GA - GAC
Rules and Regulations of the State of Georgia
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Subject 40-16-1 BIOLOGICALS

Rule 40-16-1-.01 Definitions

The following words or terms shall have the meaning set forth herein when used in these rules and regulations:

(a) The term "Department" shall mean the Department of Agriculture.
(b) The term "Commissioner" shall mean the Commissioner of Agriculture.
(c) The term "Biologicals" shall be defined as medical preparations made from living organisms and their products, including serums, vaccines, antigens and antitoxins which are for use on poultry and animals, excluding humans.
(d) The term "Adulterant" shall mean a substance use as an addition to another substance for sophistication or adulteration.
(e) The term "Adulteration" shall mean an addition of an impure, cheap, or unnecessary ingredient to cheat, cheapen, or falsify a preparation.
(f) The term "Contaminant" shall mean something that causes contamination, such as a foreign organism developing accidentally in a pure culture.
(g) The term "Contamination" shall mean the soiling or making inferior by contact or mixing.
(h) "Dealer in Biologicals" shall include every producer, manufacturer, distributor, or sales outlet selling, offering for sale, exposing for sale, distributing, or storing biologicals as herein defined, and every such dealer shall register with and obtain a permit from the Department of Agriculture prior to engaging in such activities. Provided, however, that the provisions of this Act shall not apply to any department of Federal or State Government or any County Board of Health, or any joint City-County Board of Health, or any licensed graduate veterinarian, whose primary use of biologicals is in his practice, or any retail establishment which purchases pre-packaged biologicals not under its private label from a producer, manufacturer, distributor, or sales outlet registered under this Act for sale to the general public only. Retail establishments selling biologicals, the producer, manufacturer, and distributor neither of which are registered under this Act must obtain a separate permit for biologicals obtained from each nonregistered source.

Rule 40-16-1-.02 Rules Regarding Permits

Each dealer in biologicals shall apply to the Commissioner for a permit to do business in Georgia prior to any storing of biologicals, or soliciting business from any class of trade in the State of Georgia. Such permit shall be made on a form prescribed and furnished by the Commissioner of Agriculture which when properly executed shall indicate the name of the owner, manager, trustee, leasee, receiver or other person or persons desiring such permit, as well as location of such business, and the names and addresses of companies in the State of Georgia who act as wholesale distributors. Those producers who, with headquarters outside of the State of Georgia, sell directly to retail establishments within the State of Georgia shall provide the Department of Agriculture with a list of these retail accounts and their addresses. No person, firm, or partnership shall engage in any storing or selling activities without a permit or while its permit is suspended or revoked. A previous violation of the law or any regulation of the Department of Agriculture by the applicant shall constitute just cause for refusal of a permit. Effective July 1, 1992, the permit must be renewed annually. The permit will be valid from July 1 to June 30 of the following year. The fee for the permit shall be based on the gross revenue derived from biologicals. The fee for the permit shall be:

up to $25,000 revenue

$25.00

$25,001 to $50,000

$50.00

$50,001 to $75,000

$75.00

$75,001 and over

$100.00

Rule 40-16-1-.03 Registration of Poultry Biologicals

Each poultry biological to be sold or used in Georgia shall be registered with the Georgia Department of Agriculture on or before July 1, 1965, including new products for experimental purposes, not yet licensed by the United States Department of Agriculture. Each biological shall be listed on the application for registration. There shall be a registration fee of one dollar ($1.00) for each product registered. Such registration shall include:

(a) name and address of manufacturer;
(b) veterinary license number;
(c) name of product;
(d) hazards or limitations of use of product;
(e) printed literature and other data which will improve understanding of value of product; and
(f) such additional information as shall be necessary to satisfy the Commissioner as to the efficiency, potency, hazards and limitations of any such product shall be furnished upon request. The Commissioner of Agriculture shall be the sole determining authority as to what shall constitute sufficient information hereunder.

Rule 40-16-1-.04 Sale of Unregistered Biologicals

The sale or use of any unregistered biologicals except such biologicals as may be exempted herein, is hereby prohibited.

Rule 40-16-1-.05 Access to Records of Sales

All records pertaining to biologicals shall be made available to the Commissioner or his representative upon request.

Rule 40-16-1-.06 Biologicals Holding Facilities

(1) Each dealer in biologicals herein referred to shall have and maintain sufficient mechanically refrigerated storage facilities to handle inventories. Such storage facilities shall be capable of adjustment to maintain a temperature of 45 degrees Fahrenheit, or lower. Such facilities shall be subject to be inspected periodically.
(2) Biologicals shall be held or stored at temperatures of not over 45 degrees or less than 32 degrees Fahrenheit.

Rule 40-16-1-.07 Transportation of Biologicals

Biologicals referred to in these regulations shall be transported under such temperature conditions as not to adversely effect the potency thereof. Insulated containers or cooling agents shall be used, where necessary, to avoid temperatures above 45 degrees or below 32 degrees Fahrenheit.

Rule 40-16-1-.08 Specific Limited Provisions

Biologicals produced under special licensing procedures of the United States Department of Agriculture shall not be sold, shipped, stored or used until such products are registered and a permit obtained from the Georgia Department of Agriculture.

Rule 40-16-1-.09 Hazardous Biologicals, Authority to Impound

Biologicals which are determined to be hazardous, and those biologicals not meeting the requirements as set out in these and any other rules and regulations or orders as may be promulgated by the Commissioner of Agriculture of this state and any laws as may pertain thereto, shall be subject to impoundment, confiscation, seizure, and any other action that may be deemed necessary to assure the proper control thereof. Biologicals and test antigens such as Brucella vaccine, Pseudorabies vaccine, Brucella antigen, and tuberculin are restricted for sale to and use by or under direction of a veterinarian accredited by the USDA and licensed under the Georgia Veterinary Practice Act, and employees of the state and federal government approved by the State Veterinarian; provided, however, that rabies vaccine may be sold to and used by any veterinarian licensed under the Georgia Veterinary Practice Act.

Rule 40-16-1-.10 Purity and Potency Testing

Such testing as may be deemed necessary by the Commissioner of Agriculture of this state shall be done at his direction and by such testing authority as he shall designate. The findings of such testing authority shall be admissible in any proceeding under these rules and regulations.

Rule 40-16-1-.11 Interstate Commerce

No provisions within these rules and regulations shall be construed to effect any herein referred to biological product that shall be subject to the laws of the United States Governing Interstate Commerce, so long as such biological shall remain in Interstate Commerce. However, these rules and regulations shall apply to the producer, manufacturer, distributor, or sales outlet at the source of shipment if such biologic products are destined for distribution, sales, and/or use in the State of Georgia.

Rule 40-16-1-.12 Protection of Confidential Information

Information submitted by handlers, dealers, distributors, vendors, manufacturers or users of biologicals herein referred to shall be treated as confidential information to the extent that the release thereof will divulge the contents or formulation of such product.

Rule 40-16-1-.13 Violation: Penalty Therefor

Any violation of these rules and regulations or any laws pertaining to such products shall be deemed sufficient cause for the revocation of any permit or registration issued hereunder or pursuant to law.

Rule 40-16-1-.14 Potency Standards.* Amended

The standards set forth by the United States Department of Agriculture, pertaining to the manufacture, sale and use of biologicals, are hereby adopted by reference and shall constitute the minimum requirement for the manufacture, sale and use of these biologicals within this State. Any exception thereto shall be made by the Commissioner of Agriculture of this State, on an individual basis, upon application and proper showing by the manufacturer of unusual circumstances and conditions warranting such exception.

* Standard Requirements for Biologicals obtainable from Commissioner's office.