811—12.2(169) Controlled substances, drugs, prescription medications and specific 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 can only sell, distribute or order the drug or medication 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. Orders 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 can only be administered by or under the order of a licensed veterinarian and is subject to the following criteria:
	a. 	There is a valid 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 or 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. 	The appropriate withdrawal period is 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 CFR Part 530 as amended through December 21, 2023). Licensed veterinarians are encouraged to consult the Food Animal Residue Avoidance Databank (FARAD) or public peer-reviewed documents when determining appropriate withdrawal period.
[ARC 8021C, IAB 5/15/24, effective 7/1/24]