the label of a veterinary product indicating that it is the manufacturer or had the product manufactured for them. (7) “Pharmaceutical” means drug products labeled for veterinary/animal use by the U.S. Food and Drug Administration (8) "Product" means an item readily distinguishable from any other item by its content, brand name, trade name, manufacturer, use as specified in labeling, formulation, concentration, dosage form, or other distinction, but not including packaging size or quantity. (9) “Repeat violation” means the same or similar violation by a person for which the Department has pursued an enforcement action, including alternative enforcement actions such as a letter of advisement, within the past five years, including a violation which is the subject of a pending appeal, but not including a violation addressed in an order that has been withdrawn or successfully appealed. Without limiting the foregoing, a person’s failure to register a veterinary product after receiving a letter of advisement regarding nonregistration of a different veterinary product shall be considered a repeat violation. (10) “Veterinary biologic” means biological products licensed for veterinary/animal use by the U.S. Department of Agriculture, Animal and Plant Health Inspection Service. (11) “Veterinary client patient relationship” has the meaning given that term in OAR 875-005-0005 (12) “Veterinary product” means an animal remedy, pharmaceutical, or veterinary biologic.