Okla. Admin. Code § 35:15-5-1

Current through Vol. 41, No. 24, September 3, 2024

Section 35:15-5-1 - [Effective 8/11/2024] Biological products

(a) No biological product used in the treatment of livestock or any other species of animals shall be manufactured, produced, transported, distributed, sold, offered for sale, or used in Oklahoma unless the biological product has been:

(1) Licensed or permitted by the United States Veterinary Biologics Division of the United States Department of Agriculture;

(2) Produced in an establishment licensed by the United States Veterinary Biologics Division of the United States Department of Agriculture; and

(3) Approved by the Oklahoma Department of Agriculture, Food, and Forestry.

(b) Biological products prepared by any person solely for the treatment of livestock or any other species of animals of such person or prepared solely for treatment of livestock or any other species of animals under a veterinary-client-patient relationship during the state licensed professional practice of veterinary medicine by such person shall be exempt from (a) and (d) of this section if used as follows:

(1) Permission is obtained from the State Veterinarian in the form of a one (1) year memorandum of understanding between the Department and the persons owning the livestock or any other species of animals;

(2) An authorized agent of the Board may inspect and monitor the application of the product and verify the proper handling, cleaning, and disinfection of equipment utilized in the application.

(c) Johne's (Paratuberculosis) vaccine is expressly prohibited in Oklahoma without prior approval of the Department. This approval may be obtained only after a written agreement is developed between the producer, attending veterinarian, and state regulatory officials. A plan of herd management, vaccination, and any restrictions shall be a part of this agreement.

(d) Each biological product manufactured, produced, distributed, sold, offered for sale, or used in Oklahoma or delivered for transportation or transported in intrastate or interstate commerce shall be registered with the Department on an annual basis.

(e) Each person registering biological products shall pay an annual registration fee of Two Hundred Dollars ($200.00) for each biological product registered.

(1) The Department may require the submission of the complete formula of any biological product.

(2) Trade secrets and formulations submitted with the registration shall be kept confidential.

(3) Autogenous biologics shall be registered individually by the specific microorganisms (seed) which make up the composition of the vaccine.

(f) If it appears to the Department that the composition of the biological product is adequate to warrant the proposed claims and if the biological product, its labeling, and other material required to be submitted comply with the requirements of this section, then the biological product shall be registered.

(g) Additional registration of a biological product shall not be required in the case of a biological product shipped from one location within Oklahoma to another location within Oklahoma if the location is operated by the same person.

(h) All biological product registrations shall expire on March 20 of each year but may be renewed by the Department. Any person who fails to renew a biological product by March 20 of each year shall pay a penalty of an additional Two Hundred Dollars ($200.00).

(i) No person shall sell or offer for sale an unregistered biological product or an expired biological product.

(j) The term "biological product" shall mean all viruses, serums, toxins (excluding substances that are selectively toxic to microorganisms, including antibiotics), or analogous products at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of livestock or any other species of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. The term biological products includes but is not limited to vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components that are of natural or synthetic origin, or that are derived from synthesizing or altering various substances or components of substances such as microorganisms, genes or genetic sequences, carbohydrates, proteins, antigens, allergens, or antibodies. The term shall not include any product identified and regulated as a pesticide by the Department.

(1) A product's intended use shall be determined through an objective standard dependent upon factors such as representations, oral or written claims, packaging, labeling, or appearance.

(2) The term "analogous products" shall include the following:

(A) Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of livestock or any other species of animals and which are similar in function to biological products in that they act, or are intended to act, through the stimulation, supplementation, enhancement, or modulation of the immune system or immune response;

(B) Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of livestock or any other species of animals through the detection or measurement of antigens, antibodies, nucleic acids, or immunity; or

(C) Substances, at any stage of production, shipment, distribution, or sale, which resemble or are represented as biological products intended for use in the treatment of livestock or any other species of animals through appearance, packaging, labeling, claims (either oral or written), representations, or through any other means.

(k) The term "treatment" shall mean the prevention, diagnosis, management, or cure of diseases of livestock or any other species of animals.

(l) The term "unregistered biological product" shall mean a biological product that has not been registered with the Department or a biological product that has been previously registered with the Department but the registration has lapsed.

(m) The term "expired biological product" shall mean a biological product which exceeds the expiration date established by the manufacturer.

Okla. Admin. Code § 35:15-5-1

Amended at 26 Ok Reg 1381, eff 7-1-09; Amended at 28 Ok Reg 2170, eff 7-25-11; Amended at 29 Ok Reg 1689, eff 8-1-12

Amended by Oklahoma Register, Volume 33, Issue 24, September 1, 2016, eff. 9/11/2016

Amended by Oklahoma Register, Volume 36, Issue 23, August 15, 2019, eff. 9/14/2019

Amended by Oklahoma Register, Volume 37, Issue 24, September 1, 2020, eff. 9/14/2020

Amended by Oklahoma Register, Volume 38, Issue 24, September 1, 2021, eff. 9/11/2021

Amended by Oklahoma Register, Volume 39, Issue 24, September 1, 2022, eff. 9/12/2022

Amended by Oklahoma Register, Volume 41, Issue 22, August 1, 2024, eff. 8/11/2024