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Chapter 480-7A LISTED CHEMICAL WHOLESALE DISTRIBUTOR

Rule 480-7A-.01 Definitions

(1) Board. Board means the Georgia State Board of Pharmacy.
(2) Brokerage. Brokerage means any firm or broker who arranges for the buying for resale, selling, transferring, or otherwise arranging to distribute dangerous drugs, controlled substances, or listed chemicals, whether or not such firm physically handles, receives, distributes, or bills for the actual drug product.
(3) Broker. Broker means any individual, corporation, corporation division, partnership, association, or other entity which assists in arranging a transaction of a listed chemical by negotiating contracts, serving as an agent or intermediary, or fulfilling a formal obligation to complete a transaction by bringing together a buyer and seller, a buyer and transporter, or a seller and a transporter, or by receiving any form of compensation for so doing.
(4) DEA. DEA means the U.S. Department of Justice Drug Enforcement Administration.
(5) Designated Representative. Designated Representative means a person designated by a listed chemical wholesale Distributor who will serve as the designated representative of the listed chemical wholesale distributor with the Board and GDNA who is actively involved in and aware of the actual daily operation of the listed chemical wholesale distributor.
(6) Distribute or Distribution. Distribute or distribution means to sell, offer to sell, broker, give away, transfer, whether by passage of title, physical movement, or both; deliver or offer to deliver a listed chemical or drug. The term does not mean to administer or dispense.
(7) Excessive. Excessive means any sale, distribution, purchase, or transfer of a quantity of any listed chemical by a retail store which the wholesale distributor deems or judges to in excess of routine sales for that particular store.
(8) GBI. GBI means the Georgia Bureau of Investigation.
(9) GDNA. GDNA means the Georgia Drugs and Narcotics Agency.
(10) Listed Chemical. Listed Chemical means any drug or product containing a chemical defined by the Board as a listed chemical in 480-7A-.02 and/or designated as a listed chemical by law.
(11) Listed Chemical Wholesale Distributor. Listed Chemical Wholesale Distributor means any firm named under O.C.G.A. 16-13-30.3 (b.1) as a Wholesale Distributor which sells, transfers, purchases for resale, sells for resale, or otherwise furnishes any product containing a drug or listed chemical to a retail outlet.
(12) Listed Chemical Wholesale Distributor Permit. Listed Chemical Wholesale Distributor Permit means a permit issued by the Board to a wholesale distributor to distribute listed chemical products to retail outlets.
(13) Manufacturer. Manufacturer means any firm which is engaged in the manufacturing, preparing, propagating, processing, repackaging, or labeling of a dangerous drug, controlled substance, or a listed chemical for distribution.
(14) Manufacturing Pharmacy. Manufacturing pharmacy means a drug manufacturer who holds a manufacturing pharmacy permit issued by the Board authorizing such firm to manufacture, but not distribute, drugs in this state.
(15) Police Chief of a Municipality. Police Chief of a Municipality means the Chief of Police of a municipality located in the State of Georgia, or an officer or person otherwise authorized by the Police Chief to act in his or her behalf in regards to O.C.G.A. 16-13-30.3.
(16) Reportable Transaction. Reportable transaction means a report generated regarding a transaction in which a retail store orders and receives what the listed chemical wholesale distributor deems to be an excessive quantity of any listed chemical products.
(17) Retail Outlet. Retail Outlet means a grocery store, general merchandising store, drug store, or other entity or person whose activities with listed chemicals is almost exclusively to sales for personal use, directly to walk-in customers, in face to face transactions by direct sales.
(18) Sheriff of a County. Sheriff of a County means either the Sheriff of a county located in the State of Georgia, or a deputy or person otherwise authorized by the Sheriff to act on his or her behalf in regards to O.C.G.A. 16-13-30.3.
(19) Wholesale Distributor. Wholesale Distributor means:
(a) A firm as defined by O.C.G.A. 26-4-5(41) and holding a wholesaler pharmacy permit issued by the Board and licensed under O.C.G.A. 16-13-113, which authorizes a firm to distribute dangerous drugs, controlled substances, and listed chemicals; or
(b) A firm as specified by O.C.G.A. 16-13-30.3 which is authorized to distribute certain drugs or listed chemicals as specified by paragraph (b.1) of that statute, and has been issued a chemical wholesale distributor permit by the Board under O.C.G.A. 16-13-30.3.
(20) Wholesaler Pharmacy. Wholesaler Pharmacy means a firm holding a permit issued by the Board to distribute drugs at wholesale, not at retail, and which permit authorizes a firm to distribute dangerous drugs, controlled substances, and listed chemicals. A wholesaler pharmacy is not intended to be, nor should it be considered a retail, hospital, clinic or any other type of pharmacy which has separate permits issued by the Board.

Rule 480-7A-.02 Listed Chemicals

Drugs or chemicals which are restricted by the Board or by law to wholesale distribution only by a firm licensed by the Board as a listed chemical wholesale distributor or a wholesale distributor, which are also known as listed chemicals, are as follows:

(1) Pseudoephedrine or a product containing any quantity of this drug, except as follows:
(a) Pediatric products labeled pursuant to federal regulation as primarily intended for administration to children under 12 years of age according to label instructions; and
(b) Products that the Board, upon application of a manufacturer, exempts because the product is formulated in such a way as to effectively prevent the conversion of the active ingredient into methamphetamine or its salts or precursors.

Rule 480-7A-.03 Restriction on the Distribution of Listed Chemicals

Chemicals listed in 480-71-.02 may only be distributed to retail outlets by a listed chemical drug wholesale distributor licensed by the Board, or a wholesale distributor licensed by the Board. In order for any person or firm to conduct an act of brokerage for any dangerous drug, controlled substance, or listed chemical which is received by retail outlet or pharmacy in this state, regardless of where the shipment originates, such person or firm is required to be licensed as a wholesale distributor or a listed chemical wholesale distributor. Any manufacturer which distributes a drug to any wholesale distributor or listed chemical wholesale distributor located in the State of Georgia must have been issued the appropriate wholesale distributor permit from the Board. Having been issued a manufacturing pharmacy permit by the Board does not authorize a manufacturing firm to distribute drugs to any firm located in this state.

Rule 480-7A-.04 Requirements for licensure as a Listed Chemical Wholesale Distributor

(1) Listed chemical wholesale distributors that provide services within this State, whether the listed chemical wholesale distributor is located within this State or outside this State, shall be licensed by the Board and shall biennially renew their permit or license with the Board using an application provided by the Board.
(2) Where listed chemical wholesale distribution operations are conducted at more than one location, each such location shall be licensed by the Board.
(3) A person or firm holding a valid permit issued by the Board and licensed as a wholesale distributor under Code Section 26-4-113 shall not be required to obtain an additional license under this Code section; Wholesale distributors licensed under Code Section 26-4-113 shall be subject to the provisions of this Code section in the same manner as chemical wholesale distributors licensed under this Code section.
(4) Licenses become null and void upon the sale, transfer or change of mode of operation or location of the business.
(5) The Board requires the following and such additional information as found on an approved Board application from each listed chemical wholesale distributor as part of the initial licensing procedure and as part of any biennial renewal of such license:
(a) The name, trade or business name, full business address, and telephone number of the applicant. Trade or business names cannot be identical to that of another Board licensee.
(b) The type of ownership or operations (i.e., partnership, corporation, or sole proprietorship).
(c) Name(s) of the owner and operator of the licensee (if not the same person), including:
(i) If a person: the name, address, and social security number;
(ii) If a partnership: the name, address, and social security number of each partner, and the name of the partnership and federal employer identification number;
(iii) If a corporation: the name, address, social security number, and title of each corporate officer and director, the corporate names, the name of the State of incorporation, federal employer identification number, and the name of the parent company, if any; the name, address, and social security number of each shareholder owning ten percent (10%) or more of the voting stock of the corporation, including over-the-counter stock, unless the stock is traded on a major stock exchange and not over-the-counter;
(iv) If a sole proprietorship: the full name, address, and social security number of the sole proprietor, and the name and federal employer identification number of the business entity;
(v) If a limited liability company, the name of each member, the name of each manager, the name of the limited liability company and federal employer identification number, and the name of the state in which the limited liability company was organized; and
(vi) Any other relevant information that the Board requires.
(d) Name(s), address(es), telephone number(s), date(s) of birth of a person(s) to serve as the designated representative(s) for listed chemicals and additional information as required.
(e) A non-refundable application and/or renewal fee as determined by the Board and set forth in the fee schedule.
(6) By submitting an application for licensure as a listed chemical wholesale distributor, said applicant consents to a criminal background check of the applicant, all personnel involved in the operations of the listed chemical wholesale distributor, all shareholders involved in operations, and anyone owning or being involved in operations to determine if an applicant or others associated with the ownership, management, or operations of the listed chemical wholesale distributor has committed criminal acts that would constitute grounds for denial of licensure. The background check will be conducted in compliance with any applicable state laws, at the applicant's expense, and will be sufficient to include all states of residence since the person has been an adult.
(7) Each facility which engages in listed chemical wholesale distribution must undergo an inspection on behalf of the Board by an agent with the GDNA for the purpose of inspecting the in-state listed chemical wholesale distribution operations prior to initial licensure and periodically thereafter in accordance with a schedule to be determined by the Board but no less than once every three (3) years.
(8) Each facility which is located outside the State and engages in listed chemical wholesale distribution must undergo a background investigation by GDNA on behalf of the Board and be approved by the GDNA prior to being approved for licensure, and as necessary submit to an inspection by either GDNA or an agent contracted with by GDNA.

Rule 480-7A-.05 Denial of Licensure as a Listed Chemical Wholesale Distributor

(1) An application for a license or permit provided for in this chapter may be denied by the Board for reasons including, but not limited to:
(a) Furnishing false or fraudulent material information in any application filed under this rule or Chapter 13 of Title 16;
(b) Being convicted of a crime under any state or federal law;
(c) Having his or her federal registration suspended or revoked to manufacture, distribute, or dispense controlled substances or listed chemicals;
(d) Violating the provisions of Chapter 4 of Title 26 or Chapter 13 of Title 16;
(e) Being located in a place of residence;
(f) Failing to maintain effective controls against the diversion of products containing listed chemicals to unauthorized persons or entities; and/or
(g) Any other factors or qualifications provided by law or that the Board considers relevant to and consistent with the public health and safety.

Rule 480-7A-.06 Records and Recordkeeping; Reporting Requirements

(1) Listed chemical wholesale distributors and other wholesale distributors shall, at a minimum, maintain records regarding the distribution of listed chemicals as follows:
(a) Produce and maintain, for a minimum of three years from the date of the transaction, inventories and records of all transactions regarding the receipt, sale, credit, transfer, disposition, and distribution of all listed chemicals to any firm, person, or retail outlet located in this State. Inventories and records shall be made available for inspection and photocopying by any authorized agent of any State or federal agency for a period of three (3) years following their creation date.
(b) Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two working days of a request by an authorized official of any State and federal governmental agency charged with enforcement of these rules.
(c) Maintain an up to date list of firms, persons or retail outlets with whom they do business in regards to listed chemicals.
(2) Listed chemical wholesale distributors and other wholesale distributors shall, at a minimum, maintain and provide documents and reports regarding the distribution of listed chemicals as follows:
(a) Supply a copy of their Board issued permit to any firm, person, or retail outlet in this state which has received, purchased, or gained access to any product containing a listed chemical.
(b) Supply each firm, person, or retail outlet with a copy of all records involving sales, credits, transfers or the like whenever such transaction involves a product containing a listed chemical.
(c) Report to GDNA of shortages or losses of listed chemicals within seven (7) business days.
(d) Within seven days, notify the GDNA of any purchases of a product containing a listed chemical from the listed chemical wholesale distributor which the wholesaler judges to be excessive, or have knowledge or suspicion of said purchases being used in the unlawful manufacture of a controlled substance or file with the GDNA any reportable transaction. A reportable transaction should be sent to the attention of the Director of the GDNA. Such reports should be sent to GDNA located at 40 Pryor Street, SW - Suite 2000 in Atlanta, Georgia 30303.
(e) Upon verbal or written request from the GDNA, the GBI, or the sheriff of a county or the police chief of a municipality located in this state, submit reports to account for the transactions of any listed chemicals with persons or firms located within this state; such transactions shall include all sales, distribution, or transactions dealing with products containing a listed chemical; All such records shall be submitted by the distributor within two working days.
(3) Any and all retail outlets or persons receiving a listed chemical product from a licensed listed chemical wholesale distributor, licensed by this State, are required to maintain records of all such transactions for a minimum of three years, and upon request, by law enforcement officials, are required to provide such records for review within five business days, with failure to provide such records accounting for the presence of such products shall result in the embargo or seizure of such products.
(4) Changes in any information required on the initial application shall be submitted to the Board no less than 30 days prior to such change.

Rule 480-7A-.07 Requirements for Storage, Handling, Transport, and Shipment of Listed Chemicals

The following are required for the shipping, transporting, storage and handling of listed chemicals, and for the establishment and maintenance of listed chemical wholesale distribution records by listed chemical wholesale distributors and other wholesale distributors and their officers, agents, representatives, and employees:

(1) All facilities at which listed chemicals are received, stored, warehoused, handled, held, offered, marketed, displayed, or transported from shall:
(a) Be of suitable construction to ensure that all listed chemicals in the facilities are maintained in accordance with official compendium standards, such as USP/NF;
(b) Be of suitable size and construction to facilitate cleaning, maintenance, and proper listed chemical wholesale distribution operations;
(c) Have adequate storage areas to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;
(d) Have a quarantine area for storage of listed chemicals that are outdated, damaged, deteriorated, misbranded, adulterated, otherwise unfit for distribution, or that are in immediate or sealed secondary containers that have been opened;
(e) Be maintained in a clean and orderly condition; and
(f) Be free from infestation of any kind.
(g) Shall be a commercial location and not a personal dwelling or residence.
(h) Shall be duly registered with the DEA and in compliance with all applicable laws and rules for the storage, distribution, shipping, handling, and transporting of listed chemicals.

Rule 480-7A-.08 Security

(1) All facilities used for listed chemical wholesale distribution shall be secure from unauthorized entry:
(a) Access from outside the premises shall be kept to a minimum and be well-controlled;
(b) The outside perimeter of the premises shall be well-lighted;
(c) Entry into areas where listed chemicals are held shall be limited to authorized personnel;
(2) All facilities shall be equipped with an alarm system to detect entry after hours.
(3) All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.
(4) All facilities shall be equipped with inventory management and control systems that protect against and detect and document any instances of theft, diversion, or counterfeiting.
(5) Listed chemical wholesale distributors should possess and maintain in good working order technology and equipment that allows the listed chemical wholesale distributor to authenticate, track, and trace listed chemicals. The technology and equipment shall satisfy any standards set by the Board for such technology and equipment. The technology and equipment shall be used, as required by the Board, to conduct "for cause" and random tracking, tracing, and authentication of listed chemicals.
(6) Listed chemical wholesale distributors shall employ, train, and document the training of personnel in the proper use of such technology and equipment.
(7) All facilities shall be equipped with security systems to protect the integrity and confidentiality of data and documents and make such data and documents readily available to the Board and other state and federal law enforcement officials.

Rule 480-7A-.09 Storage

All listed chemicals shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such listed chemicals, or with requirements in the current edition of an official compendium such as the USP/NF.

(1) If no storage requirements are established for a listed chemical, the listed chemical may be held at "controlled" room temperature, as defined in an official compendium such as USP/NF, to help ensure that its identity, strength, quality, and purity are not adversely affected.
(2) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, and/or logs shall be utilized to document proper storage of listed chemicals.
(3) Packaging of the listed chemicals should be in accordance with an official compendium such as USP/NF and identify any compromise in the integrity of the listed chemicals due to tampering or adverse storage conditions.
(4) The record-keeping requirements in 480-7A-.06 shall be followed for the listed chemical wholesale distribution of all listed chemicals.

Rule 480-7A-.10 Returned, Damaged, and Outdated Listed Chemicals

(1) Any drug or device that is outdated, damaged, deteriorated, misbranded, adulterated, or otherwise deemed unfit for human consumption shall be quarantined and physically separated from other listed chemicals until they are returned to either the manufacturer or wholesale distributor from which it was acquired or destroyed.
(a) When listed chemicals are adulterated, or misbranded, notice of the adulteration, or misbranding shall be provided to the Board and manufacturer or wholesale distributor from which it was acquired within three (3) business days.
(b) Any listed chemical returned to a manufacturer or wholesale distributor shall be kept under proper conditions for storage, handling, and shipping, transporting, and documentation showing that proper conditions were maintained is provided to the manufacturer or wholesale distributor to which the drugs are returned.
(2) Any listed chemical whose immediate or sealed outer or secondary containers or labeling are adulterated or misbranded shall be quarantined and physically separated from other listed chemicals until they are returned to either the manufacturer or wholesale distributor from which it was acquired or destroyed.
(a) When the immediate or sealed outer or secondary containers or Labeling of any listed chemical are adulterated or misbranded notice of the adulteration or misbranding shall be provided to the Board and manufacturer or wholesale distributor from which it was acquired within three (3) business days.
(3) Any listed chemical that has been opened, outdated, or used, shall be identified as such, and shall be quarantined and physically separated from other drugs or devices until they are returned to the manufacturer or wholesale Distributor from which acquired or destroyed via distribution to a reverse distributor.
(4) The record-keeping requirements in 480-7A-.06 of this rule shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated listed chemicals, as provided by law, and such action shall be consistent with relating the drugs.

Rule 480-7A-.11 Violations

A license issued to a listed chemical wholesale distributor pursuant to this part may be subject to revocation, fines, suspension, or otherwise disciplined as provided by law, for reasons, including but not limited to the following:

(1) The permit or license holder being convicted or being arrested, charged and sentenced for violations of Federal, State, or local laws and/or regulations relating the drugs.
(2) Violating any of the provisions of any applicable Board laws or rules.
(3) If any owner, officer, designated representative, or other significant person employed by the permit holder has:
(a) Furnished false or fraudulent material information in any application filed under this Code section;
(b) Been convicted of a crime under any state or federal law;
(c) Had his or her federal registration suspended or revoked to manufacture, distribute, or dispense controlled substances or listed chemicals;
(d) Violated the provisions of Chapter 4 of Title 26 or Chapter 13 of Title 16;
(e) Failed to maintain effective controls against the diversion of listed chemical products to unauthorized persons or entities.
(f) Failed to comply with the reporting requirements of this chapter; or
(g) Made a false statement in a report or record required by this chapter or State law.
(4) The adulteration or misbranding of any listed chemical;
(5) The receipt of any listed chemical that is adulterated, misbranded, stolen, obtained by fraud or deceit, or the delivery or proffered delivery of such chemical for distribution.
(6) The alteration, mutilation, destruction, forging, obliteration, or removal of the whole or any part of the labeling of a listed chemical or the commission of any other act with respect to a listed chemical that results in the listed chemical being misbranded;
(7) Failing to maintain records to verify the sale, transfer, or distribution of any and all chemical products to a firm, person or retail outlet in this State.
(8) Failing to maintain or provide records or submit to an inspection as required by any Rule or laws of this State;
(9) Providing the Board or any of its representatives or any state or federal official with false or fraudulent records or making false or fraudulent statements regarding any matter within the provisions of any rule or law of this State.
(10) Failing to obtain a license or operating without a valid permit or license when a permit or license is required;
(11) Obtaining or attempting to obtain a listed chemical by fraud, deceit, misrepresentation or engaging in misrepresentation or fraud in the distribution of a listed chemical;
(12) Failing to report any violations of the rules or law regarding listed chemicals.

Rule 480-7A-.12 Licensure Exception

Notwithstanding any other provision of this chapter, no person shall be required to obtain a license or permit for the sale, receipt, transfer, or possession of a listed chemical product when:

(a) Such lawful distribution takes place in the usual course of business between agents or employees of a single regulated person or entity; or
(b) A listed chemical product is delivered to or by a common or contract carrier for carriage in the lawful and usual course of the business of the common or contract carrier or to or by a warehouseman for storage in the lawful and usual course of the business of the warehouseman.