Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-52 - RETAIL PHARMACY REQUIREMENTS FOR DISPENSING LOW-THC PRODUCTS › Rule 480-52-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
(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.
O.C.G.A.
				§§
										16-12-206,  26-4-28,  26-4-110.