Rule 351-2-.01 - Definitions(1) "Accreditation" means the procedure by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks and verifies that the appropriate quality management system is in place.(2) "Act" means O.C.G.A. Sections 16-12-200 through 16-12-236, as amended, and referred to as "Georgia's Hope Act."(3) "Action level" means the threshold at or above which the testing of a product sample would result in a failed certificate of analysis for a given analyte.(4) "Adverse event" means an undesirable experience associated with the lawful use of product in final packaged form where the outcome was death, life-threatening complications, hospitalization, disability or permanent damage, congenital anomaly or birth defect, required intervention to prevent permanent impairment or damage, or any other medical event that required medical treatment.(5) "Advertise" means, but is not limited to, the act of publicizing, disseminating, soliciting, or circulating visual, oral, or written communication to induce or persuade any person to purchase or consume any specific regulated cannabis. This definition does not include education and consultation provided directly to patients and caregivers regarding product safety information.(6) "Agent" means a person who is authorized to serve as a representative of an entity and whose signature has binding legal authority of such an entity.(7) "Analyte" means a chemical, compound, element, bacteria, yeast, fungus, microbial, or toxin for which a product sample is tested by an independent laboratory.(8) "Applicant" means an entity applying for a license as set forth in Code Section 16-12-200(1).(9) "Batch" means a quantity of regulated cannabis harvested or produced together at the same time by the same production licensee, the meaning of which shall include the following: (a) "Harvest batch" means a specific quantity of regulated cannabis grown under the same conditions, and harvested during a specified period of time from specified cultivation space(s) using the same standards.(b) "Manufactured batch" means a quantity of regulated cannabis produced and manufactured together at the same time, using the same standards.(10) "Batch number" means the number assigned to each batch of regulated cannabis by a production licensee.(11) "Cannabinoid profile" means a list of the chemical compounds that are the active constituents of cannabis, which are present in the product.(12) "Cannabis" means marijuana, hashish, and other substances which are identified as including any parts of the plant family Cannabaceae and including any and all genera, strains, and subspecies, such as cannabis sativa, indica, ruderalis, and any and all derivatives thereof, whether growing or not, the seeds thereof, the resin extracted from any part of such plant, and any compound, salt, derivative, mixture, or preparation of such plant, its seeds, or resin, including tetrahydrocannabinol (THC), cannabidiol, and all other cannabinol derivatives, including its naturally occurring ingredients, whether produced directly or indirectly by extraction.(13) "Canopy" means the designated area(s) of a production licensee's cultivation space that contains mature, flowering plants at any point in time.(14) "Caregiver" shall have the same meaning as set forth in Code Section 31-2A-18.(15) "Certificate of analysis" means the report of analytical testing of product in final packaged form performed and the results obtained by an independent laboratory.(16) "Child-resistant package" means the special packaging of a product in final package form in compliance with the United States Poison Prevention Packaging Act of 1970, 15 U.S.C. Section 1471et seq., as amended, and with the rules of the Commission.(17) "Clone" means regulated cannabis that is produced by asexual reproduction and is a genetic match to the mother plant.(18) "Commission" or "GMCC" means the Georgia Access to Medical Cannabis Commission created as set forth in Code Section 16-12-202.(19) "Complainant" means the person who submitted a written complaint to the Commission alleging violations of state laws, rules, and/or regulations by an entity or person.(20) "Concentrate" means a condensed accumulation of cannabis, having a greater proportion of cannabinoids and terpenes than those that are naturally occurring in cannabis.(21) "Contaminant" means any pollutant, physical, chemical, biological, or radiological substance or matter found in the production of regulated cannabis.(22) "Contractor" means a third-party person or entity performing work for a licensee or registrant under contractual agreement directly associated with the operations and activities regulated by the Commission.(23) "Corrective action plan" means the plan created by a licensee or registrant detailing how they will correct any deficiencies or violations found during an inspection.(24) "Cultivation space" means the measured canopy for the indoor production of regulated cannabis and equipped with locks or other security devices that allow access only by an authorized person, but which does not include propagation or vegetative spaces, ancillary spaces, and aisles between grow spaces, as set forth in Code Sections 16-12-211 and 16-12-212.(25) "Day" means a calendar day.(26) "Dispensary" means the retail location of a dispensing licensee. As used throughout the rules of the Commission, the related terms "dispensing licensee" and "dispensing license" refer to such terms as set forth in Code Section 16-12-206(a)(2).(27) "Duress alarm" means a silent security alarm signal generated by the entry of a designated code into an arming station that signals duress.(28) "Employee" means, but is not limited to, a person whose duties involve any aspect of the production, research, testing, transportation, or dispensing of regulated cannabis, whether or not compensated for the performance of such duties. This definition does not apply to the term "employee" as used in these rules when referring to the employees of the Commission.(29) "Enclosed" means a structure with a floor that is covered securely, or able to be covered securely on all vertical sides and an ultimate horizontal covering affixed on top of said vertical sides.(30) "Entity" means, but is not limited to, a corporation and foreign corporation, nonprofit corporation and foreign nonprofit corporation, professional corporation and foreign professional corporation, limited partnership and foreign limited partnership, foreign limited liability partnership, and limited liability company and foreign limited liability company as set forth in Code Section 14-2-203.(31) "Extract" means a preparation that contains the active ingredient(s) of a substance in concentrated form.(32) "Fence" or "fencing" means a locking barrier, railing, or other upright structure fully enclosing an area of ground to mark a boundary, and to effectively prevent or control access.(33) "Final packaged form" means product in properly labeled, tamper-evident, child-resistant packaging, including the unique batch number for the purposes of identifying and tracking, ready for dispensing. This definition does not include exit packaging or a shipping container or an outer wrapping used solely for the transport of products in bulk quantity.(34) "Floor" means the lower inside surface of a structure that serves as a barrier between the native soil and regulated cannabis that is nonporous, impermeable, impervious, waterproof, or otherwise sealed from, covered over, and permanently restrictive to the earth's terranean shell.(35) "Formulation" means the ingredients, recipe, method of processing in order to be shelf stable, certificates of analysis for any ingredient used, and description of the process in which all ingredients are combined to produce a final form.(36) "Fully operational" means: (a) A Class 1 or Class 2 production licensee is active and operational such that its production facility is capable of producing adequate amounts of product in final packaged form to ensure uninterrupted availability at its dispensaries, for a period of thirty (30) days for patients; or(b) A dispensing licensee is active and operational such that it maintains an adequate on-site inventory of product in final package form to ensure uninterrupted availability of inventory for a period of thirty (30) days for patients.(37) "Holdup alarm" means a silent alarm signal generated by the manual activation of a device for the purpose of signaling that a robbery is in progress.(38) "Immature plant" means a non-flowering cannabis plant that is no taller than 8 inches (203.2 mm) from the growing or cultivating medium and no wider than 8 inches (203.2 mm), produced from a cutting, clipping, tissue culture, or seedling that is in a growing or cultivating medium or in a growing or cultivating container.(39) "Independent laboratory" means a laboratory approved and authorized by the Commission, pursuant to the rules of the Commission, to test product for purposes specified in the Act and the rules of the Commission.(40) "Indoor" means of or relating to the interior of a building or enclosed structure.(41) "Ingredient" means a component of regulated cannabis that is:(b) An active ingredient, substance, or group of substances, which includes, but is not limited to, purified compounds, oils, therapeutic chemicals, oleoresins, essences or extracts, protein hydrolysates, distillates, or isolates.(42) "Inspection" means an evaluation of facilities, laboratory, testing, records, employees, equipment, operations, methodology, and quality assurance practices conducted by the Commission or its employees for the purpose of ensuring compliance with the requirements of the Act and these rules.(43) "Labeling" means any display of written, printed, or graphic matter printed on or affixed to any container, wrapper, liner, or insert accompanying the product. This shall include any material or image printed on or attached to the final retail package and bulk package unit.(44) "Licensee" means any entity with an active license issued by the Commission.(45) "Low-THC oil" shall have the same meaning as set forth in Code Section 16-12-190.(46) "Low-THC Oil Patient Registry" means the registration of individuals who have been issued registration cards by the Georgia Department of Public Health.(47) "Manufacture" shall have the same meaning as set forth in Code Section 16-12-200(13).(48) "Manufacturing space" means the indoor area utilized to manufacture and package products, including extraction and other related practices applied to harvested plant material.(49) "Market" or "marketing" means any act or process of promoting or selling products, including, but not limited to, sponsorship of sporting events, point-of-sale advertising, and development of products specifically designed to appeal to certain demographics.(50) "Minor" shall have the same meaning as set forth in Code Section 39-1-1.(51) "Minority Business Enterprise" shall have the same meaning as set forth in Code Section 50-5-131.(52) "Mother plant" means a plant grown for the purpose of being a source of propagative material.(53) "Package" or "packaging" means any container or wrapper that may be used for enclosing or containing any product. This definition does not include a shipping container or an outer wrapping used solely for the transport of products in bulk quantity to the premises of a licensee, pharmacy, or registrant.(54) "Panic alarm" means an audible system signal to indicate an emergency situation.(55) "Patient" means the same as set forth in Code Section 16-12-200(16).(56) "Perimeter alarm" means a security alarm signal generated by a breach or crossing of, or entry to, the outermost parts or boundary of a premises.(57) "Pest" means an undesired insect, rodent, nematode, fungus, bird, vector, vertebrate, invertebrate, undesired herbaceous plant, virus, bacteria, or other microorganism (except for microorganisms on or in living humans or other living animals) that is, or is likely to become, injurious, dangerous, or detrimental to health, the environment, or the agricultural environment of the state; provided however, nothing in this definition shall apply to industry recognized beneficial biological control agents.(58) "Pesticide" means any substance or mixture of substances intended for preventing, destroying, eradicating, repelling, or mitigating any pest.(59) "Pharmacy" means a pharmacy licensed by the Georgia Board of Pharmacy to dispense low-THC oil and products that have been purchased or received from a licensee.(60) "Physician" means a person licensed to practice medicine by and in good standing with the Georgia Composite Medical Board as set forth in Code Section 43-34-2.(61) "Plant waste" means all plant parts including roots, stalks, leaves, stems, flower, trim, or solid plant material and any plant material rendered from the extraction process not used directly for production that have been pruned, trimmed, shucked, or otherwise removed during cultivation, harvest, or manufacturing.(62) "Premises" means a licensee's or registrant's building(s), together with its real property.(63) "Produce" means to grow and harvest regulated cannabis to manufacture and create low-THC oil and products in accordance with the Act and these rules.(64) "Product" shall have the same meaning as set forth in Code Section 16-12-200(15).(65) "Proficiency testing" means the evaluation, relative to a given set of criteria, of the performance, under controlled conditions, of an independent laboratory in analyzing unknown samples provided by an external source.(66) "Program participant" means the same as set forth in Code Section 16-12-191(b)(1)(A)(i).(67) "Propagation space" means an indoor area or facility used for the growing of immature or nonflowering plants including but not limited to: seeds, seedlings, clones or cuttings, tissue culture, and any other propagative means. This definition does not include space used for mother plants which will be used for harvest.(68) "Quality control" means the set of measures implemented within an analytical procedure to ensure that the measurement system is operating in a state of statistical control for which errors have been reduced to acceptable levels.(69) "Recall" means the return of product in final packaged form, whether Commission-ordered or licensee-initiated, due to the potential for, or actual occurrence of, adverse events from the use of such product by patients.(70) "Registrant" means an entity that is approved by the Commission, pursuant to the rules of the Commission, as an independent laboratory for purposes of testing low-THC oil and products and is on the Commission's approved and current list of such approved independent laboratories.(71) "Regulated cannabis" means all cannabis regulated by the Commission, including, but not limited to, plants and plant material, plant waste, extracts, concentrates, and products.(72) "Regulated cannabis waste" means the waste related to or directly produced by regulated cannabis.(73) "Remediation" means the neutralization or removal of any substances or contaminants from product.(74) "Restricted access area" means a building, room, or other area in a licensee's or registrant's premises where regulated cannabis is grown, cultivated, harvested, weighed, packaged, tested, researched, processed, or stored.(75) "Sample" means a single or representative part of a batch which is composed of several sample increments. (a) "Controlled sample" means the official sample of product in final packaged form collected by a sample collector from an independent laboratory, which is used to determine, among other things, official compliance with THC limits.(b) "Reserve sample" means an internal sample of regulated cannabis taken for purposes of ensuring product quality and making determinations about whether to dispense the product.(76) "Standard operating procedures" means a written document that provides detailed instructions for the performance of all aspects of an analysis, operation, process, task, or action.(77) "Tag" means an approved unique identifier for the purpose of tracking regulated cannabis in the tracking system provided or operated by a Commission-approved vendor. (a) "Plant tag" means an approved tag attached to each individual plant.(b) "Product tag" means an approved tag printed on, or attached to, the individual product in final packaged form.(c) "Bulk package tag" means an approved tag printed on, or attached to, the product batch package for the purpose of storage and transport.(78) "Tamper-evident" means having one (1) or more indicators of modification which, if breached, missing, or altered, can reasonably be expected to provide visible evidence that tampering has occurred.(79) "Total THC" means the sum of the percentage by weight of delta-9-tetrahydrocannabinolic acid (D9-THCA) multiplied by 0.877, plus the percentage by weight of delta-8-tetrahydrocannabinol (D8-THC), plus the percentage by weight of delta-9-tetrahydrocannabinol (D9-THC), plus the percentage by weight of exo-tetrahydrocannabinol (Exo-THC), plus the percentage by weight of delta-10-tetrahydrocannabinol (D10-THC). I.e., Total THC = (% D9-THCA * 0.877) + % D8-THC + % D9-THC + % Exo-THC + % D10-THC.(80) "Tracking system" or "Commission-approved tracking system" means a seed-to-sale tracking system provided or operated by a vendor approved by the Commission to track regulated cannabis that is grown, processed, manufactured, transferred, transported, stored, dispensed, recalled, or disposed of.(81) "Transport" and "transportation" means to move or transfer product from one location to another.(82) "Universal symbol" means the universal cannabis product symbol authorized by the Commission for use on product containers, packaging, and labeling.(83) "Visitor" means a non-employee or contractor, present on a licensee's or registrant's premises for a specific purpose or task not directly related to the production of regulated cannabis, dispensing of product in final packaged form, or testing of regulated cannabis and product in final packaged form.(84) "Visitor identification badge" means a physical badge issued to a visitor used to easily verify the status of a person while on a licensee's or registrant's premises.Ga. Comp. R. & Regs. R. 351-2-.01
O.C.G.A. §§ 16-12-200, 16-12-203, 16-12-206, 16-12-210.
Original Rule entitled "Definitions" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.Amended: F. Nov. 9, 2023; eff. Nov. 29, 2023.