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(a) A Reverse Distributor does not have to maintain a separate quarantine area for storing drugs which are outdated, damaged, etc., as noted under Rule 480-7-.03;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

Notes

Ga. Comp. R. & Regs. R. 480-7-.05

O.C.G.A. §§ 26-4-5, 26-4-27, 26-4-28, 26-4-113, 26-4-115.

Original Rule entitled "Reverse Distributors" adopted. F. Aug. 6, 2001; eff. Aug. 26, 2001. Amended: F. June 29, 2015; eff. July 19, 2015. Amended: F. Feb. 22, 2018; eff. Mar. 14, 2018.