Ga. Comp. R. & Regs. 480-52-.01

Current through Rules and Regulations filed through November 21, 2024
Rule 480-52-.01 - Definitions
(1)"Board" shall mean the Georgia Board of Pharmacy.
(2)"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.
(3)"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.
(4)"Immediate notification" shall mean written notification sent within twenty-four hours of the event.
(5)"Low THC oil" shall mean an oil that contains an amount of cannabidiol and not more than 5 percent by weight of tetrahydrocannabinol, tetrahydrocannabinolic acid, or a combination of tetrahydrocannabinol and tetrahydrocannabinolic acid which does not contain plant material exhibiting the external morphological features of the plant of the genus Cannabis. Such term shall not mean products approved by the federal Food and Drug Administration under Section 505 of the federal Food, Drug, and Cosmetic Act.
(6)"Low THC Pharmacy Dispensary" shall mean a retail pharmacy, previously licensed by the Georgia Board of Pharmacy, which has obtained a permit Low THC Pharmacy Dispensary license.
(7)"Low THC Product" shall mean low THC oil delivered through an oil, tincture, transdermal patch, lotion, or capsule, except as prohibited by O.C.G.A. § 16-12-234, but not including any food products infused with low THC oil, including, but not limited to, cookies, candies, or edibles.
(8)"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.
(9)"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.
(10)"Predicate Retail License" shall mean the presently active Retail Pharmacy license, previously issued by the Georgia Board of Pharmacy, to the applicant for, or licensee of a Low THC Pharmacy Dispensary license.
(11)"Predicate Retail Licensee" shall mean the entity licensed by the Georgia Board of Pharmacy as a Retail Pharmacy and attendant to whose licensure a Low THC Pharmacy Dispensary license has been applied for or obtained.
(12)"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.
(13)"Prescription Department" shall mean an area set aside for the preparation and dispensing of prescription drugs and Low THC Products. 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.
(14)"Registered Patient" means an individual who is legally authorized to possess and use low THC oil and products pursuant to O.C.G.A. § 31-2A-18.
(15)"Significant adverse drug reaction" shall mean any reaction which requires any medical treatment beyond a consultation between Pharmacist/patient, Pharmacist/Prescriber, patient/prescriber or Pharmacist/patient/Prescriber.
(16)"Vaccination room" is an area adjacent to the pharmacy where vaccinations are administered.
(17)"Written notification" shall mean in writing and sent by statutory overnight delivery or by email.

Ga. Comp. R. & Regs. R. 480-52-.01

O.C.G.A. §§ 16-12-206, 26-4-28, 26-4-110.

Original Rule entitled "Definitions" adopted. F. Sept. 14, 2023; eff. Oct. 4, 2023.