Iowa Admin. Code r. 811-12.2

Current through Register Vol. 47, No.14, January 8, 2025

Rule 811-12.2 - 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.

(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.

(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.

Iowa Admin. Code r. 811-12.2

ARC 1465C, IAB 5/28/2014, effective 7/2/2014

Adopted by IAB May 15, 2024/Volume XLVI, Number 24, effective 7/1/2024