Okla. Admin. Code § 310:681-1-4 - [Effective until 9/14/2022] Definitions

Current through Register Vol. 39, No. 7, December 15, 2021

The following words and terms, when used in this Chapter, shall have the following meaning, unless the context clearly indicates otherwise:

"Actively operating" or "Actively conducting business operations" means a commercial licensee that possesses, sells, purchases or transfers medical marijuana and/or medical marijuana products to or from its licensed premises in a regular or seasonal capacity.

"Advertising" means the act of providing consideration for the publication, dissemination, solicitation, or circulation of visual, oral, or written communication to induce directly or indirectly any person to patronize a particular medical marijuana business or to purchase any particular medical marijuana or medical marijuana products. "Advertising" includes marketing but does not include packaging and labeling.

"Applicant" means the natural person or entity in whose name a license would be issued.

"Application status" means the status of a submitted application and includes the following:

(A) "Submitted" means the application has been submitted but a review is not yet complete;

(B) "Rejected" means the application has been reviewed but contains one or more errors requiring correction by the applicant at no additional fee before a final determination on the application can be made. "Rejected" does not mean the application is denied;

(C) "Approved" means the application has been approved and that a license will be issued and mailed to the applicant; and

(D) "Denied" means the applicant does not meet the qualifications under Oklahoma law and this Chapter for a license.

"Authority" or "OMMA" means the Oklahoma Medical Marijuana Authority, a division of the Oklahoma State Department of Health.

"Batch number" means a unique numeric or alphanumeric identifier assigned prior to any testing to allow for inventory tracking and traceability.

"Business license" means a license issued by the Department to a medical marijuana dispensary, grower, processor, testing laboratory, or transporter.

"Cannabinoid" means any of the chemical compounds that are active principles of marijuana.

"Caregiver" means a family member or assistant who regularly looks after a licensed patient whom a physician certifies is homebound or needs assistance.

"CFR" means the Code of Federal Regulations, the compilation of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government which is published by the U.S. Government Printing Office. Citations in this Chapter to the CFR refer sequentially to the Title, Part and Section numbers.

"Child-resistant" means packaging that is:

(A) Designed or constructed to be significantly difficult for children under five (5) years of age to open and not difficult for normal adults to use properly as defined by 16 CFR § 1700.15 (1995) and 16 CFR § 1700.20 (1995);

(B) Opaque so that the outermost packaging does not allow the product to be seen without opening the packaging material; and

(C) Resealable to maintain its child-resistant effectiveness for multiple openings for any product intended for more than a single use or containing multiple servings.

"Clone" means a non-flowering plant cut from a mother plant that is capable of developing into a new plant and has shown no signs of flowering.

"Commercial license" means any license issued to an individual or entity that is not a patient, caregiver, or transporter agent.

"Commercial licensee" means an individual or entity issued a commercial license and does not mean a patient, caregiver, or transporter agent.

"Commissioner" means the State Commissioner of Health of the Oklahoma State Department of Health.

"Complete(d) application" means a document prepared in accordance with Oklahoma law, these Rules, and the forms and instructions provided by the Department, including any supporting documentation required by the Department and the license fee.

"Decontamination" means a process that attempts to remove or reduce to an acceptable level a contaminant exceeding an allowable threshold set forth in these Rules in a harvest batch or production batch.

"Department" means the Oklahoma State Department of Health or its agent or designee.

"Dispense" means the retail selling of medical marijuana or marijuana products that are packaged and labeled in accordance with the law to a licensed patient, the licensed patient's parent(s) or legal guardian(s) if licensed patient is a minor, or a licensed caregiver.

"Dispensary" or "Commercial Dispensary" means an individual or entity that has been issued a medical marijuana business license by the Department, which allows the dispensary to purchase medical marijuana or medical marijuana products from a licensed processor, grower, or dispensary; to sell medical marijuana and medical marijuana products to a licensed patient, to the licensed patient's parent(s) or legal guardian(s) if licensed patient is an minor, and a licensed caregiver; and to sell, transfer, and transport or contract with a commercial transporter to transport medical marijuana or medical marijuana products to another licensed dispensary, a research facility, and an educational facility; and to transfer to testing laboratories.

"Dispose" or "Disposal" means the final disposition of medical marijuana waste by either a process which renders the waste unusable through physical destruction or a recycling process.

"Disqualifying criminal conviction" means:

(A) Any non-violent felony conviction within last two (2) years of submitting an application to the Department;

(B) Any violent felony conviction for an offense listed in 57 O.S. § 571(2) within last five (5) years of submitting an application to the Department; or

(C) Incarceration for any reason during submission of application to the Department.

"Education facility" means an individual or entity that has been issued a license by the Department to operate a facility providing training and education to individuals involving the cultivation, growing, harvesting, curing, preparing, packaging, or testing of medical marijuana, or the production, manufacture, extraction, processing, packaging, or creation of medical-marijuana-infused products or medical marijuana products for the limited education and research purposes permitted under state and federal law and these Rules; to transfer, by sale or donation, medical marijuana grown within its operation to licensed research licensees; and to transfer to licensed testing laboratories.

"Entity" means an individual, sole proprietorship, a general partnership, a limited partnership, a limited liability company, a trust, an estate, an association, a corporation, or any other legal or commercial entity.

"Entrance to a private or public school" means an opening, such as a door, passage, or gate, that allows access to any public or private schools, including school buildings, facilities, or other indoor and outdoor properties utilized for classes or school activities.

"Error in measurement" means a mistake made by the Department or a municipality in the setback measurement process where either the distance between a medical marijuana dispensary and a school is miscalculated due to mathematical error or the method used to measure the setback distance is inconsistent with 63 O.S. § 425(G).

"Error in measurement allowance" means an allowance of an error in measurement of the distance between a medical marijuana dispensary and a school up to and including five hundred (500) feet when remeasured after an original license has been issued.

"Flower" means the reproductive organs of the marijuana or cannabis plant referred to as the bud or parts of the plant that are harvested and used to consume in a variety of medical marijuana products.

"Flowering" means the reproductive state of the marijuana or cannabis plant in which there are physical signs of flower or budding out of the nodes of the stem.

"Food" has the same meaning as set forth in 63 O.S. § 1-1101 (('food' means (1) articles used for food or drink for man, (2) chewing gum, and (3) articles used for components of any such article) and set forth in the Oklahoma Administrative Code ("OAC") OAC 310:257-1-2 and OAC 310:260-1-6 ("'food' means any raw, cooked, or processed edible substance, ice, beverage or ingredient used or intended for use or for sale in whole or in part for human consumption").

"Grower" or "Commercial grower" means an individual or entity that has been issued a medical marijuana business license by the Department, which allows the grower to grow, harvest, dry, cure, package, sell, transfer, and transport or contract with a commercial transporter for the transport of medical marijuana in accordance with Oklahoma law and this Chapter to a dispensary, processor, grower, research facility, education facility, or testing laboratory.

"Harvest Batch" means a specifically identified quantity of usable medical marijuana, no greater than ten (10) pounds, that is uniform in strain, cultivated utilizing the same cultivation practices, harvested at the same time from the same location, and dried or cured under uniform conditions.

"Immature plant" means a nonflowering marijuana plant that has not demonstrated signs of flowering.

"Indirect beneficial owner" means an individual or entity who indirectly, through any contract, arrangement, understanding, relationship or otherwise, owns ten percent (10%) or more of the equity interests of a grower, processor, or dispensary.

"Information panel" has the same definition as set forth in 21 CFR § 101.2 and means "that part of the label immediately contiguous and to the right of the principal display panel as observed by an individual facing the principal display panel."

"Integration" or "Integrated" means a third-party vendor's software application or software service that has been fully validated to share inventory tracking or other data directly with the State inventory tracking system via a secure Application Programming Interface ("API").

"Inventory tracking system" or "State inventory tracking system" means the required tracking system established by the Department that accounts for medical marijuana from either the seed or immature plant stage until the medical marijuana or medical marijuana product is sold to a patient at a medical marijuana dispensary, transferred to a medical marijuana research facility, disposed of in accordance with these rules or used in a research project by a medical marijuana research facility.

"Label" carries the same definition as set forth in 63 O.S. § 1-1101 and means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this article that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if there be any, of the retail package of such article, or is easily legible through the outside container or wrapper.

"License" means a state issued license or other state issued documentation proving the holder of such license is a member of a state-regulated medical marijuana program.

"License number" means the unique multi-character identifier issued and printed upon each license.

"Licensee" means any natural born person or entity that holds a medical marijuana license provided for in this Chapter, excluding inmates of any local, county, state, or federal correctional facility or jail.

"Licensed Packager" means as used in 63 O.S. § 422(C) a processor.

"Licensed premises" means the premises specified in an application for a medical marijuana business, research facility, education facility, or waste disposal facility that is owned or in lawful possession of the licensee and within which the licensee is authorized to operate.

"Lot" means the food produced during a period of time indicated by a specific code.

"Marijuana" means the same as the term that is defined in 63 O.S. § 2-101 and shall not include any plant or material containing delta-8 or delta-10 tetrahydrocannabinol which is grown, processed or sold pursuant to the provisions of the Oklahoma Industrial Hemp Program.

"Mature plant" means harvestable female marijuana plant that is flowering.

"Medicaid" means the program that is also commonly known in Oklahoma as "SoonerCare."

"Medical marijuana" means marijuana that is grown, processed, dispensed, tested, possessed, or used for a medical purpose.

"Medical marijuana business" means an individual or entity licensed by the Department as a medical marijuana dispensary, grower, processor, testing laboratory, or transporter.

"Medical marijuana concentrate" ("Concentrate") means a substance obtained by separating cannabinoids from any part of the marijuana plant by physical or chemical means, so as to deliver a product with a cannabinoid concentration greater than the raw plant material from which it is derived. Categories of concentrate include water-based medical marijuana concentrate, food-based medical marijuana concentrate, solvent-based concentrate, and heat- or pressure-based medical marijuana concentrate as those terms are defined in the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq.

"Medical marijuana product" means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

"Medical marijuana research" means research on medical marijuana and medical marijuana products for public purposes, including the advancement of (A) Public health policy and public safety policy, (B) Agronomic and horticultural best practices, and (C) Medical and pharmacopoeia best practices. For purposes of this Chapter, this term does not include biomedical and clinical research that is subject to federal regulations and institutional oversight and shall not be subject to Department oversight.

"Medical marijuana waste" means

(A) unused, surplus, returned or out-of-date marijuana; recalled marijuana; unused marijuana; plant debris of the plant of the genus cannabis, including dead plants and all unused plant parts, except the term shall not include seeds , roots, stems, stalks and fan leaves,

(B) all product which is deemed to fail laboratory testing and cannot be remediated or decontaminated, or

(C) all product and inventory from commercial licensees that:

(i) have gone out of business,

(ii) are not subject to the provisions of Section 1560 of Title 12 of the Oklahoma Statutes, and

(iii) are unable to lawfully transfer or sell the product and inventory to another commercial licensee.

"Minor" means any natural person younger than eighteen (18) years of age.

"Mother plant" means a marijuana plant that is grown or maintained for the purpose of generating clones, and that will not be used to produce plant material for sale to a processor or dispensary.

"Municipality" means the same definition as set forth in the Oklahoma Municipal Code, 11 O.S. § 1-102, and "means any incorporatedcity or town."

"Nonoperational" means a commercial licensee that cannot provide proof that it is actively operating or working towards operational status.

"Officer of a corporate entity" or "Principal officer" means an officer identified in the corporate bylaws, articles of organization or other organizational documents, or in a resolution of the governing body.

"Officer of a municipality" means the same definition as set forth in the Oklahoma Municipal Code, 11 O.S. § 1-102, and means any person who is elected to an office in municipal government or is appointed to fill an unexpired term of an elected office, and the clerk and the treasurer whether elected or appointed.

"Oklahoma resident" or "Resident" means an individual who can provide proof of residency as required by OAC 310:681-1-6 (relating to proof of residency) or OAC 310:681-5-3.1 (relating to proof of residency for commercial business licensees).

"Oklahoma uniform symbol" or "Universal symbol" means the image, established by the Department and made available to commercial licensees through the OMMA website, which indicates the package contains medical marijuana or medical marijuana products with THC and must be printed at least one-half inch in size by one-half inch in size in the color designated by the Department.

"Openly in existence" means any building, location, or structure on a school site that has visible outward markings indicating the building, location or structure was operating as a school which would serve as sufficient notice of the existence of the school or a reason for further inquiry on the part of the medical marijuana dispensary license applicant. "Openly in existence" shall not mean any school that operated secretly or discreetly without any signs or other markings on any building, location, or structure on the school site, undeveloped land or a structure owned by a school that was not openly used and marked as a school site, or any school site that was established after the medical marijuana dispensary had been established and licensed by the Department.

"Organic" means the same as the term defined in the National Organic Program codified at 7 CFR § 205.2. This includes the terms "organically produced" as set forth in 7 U.S.C. § 6502(15) and "100 percent organic" and "made with organic (specified ingredients or food group(s))" as set forth in 7 CFR § 205.102.

"Out-of-state medical marijuana patient license" means an unexpired medical marijuana patient license issued by another U.S. state, which is the substantial equivalent of the Oklahoma medical marijuana patient license issued pursuant to OAC 310:681-2-1 and OAC 310:681-2-2.

"Owner" means, except where the context otherwise requires, a direct beneficial owner, including, but not limited to, all persons or entities as follows:

(A) All shareholders owning an interest of a corporate entity and all officers of a corporate entity;

(B) All partners of a general partnership;

(C) All general partners and all limited partners that own an interest in a limited partnership;

(D) All members that own an interest in a limited liability company;

(E) All beneficiaries that hold a beneficial interest in a trust and all trustees of a trust;

(F) All persons or entities that own interest in a joint venture;

(G) All persons or entities that own an interest in an association;

(H) The owners of any other type of legal entity; and

(I) Any other person holding an interest or convertible note in any entity which owns, operates, or manages a licensed medical marijuana facility.

"Package" or "Packaging" means any container or wrapper that a medical marijuana business may use for enclosing or containing medical marijuana or medical marijuana products, except that "package" or "packaging" shall not include any carry-out bag or other similar container.

"Patient" or "Licensed patient" means a person that has been properly issued a medical marijuana license pursuant to Oklahoma law and these Rules.

"Pesticide" means

(A) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or

(B) any substance or mixture of substances intended for use as a plant regulator, defoliant or desiccant. "Pesticide" shall not include any article that is a "new animal drug" as designated by the United States Food and Drug Administration.

"Physician" or "Oklahoma Physician" means a doctor of medicine, a doctor of osteopathic medicine, or a doctor of podiatric medicine who holds a valid, unrestricted and existing license to practice in the State of Oklahoma.

"Plant material" means the leaves, stems, buds, and flowers of the marijuana plant, and does not include seedlings, seeds, clones, stalks, or roots of the plant or the weight of any non-marijuana ingredients combined with marijuana.

"Political subdivision" means any county or municipal governments.

"Preschool" means a public early childhood education program offered under 70 O.S. §§ 11-103.7 and 1-114 (B) or similar program offered by a private school whose primary purpose is to offer educational (or academic) instruction. Preschool does not include a homeschool, daycare, or child care facility licensed under the Oklahoma Child Care Facilities Licensing Act, 10 O.S. § 401 et seq.

"Principal display panel" has the same definition as set forth in 21 CFR § 101.1 and "means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale."

"Private school" means a preschool, elementary, middle, or high school maintained by private individuals, religious organizations, or corporations, funded, at least in part, by fees or tuition, and open only to pupils selected and admitted based on religious affiliations or other particular qualifications. "Private school" shall not include a homeschool, daycare, or child care facility licensed under the Oklahoma Child Care Facilities Licensing Act, 10 O.S. § 401 et seq.

"Process" means to distill, extract, manufacture, prepare, or otherwise produce a medical marijuana product.

"Processor" or "Commercial Processor" means an individual or entity that has been issued a medical marijuana business license by the Department, which allows the processor to: purchase medical marijuana or medical marijuana products from a grower or processor; process, package, sell, transfer, and transport or contract with a commercial transporter to transport medical marijuana and medical marijuana products that they processed to a licensed dispensary, processor, or testing laboratory in accordance with Oklahoma law and this Chapter; and process medical marijuana received from a licensed patient into a medical marijuana concentrate, for a fee.

"Production batch" means

(A) Any amount of medical marijuana concentrate, not to exceed ten (10) pounds, of the same category and produced using the same extraction methods, standard operating procedures, and an identical group of harvest batch of medical marijuana; and

(B) Any amount of finished medical marijuana product, not to exceed ten (10) pounds, of the same exact type, produced using the same ingredients, standard operating procedures, and same production batch of medical marijuana concentrate or same harvest batch of medical marijuana.

"Public institution" means any entity established or controlled by the federal government, state government, or a local government or municipality, including, but not limited, institutions of higher education and related research institutions.

"Public money" means any funds or money obtained from any governmental entity, including, but not limited to, research grants.

"Public school" means a preschool, elementary, middle, or high school established under state law, regulated by the local state authorities in the various political subdivisions, funded and maintained by public taxation, and open and free to all children of the particular district where the school is located.

"Publicly traded company" means a business entity organized under the laws of the United States or Canada where the domicile for the business entity permits the sale of marijuana and such business entity has a class of securities that are registered and traded for investment pursuant to the Securities Exchange Act of 1934 or listed and traded for investment on a reputable recognized foreign stock exchange or foreign market.

"Quality assurance laboratory" means a laboratory designated by the Department to conduct surveillance of testing laboratories for compliance purposes.

"Readily accessible" means that a licensee can immediately produce the documentation upon the Department's request.

"Registered to conduct business" means any individual or entity that is required under Oklahoma law to register with the Oklahoma Secretary of State and/or the Oklahoma Tax Commission and has provided sufficient proof to the Department of its good standing with such.

"Remediation" means the process by which the medical marijuana flower or trim, which has failed microbial testing, is processed into solvent-based medical marijuana concentrate and tested in accordance with these Rules.

"Research project" means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

"Research facility" means an individual or entity that has been issued a license by the Department to grow, cultivate, possess, and transfer to testing laboratories, and to transfer by sale or donation to other licensed research facilities, medical marijuana for the limited research purposes permitted under state and federal law and these Rules.

"Retailer" or "Retail marijuana establishment" as used in 63 O.S. § 420 et seq. means an entity licensed by the State Department of Health as a medical marijuana dispensary.

"Revocation" means the Department's final decision in accordance with the Oklahoma Administrative Procedures Act, 75 O.S. § 250 et seq., that any license issued by the Department pursuant to Oklahoma law and this Chapter is rescinded.

"RFID" means Radio Frequency Identification.

"Rules" means, unless otherwise indicated, the rules as adopted and set forth in OAC 310:681.

"Sampler" means a person who is employed by or is an owner of a licensed laboratory, grower, or processor and is authorized by that employer to collect samples in accordance with the testing laboratory's standard operating procedures and these Rules.

"Seedling" means a marijuana plant that has no flowers.

"Seed-to-sale tracking system" means an electronic inventory tracking system utilized by a commercial licensee to track inventory, any steps through the process of cultivating or manufacturing medical marijuana and/or medical marijuana products, transactions with other licensees, testing, and other required information for the purpose of reporting that information to the Department in accordance with Oklahoma law, rules, and regulations.

"Shipping container" means a hard-sided container with a lid or other enclosure that can be secured into place. A shipping container is used solely for the transport of medical marijuana, medical marijuana concentrate, or medical marijuana products between medical marijuana businesses, a medical marijuana research facility, or a medical marijuana education facility.

"State question" means Oklahoma State Question No. 788 and Initiative Petition Number 412.

"Strain" means the classification of marijuana or cannabis plants in either pure sativa, indica, afghanica, ruderalis, or hybrid varieties.

"Terpenoids" means isoprenes that are the aromatic compounds found in cannabis, including, but not limited to: limonene, myrcene, pinene, linalool, eucalyptol, [DELTA]-terpinene, [BETA]-caryophyllene, caryophyllene oxide, nerolidol and phytol.

"Testing laboratory" or "Laboratory" means a public or private laboratory licensed pursuant to state law and these Rules to conduct testing and research on medical marijuana and medical marijuana products.

"THC" means tetrahydrocannabinol, which is the primary psychotropic cannabinoid formed by decarboxylation of naturally testrahydrocannabinolic acid, which generally occurs by exposure to heat.

"Transporter" or "Commercial Transporter" means an individual or entity issued a medical marijuana commercial license by the Department, which allows the transporter to transport, store, and distribute medical marijuana and medical marijuana products to and from the licensed premises of commercial licensee. As used in this Chapter, "Transporter" or "Commercial Transporter" does not mean licensed commercial growers, processors, and dispensaries who are automatic holders of transporter licenses.

"Transporter Agent" means an agent, employee, officer, or owner of commercial transporter, grower, processor, or dispensary who has been issued a transporter agent license by the Department to transport medical marijuana and medical marijuana products on behalf of the said commercial transporter, grower, processor, or dispensary.

"Transporter license" means a medical marijuana business license issued by the Department either (A) automatically to commercial growers, processors, and dispensaries upon approval of a business license, or (B) to commercial transporters solely for the transportation, storage, and distribution of medical marijuana and medical marijuana products.

"Usable medical marijuana" means the dried leaves, flowers, oils, vapors, waxes, and other portions of the marijuana plant and any mixture or preparation thereof, excluding seed, roots, stems, stalks, and fan leaves.

"Waste disposal facility" means an individual or entity that has been issued a medical marijuana waste disposal facility license by the Department to dispose of medical marijuana waste as authorized in Oklahoma law and these Rules.

"Waste disposal facility license" means a license issued by the Department to possess, transport, and dispose of medical marijuana waste. The waste disposal facility license shall be issued to the location submitted by the applicant that is first approved by the Department.

"Waste disposal facility permit" means a permit issued by the Department to a waste disposal licensee to possess, transport, and dispose of medical marijuana waste at the location submitted on the permit application. Waste disposal facility permits shall be required for each approved facility operated by a waste disposal facility licensee.

"Wholesale package" means medical marijuana from the same harvest batch or multiple units of medical marijuana product from the same production batch that are combined together as a single unit for the purpose of RFID tagging and are transported to a single commercial licensee.

"Working towards operational status" means a commercial licensee that:

(A) Has applied for any additional permits, registrations, or licenses required by the Department or another Oklahoma agency, organization, or political subdivision to lawfully conduct operations at the licensed premises and is awaiting issuance of such permit(s), registration(s), or other license(s);

(B) Is performing construction or other material changes to the licensed premises in preparation of operations at the licensed premises;

(C) Is onboarding or training initial staff in preparation of operations at the licensed premises;

(D) Is in the process of purchasing or is awaiting receipt or delivery of physical materials essential to operations at the licensed premises, such as furniture or equipment; or

(E) Any additional actions determined to be sufficient by the Department.

Notes

Okla. Admin. Code § 310:681-1-4
Amended by Oklahoma Register, Volume 38, Issue 06, December 1, 2020, eff. 10/15/2020 Amended by Oklahoma Register, Volume 38, Issue 23, August 16, 2021, eff. 6/28/2021 Amended by Oklahoma Register, Volume 39, Issue 04, November 1, 2021, eff. 9/16/2021

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