Permanent Final Adoptions

TITLE 775. Board of Veterinary Medical Examiners

CHAPTER 26. Wholesaler/Distributor of Veterinary Prescription Drugs

[OAR Docket #09-502]

RULEMAKING ACTION:

PERMANENT final adoption

RULES:

775:26-1-1. Distribution of veterinary prescription labeled drugs [AMENDED]

AUTHORITY:

59 O.S. Supp.2007, SEC. 698.1 et seq.; Board of Veterinary Medical Examiners

DATES:

Comment period:

December 1, 2008 through January 5, 2009

Public hearing:

January 9, 2009

Adoption:

January 9, 2009

Submitted to Governor:

January 13, 2009

Submitted to House:

January 13, 2009

Submitted to Senate:

January 13, 2009

Gubernatorial approval:

February 9, 2009

Legislative approval:

Failure of the Legislature to disapprove the rules resulted in approval on March 25, 2009

Final adoption:

March 25, 2009

Effective:

April 30, 2009

SUPERSEDED EMERGENCY ACTIONS:

N/A

INCORPORATIONS BY REFERENCE:

N/A

ANALYSIS:

The proposed revision to Chapter 26 defines a Wholesaler or Distributor

CONTACT PERSON:

Cathy Kirkpatrick, Executive Director, 201 N.E 38th Terr. Suite 1, Oklahoma City, OK 73105, 405-524-9006

PURSUANT TO THE ACTIONS DESCRIBED HEREIN, THE FOLLOWING RULES ARE CONSIDERED FINALLY ADOPTED AS SET FORTH IN 75 O.S., SECTION 308.1(A), WITH AN EFFECTIVE DATE OF APRIL 30, 2009:

775:26-1-1. Distribution of veterinary prescription labeled drugs

(a) This chapter sets forth the rules for compliance with those sections of the Oklahoma Pharmacy Act (Pharmacy Act), 59 O.S. Suppl. 2005 Sect.353.1, et seq., which relate to veterinary prescription labeled drugs. A wholesaler or distributor means a person engaged in the business of distributing prescription drugs, including controlled dangerous substances, at wholesale or retail to pharmacies, hospitals, practitioners, government agencies or other lawful drug outlets licensed or permitted under the Pharmacy Act to sell, distribute, deliver or use drugs or medicines.

(b) In accordance with Sect. 353.13 G of the Pharmacy Act, "veterinary prescription labeled drugs", defined as "veterinary prescription drugs" in the Oklahoma Veterinary Practice Act (Act), may be supplied by a "wholesaler or distributor", as those terms are defined in the Pharmacy Act, and shipped directly to a client located in the State of Oklahoma pursuant to a written order of an Oklahoma licensed veterinarian, but only after a valid veterinarian-client-patient relationship (VCPR), as defined in the Act, has been established and referenced in such written order.

(c) No wholesaler or distributor shall sell, dispense or supply a veterinary prescription drug to an owner or their authorized agent in the State of Oklahoma without first obtaining a written order for such drug from an Oklahoma licensed veterinarian with a valid VCPR in place. Certification by a pharmacist prior to dispensing veterinary prescription drugs by a wholesaler or distributor under these rules or under the Pharmacy Act shall not be required. No person shall acquire or use any veterinary prescription drug other than in accordance with the label affixed to the drug container and/or outside of a valid VCPR.

(d) Any wholesaler or distributor selling, supplying or dispensing veterinary prescription drugs for use in the State of Oklahoma shall comply with the dispensing and labeling requirements set forth in Chapter 25 of the Oklahoma Veterinary Administrative Rules found in Title 775 of the Oklahoma Administrative Code.

(e) Any wholesaler or distributor selling, supplying or dispensing veterinary prescription drugs for use in the State of Oklahoma shall maintain accurate written records containing information relating to the sale and/or distribution of such drugs, with sufficient detail to specifically identify the drug, the veterinarian ordering the drug, the date of distribution, the quantity of the drug, and the client receiving the drug. Such records shall be maintained by the wholesaler or distributor for a period of five years from the date of distribution of the drug and shall include, but not be limited to, the written order received from the veterinarian, a copy of the drug invoice and the bill of lading or other evidence of shipment. The records of a wholesaler or distributor selling, supplying or dispensing veterinary prescription drugs for use in the State of Oklahoma shall be available for inspection upon request by the Oklahoma State Board of Veterinary Medical Examiners or their designated representatives, during reasonable business hours.

(f) A violation of the provisions of the Pharmacy Act pertaining to veterinary prescription labeled drugs, by a person or entity, including an owner, a veterinarian and/or a wholesaler or distributor, shall constitute a violation of the Act.

(g) Every wholesaler or distributor selling, supplying or dispensing veterinary prescription drugs for use in the State of Oklahoma shall annually notify the Board of the name, address and business telephone number of each sales representative and/or veterinarian doing business in Oklahoma that is employed by or under contract with the wholesaler or distributor, by filing a written notice with the Board no later than January 1 of each year on printed forms provided by the Board for such purpose.

[OAR Docket #09-502; filed 3-26-09]