CHAPTER 12
STANDARDS OF PRACTICE
[Prior to 2/8/89, Veterinary Medicine, Board of[842] Ch 9]
811—12.1(169) Prescription drugs and restricted immunization products. A drug or immunization product intended for veterinary use where state or federal law restricts this drug or immunizing product to use by or under the order of a licensed veterinarian, shall only be sold or distributed to, or on the order of, a licensed veterinarian, to be used in the course of the veterinarian’s professional practice.
	12.1(1) The order for all such drugs or immunizing products shall be accompanied by the veterinarian’s original prescription which should show the quantity of the product, the number of times the prescription can be refilled, the veterinarian’s name, address and telephone.
	12.1(2) A prescription veterinary product shall not be deemed to be used “in the course of the veterinarian’s professional practice” unless the veterinarian is supervising the use of the product or a veterinarian/client/patient relationship exists.
	12.1(3) The board shall determine, on a case-by-case basis, if a veterinarian/client/patient relationship exists. The board may consider, among other items, the following criteria:
	a. 	The veterinarian has assumed the responsibility for making medical judgments regarding the health of the animal(s) and the need for medical treatment, and the client (owner or other caretaker) has agreed to follow the instructions of the veterinarian; and when
	b. 	There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s); or by medically appropriate and timely visits to the premises where the animal(s) is kept; and when
	c. 	The practicing veterinarian is readily available for follow-up in case of adverse reactions of failure of the regimen of therapy.
811—12.2(169) Extra-label use of veterinary drugs and immunization products. Any extra-label use of veterinary drugs and immunization products shall be by or under the order of a licensed veterinarian only and shall be subject to the following criteria:
	12.2(1) There shall be a veterinarian-client-patient relationship as defined in subrule 12.1(3).
	12.2(2) For drugs used in animals not intended for food, there are no marketed drugs and immunization products specifically labeled for the conditions diagnosed; or in the 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.
	12.2(3) The health of the treated animal(s) is immediately threatened, and suffering or death would result from a failure to treat the affected animal(s).
	12.2(4) Appropriate withdrawal times shall be specified when the veterinary 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).
811—12.3(169) Prescription labeling and packaging. A licensed veterinarian shall comply with all of the following requirements for the storage, handling, dispensing, and administering of medication:
	12.3(1) The veterinarian shall maintain all controlled substances in compliance with state and federal requirements.
	12.3(2) All medications that are dispensed from a container other than the original container shall be placed in a child-resistant container unless otherwise requested by the owner or unless the medication is in a form or size that cannot be easily dispensed in a child-resistant container.
	12.3(3) All medications dispensed shall be labeled with the following information:
	a. 	Name, telephone number, and address of the veterinary clinic, hospital, or service facility.
	b. 	Name of the prescribing licensed veterinarian.
	c. 	Date on which the prescription is dispensed.
	d. 	Directions for use, including any cautionary statements and withdrawal times when appropriate.
	e. 	Name and species of the patient.
	f. 	Name of the owner.
	g. 	Name, strength, and dosage form of the medication. If the medication is a compounded product, all active ingredients must be listed on the label, with corresponding strengths or concentrations of each ingredient.
	h. 	Number of units dispensed.
	i. 	Expiration date. If the medication is a compounded product with no assigned expiration date, the veterinarian shall determine a beyond-use date as supported by the literature or by the veterinarian’s professional judgment when no such supportive information exists.
	j. 	Appropriate withdrawal times, when the animal patient is intended as food.
	12.3(4) All medications dispensed in the original container shall retain the original label and, in addition, shall be labeled with the same information as required in subrule 12.3(3).
	12.3(5) Medications which have expired shall be removed from current inventory and shall not be dispensed or sold.
	12.3(6) Medications shall be dispensed only for specific animals and for specific veterinary medical therapies with the exception of groups of similar animals and other groups such as pet fish, kennels, and catteries for which dispensing shall be done judiciously within a valid veterinarian-client-patient relationship.
These rules are intended to implement Iowa Code chapter 169.
[Filed 9/21/84, Notice 8/15/84—published 10/10/84, effective 11/14/84]
[Filed emergency 9/4/85—published 9/25/85, effective 9/4/85]
[Filed 11/1/85, Notice 9/25/85—published 11/20/85, effective 12/25/85]
[Filed 1/20/89, Notice 11/16/88—published 2/8/89, effective 3/15/89]
[Filed 9/4/08, Notices 4/23/08, 6/18/08—published 9/24/08, effective 10/29/08]