Chapter 480-7 PERMITS

Rule 480-7-.01 Manufacturer's Permit

(1)	Applications for registration for a manufacturer's permit must be filed with the Office of the Georgia State Board of Pharmacy ("Board") with the required fee.

(2)	Registration of a manufacturer will be considered on the basis of the application filed, fee paid, and a report from the Director of the Georgia Drugs and Narcotics Agency (GDNA) certifying the applicant possesses the necessary qualifications for a permit.

(3)	Application fees shall NOT be refundable.

(4)	Permits shall not be transferable. Permits become null and void upon the sale, or change of mode of operation of the business, or location of business.

(5)

Licenses are renewed for two years and expire on June 30th of each odd numbered year and may be renewed upon the payment of the required fee and the filing of an application for renewal. If the application for renewal is not made and the fee paid before September 1st of the odd numbered year, the license shall lapse and shall not be renewed, and an application for reinstatement shall be required. Reinstatement is at the sole discretion of the Board.

(6)

Upon request by the Board or its designee, any manufacturer holding a permit issued by the Board that causes a dangerous drug or controlled substance product to be marketed or distributed in this state shall provide, at no cost to this state, a quantity of one gram or more of the pure compound of each such product to the Georgia Drugs and Narcotics Agency. Such quantities of pure compound will only be used for testing and analysis purposes.

(a)	All quantities of a pure compound provided to the Georgia Drugs and Narcotics Agency will be accounted for using a perpetual inventory system, and a copy of each product inventory will be available for review by the manufacturer providing the compound upon written request to the Board.

(b)	As the manufacturer is required by this subsection to submit the dangerous drug or controlled substance for analysis, the results of any chemical analysis shall be considered a trade secret within the meaning of Code Section 50-18-72(b)(1).

Rule 480-7-.02 Drug Wholesale, Distribution Permits

(1)

Definitions. For the purpose of this chapter, definitions include:

(a)	Blood means whole blood collected from a single donor and processed either for transfusion or further manufacturing.

(b)	Blood component means that part of blood separated by physical or mechanical means.

(c)	Brokerage means a firm engaged in buying, selling, or distributing prescription drugs.

(d)	Drug sample means unit of a prescription drug that is not intended to be sold to, maintained by, or sold by any licensed pharmacy.

(e)	Manufacturer means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling of a prescription drug.

(f)	Prescription drug means any drug required by Federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to Section 503(b) of the Federal Food, Drug, and Cosmetic Act.

(g)

Wholesale distribution means distribution, or brokerage, of prescription drugs to persons other than a consumer or patient, but does not include:

1.

The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons; for purposes of this section,"emergency medical reasons" includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy or other practitioner of the healing arts, except that total sales of such drugs shall not exceed five percent (5%) of the total dosage units for the transferor retail pharmacy.

2.	The sale, purchase, or trade of a drug, or the dispensing of a drug pursuant to a prescription;

3.	The lawful distribution of drug samples by manufacturers' representatives or distributors' representatives; or

4.	The sale, purchase, or trade of blood and blood components intended for transfusion.

h)

Wholesale distributor means anyone engaged in wholesale distribution or brokerage of prescription drugs, including but not limited to, manufacturers, repackers, own-label distributors, private-label distributors, jobbers, brokers, warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and whole drug warehouses, independent wholesale drug traders, brokerage firms, and retail pharmacies that conduct whole distributions.

Rule 480-7-.03 Drug Wholesale Distribution Licensing Requirements

(1)

Every drug wholesale distributor, wherever located, who engages in drug wholesale distribution into, out of, or within the State of Georgia must be licensed by the Georgia State Board of Pharmacy in accordance with the laws and regulations of this State before engaging in wholesale distribution of prescription drugs.

(2)

Minimum Required Information for Licensure: The Board requires the following from each wholesale drug distributor as part of the initial licensing procedure and as part of any renewal of such license.

(a)	The name, full business address, and telephone number of the licensee;

(b)	All trade or business names used by the licensee:

(c)	Address, telephone numbers, and the names of contact persons for the facility used by the licensee for the storage, handling, and distribution of prescription drugs;

(d)	The type of ownership or operations (i.e., partnership, corporation, or sole proprietorship); and

(e)

The name(s) of the owner and/or operator of the licensee, including:

1.	If a person, the name of the person;

2.	If a partnership, the name of each partner, and the name of the partnership;

3.	If a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the incorporation; and the name of the parent company, if any;

4.	If a sole proprietorship, the full name of the sole proprietorship and the name of the business entity.

(f)	Where operations are conducted at more than one location by a single drug wholesale distributor, each such location shall be licensed by the Board.

(g)

Every drug wholesale distributor in this state, which is licensed by the Board, is required to be located in a commercially zoned business district and possess the appropriate local business license in order to conduct business. No drug wholesale distributor may be located in or operate out of a residential dwelling, building, or location, or a building, dwelling or location attached to a residential location. A drug wholesale distributor located in a hospital pharmacy or a retail pharmacy is deemed to meet this requirement.

(3)

Applications for Licensure.

(a)	Registration of a drug wholesaler distributor will be considered on the basis of the application filed with the Board, fee paid, and a report from the Director of the GDNA certifying the applicant possesses the necessary qualifications of a license.

(b)	Application fees shall not be refundable.

(c)	Licenses become null and void upon the sale, transfer or change of mode of operation or location of the business.

(d)

Licenses are renewed for two years and expire on June 30th of each odd numbered year and may be renewed upon the payment of the required fee for each place of business and the filing of an application for renewal. If the application for renewal is not made and the fee paid before September 1st, of the odd numbered year, the license shall lapse and shall not be renewed. An application for reinstatement shall be required. Reinstatement shall be at the sole discretion of the Board.

(e)	Changes in any information in this section shall be submitted to the Board prior to such change.

(4)

Minimum Qualifications.

(a)

The Board will consider the following factors in determining eligibility for licensure for persons who engage in the wholesale distribution of prescription drugs:

1.	Any convictions of the applicant under any Federal, State, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;

2.	Any felony convictions of the applicant under Federal, State, or local laws;

3.	The applicant's past experience in the manufacture or distribution of prescription drugs, including controlled substances;

4.	The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;

5.	Suspension or revocation by Federal, State, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;

6.	Compliance with licensing requirements under previously granted licenses, if any;

7.	Compliance with requirements to maintain and/or make available to the State Licensing Authority or to Federal, State, or local law enforcement officials, those records required to be maintained by drug wholesale distributors; and

8.	Any other factors or qualifications the Board considers relevant to and consistent with the public health and safety.

(b)	The Board reserves the right to deny a license to any applicant if it determines that the granting of such a license would not be in the public's interest.

(5)	Personnel. The licensed wholesale distributor shall employ adequate personnel with the education and experience necessary to safely and lawfully engage in the wholesale distribution of drugs.

(6)

Violations:

(a)	A license issued to a wholesale distributor pursuant to this part shall be subject to revocation or suspension upon conviction of the license holder for violations of Federal, State, or local drug laws and/or regulations.

(b)	Violation of any of the provisions of any applicable Board laws or rules shall be grounds for the suspension or revocation of the license issued hereunder.

(c)	Any revocation or suspension of a license pursuant to this part shall be carried out pursuant to the Georgia Administrative Procedure Act, O.C.G.A. Title 50 Chapter 13.

(d)	Drug samples shall not be sold in any licensed pharmacy.

(7)

Minimum Requirements for the Storage and Handling of Prescription Drugs and for the Establishment and Maintenance of Prescription Drugs Distribution Records. The following are required for the storage and handling of prescription drugs, and for the establishment and maintenance of prescription drug distribution records by wholesale drug distributors and their officers, agents, representatives, and employees.

(a)

Facilities. All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:

1.	Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

2.	Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

3.

Have a quarantine area for storage or prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened; 4. Be maintained in a clean and orderly condition; and 5. Be free from infestation by insects, rodents, birds, or vermin of any kind.

(b)

Security. All facilities used for wholesale drug distribution shall be secure from unauthorized entry.

1.	Access from outside the premises shall be kept to a minimum and be well controlled.

2.	The outside perimeter of the premises shall be well lighted.

3.	Entry into areas where prescription drugs are held shall be limited to authorized personnel.

4.	All facilities shall be equipped with an alarm system to detect entry after hours.

5.	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.

(c)

Storage. All prescription drugs or chemicals shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium, such as the United States Pharmacopeia (USP) Compendium.

1.	If no storage requirements are established for a prescription drug, the drug may be held at "controlled" room temperature, as defined in the official compendium, 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, devices, and/or logs shall be utilized to document proper storage of prescription drugs.

3.	The record keeping requirements in subparagraph (f) of this section shall be followed for all stored drugs.

(d)

Examination of materials.

1.

Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

2.	Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.

3.	The record keeping requirements in subparagraph (f) of this section shall be followed for all incoming and outgoing prescription drugs.

(e)

Returned, damaged, and outdated prescription drugs.

1.	Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier.

2.

Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be quarantined as such, and shall be quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.

3.

If the conditions under which a prescription drugs has been returned cast doubt on the drug's safety, identify, strength, quality, or purity, then the drug shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which the drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the wholesale drug distributor shall consider, among other things, the conditions under which the drugs has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling as a result of storage or shipping.

4.	The record keeping requirements in subparagraph (f) of this section shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.

(f)

Record keeping:

1.

Wholesale drug distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records shall include the following information:

(i)	The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs are shipped;

(ii)	The identity and quantity of the drugs received and distributed or disposed of; and

(iii)

The date of receipt and distribution or other disposition of the drugs.

(g)

For each person or firm, whether located inside or outside the State of Georgia, to which a drug wholesale distributor, located inside the State of Georgia, sells to, ships to, delivers to, or otherwise distributes drugs to, such drug wholesale distributor shall request and maintain a copy of that person or firm's current license or permit which authorizes them to purchase, buy, receive, or otherwise possess drugs.

1.

NO drug wholesale distributor, located inside the State of Georgia, may ship to, sell to, or otherwise deliver a dangerous drug or controlled substance to a person or firm unless that person or firm holds a license or permit which authorizes them to purchase, buy, receive or otherwise possess drugs.

(h)

Nothing in this chapter or Georgia law authorizes any drug wholesale distributor, located inside the State of Georgia, to sell, ship, or otherwise distribute any drugs to any person or firm located outside the United States of America or its territories without first receiving written permission to do so from the Board. Such permission can only be granted by the Board after it has received a written request from the drug wholesale distributor giving the details of the proposed transaction. The Board reserves the right to have the GDNA investigate any and all such requests, and the Board reserves the right to deny any such request.

(i)	Inventories and all records required under this rule shall be made available for inspection and photocopying by any authorized official of a government agency charged with enforcement of these regulations for a period of two (2) years following deposition of the drugs.

(j)

Records described in this rule that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be made readily available for authorized inspection during the retention period. Records kept at a central record keeping location apart from the inspection site and not electronically retrievable, shall be made available for inspection within two (2) working days of a request by an authorized official of any governmental agency charged with enforcement of these regulations.

(8)

Written Policies and Procedures. Wholesale drug distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale drug distributors shall include in their written policies the following:

(a)	A procedure whereby the oldest approved stock of a prescription drug product is distributed first. The procedure may permit deviation from this requirement, if such deviation is temporary and appropriate.

(b)

A procedure to be followed for handling recalls and withdrawals of prescription drugs. Such procedure shall be adequate to deal with recalls and withdrawals due to:

1.	Any action initiated at the request of the FDA or other Federal, State, or local law enforcement or other government agency, including the Georgia State Board of Pharmacy;

2.	Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

3.	Any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.

(c)	A procedure to ensure that wholesale drug distributors prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or natural emergency.

(d)

A procedure to ensure that any outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for two (2) years after disposition of the outdated drugs.

(9)	Responsible persons. Wholesale drug distributors shall establish and maintain lists of officer, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

(10)

Compliance with Federal, State, and local laws. Wholesale drug distributors shall operate in compliance with applicable Federal, State, and local laws and regulations.

(a)

Wholesale drug distributors shall permit the Georgia State Board of Pharmacy and authorized Federal, State, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operation procedures, at reasonable times and in a reasonable manner, to the extent authorized by law.

(b)	Wholesale drug distributors that deal in controlled substances shall register with the appropriate State controlled substance authority and with the Drug Enforcement Administration (DEA), and shall comply with all applicable State, Local, and DEA regulations.

(11)	Salvaging and reprocessing. Wholesale drug distributors shall be subject to the provisions of any applicable Federal, State or local laws or regulations that relate to prescription drug product salvaging or reprocessing.

Rule 480-7-.04 Researcher's Permit

(1)	Applications for registration must be filed with the Office of the Georgia State Board of Pharmacy ("Board") with the required fees.

(2)	Registration of a Researcher will be considered on the basis of the application filed and a report from the director of the GDNA certifying the applicant possesses the necessary qualifications for a permit.

(3)	Application fees shall NOT be refundable.

(4)	Permits shall not be transferable. Permits become null and void upon the change of mode, operation and/or location of the permit-holder.

(5)

Permits are renewable every two (2) years and expire on June 30th of the even- numbered years. Permits may be renewed upon the payment of the required renewal fee and the filing of the renewal application form. If the application is not made and the fee not pa id before September 1st of the even-numbered year, the permit shall lapse and shall not be renewable except by application f or a new permit.

(6)

Minimum Qualifications:

(a)

The Board will consider the following factors in determining eligibility for persons or entities applying for permits to engage in research.

1.	Any convictions of the applicant under any Federal, State, or local laws related to dangerous drugs or controlled substances;

2.	Any felony convictions of the applicant under any Federal, State, or local laws;

3.	The applicant's past experience in research related to dangerous drugs including controlled substances;

4.	The furnishing by the applicant of false or fraudulent material in any application made in connection with drug research;

5.	Suspension or revocation by Federal, State or local government of any permit currently or previously held by the applicant for drug research;

6.	Compliance with the requirements under previously granted permits or licenses, if any;

7.	Compliance with requirements to maintain and/or make available to the State licensing or permitting authority or to Federal, State or local law enforcement officials those records required to be maintained by researchers;

8.	Any other factors or qualifications such as age, education, training, etc. the Board considers relevant to be inconsistent with the public health and safety; and

9.	Having a Peace Officer Certification suspended or revoked by the Georgia Peace Officers Standard and Training (POST) or other professional licensing authority.

(b)	The Board reserves the right to deny a permit to any applicant if it deter mines that the granting of such a permit would not be in the public interest.

(7)

Storage and Security:

(a)

All drugs including dangerous drugs and controlled substances shall be stored at appropriate temperatures and under appropriate conditions in accordance with labeled requirements or those published in the current edition of an official compendium, such as the United States Pharmacopoeia (USP) Compendiums;

(b)

All facilities used for storage of drugs including dangerous drugs and controlled substances shall be of suitable size and construction to facilitate cleaning, maintenance and proper operations; and shall provide security from unauthorized entry as approve d by the Board or GDNA.

1.

All such facilities will be located in an appropriately zoned district, such as a college, school, university, law enforcement off ice, or commercial area. No permit will be issued to any researcher whose facility is located in a residential area, dwelling, or location. The Board may choose to grant an exception to this rule upon receipt of a written request from such applicant stating the reason for such an exemption.

(8)

Record Keeping and Accountability:

(a)	Researchers shall establish and maintain records of all transactions regarding receipt, distribution or other disposition of dangerous drugs or controlled substances.

(b)	All records required by these regulations shall be retained for a minimum period of two (2) years following any disposition of any drugs received.

(c)	Such records shall be kept at the storage site or shall be immediately retrievable by computers or other electronic means for authorized inspection during the retention period.

(9)

Sanctions and Penalties:

(a)

The Board under these regulations shall have the power to suspend or revoke any permit issued or to reprimand or to fine, not to exceed $500 per violation, the holder of such permit when such holder shall have:

1.	Become unfit or incompetent;

2.	Been convicted of a felony or any other crime involving moral turpitude;

3.	Violated any Pharmacy laws or rules or regulations promulgated by the Board, or violated any other state, federal, or local laws and rules related to drugs.

4.	The Board may refuse to grant a permit or renewal to any person, firm, corporation, agency, department or other entity for any of the grounds set forth in O.C.G.A. Section 26-4-49 and/or 26-4-60 of the Georgia Pharmacy Practice Act.

Rule 480-7-.05 Reverse Distributors

(1)

Every firm, whether located inside or outside the State of Georgia, which receives drugs for destruction, return credit, or otherwise disposes of drugs received from a registrant located in the State of Georgia which holds a permit or license to dispense or possess drugs, shall be known as a Reverse Distributor or a Reverse Drug Distributor.

(2)	In order or any Reverse Distributor, wherever located, to engage in the business of receiving drugs for destruction, return credit, or other disposal from a registrant located in Georgia, it must be licensed as a Reverse Distributor by the Georgia State Board of Pharmacy ("Board").

(3)	The minimum information required by the Board in order to register a Reverse Distributor will be the same as required under Rule 480-7-.03(2).

(4)	The minimum requirements for applications for registration as a Reverse Distributor with the Board will be the same as required under Rule 480-7-.03(3).

(5)

Personnel: The licensed Reverse Distributor shall employ adequate personnel with the education and experience necessary to safely and lawfully engage in the process of receiving drugs for destruction, credit return, or other means of disposal. Each such person shall have a working knowledge of the requirements for the law and rules for handling such drugs.

(6)

Violations:

(a)	A license issued to a Reverse Distributor pursuant to this part may be subject to revocation or suspension upon conviction of the license holder of or an employee of a reverse distributor for violations related to federal, state or local laws and/or rules.

(b)	Violation of any provisions of any applicable Board Rules shall be grounds for the suspension, revocation, or other sanctions of the permit issued hereunder.

(c)	Any action taken on a license pursuant to this part shall be carried out pursuant to the Georgia Administrative Procedure Act, O.C.G.A. Title 50, Chapter 13.

(7)

Minimum requirements for the storage and handling of prescription drugs and or the establishment and maintenance of prescription drug distribution records by Reverse Distributors. A Reverse Distributor shall follow the same requirements as listed under Board Rule 480-7-.03(7), except as follows:

(a)	A Reverse Distributor does not have to maintain a separate quarantine area for storing drugs which are outdated, damaged, etc., as noted under Rule 480-7-.03;

(b)	A Reverse Distributor does not have to maintain drugs under controlled temperature and humidity as required under Rule 480-7-.03;

(c)	A Reverse Distributor does not have to ensure the condition of drugs that are received or shipped as required under Rule 480-7-.03(7)(d) or (e);

(d)

Prior to a Reverse Distributor removing drugs from a registrant, the Reverse Distributor must generate paperwork, a copy of which must be provided to and maintained by the registrant and a copy to be maintained by the Reverse Distributor, both for two (2) years, which at minimumrecords the following:

1.	The date and time that the drugs left or were taken from the registrant;

2.	A complete inventory of the drugs being transferred to the Reverse Distributor;

3.	The name, Board permit number, address, and telephone number of the Reverse Distributor removing the drugs;

4.	The name and signature of the responsible person representing the Reverse Distributor physically removing the drugs;

5.	The name and signature of the pharmacist representing a pharmacy or responsible person representing another type of registrant transferring the drugs to the Reverse Distributor and the name and principal address of the pharmacy or other registrant from which the drugs are removed; and

6.	Any and all other information required under Ga. Comp. R. & Reg. c. 480-50 and applicable federal law and regulation.

(e)

Upon a Reverse Distributor's receipt of drugs from a registrant by contract or common carrier, the Reverse Distributor must generate paperwork, a copy of which must be maintained by the Reverse Distributor for two (2) years, which at minimum records the following:

1.	The date and time that the drugs were received by the Reverse Distributor;

2.	A complete inventory of the drugs received by the Reverse Distributor;

3.	The name and signature of the pharmacist representing a pharmacy or responsible person representing another type of registrant sending the drugs to the Reverse Distributor and the name and principal address of the pharmacy or other registrant from which the drugs are sent; and

4.	Any and all other information required under Ga. Comp. R. & Reg. c. 480-50 and applicable federal law and regulation.

Rule 480-7-.06 Background Investigations of Applicants

Whenever a person or firm applies for licensure under this Chapter, the GDNA has the authority to conduct whatever thorough background investigation necessary to ensure the applicant meets all the requirements of this Chapter.

Rule 480-7-.07 Credit for Returned Expired Drugs

(1)

Effective with all drug orders placed on or after July 1, 2002, all wholesale drug distributors shall make adequate provisions for the return of outdated prescription drugs, both full and partial containers, for up to six months after the labeled expiration date for prompt full credit or replacement.

(2)

Wholesale drug distributors shall establish a written policy consistent with O.C.G.A. Section 26-4-115(c)providing for the return of outdated prescription drugs sold to a client by such wholesale drug distributor. Such policy may include a procedure for the drugs to be returned to the drug manufacturer, may include a requirement that the drugs be returned in the original containers in which it was purchased, and may include the use of a reverse drug distributor. Said policy shall be available to the Board or its agents upon request.

(3)

The Board has determined the following listed drugs will be exempt from the requirements of this provision as they are essential to health care treatment and have an expiration date of less than one year from the date such drug is manufactured:

(a)	Influenza Vaccines

(4)

In order to be eligible for full credit or replacement, the drug must be received by the wholesale drug distributor, or if not the wholesale drug distributor, its agent designated in its return policy, no later than the sixth month from the labeled expiration date. A signed delivery receipt shall constitute evidence of the drugs having been returned.

(5)

Prompt full credit to the purchaser shall occur within sixty days from the date the return drugs were received by the wholesale drug distributor or its designated agent. If the wholesale drug distributor determines that the drugs were not returned within six months of the labeled expiration date, or were not returned consistent with the written return policy, then the wholesale drug distributor shall notify said purchaser in writing within thirty (30) days of the receipt of the drugs of its intent not to give full credit or replacement. Wholesale drug distributors shall maintain documentation supporting its refusal to give full credit or replacement for a period of two (2) years. Such documentation shall be available to the Board or its agent upon request.

(a)

"Full credit" shall be defined to include a cash refund or credit with the drug wholesale distributor for the purchase price of the drug as established by drug invoice less a reasonable fee for handling of the returned drugs. A reasonable fee shall not be more than 7% of the total invoice price of the returned drugs.

(6)

In lieu of full credit, a wholesale drug distributor may elect to replace the drug. Said replacement drug must be a drug of like value mutually agreed upon by the wholesale drug distributor and the original drug purchaser. Said replacement drug must be sent to the original drug purchaser within sixty (60) days from the date of return.

(7)	Wholesale drug distributors shall maintain records of all credits and replacements made under this rule for a period of two (2) years and such record shall be made available to the Board or its agent upon request.

(8)

The submission of drugs by a purchaser licensed by the Board in State of Georgia for refund or credit to a wholesale drug distributor pursuant to O.C.G.A. Section 26-4-115 and this rule when said drugs are in a container other than the one in which it was purchased, when said drugs were not purchased from that wholesale drug distributor, or when the drugs were purchased for a pharmacy or facility outside the State Of Georgia shall constitute fraudulent and unprofessional conduct and may subject the purchaser to disciplinary action by the Board.

(9)	The return of drugs under this rule shall also be consistent with all other applicable Federal, State, and local laws and regulations.

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