Current through Register Vol. 54, No. 36, September 7, 2024
Section 403.18 - Compounded medications on racetrack grounds(a) The possession or use of any drug, substance, or medication on the licensed racetrack grounds which has not been approved by the appropriate Federal agency (for example, the United States Food and Drug Administration) for use in humans or animals is forbidden without prior approval from the Commission or its designee.(b) It is a violation of this regulation to possess, use, or distribute a compounded medication on licensed racetrack grounds if there is an FDA approved equivalent of that substance available for purchase. A difference in available formulations or concentrations does not alleviate the need to use FDA approved products.(c) It is a violation of this regulation to possess, use or distribute a compounded medication on licensed racetrack grounds made from bulk substances, if an FDA approved equivalent is available for purchase.(d) Combining two or more substances with pharmacologic effect constitutes the development of a new drug and is prohibited. This may only be done in accordance with state and local laws and must contain FDA approved medications, if available.(e)Compounded veterinary drugs. Veterinary drugs shall be compounded in accordance with all applicable state and Federal laws. Compounded medication shall be dispensed only by prescription issued by a licensed veterinarian to meet the medical needs of a specific horse and for use only in that specific horse.(f) All compounded medications must be labeled in accordance with § 403.12 (relating to medical labeling).(g) Possession of an improperly labeled product by any person on the licensed racetrack grounds is considered a violation of this section and may subject the person to a penalty.