Ga. Comp. R. & Regs. R. 480-10-.02 - Prescription Department, Requirement, Supervision, Hours Closed

(1) For the purpose of this rule, the following definitions shall apply:

(a) "Direct supervision" shall mean that a pharmacist is physically present, providing care at the address listed on the pharmacy license, and is in the prescription department, consultation room, vaccination room, or areas where over-the-counter drugs, devices, or durable medical equipment are displayed. The supervising pharmacist is professionally responsible and accountable for all activities performed by authorized pharmacy personnel and is available to provide assistance and direction to authorized pharmacy personnel. This shall not require a pharmacist to maintain a direct line of sight to authorized pharmacy personnel. The supervising pharmacist shall provide a final check of prepared products and document final checks before any prescription drug is dispensed.

(b) "Pharmacy care" shall mean those services related to the interpretation, evaluation, or dispensing of prescription drug orders, the participation in drug and device selection, drug administration, and drug regimen reviews, and the provision of patient counseling related thereto.

(c) "Preparation" shall mean the functions of preparing a prescription to be dispensed, including product selection, data entry into a pharmacy dispensing system, and any other functions required to have the prescription ready to be verified, checked, and dispensed by a pharmacist or pharmacy intern working under the direct supervision of a pharmacist

(d) "Pharmacy" shall mean all areas of a facility when the prescription department is not closed or locked separately from the facility or only the area of the prescription department in those facilities where the prescription department is locked and separated.

(e) "Prescription Department" shall mean an area set aside for the preparation and dispensing of prescription drugs. In a facility offering other departments and types of merchandise not requiring a pharmacist to be open for business, this term shall apply only to the area in which prescriptions are prepared and dispensed.

(f) "Vaccination room" is an area adjacent to the pharmacy where vaccinations are administered.

(g) "Consultation room" is an area adjacent to the pharmacy where patient or customer consultations are done, and more in-depth pharmacy care may be provided.

(2) Except for pharmacy benefit manager retail pharmacies and retail pharmacies located in the same space as hospital pharmacies, the owner, manager or proprietor of each pharmacy shall designate an area, room or rooms, which shall be known as the "Prescription Department," and which is primarily devoted to activities related to prescriptions, including preparation and dispensing.

(3) A licensed pharmacist shall be in charge of each pharmacy. His or her name shall be upon the application for the license of the pharmacy; he or she shall be the pharmacist in charge of and have supervision of not more than one pharmacy at one time; and he or she shall be responsible and accountable for the conduction of business related to prescriptions within and access to said retail pharmacy.

(a) This regulation is not intended to prohibit any pharmacist from engaging in the practice of pharmacy at more than one pharmacy, if conducted in compliance with the other provisions of this rule and regulation.

(b) This regulation does not prohibit a pharmacist from being in charge of one separately licensed Home Health Care Pharmacy, as defined by Board Rule 480-21, and/or one Nursing Home Pharmacy, and/or one Long Term Health Care Facility Pharmacy, as both are defined in Board Rule 480-24, in addition to being in charge of a retail pharmacy, licensed under Rule 480-10, as long as each pharmacy is operated under the same ownership and is located under the same roof, provided that there is a physical separation of the two pharmacies and separate inventories are maintained for the two pharmacies.

(4) Except for pharmacy benefit manager retail pharmacies and retail pharmacies located in the same space as hospital pharmacies, a Licensed Pharmacist shall be present and on duty in a licensed retail pharmacy as follows:

(a) Entire business establishments which are licensed under O.C.G.A. § 26-4-110 as a pharmacy shall have a pharmacist on duty at all times the pharmacy is open for business as follows:

1. Such times when the pharmacist is absent from the pharmacy cannot exceed three (3) hours daily, or more than one and one half (11/2) hours at any one time. If a pharmacist is absent less than five minutes from the prescription department, this absence is not considered an "absence" within the meaning of this rule and will not require a posted notice, provided that the prescription department's security is not compromised.

2. In the absence of a pharmacist from the pharmacy, the area designated as the prescription department shall be closed and locked in such a manner as to prevent unauthorized entry; and

3. Whenever the pharmacist is absent from the pharmacy, a sign shall be prominently displayed on the entrance to the prescription department announcing "Prescription Department Closed" and such sign shall be clear and legible with letters not less than three (3) inches in size.

4. The pharmacist on duty shall be responsible and accountable for the direct supervision of all personnel working in the pharmacy or prescription department. Pharmacy technicians and pharmacy interns/externs can continue preparation of a prescription when the pharmacist is in the immunization or consultation room or is providing pharmacy care services.

(b) If a pharmacy is located in a general merchandising establishment, or if the owner of a business licensed as a pharmacy so chooses, a portion of the space in the business establishment may be set aside and permanently enclosed or otherwise secured; only the permanently enclosed area shall be subject to provisions of this rule and shall be licensed as a pharmacy;

1. In such cases, the area to be licensed or registered as a pharmacy shall be permanently enclosed with a partition built from the floor to the ceiling or in a manner which meets security guidelines submitted to and approved by the Board and upon inspection by the GDNA;

2. In the absence of a pharmacist from the Prescription Department, consultation room, vaccination room, and area where over-the-counter drugs, devices, and durable medical equipment are displayed, the area designated as the Prescription Department shall be closed and locked in such a manner as to prevent unauthorized entry; and

3. Whenever the pharmacist is absent from the Prescription Department, consultation room, vaccination room, and area where over-the-counter drugs, devices, and durable medical equipment are displayed, a sign shall be prominently displayed on the entrance to the Prescription Department announcing "Prescription Department Closed" and such sign shall be clear and legible with letters not less than three (3) inches in size.

4. If a pharmacist is absent less than five minutes from the prescription department, this absence is not considered an "absence" within the meaning of this rule and will not require a posted notice, provided that the prescription department's security is not compromised. No prescription shall be dispensed in the absence of a licensed pharmacist. The pharmacist on duty shall be responsible and accountable for the direct supervision of all personnel working in the pharmacy or prescription department. Pharmacy technicians and pharmacy interns/externs can continue preparation of a prescription when the pharmacist is in the immunization or consultation room or is providing pharmacy care services.

(5) If a retail pharmacy license and hospital pharmacy license occupy the same physical space, nothing shall prohibit one nursing supervisor from having access to the pharmacy in accordance with Board Rule 480-13-.04(8).

Notes

Ga. Comp. R. & Regs. R. 480-10-.02

O.C.G.A. §§ 26-4-27, 26-4-28, 26-4-82, 26-4-110, 26-4-110.1

Original Rule entitled "Prescription Department, Requirement, Supervision, Hours Closed" adopted. F. Oct. 6, 1970; eff. Oct. 26, 1970. Amended: F. Oct. 6, 1976; eff. Oct. 26, 1976. Amended: F. Aug. 12, 1997; eff. Sept. 1, 1997. Repealed: New Rule of same title adopted. F. Mar. 5, 2003; eff. Mar. 25, 2003. Amended: F. May 1, 2003; eff. May 21, 2003. Amended: F. May 24, 2017; eff. June 13, 2017. Amended: F. Apr. 13, 2021; eff. May 3, 2021.