Ga. Comp. R. & Regs. 480-10-.16

Current through Rules and Regulations filed through November 21, 2024
Rule 480-10-.16 - Security System Approval

As set forth by O.C.G.A. 26-4-110, the Board may provide in its rules and regulations the manner in which the prescription department of a retail pharmacy may be secured. This requirement will be met in the following manner:

(1) Any retail pharmacy located in a general merchandising establishment which does not have a prescription department set aside and permanently enclosed with a partition from floor to ceiling as set forth in O.C.G.A. 26-4-110, must submit to the Board in writing a request to approve its particular security system accompanied by a detailed description of that security system. This request must be made prior to a pharmacy receiving its retail pharmacy permit;
(a) Any retail pharmacy located in a general merchandising establishment which chooses to close its prescription department for more than three (3) hours per day, and more than one and one half (1 1/2) hours at any one time, MUST have its prescription department permanently enclosed with a partition from floor to ceiling;
(b) Any retail pharmacy located in a general merchandising establishment in which the prescription department is not permanently enclosed and utilizes ONLY an electronic security system to separate the prescription department from the rest of the business establishment, MAY NOT close for more than three (3) hours per day, nor more than one and one half (1 1/2) hours at any one time. Board approval of a pharmacy's electronic security system, without the presence of a permanent partition, does not exempt a pharmacy from this requirement.
(2) Each security system description shall be reviewed and either approved or disapproved by the Board.
(3) The Board shall notify the pharmacy submitting the security description in writing as to whether or not the Board approves or disapproves the system. In cases in which a system is not approved, the Board may submit suggestions or reasons as to why the system was not acceptable.
(4) Upon receiving a written approval of a security system, a pharmacy MUST maintain a copy of the Board's approval letter, along with a copy of the security system description, making both available in the pharmacy for inspection by the GDNA. This requirement can be met by posting the approval letter with the last GDNA inspection report.
(5) Any change in a security system must first be approved in writing by the Board and a copy of the approval maintained by the pharmacy.
(6) In the case of multiple retail pharmacies being operated by a parent corporation, the parent corporation may submit a request for a blanket approval of the same security system to be used by all pharmacies operated by that corporation. A copy of the written Board approval and the system description must be maintained at each pharmacy operated by the corporation. Thereafter, any new pharmacy operated by that corporation may utilize the same security system which was previously approved by the Board.
(7) Whenever a corporation or business entity operates multiple pharmacies, each of which has a secured prescription department, whether or not it is an electronically secured or permanently enclosed area, the pharmacist in charge (PIC) shall develop a method, approved by the Board, of allowing authorized access to that area. This method may consist of a Board approved lockbox containing a key, security access code, or other means by which security is maintained. Nothing in this rule is meant to prevent the PIC from having the authority to limit access to such area in regards to non-pharmacy related persons.
(a) Before any such pharmacy can utilize a method of such access, a description of this method, including details of any lockbox to be utilized, must be submitted to the Board for approval.
1. A corporation or business entity may choose to utilize the same method of access to secure a key or access code for each pharmacy it operates in the State of Georgia by notifying the Board in writing. A copy of the Board approved method must be attached to the last GDNA inspection report. Any change in such method must be approved by the Board.
(b) Upon approving or disapproving a method, the Board will notify the pharmacy of such in writing. A copy of such approvals must be posted by the pharmacy with the last GDNA inspection report. When a method is not approved, the Board may offer suggestions as to what must be done before the method can be approved.
(8) All pharmacies licensed on or after January 1, 2006 that utilize a drive-through system for the delivery of drugs, or any currently licensed pharmacy that relocates or has construction or modification of the pharmacy or pharmacy department on or after January 1, 2006 that creates a drive-through or alters an existing drive-through system for delivery of drugs, must submit the construction and security plans for utilization of a pharmacy drive-through to the Board before such construction or modification, and any such drive-through must be approved by the Board and must meet the requirements set forth herein. For purposes of this rule, a pharmacy drive-through is a delivery method by which a patient, or their designated agent, hereafter referred to as "patient", leaves a prescription to be filled or receives a filled prescription drug at the licensed pharmacy location other than by physically being inside the pharmacy.
(a) Any Pharmacy Drive-Through must include a window of transparent material, measuring no less than 2 X 3 feet. The window must be placed in a wall of the prescription department or pharmacy. A pharmacist must be able to observe the patient through the window, whether or not the patient is in a drive-through lane directly next to the window or in a drive-through lane which is one lane over from the window. There shall be no more than two drive-through lanes with the lane farthest from the pharmacy/prescription department drive-through window being no more than twenty-four feet from the window.
(b) Any Pharmacy Drive-Through that utilizes a pneumatic tube system, through which prescription drug orders are received from the patient or prescription drugs are dispensed to the patient, must meet the following standards:
1. Secured carriers must be utilized in the pneumatic tube system;
2. Tubes must be constructed in a manner as to prevent access by unauthorized persons;
3. The tube must originate in the prescription drug area of the pharmacy, be accessible only by a pharmacist or personnel in the pharmacy and must terminate in a secure terminal in the drive-through.
(c) Access to the pneumatic tube system must be constructed in such a way as to provide protection from the natural elements for the patient accessing the prescription.
(d) Any Pharmacy Drive-Through must be inspected by a GDNA Special Agent prior to utilization. Such Special Agent must file an inspection report with the Board with a recommendation for approval or non-approval.
(9) All pharmacies licensed prior to January 1, 2006 that utilize drive-throughs that do not comply with subsection 8(a) through (d) shall be grandfathered in.

Ga. Comp. R. & Regs. R. 480-10-.16

O.C.G.A. Secs. 26-4-27, 26-4-28, 26-4-87, 26-4-110.

Original Rule entitled "Security System Approval" adopted. F. Apr. 23, 1998; eff. May 13, 1998.
Repealed: New Rule of same title adopted. F. Mar. 5, 2003; eff. Mar. 25, 2003.
Amended: F. Dec. 9, 2005; eff. Dec. 29, 2005.