Section 811.12.2. Controlled substances, drugs, prescription medications and restricted immunization products.

When state or federal law restricts a drug, medication or immunization product intended for use by or on the order of a licensed veterinarian, the licensed veterinarian shall sell, distribute, or order the drug or medication only in the course of the licensed veterinarian’s professional practice. A prescription veterinary drug, medication or immunization product shall not be deemed to be used “in the course of the licensed veterinarian’s professional practice” unless a valid veterinarian/client/patient relationship exists.

         12.2(1) Prescriptions. The order for all such drugs, medications or immunization products shall be accompanied by the licensed veterinarian’s original prescription that shows the following:

            a.               Licensed veterinarian’s name, address and telephone number;

            b.               Client’s name;

            c.               Patient’s name or identification;

            d.               Date issued;

            e.               Drug, medication or product name, strength, and quantity;

            f.                Directions for use;

            g.               Number of times the prescription may be refilled;

            h.               Expiration date of the drug, medication or product; and

            i.                Applicable withdrawal period (paragraph 12.2(2)“d”) for livestock and poultry.

         12.2(2) Extra-label use of veterinary drugs, medications, and immunization products. Any extra-label use of veterinary drugs, medications or immunization products shall be by or under the order of a licensed veterinarian only and shall be subject to the following criteria:

            a.               There shall be a veterinarian/client/patient relationship as defined in subrule 12.1(1).

            b.               For drugs or medications used in patients not intended for food, one of the following applies:

             (1)             There are no marketed drugs, medications and immunization products specifically labeled for the condition(s) diagnosed;

             (2)             The approved product is clinically ineffective; or

             (3)             In the licensed veterinarian’s clinical judgment, the labeled dosage is inappropriate for the condition or the extra-label use should result in a better outcome for the patient.

            c.               The health of the treated patient is immediately threatened, or suffering or death would result from a failure to treat the affected patient.

            d.               Appropriate withdrawal period shall be specified when the drugs, medications or immunization products are used in animals intended as food. Extra-label drug use in food-producing animals must follow Food and Drug Administration - Animal Medicinal Drug Use Clarification Act regulations (21 Code of Federal Regulations 530). Licensed veterinarians are encouraged to consult the Food Animal Residue Avoidance Databank (FARAD) or public peer-reviewed documents when determining appropriate withdrawal period.

[ARC 1465C, IAB 5/28/14, effective 7/2/14]