Iowa Admin. Code r. 811-12.3

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

Rule 811-12.3 - Prescription drug or medication labeling and packaging

A licensed veterinarian shall comply with all of the following requirements for the storage, handling, dispensing and administering of a drug or medication.

(1) All prescription drugs, medications and controlled substances shall be purchased, maintained, handled, prescribed and dispensed in compliance with state and federal requirements including but not limited to the requirements of the Iowa board of pharmacy, the U.S. Occupational Safety and Health Administration, the U.S. Department of Agriculture, the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency and the U.S. Drug Enforcement Administration.

a. A valid veterinarian/client/patient relationship shall be established before prescription drugs or medications may be dispensed or a prescription released. All drugs or medications administered, prescribed or dispensed shall be documented in the patient's medical record. The sale of veterinary prescription drugs or medications or the extra-label use of any drug, medication or product by a licensed veterinarian without a valid veterinarian/client/patient relationship is not permissible.

b. If a veterinarian prescribes a drug for the client's animal, the veterinarian shall, upon request, provide the prescription to the client, unless barred by state or federal law or to prevent inappropriate use. The veterinarian may charge a fee for issuing the prescription. This paragraph does not apply to livestock as defined in Iowa Code section 717.1(4).

(2) All drugs or 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. Species of the patient.

f. Name, or identification, or location of the patient.

g. Name of the owner.

h. Name, strength and dosage form of the drug or medication. If the drug or medication is a compounded product, all active ingredients must be listed on the label, with corresponding strengths or concentrations of each ingredient.

i. Number of units dispensed.

j. Expiration date. If the drug or medication is a compounded product with no assigned expiration date, the licensed veterinarian shall determine a beyond-use date as supported by the literature or by the licensed veterinarian's professional judgment when no such supportive information exists.

k. Appropriate withdrawal period for livestock or poultry, when the patient or its product is intended as food.

(3) All drugs or medications dispensed in the original container shall retain the original label and be labeled with the same information identified in subrule 12.3(2).

(4) All drugs or medications that are dispensed in a container other than the original container shall be placed in a tamper-resistant container unless otherwise requested by the owner or unless the drug or medication is in a form or size that cannot be easily dispensed in a tamper-resistant container.

(5) Drugs or medications that have expired shall be removed from current inventory and cannot be dispensed or sold. Expired drugs or medications shall be disposed of in accordance with local, state and federal regulations.

(6) Drugs or 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.

Iowa Admin. Code r. 811-12.3

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

Amended by IAB June 2, 2021/Volume XLIII, Number 25, effective 7/7/2021

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