Medical Cannabis Program

ADMINISTRATIVE RULES TITLE 15—MISSISSIPPI STATE DEPARTMENT OF HEALTH PART 22—MEDICAL CANNABIS PROGRAM Subparts 1-11

Table of Contents Subpart 1

General Provisions

Subpart 2

Practitioners, Certifications, Patients Cards & Caregivers

Subpart 3

Licensing, Background Checks, & Work Permits

Subpart 4

Operational & Recordkeeping Requirements

Subpart 5

Product Testing & Safety

Subpart 6

Packaging & Labeling

Subpart 7

Transportation

Subpart 8

Waste Disposal

Subpart 9

Advertising & Marketing

Subpart 10

Variance Requests

Subpart 11

Enforcement & Penalties

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Subpart 1

GENERAL PROVISIONS

1.1

Legal Authority.

1.1.1

This regulation has been promulgated under the authority of and pursuant to Miss. Code Ann. §§ 41-137-1 – 41-137-67.

1.2

Definitions. The following terms shall have the meanings indicated for purposes of the Mississippi State Department of Health’s Mississippi Medical Cannabis Program rules and regulations.

1.2.1

Accreditation – The term “accreditation” means being currently deemed as technically competent under ISO/IEC 17025:2017 by an international mutual recognition arrangement signatory that has been found to meet ISO/IEC 17011, Conformity Assessment-Requirements for accreditation bodies accrediting conformity assessment bodies.

1.2.2

Accreditation Body – The term “accreditation body” means an impartial nonprofit organization that operates in conformance with the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) standard 17011 and is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) for Testing.

1.2.3

Acquire – The term “acquire” means coming to possess cannabis by means of any legal source in compliance with the Mississippi Medical Cannabis Act (the Act) and any rules promulgated under the Act.

1.2.4

Additive – The term “additive” means any non-cannabis derived substance added to regulated cannabis and/or cannabis products to achieve a specific technical and/or functional purpose during processing, storage, or packaging. Additives may be direct or indirect. Direct additives are used to impart specific technological or functional qualities. Indirect additives are not intentionally added but may be present in trace amounts as a result of processing, packaging, shipping, or storage. Botanically Derived Compounds which have been isolated or enriched and subsequently added back into cannabis products are additives.

1.2.5

Advertising – The terms “advertising” and “advertisement” shall mean all representations disseminated in any manner or by any means, other than labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of medical cannabis. Advertising does not include labeling as required by the regulations of the Medical Cannabis Program.

1.2.6

Affiliate – The term “affiliate” means any entity effectively controlling or controlled by another entity or associated with other entities under common ownership or control, including a parent or subsidiary. 3

1.2.7

Agent – The term “agent” means a person who acts for or on behalf of or represents another (e.g., employee, representative).

1.2.8

Allergen – The term “allergen” means a major food allergen as defined in 21 U.S.C § 321(qq).

1.2.9

Allowable Amount of Medical Cannabis – The term “allowable amount of medical cannabis” means an amount not to exceed the maximum amount of Mississippi Medical Cannabis Equivalency Units (“MMCEU”).

1.2.10

Analytical Batch – The term “analytical batch” means a set of no more than twenty (20) samples that are prepared together for the same type of analysis, are sequentially analyzed using the same instrument calibration curve, and have common analytical quality control requirements. The batch shall include testing samples as well as all applicable quality control samples.

1.2.11

Applicant – Ther term “applicant” means a person who registers/applies for an initial work permit or renewal of a work permit who must complete a fingerprintbased background check of the Mississippi Central Criminal Database and the Federal Bureau of Investigation Criminal History Database and must not have a disqualifying felony offense. Once such an applicant passes the criminal background check, the applicant may then work for, or maintain ownership in, a medical cannabis establishment licensed and registered by the Department or MDOR as applicable. For the purpose of these regulations, the term “applicant” may also be defined as a practitioner, patient, or caregiver, who do not require criminal-based background checks.

1.2.12

Batch – The term “batch” means, with regard to usable medical cannabis, a homogenous, identified quantity of usable medical cannabis, no greater than twenty-five pounds (25 lbs), that is harvested during a specified time period from a specified cultivation area, and with regard to oils, vapors and waxes derived from usable medical cannabis, means an identified quantity that is uniform, that is intended to meet specifications for identity, strength, and composition, and that is )d, packaged and labeled during a specified time period according to a single manufacturing, packaging and labeling protocol.

1.2.13

Batch Number – The term “batch number” means a unique numeric or alphanumeric identifier assigned to a batch by a cultivation or processing entity. The batch number for plant batches shall contain the strain name and date created. The batch number for harvest batches shall contain the strain name and date harvested. The batch number for production batches shall contain the item name and date produced. In the event that multiple batches of the same product or item

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are created on the same date, a unique suffix shall be added such as a numeric or alphabetical character. (e.g., 1, 2, 3, a, b, c, etc.). 1.2.14

Biosecurity Measures – The term “biosecurity measures” means a set of preventative measures designed to reduce the risk of transmission of infectious diseases in crops, quarantined pests, invasive alien species, and living modified organisms that could impact the safety of cannabis and cannabis products.

1.2.15

Board Member – The term “board member” means an individual serving as a representative on the governing body of a medical cannabis establishment.

1.2.16

Botanically-Derived Compounds – The term “botanically-derived compounds” means organic chemicals that typically have a high vapor pressure at room temperature and are likely to be dispersed into the air. Botanically Derived Compounds include, but are not limited to terpenes, terpenoids, ketones, esters, and other molecules which are naturally occurring in plants and are used to affect the flavor and aroma of cannabis products. Synthetic cannabinoids are not botanically derived compounds and are prohibited.

1.2.17

Brand – The term “brand” shall mean a name, term, design or symbol or any other feature that identifies one seller’s goods or services as distinct from those of other sellers. For purposes of these regulations, a company logo is considered a brand.

1.2.18

Branding – The term “branding” shall mean the process of giving a meaning to a specific medical cannabis establishment’s business by publicizing the business’s name and logo.

1.2.19

Cannabinoid Extract – The term “cannabinoid extract” means a substance obtained by separating cannabinoids from cannabis by any of the following methods: A. A chemical extraction process using a hydrocarbon-based solvent; or B. A chemical extraction process using the hydrocarbon-based solvent carbon dioxide if the process uses high heat or pressure.

1.2.20

Cannabis – The term “cannabis” means all parts of the plant of the genus cannabis, the flower, the seeds thereof, the resin extracted from any part of the plant and every compound, manufacture, salt, derivative, mixture or preparation of the plant, its seeds or its resin, including whole plant extracts. Such term shall not mean 1) industrial hemp as defined in this Part per Miss. Code § 41-13725(22) nor 2) cannabis-derived products approved by the federal Food and Drug Administration under Section 505 of the Federal Food, Drug, and Cosmetic Act.

1.2.21

Cannabis Container – The term “cannabis container” means an individual locked and secure container in which an originating medical cannabis

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establishment places cannabis and/or cannabis products for transport to a receiving medical cannabis establishment. 1.2.22

Cannabis Cultivation Entity – The term “cannabis cultivation entity” means a business entity licensed and registered by the Mississippi Department of Health that acquires, grows, cultivates, and harvests medical cannabis in an indoor, enclosed, locked, and secure area. The terms “cannabis cultivator”, “cultivator”, or “micro-cultivator” also have the same meaning.

1.2.23

Cannabis Disposal Entity – The term “cannabis disposal entity” means a business licensed and registered by the Mississippi Department of Health that is involved in the commercial disposal or destruction of medical cannabis. These entities may also be known as “waste disposal entities”.

1.2.24

Cannabis Facility – The term “cannabis facility” or “facility” means a permanent structure in a fixed location where a medical cannabis establishment operates or conducts commercial cannabis activities.

1.2.25

Cannabis Processing Entity – The term “cannabis processing entity” means a business entity that is licensed and registered by the Mississippi Department of Health that: acquires or intends to acquire cannabis from a cannabis cultivation entity or other cannabis processing entity; possesses cannabis with the intent to manufacture a cannabis product; manufactures or intends to manufacture a cannabis product from unprocessed cannabis or a cannabis extract; and sells or intends to sell a cannabis product to a medical cannabis dispensary licensed by MDOR or cannabis research entity licensed by the Department. These entities may also be known as “processing entities”, “processors”, or “cannabis processors”.

1.2.26

Cannabis Products – The term “cannabis products” means concentrated cannabis, cannabis extracts, and products that are infused with cannabis or an extract thereof and are intended for use or consumption by humans. The term includes, without limitation, edible cannabis products, beverages, topical products, ointments, oils, tinctures and suppositories that contain tetrahydrocannabinol (THC) and/or cannabidiol (CBD) except those products excluded from control under Miss. Code §§ 41-25-113 and 41-25-136. The term medical cannabis products may also be used with the same meaning.

1.2.27

Cannabis Research Entity – The term “cannabis research entity” or “research entity” means a research entity at any university or college in this state or an independent entity licensed and registered by the Mississippi Department of Health pursuant to this chapter that acquires cannabis from cannabis cultivation entities and cannabis processing entities in order to research cannabis, develop

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best practices for specific medical conditions, develop medicines and provide commercial access for medical use. 1.2.28

Cannabis Testing Entity – The term “cannabis testing entity” or “testing entity” means an independent entity licensed and registered by the Mississippi Department of Health that analyzes the safety and potency of cannabis.

1.2.29

Cannabis Waste – The term “cannabis waste” means: A. Unused, surplus, returned or out-of-date cannabis; recalled cannabis; 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, and stalks; B. All product which is deemed to fail laboratory testing and cannot be remediated or decontaminated; C. All products and inventory from medical cannabis establishments that have gone out of business and/or are unable to legally transfer or sell cannabis and/or cannabis products and inventory to another medical cannabis establishment; or D. Products and inventory from medical cannabis establishments that may be destroyed and/or rendered unrecognizable and unusable through disposal as a result of Department corrective and/or administrative actions. E. All cannabis waste must be disposed of by a licensed disposal entity.

1.2.30

Canopy – The term “canopy” means the total surface area within a cultivation area that is dedicated to the cultivation of flowering cannabis plants. The surface area of the plant canopy shall be calculated in square feet. Measurement shall include all of the area within the boundaries where the cultivation of the flowering cannabis plant occurs. If the surface area of the canopy consists of noncontiguous areas, each component area shall be separated by identifiable boundaries. If a tiered or shelving system is used in the cultivation area, the surface of each tier or shelf shall be included in the calculation. Calculation of the area of the plant canopy should not include: A. The areas within the cultivation area that are used to cultivate immature cannabis plants and seedlings prior to flowering; and, B. The areas within the cultivation area that are used to support mature cannabis plants.

1.2.31

Commercial Cannabis Activity – The term “commercial cannabis activity” includes the cultivation, possession, manufacture, distribution, processing, storing, laboratory testing, packaging, labeling, transportation, delivery, or sale of

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cannabis or cannabis products as authorized by the Mississippi Medical Cannabis Act or this Part. 1.2.32

Cardholder – The term “cardholder” means a registered qualifying patient or a registered designated caregiver who has been issued and possesses a valid registration identification card by the Mississippi State Department of Health.

1.2.33

Certificate of Analysis – The term “certificate of analysis” means the report prepared for the party requesting testing and the Department about the analytical testing performed and results obtained by the cannabis testing facility. This term may be abbreviated as “COA”.

1.2.34

CFR – The abbreviation “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.

1.2.35

Child Resistant Packaging – The term “child-resistant packaging” 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 (1555) and 16 CFR § 1700.20 (1555) to the extent that such laws, rules, regulations do not conflict with the MS Medical Cannabis Act; and B. Resealable to maintain its child-resistant effectiveness for multiple openings by the patient for any product intended for more than a single use or containing multiple servings.

1.2.36

Church – The term “church” means a permanent building primarily and regularly used as a place of religious worship.

1.2.37

Clone – The term “clone” means a non-flowering plant cut from a mother plant that is capable of developing into a new plant but has shown no signs of flowering.

1.2.38

Concentrate – The term “concentrate” means a product derived from medical cannabis that is kief, hashish, bubble hash, oil, wax, or other product, produced by extracting cannabinoids from the plant through the use of: A. A mechanical extraction process; B. A chemical extraction process using a nonhydrocarbon-based or other solvent, such as water, vegetable glycerin, vegetable oils, animal fats, food-grade ethanol or steam distillation; or C. A chemical extraction process using carbon dioxide, provided that the process 8

does not involve the use of high heat or pressure. 1.2.39

Compliance Test Sample - The term “compliance test sample” includes a package derived from a harvest batch package or production batch intended for compliance testing by a licensed cannabis testing entity.

1.2.40

Contaminant – The term “contaminant” means an unacceptable level of an unwanted or objectionable substance, toxin, pollution or foreign material that causes impurity in a product. Contaminants include, but are not limited to, pesticides, microbiology, filth, heavy metals and residual chemical solvents.

1.2.41

Daycare – The term “daycare” means a child-care facility, as defined by Miss. Code § 43-20-5.

1.2.42

Demonstration of Capability – The term “demonstration of capability” means an examination, provided by a medical cannabis testing laboratory, undertaken by an analyst to determine whether he or she is able to correctly, accurately, and repeatedly perform a specific analysis or analyze a specific measurement.

1.2.43

Department – The term “Department” means the Mississippi State Department of Health.

1.2.44

Designated Caregiver – The term “designated caregiver” means a person, at least 21 years of age, who has agreed to assist no more than five (5) registered qualifying patients with their medical use of medical cannabis. A designated caregiver may also be referred to as a “caregiver”.

1.2.45

Designated Caregiver Entity – The term “designated caregiver entity” means a health care facility or facility providing residential care services or day services that has agreed to accommodate registered qualifying patients with their medical use of medical cannabis. A designated caregiver entity may also be referred to as a “caregiver entity”.

1.2.46

Dispense – The term “dispense” means the retail selling of medical cannabis or medical cannabis 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 the licensed patient is a minor, or a licensed caregiver.

1.2.47

Dispose – The term “dispose” or “disposal” means the final disposition of medical cannabis waste by either a process which renders the waste unusable and unrecognizable through physical destruction or a recycling process.

1.2.48

Disqualifying Felony Offense – The term “disqualifying felony offense” means: A. A conviction for a crime of violence, as defined in Section 97-3-2 Mississippi Code of 1972, as amended, or

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B. A conviction for a crime that was defined as a violent crime in the law of the jurisdiction in which the offense was committed, and that was classified as a felony in the jurisdiction where the person was convicted; or C. A conviction for a violation of a state or federal controlled substances law that was classified as a felony in the jurisdiction where the person was convicted, including the service of any term of probation, incarceration or supervised release within the previous five (5) years and the offender has not committed another similar offense since the conviction A disqualifying felony offense shall not include a conviction that consisted of conduct for which the Mississippi Medical Cannabis Act would likely have prevented the conviction but for the fact that the conduct occurred before the effective date of the Medical Cannabis Act. 1.2.49

D.O. – The term “D.O.” means a Doctor of Osteopathy. Also includes DO as an abbreviation.

1.2.50

Economic Interest – The term “economic interest” means holding an ownership interest as a sole proprietor, partner, member, limited partner, member holding at least a ten percent (10%) equity or similar interest, stockholder owning at least ten percent (10% )of available stock, or as any other type of interest that entitles the individual or entity to regular payments for amounts based on a percentage of revenue derived from the licensed medical cannabis establishment’s business operations as defined by the Mississippi Medical Cannabis Act.

1.2.51

Edible Cannabis Products – The term “edible cannabis products” means products that: A. Contain or are infused with cannabis or an extract thereof; B. Are intended for human consumption by oral ingestion; and, C. Are presented in the form of foodstuffs, beverages, extracts, oils, tinctures, lozenges and other similar products.

1.2.52

Enclosed – The term “enclosed” means surrounded by roof and walls permanently in place.

1.2.53

Final Form – The term “final form” means cannabis or cannabis product(s) that is in the form in which the cannabis or cannabis product will be consumed or used.

1.2.54

Flowering – The term “flowering” means the reproductive state of cannabis in which the plant is in a light cycle intended to stimulate the production of flowers, trichomes, and cannabinoid characteristics of cannabis. There are physical signs of flower or budding out of the nodes of the stem.

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1.2.55

1.2.56

Harvest Batch – The term “harvest batch” means a specifically identified quantity of cannabis that is uniform in strain, cultivated using the same practices, harvested at the same time at the same location and cured under the same conditions. There may be multiple harvest batches for the same strain on the same date. Harvest Batch Package – The term “harvest batch package” means a package derived from a harvest batch that is restricted by volume to twenty-five pounds (25 lbs) or less of cannabis for testing purposes. If a finished harvest batch (bud/flower, shake/trim) is larger than twenty-five pounds (25 lbs), the harvest batch shall be separated into harvest batch packages for purposes of compliance testing. Harvest batch packages sent only to processors for extraction are not required by the Department to be tested prior to processing, unless the cannabis processing facility requests that of the cannabis cultivation entity supplying the batch.

1.2.57

Homogeneity – The term “homogeneity” means the amount of cannabinoids within a cannabis product being consistent and reasonably equally dispersed throughout the cannabis product, including each portion of the cannabis product.

1.2.58

Homogenization – The term “homogenization” means the process by which the unit increments of a test sample are combined by grinding or mixing prior to testing to obtain uniformity of all components or ingredients.

1.2.59

Identification Badge – The term “identification badge” means a physical badge issued by a licensed medical cannabis establishment to each employee, volunteer, and visitor who has access to the licensee’s premises, for purposes of verifying each such person’s identity and status.

1.2.60

Immature Cannabis Plants – The term “immature cannabis plants” means seedlings or nonflowering cannabis plants. There are no demonstrated signs of flowering.

1.2.61

Inclusivity – The term “inclusivity” means, related to microbiological method validation, the sensitivity of the test method. It evaluates the ability of the test method to detect a wide range of target organisms by a defined relatedness.

1.2.62

Indoor Cannabis Cultivation – The term “indoor cannabis cultivation” means production of plants in a completely enclosed and secure facility with a sealed, controlled environment that prevents unfiltered air exchange with the outdoors, provides control of environmental conditions such as humidity, temperature, light, and carbon dioxide levels.

1.2.63

Industrial Hemp – The term “industrial hemp” means a plant of the genus Cannabis and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration of no more than three-tenths of one 11

percent (0.3%) on a dry weight basis as set forth in the 2018 Farm Bill, Public Law No. 115-334. 1.2.64

Infused Pre-Roll – The term “infused pre-roll” means a medical cannabis product produced by rolling, filling, or stuffing harvested medical cannabis flower, shake, and/or trim with regulated cannabis concentrate(s) into paper, leaves, or an equivalent wrapper and is intended for consumption by inhalation.

1.2.65

Infused Cannabis Product – The term “infused cannabis product” means a cannabis product that includes one or more concentrate(s) along with other materials or ingredients, and includes without limitation, any oil, wax, ointment, salve, tincture, capsule, suppository, dermal patch, cartridge or other product containing a medical cannabis concentrate or usable cannabis that has been processed so that the dried leaves and flowers are integrated into other material.

1.2.66

Infusion – The term “infusion” means a process by which cannabis concentrates are directly incorporated into a product formulation to produce a cannabis product.

1.2.67

Ingredient – The term “ingredient” means any non-cannabis derived substance that is added to cannabis products to achieve a desired effect. The term includes all additives as defined in this Part.

1.2.68

Inhalable Compound Concentrate Product – The term “inhalable compound concentrate product” means a cannabis product created by combining one or more cannabis products with cannabis (i.e., cannabis flower, kief) into a final form that is intended for inhalation.

1.2.69

Initial Display of Competency – The term “initial display of competency” means an examination, provided by a cannabis testing laboratory, undertaken by an analyst to determine whether he or she is able to correctly, accurately, and repeatedly perform a specific analysis or analyze a specific measurement.

1.2.70

Kief – The term “kief” means the resinous, crystal-like trichomes that have been physically separated from the cannabis plant that results in a higher concentration of cannabinoids.

1.2.71

Label – The term “label” means display of written, printed or graphic matter on the immediate container of any product containing cannabis.

1.2.72

Laboratory Control Sample (LCS) – The term “laboratory control sample (LCS)” means a blank matrix to which known concentrations of each of the target method analytes are added. The spiked concentration shall be within the calibration range of the method. The LCS shall be carried through the entire sample preparation process and shall be analyzed in the same manner as a representative sample. The LCS shall be made from a standard that is not from the

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same vendor, or from the same lot if only one vendor is available, that is used for the calibration curve. 1.2.73

Laboratory Replicate Sample – The term “laboratory replicate sample” means a sub-sample taken of the representative sample used for laboratory quality control purposes to demonstrate reproducibility. It is prepared and analyzed in the identical manner as the representative sample. The results from replicate analyses are used to evaluate analytical precision.

1.2.74

Limit of Detection (LOD) – The term “limit of detection (LOD)” means the lowest quantity of a substance or analyte that can be distinguished from the absence of that substance within a stated confidence limit.

1.2.75

Limit of Quantitation (LOQ) – The term “limit of quantitation (LOQ)” means the minimum concentration of an analyte in a specific matrix that can be reliably quantified while also meeting predefined goals for bias and imprecision. The LOQ can be no lower than the lowest calibration standard used in the analysis.

1.2.76

Linear Regression – The term “linear regression” means the determination, in analytical chemistry, of the best linear equation for calibration data to generate a calibration curve. The concentrate of an analyte in a sample can then be determined by comparing a measurement of the unknown to the calibration curve. A linear regression uses the following equation: y = mx + b; where m = slope, b = intercept.

1.2.77

Locked Storage Container – The term “locked storage container” means a secure storage/packing/loading container that may contain multiple individual cannabis containers for transport. A locked storage container is a fixed part of the vehicles used for transportation and is inaccessible to the driver during transport.

1.2.78

Manicure Batch – The term “manicure batch” means a specifically-identified quantity of cannabis harvested from plants that have not yet been cut down in a primary harvest batch.

1.2.79

Manufacture – The term “manufacture” means to compound, blend, extract, infuse or otherwise make or prepare cannabis products. The term “manufacture” includes the following processes: A. Extraction; B. Infusion; C. “Post-extraction processing” or “post-processing,” which means a process by which one or more active cannabinoids in cannabis concentrate are further concentrated either by chemical or physical means. The term “manufacture” does not include the following:

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A. The preparation of raw pre-rolls by a licensed cultivator B. The collection of the resinous trichomes that are dislodged or sifted from the cannabis plant incidental to cultivation activities by a licensed cultivator. The terms “manufacturing” or “process” may also be used with the same meaning. 1.2.80

Marketing – The term “marketing” shall mean the activity, set of institutions, and processes for creating, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large. The term also includes all representations disseminated in any manner or by any means, other than labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of medical cannabis.

1.2.81

Matrix – The term “matrix” means the substances that are present in a sample except for the analyte(s) of interest.

1.2.82

Matrix Spike Sample (MS) – The term “matrix spike sample (MS)” means a portion of an actual sample that is first spiked with a known quantity of target analytes, and then carried through the entire sample preparation and analysis process. The sample from which the portion to be spiked was taken shall be analyzed separately to determine endogenous background analyte concentrations. The MS is corrected for background concentrations and used to determine whether or not the sample matrix affects the sample results.

1.2.83

Matrix Spike Duplicate (MSD) – The term “matrix spike duplicate (MSD)” means the second portion of the actual sample used to prepare the MS that is spiked and processed in the same manner as the MS. The MS and MSD are used together to measure the precision of the methodology.

1.2.84

Mature Cannabis Plant – The term “mature cannabis plant” means a cannabis plant that is flowering.

1.2.85

M.D. – The term “M.D.” means a Doctor of Medicine. Also includes M.D. as an abbreviation.

1.2.86

MDOR – The term “MDOR” means the Mississippi Department of Revenue, the agency which has the responsibility of licensing and regulating cannabis dispensaries.

1.2.87

Media – The term “media” shall mean the communication channels through which we disseminate news, movies, education, promotional messages, and other data. It includes, but is not limited to, physical and online newspapers and magazines, television, radio, billboards, telephone, internet, fax, social media and billboards.

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1.2.88

Medical Cannabis – The term “medical cannabis” means cannabis and cannabis products that are intended to be used by registered qualifying patients as provided in the Act.

1.2.89

Medical Cannabis Establishment – The term “medical cannabis establishment” shall mean a cannabis cultivation entity, cannabis processing entity, cannabis testing entity, cannabis transportation entity, cannabis disposal entity, and/or cannabis research entity licensed and registered by the Department. Medical Cannabis Establishments may also be known as licensed entities, licensees, or establishments.

1.2.90

Medical Cannabis Establishment Representative – The term “medical cannabis establishment representative” means an owner holding a ten percent (10%) or greater economic interest in the establishment, director, officer, board member, manager, employee, volunteer or agent of a medical cannabis establishment. This term also includes independent contractors who perform services for a medical cannabis establishment if the establishment controls what will be done and how it will be done. Control can include, but isn’t limited to, instructions on how work is to be done, direction on equipment to use to perform work, and training on required policies and procedures of the licensed establishment. All medical cannabis establishment representatives must possess a work permit.

1.2.91

Medical Cannabis Dispensary – The term “medical cannabis dispensary” means an entity licensed and registered with the MS Department of Revenue that acquires, possesses, stores, transfers, sells, supplies, or dispenses medical cannabis, equipment used for medical cannabis, or related supplies and educational material to cardholders. The terms “dispensary” and “cannabis dispensary” also have the same meaning.

1.2.92

Medical Cannabis Transportation Entity – The term “medical cannabis transportation entity” or “cannabis transportation entity” means an entity licensed and registered with the Mississippi State Department of Health that acquires, possesses, stores, transfers, and transports cannabis and/or cannabis products to other medical cannabis establishments licensed by the Mississippi State Department of Health and/or Mississippi Department of Revenue. The term “transporter” may also be utilized to describe these entities.

1.2.93

Method Blank – The term “method blank” means an analyte-free matrix to which all reagents are added in the same volumes or proportions as used in the sample preparation and is processed in exactly the same manner as the samples.

1.2.94

Micro-cultivation Entity – The term “micro-cultivation entity” means an entity licensed and registered with the Mississippi State Department of Health that produces (e.g., acquires, grows, cultivates, and harvests) medical cannabis in an 15

indoor, enclosed, locked, and secure area. Micro-cultivation entities are owned by individuals who have been residents of the State Mississippi for three consecutive years prior to date of application to the Department and entities with equity ownership held by individuals who have been residents of the State of Mississippi for three (3) consecutive years prior to the date of application to the Department. 1.2.95

Micro-processing Entity – The term “micro-processing entity” means an entity licensed and registered with the Mississippi State Department of Health that acquires medical cannabis and manufactures cannabis products from unprocessed cannabis. Micro-processing entities are owned by individuals who have been residents of the State of Mississippi for three (3) consecutive years prior to date of application to the Department and entities with equity ownership held by individuals who have been residents of the State of Mississippi for three (3) consecutive years prior to the date of application to the Department.

1.2.96

Mississippi Medical Cannabis Act – The term “Mississippi Medical Cannabis Act” means Senate Bill 2095 passed during the 2022 Regular Session of the Mississippi Legislature and signed by the Governor and any reference to the codified section of the MS Code. The term “the Act” may also be utilized to reference the Mississippi Medical Cannabis Act.

1.2.97

MMCEU – The term “MMCEU” means Mississippi Medical Cannabis Equivalency Unit. One unit of MMCEU shall be considered equal to: A. Three and one-half (3.5) grams of medical cannabis flower; B. One (1) gram of medical cannabis concentrate; or, C. One hundred (100) milligrams of THC in an infused product.

1.2.98

Modification – The term “modification” means changes in structures, processes or activities at a cannabis cultivation facility that will alter the functions of cultivation structures, systems, and/or changes in the physical footprint of the cultivation facility.

1.2.99

Moisture Content – The term “moisture content” means the percentage of water in a sample, by weight.

1.2.100

Non-cannabis Waste -The term “non-cannabis waste” means the seeds, roots, stems, and stalks of a plant of the genus cannabis.

1.2.101

Owner – The term “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 with at least a 10% equity in a corporate entity;

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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 that owns, operates, or manages a medical cannabis establishment. 1.2.102

Package – The terms “package” or “packaging” means any container or wrapper that a medical cannabis establishment may use for enclosing or containing cannabis and/or cannabis products, except that “package” or “packaging” shall not include any carry-out bag or other similar container. Packaging is not considered processing.

1.2.103

Percent Recovery – The term “percent recovery” means the percentage of a measured concentration relative to the added (spiked) concentration in a reference material or matrix spike sample. A laboratory shall calculate the percent recovery by dividing the sample result by the expected result then multiplying the quotient by one hundred (100).

1.2.104

Permanent – The term “permanent” means a structure that is fixed in place.

1.2.105

Pesticide – The term “pesticide” means any substance or mixture of substances (organic or conventional) intended for preventing, destroying, repelling, or mitigating any pest, or 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.

1.2.106

Physical Plant – The term “physical plant” means the necessary infrastructure used in the operations and maintenance of a cannabis cultivation facility. In addition to the buildings and facilities in which commercial cannabis activities are confined, the physical plant also includes the mechanical systems (lighting, ventilation, plumbing, heating and cooling, etc.) necessary to support operations. The actual cannabis plant(s) are not included in this definition.

17

1.2.107

Plant Batch - The term “plant batch” is a batch of identical immature plants logged into the seed-to-sale system as a group on the date received as clones or planted, whichever is earliest, and prior to maturing to the vegetative phase of growth.

1.2.108

Plant Growth Regulator Cannabis – The term “plant growth regulator cannabis” shall mean a cannabis plant whose growth and structure has been modified using plant growth hormones. A cannabis processing facility shall not process and/or manufacture plant growth regulator cannabis.

1.2.109

Practitioner – The term “practitioner” means a physician (MD/DO), certified nurse practitioner, physician assistant or optometrist who is licensed to prescribe medicine under the licensing requirements of his/her respective occupational board and the laws of this state. In relation to a nonresident cardholder, the term means a physician (MD/DO), certified nurse practitioner, physician assistant or optometrist who is licensed to prescribe medicine under the requirements of his/her respective occupational board and under the laws of the state or territory in which the nonresident patient resides. For registered qualifying patients who are minors, “practitioner” shall mean a physician (MD/DO) who is licensed to prescribe medicine under the licensing requirements of his/her respective occupational board and the laws of this state. Principal Officer – The term “principal officer” means persons who have ultimate responsibility for implementing the decisions of the cannabis testing entity and, include but are not limited to, the Chief Executive Officer, Chief Administrative Officer, and Chief Financial Officer, as applicable. Production Batch – The term “production batch” means a specifically identifiable quantity of cannabis products (e.g., cannabinoid concentrate or extract, infused, edible, or topical) that are processed in one production cycle using either the same extraction methods, manufacturing methods, or formula and the same standard operating procedures. Production batches shall be utilized: (1) each time a product changes form physically or chemically; (2) each time a product changes item category; (3) when multiple item categories are combined; and/or (4) anytime an additive, lipid, flavoring, or terpene is added to any cannabis product. Production batches identify when a cannabis product undergoes processing from item category to another and the new product requires a new set of compliance tests in final form.

1.2.110

1.2.111

1.2.112

Proficiency Test – The term “proficiency test” means an evaluation of a laboratory’s performance against pre-established criteria by means of interlaboratory comparisons of test measurements.

1.2.113

Proficiency Test Sample – The term “proficiency test sample” means a sample that is prepared by a party independent of the testing laboratory with the ISO/IEC 18

17043 accreditation, where the concentration and identity of an analyte is known to the independent party but is unknown to the testing laboratory and testing laboratory employees. 1.2.114

Program – The term “program” means the Mississippi Medical Cannabis Program.

1.2.115

Provisional License – The term “provisional license” means a license issued by the Mississippi State Department of Health when a temporary condition of noncompliance with the regulations contained in this Part exists. A provisional license shall be issued only if the Mississippi State Department of Health is satisfied that preparations are being made to qualify for a regular license and that the health and safety of patients and the public will not be endangered. Business activities and operations can be limited by the Department for this licensure category.

1.2.116

Public Place – The term “public place” means a church or any area to which the general public is invited or in which the general public is permitted, regardless of the ownership of the area, and any area owned or controlled by a municipality, county, state or federal government, including, but not limited to, streets, sidewalks or other forms of public transportation. Such term shall not mean a private residential dwelling.

1.2.117

Raw Pre-Roll – The term “raw pre-roll” means a medical cannabis product that is produced by rolling, filling, or stuffing harvested cannabis flower, shake, and/or trim into paper, leaves or an equivalent wrapper and is intended for consumption by inhalation.

1.2.118

Registry Identification Card – The term “registry identification card” means a document issued by the Department that identifies a person as a registered qualifying patient, nonresident registered qualifying patient or registered designated caregiver.

1.2.119

Regular License – The term “regular license” means a license issued by the Mississippi State Department of Health when there is evidence of compliance with all applicable rules and regulations in this Part and components of the Mississippi Medical Cannabis Act.

1.2.120

Research and Development Testing – The term “research and development (R&D) testing” means optional testing performed before final compliance testing.

1.2.121

Residency – The term “residency” means a person’s dwelling where a person typically stays or stays more often than other locations. Residency may be determined by the Department with submission of two (2) of the following: Mississippi Tax Return Form 80-105; ownership, lease or rental documents for

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primary residence; utility bills (electric, water, gas bills) for primary residence; and/or vehicle registration. 1.2.122

Revocation – The term “revocation” means the Department's final decision to revoke a license in accordance with Mississippi law.

1.2.123

Restricted Area – The term “restricted area” means a building, room or other contiguous area upon the permitted premises where cannabis is grown, cultivated, harvested, stored, weighed, packaged, processed for sale or sold (to other medical cannabis establishments, not directly to an individual), under control of the licensed cannabis cultivator.

1.2.124

Sanitize – The term “sanitize” means to adequately treat cleaned equipment, containers, utensils, or any other cleaned contact surface by a process that is effective in destroying vegetative cells of pathogens, and in substantially reducing numbers of other microorganisms, but without adversely affecting the product or its safety for the end-user/consumer.

1.2.125

School – The term “school” means an institution for the teaching of children, consisting of a physical location, whether owned or leased, including instructional staff members and students, and which is in session each school year. This definition shall include, but not be limited to, public, private, church and parochial programs for kindergarten, elementary, junior high and high schools. Such term shall not mean a home instruction program.

1.2.126

Scope of Practice – The term “scope of practice” means the defined parameters of various duties, services or activities that may be provided or performed by a certified nurse practitioner as authorized under Miss. Code. §§ 73-15-5 and 7315-20, by an optometrist as authorized under § 73-19-1, by a physician as authorized under § 73-25-33, or by a physician assistant under § 73-26-5, and rules and regulations adopted by the respective licensing boards for those practitioners.

1.2.127

Secure – The term “secure” means protected from danger or risk.

1.2.128

Seedling – The term “seedling” means a cannabis plant that has no flowers.

1.2.129

Seed-to-Sale System – The term “seed-to-sale system” means the specialized inventory management system utilized throughout the medical cannabis program that allows for the tracking of cannabis from early life cycle until final sale to a qualified patient or caregiver or disposal/destruction by a cannabis disposal entity.

1.2.130

THC – The terms “THC” or “Tetrahydrocannabinol” mean any and all forms of tetrahydrocannabinol that are contained naturally in the cannabis plant, as well as synthesized forms of THC and derived variations, derivatives, isomers and allotropes that have similar molecular and physiological characteristics of 20

tetrahydrocannabinol, including, but not limited to, THCA, THC Delta 5, THC Delta 8, THC Delta 10 and THC Delta 6. 1.2.131

Tincture – The term “tincture” means a liquid edible cannabis product with a concentration of greater than 1 mg of THC per ounce of liquid.

1.2.132

Topical Cannabis Product – The term “topical cannabis product” means a THCinfused product intended for external application to human body surfaces and/or absorption through the skin, does not cross the blood-brain barrier and is not intended for consumption by oral ingestion.

1.2.133

Total CBD – The term “Total CBD” means the sum of CBD and CBDA. Total CBD is calculated using the following equation: Total CBD = CBD + (CBDA*0.877).

1.2.134

Total THC – The term “Total THC” means the sum of THC and THCA. Total THC is calculated using the following equation: Total THC = delta-9 THC + (THCA*0.877).

1.2.135

Total Yeast and Mold Count (TYMC) – The term “Total Yeast and Mold Count (TYMC)” means the total combined yeast and mold count in standardized planting methodologies and is usually expressed in number of colony-forming units (CFU).

1.2.136

Unique Identification Number – The term “unique identification number” means a unique number generated by the seed-to-sale system and assigned to all usable medical cannabis for the purpose of tracking cannabis from early life cycle until final sale to a qualified patient or caregiver or disposal/destruction by a cannabis disposal entity.

1.2.137

Unusable and Unrecognizable – The term “unusable and unrecognizable” means that anything containing THC shall be destroyed to prevent THC-containing material(s) from being accessed or consumed.

1.2.138

Usable Medical Cannabis – The term “usable medical cannabis” means any medical cannabis product that has completed all required growing/processing steps, is in the final form intended for sale or distribution and intended for use or consumption by qualifying patients as defined in the Mississippi Medical Cannabis Act. The term “retail-ready medical cannabis” may also be used.

1.2.139

Validation – The term “validation” means the confirmation by examination and objective evidence that the requirements for a specific intended use or analytical method are fulfilled.

1.2.140

Variance – The term “variance” means a Department granted exception to the rules contained in this Part.

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1.2.141

Water Activity – The term “water activity” means the measure of the quantity of water in a product that is available and therefore capable of supporting bacteria, yeasts, and fungi and which is reported in units aw.

1.2.142

Work Permit – The term “work permit” means the official document issued by the Department that authorizes a person to function as a Medical Cannabis Establishment. Written Certification – The term “written certification” means a form approved by the Department, signed and dated by a practitioner, certifying that a person has a debilitating medical condition. This written certification may also be referred to as a “practitioner certification”.

1.2.143

1.3

Severability. The provisions of this Part are severable. If a court of competent jurisdiction declares any section, subsection, paragraph, or provision unconstitutional or invalid, the validity of the remaining provisions shall not be affected.

Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67.

Subpart 2

PRACTITIONERS, CERTIFICATION, REGISTRATION CARDS & CAREGIVERS

2.1

Types of Medical Cannabis Registries and Associated Fees.

2.1.1

The following types of medical cannabis registry identification cards (may also be referred to as patient cards) will be issued, in a form and manner set by the Department, upon satisfaction of all application criteria: 1. Registered Qualifying Patient Identification Card; 2. Nonresident Qualifying Patient Identification Card (i.e., temporary patient card or nonresident cardholder); and, 3. Registered Designated Caregiver Identification Card. 4. Practitioner Registration.

2.1.2

At a minimum, identification cards issued by the Department will identify: A. Type of card; B. Valid dates of the card; C. Legal name of the cardholder; D. Date of birth of the cardholder;

22

E. Photograph (headshot) of the cardholder; F. Unique identification number; G. MMCEU allotment and limitations; and, H. How the card may be verified.

2.1.3

The initial fees for Registered Qualifying Patient Identification Card are as follows: 1. The standard nonrefundable fee is $25.00. 2. The nonrefundable fee for a 100% disabled veteran or disabled first responder is waived. A disabled veteran or disabled first responder may prove their disability by providing written documentation to the Department from the Social Security Disability Office or documentation that attests the applicant is a 100% disabled veteran as determined by the U.S. Department of Veteran Affairs. 3. The nonrefundable fee for a Mississippi Medicaid participant shall be $15.00. Medicaid status will be verified at the time of application. 4. All fees are nonrefundable. Fees shall be paid in the manner set forth by the Department at the time of application.

2.1.4

The renewal fees for Registered Qualifying Patient Identification Cards are as follows: A. The standard nonrefundable fee is $25.00. B. The nonrefundable fee for a 100% disabled veteran or disabled first responder is waived. A disabled veteran or disabled first responder may prove their disability by providing written documentation to the Department from the Social Security Disability Office or documentation that attests the applicant is a 100% disabled veteran as determined by the U.S. Department of Veteran Affairs. C. The nonrefundable fee for a Mississippi Medicaid participant shall be $15.00. Medicaid status will be verified at the time of renewal. D. All renewal fees are nonrefundable. Fees shall be paid in the manner set forth by the Department at the time of renewal.

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2.1.5

The initial fees for a Designated Caregiver Registry Identification Card are as follows: A. The standard nonrefundable fee is $25.00. B. The designated caregiver criminal background check nonrefundable fee is $37.00 to be paid to the Department for conducting the required background checks. C. All fees are nonrefundable. Fees shall be paid in the manner set forth by the Department at the time of application.

2.1.6

The renewal fees for a Designated Caregiver Registry Identification Card are as follows: A. The standard nonrefundable fee is $25.00. B. The designated caregiver criminal background check nonrefundable fee is $37.00. C. All fees are nonrefundable. Fees shall be paid in the manner set forth by the Department at the time of application.

2.1.7

Both initial and renewal fees for all medical cannabis identification cards may be waived by the Department in the event of extenuating circumstances approved by the Department.

2.2

Registered Qualifying Patient Identification Cards.

2.2.1

Registered Qualifying Patient Identification Cards will only be issued by the Department when all application and practitioner certification criteria are met. Upon issuance of the identification card, the applicant is recognized as a qualified patient, or cardholder, of the medical cannabis program.

2.2.2

Registered Qualifying Patient Identification Cards issued by the Department are valid for one (1) year from the date of issuance unless a lesser timeframe is otherwise imposed through the written certification or circumstances determined by the Department.

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2.2.3

Utilizing the same process outlined in Rule 2.3.1, Qualified Patients may apply for renewal of their identification card no later than one (1) year from the date of issuance or last renewal of the identification card. For purposes of renewal, a registered practitioner may conduct a registered cardholder’s recertification assessment via telehealth if he/she previously evaluated the registered cardholder in person.

2.2.4

When there is a change in the cardholder’s name, address, designated caregiver, or if the registered qualifying patient ceases to have his or her diagnosed debilitating medical condition (as determined by the practitioner issuing the patient’s written certification) that qualified him/her for the medical cannabis program, the patient is responsible for notifying the Department within twenty (20) calendar days of the change. If the patient is unable to make these notifications, the patient’s registered designated caregiver with the program or legal representative shall make these notifications to the Department on behalf of the patient in the same required timeframes as stated above in this Rule.

2.2.5

Reporting of changes required in Rule 2.2.4 shall be done in a format required by the Department.

2.2.6

Registered Qualifying Patient Identification Cards may be denied or revoked for the following: 1. The cardholder provided false or incomplete information to the Department during application or renewal; 2. The cardholder uses his/her card to obtain medical cannabis or medical cannabis products for another individual; and/or, 3. The certifying practitioner has terminated the written certification.

2.2.7

In addition to Rule 2.2.6, if the cardholder is under the age of eighteen (18), the Registered Qualifying Patient Identification Card may be denied or revoked if the custodial parent or legal guardian with responsibility for health care decisions doesn’t provide written consent to the patient’s use of medical cannabis, agree to serve as the patient’s designated caregiver; and control the acquisition, dosage and frequency of use of the patient’s medical cannabis.

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2.3

Application to Participate in the Medical Cannabis Program as a Registered Qualifying Patient.

2.3.1

To obtain a Registered Qualifying Patient Identification Card, an applicant shall submit (in a form and manner determined by the Department) the following information: A. Full legal name and any aliases, such as a nickname (e.g., Bill as a nickname for William); B. Date of birth; C. Current physical address; D. Current mailing address; E. Current telephone number and/or email address; F. Identification issued by the State of MS – (driver’s license or ID card issued by the Mississippi Department of Motor Vehicles); G. Current photograph, meeting the following requirements: 1. clear, color photograph of the head and top of shoulders (headshot); 2. in a .jpg, .png, or .gif digital image format; 3. taken in the last six months to reflect the applicant’s appearance; 4. taken in front of a plain white or off-white background; 5. taken in full-face view directly facing the camera at eye level with nothing obscuring the face; 6. shall not be digitally enhanced to change the appearance of the applicant (e.g., use of “filters”); H. Written certification (as set forth by the Department); I. Identification card nonrefundable fee (see Rules 2.1.3 and 2.1.4); J. An attestation, signed and dated by the applicant, that the information provided is true and correct; K. An attestation, signed and dated by the applicant, pledging not to divert medical cannabis or medical cannabis products to any individual or entity; and, L. Any other information that may be required by the Department.

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2.3.2

To obtain a Qualified Patient Identification Card for a Minor (under the age of 18), a legal guardian or custodial parent with responsibility for health care decisions, on behalf of the minor applicant, shall submit (in a form and manner determined by the Department) the following information: A. The full legal name and aliases, such as a nickname (e.g., Bill as a nickname for William) of the minor applicant; B. The minor applicant’s date of birth; C. A copy of the minor applicant’s birth certificate; D. A copy of any court orders pertaining to custody of the minor applicant (including, but not limited to custody order through chancery or youth court); E. The minor applicant’s current physical address; F. Proof of minor’s residency in the State of Mississippi provided by the custodial parent and/ or legal guardian (see Rule 2.4.1 for sources required); G. The minor applicant’s telephone number and/or email address if the applicant has a telephone number and/or email address and that telephone number and/or email address is different from one provided by the applicant’s parent(s) or legal guardian(s); H. The full legal name(s) of the minor applicant’s parent(s) or legal guardian(s); I. The date(s) of birth of the minor applicant’s parent(s) or legal guardian(s); J. The current physical address(es) of the minor applicant’s parent(s) or legal guardian(s); K. The current telephone number(s) and/or email address(es) of the minor applicant’s parent(s) or legal guardian(s); L. Identification issued by the State of MS (if applicable based on minor applicant) MS – (driver’s license or ID card issued by the Mississippi Department of Motor Vehicles); M. Current photograph of minor applicant: 1. clear, color photograph of the head and top of shoulders (headshot); 2. in a .jpg, .png, or .gif digital image format 3. taken in the last six months to reflect the applicant’s appearance; 4. taken in front of a plain white or off-white background; 5. taken in full-face view directly facing the camera at eye level with

27

nothing obscuring the face; 6. shall not be digitally enhanced to change the appearance of the applicant (e.g., use of “filters”); N. Written certifications (as set forth by the Department); O. Identification card nonrefundable fee (see Rules 2.1.3 and 2.1.4); P. An attestation that the information provided is true and correct; Q. Parental or legal guardian consent for the minor to participate in the medical cannabis program; R. An attestation, signed and dated by the applicant and parent(s)/legal guardian(s), pledging not to divert medical cannabis or medical cannabis products to any individual or entity; and, S. Any other information that may be required by the Department.

2.3.3

A certification issued for an individual between the ages of eighteen (18) and twenty-five (25) must meet the following conditions: 1. The debilitating condition is confirmed by two practitioners from separate practices after an in-person consultation (this isn’t required if the person is homebound or had an identification card before the age of 18); and, 2. One of the practitioners must be a physician (MD/DO).

2.3.4

The following limitations apply to resident cardholders: A. A resident card is valid for a maximum of one (1) year from the date of issuance of the card; B. A maximum of six (6) MMCEUs of medical cannabis in a week can be dispensed to a resident cardholder; C. A maximum of twenty-four (24) MMCEUs of medical cannabis in a thirty (30) day period can be dispensed to a resident cardholder; and D. A maximum of twenty-eight (28) MMCEUs is the possession limit for resident cardholders.

2.4

Nonresident Qualifying Patients (i.e., Nonresident Cardholders).

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2.4.1

In order to participate in the program as a nonresident cardholder the following conditions shall be met: A. The individual has been diagnosed with a debilitating medical condition by a practitioner (licensed to prescribe medicine under the respective occupational board of the state of residence) in his or her respective state of residence; B. The individual is not a resident of the State of Mississippi or has been a resident of the State of Mississippi for less than forty-five (45) days; C. The individual has an active identification card for the use of medical cannabis in his/her state of residence; and, D. The individual has met the application criteria in Rule 2.4.2 below.

2.4.2

To obtain a Nonresident Qualifying Patient Identification Card, an applicant shall submit (in a form and manner determined by the Department) the following information: A. Full legal name and any aliases, such as a nickname (e.g., Bill as a nickname for William); B. Date of birth; C. Current physical address and mailing address; D. Current telephone number and/or email address; E. Identification issued by the applicant’s state of residence – (driver’s license, or state-issued ID card); F. Current photograph: 1. clear, color photograph of the head and top of shoulders (headshot); 2. in a .jpg, .png, or .gif digital image format; 3. taken in the last six months to reflect the applicant’s appearance; 4. taken in front of a plain white or off-white background; 5. taken in full-face view directly facing the camera at eye level with nothing obscuring the face; 6. shall not be digitally enhanced to change the appearance of the applicant (e.g., use of “filters”); G. Proof of active (current) participation in the medical cannabis program of

the individual’s state of residence (as set forth by the Department); 29

H. Identification card nonrefundable fee of $75.00; I. An attestation, signed and dated by the applicant, that the information provided is true and correct; J. An attestation, signed and dated by the applicant, pledging not to divert medical cannabis or medical cannabis products to any individual or entity; and, K. Any other information that may be required by the Department.

2.4.3

In compliance with Rule 2.4.2 above, an individual seeking to participate in the program as a nonresident cardholder may apply to receive his/her nonresident identification card up to thirty (30) days before arriving in Mississippi.

2.4.4

The following limitations apply to nonresident cardholders: A. A nonresident card is valid for a maximum of two (2) fifteen (15) day periods in a 365-day year from the date of issuance of the card; B. The first consecutive fifteen (15) day period is the initial approval period; C. The second consecutive fifteen (15) day period is the renewal period; D. A maximum of six (6) MMCEUs of medical cannabis shall be dispensed per week to a nonresident cardholder; E. A maximum of twelve (12) MMCEUs of medical cannabis shall be dispensed to a nonresident cardholder in a consecutive fifteen (15) day period; and F. The maximum possession limit for nonresident cardholders shall be fourteen (14) MMCEUs.

2.5

Registered Designated Caregiver Cards.

2.5.1

Registered Designated Caregiver Cards will only be issued by the Department when all application criteria are met. Upon issuance of the designated caregiver card, the applicant is recognized as a designated caregiver to a qualified patient or patients (inclusive of nonresident patients) of the medical cannabis program. The Department will not issue a designated caregiver identification card before the Department issues the designated caregiver’s qualifying patient’s identification card.

30

2.5.2

Caregiver applicants are prohibited from having a disqualifying felony offense.

2.5.3

Caregivers shall be at least twenty-one (21) years of age unless the person is the parent or legal guardian of the qualified patient cardholder that the designated caregiver assists.

2.5.4

Registered Designated Caregiver Cards issued by the Department are valid for one (1) year from the date of issuance or lesser timeframe if assisting a nonresident patient.

2.5.5

Utilizing the same process outlined in Rule 2.4.2, Caregivers may apply for renewal of their identification card no later than one (1) year from the date of issuance or last renewal of the Caregiver Identification Card.

2.5.6

Caregiver Cards may be suspended or revoked for the following: A. The caregiver provided false information to the Department; B. The caregiver uses his/her card to obtain medical cannabis for an individual who has not designated them as their caregiver or who is not a qualified patient; and/or, C. The caregiver uses the medical cannabis of the patient for whom he/she is providing care.

2.6

Application to Participate in the Medical Cannabis Program as a Caregiver.

2.6.1

To obtain a Registered Designated Caregiver Card, an applicant shall submit (in a form and manner determined by the Department) the following information: A. Full legal name and any aliases, such as a nickname (e.g., “Bill” as a nickname for “William”); B. Date of birth; C. Current physical address and mailing address; D. Current telephone number and/or email address; E. Identification issued by the State of Mississippi – (driver’s license or ID card issued by the Mississippi Department of Motor Vehicles); 31

F. Current photograph, meeting the following requirements: 1. clear, color photograph of the head and top of shoulders (headshot); 2. in a .jpg, .png, or .gif digital image format; 3. taken in the last six months to reflect the applicant’s appearance; 4. taken in front of a plain white or off-white background; 5. taken in full-face view directly facing the camera at eye level with nothing obscuring the face; 6. shall not be digitally enhanced to change the appearance of the applicant (e.g., use of “filters”). G. Name(s), date(s) of birth, and identification number(s) (if available at the time of application) of the patient(s) to whom services are being provided; H. Identification card nonrefundable fee of $25.00; I. Fingerprints on a fingerprint card or a live scan fingerprint to be submitted to the Department to conduct a criminal background check; J. Authorization to conduct state and federal criminal records checks; K. Caregiver criminal background check nonrefundable fee of $37.00 paid at the time of application to complete the required background check; L. An attestation that the information provided is true and correct; M. An attestation, signed and dated by the applicant, pledging not to divert medical cannabis or medical cannabis products to any individual or entity; N. Designation of Caregiver Form; and, O. Any other documentation required by the Department such as an acknowledgement of caregiver responsibilities.

2.6.2

In the event that an applicant is applying to become a registered designated caregiver for a qualified patient who is a minor and the caregiver applicant is not the patient’s parent and/or legal guardian, the caregiver applicant shall also submit authorization from the patient’s parent and/or legal guardian to serve in a caregiver capacity. The form of the authorization may be determined by the Department.

2.7

Application to Obtain a Caregiver Entity Card.

32

2.7.1

The following entities, licensed by the applicable state authority, may facilitate the use of medical cannabis by a qualified patient after registering with the Department as a Caregiver Entity: A. Hospitals; B. Hospice Programs; C. Assisted Living Programs; D. ICF/IDD Institutions; E. Nursing Homes; F. Personal Care Homes; G. Adult day care facilities; and H. Adult foster care facilities.

2.7.2

To register as a Caregiver Entity, the facility/program shall submit, in a form and manner determined by the Department, the following information: A. The name, address, and telephone number of the facility/program, as well as the contact information for a primary contact person at that facility/program; B. A copy of the facility/program’s current facility license; and, C. An attestation that the information provided is true and correct and shall be signed and dated by an authorized signatory of the facility/program.

2.7.3

The Caregiver Entity shall update the Department with any changes to the facility/program’s primary contact person within three (3) business days of the change and shall file a copy of their license(s) each time that license is renewed or updated.

2.7.4

A Caregiver Entity card shall remain valid unless or until the facility’s/program’s state license or certification (whichever is applicable) is no longer valid or the registration with the medical cannabis program is suspended, revoked, or restricted by the Department.

2.7.5

The Department shall provide a single card to a Caregiver Entity. The Caregiver Entity will be notified by the Department of each qualifying patient’s designation of that entity as his/her caregiver. 33

2.7.6

Individual caregivers employed by registered Caregiver Entities are subject to all other Caregiver requirements included in this Part.

2.8

Practitioner Certification for Registered Qualifying Patients (Mississippi Residents).

2.8.1

A practitioner’s written certification (in a manner set forth by the Department) is required for a person, residing in the State of Mississippi, to apply to become a qualified patient of the Medical Cannabis Program.

2.8.2

The purpose of the practitioner certification is to determine and certify that a person suffers from a debilitating medical condition for which the use of medical cannabis may mitigate the symptoms and/or effects.

2.8.3

Before issuing a Practitioner Certification for an individual seeking to participate in the medical cannabis program, a Practitioner shall: A. Have a bona fide practitioner-patient relationship with the individual; B. Examine the individual in person in Mississippi; C. Determine that the individual suffers from a Debilitating Medical Condition for which the use of medical cannabis may mitigate the symptoms and/or the effects.

2.8.4

A bona fide practitioner-patient relationship must include the following: 1. A treatment or consulting relationship between the practitioner and the individual seeking the practitioner certification; 2. A practitioner certification is included in the individual’s medical record; 3. The practitioner is available to provide follow-up care and treatment to the individual seeking certification; and, 4. Any other requirements related to the practitioner’s scope of practice put in place by the practitioner’s respective occupational/licensing board or the Department.

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2.8.5

A practitioner certification is valid for twelve (12) months from the date of issuance unless a shorter time is specified by the certifying practitioner.

2.8.6

A practitioner certification shall not exceed the allowable amount of medical cannabis. A practitioner can place restrictions on the allowable amount of medical cannabis by stating the maximum amount of medical cannabis and/or the method(s) of administration permissible on the practitioner certification.

2.8.7

A practitioner shall not issue a written certification for any individual with whom he/she does not have a bona fide practitioner-patient relationship.

2.8.8

A practitioner issuing a written certification is prohibited from being a medical cannabis dispensary representative or employee.

2.8.9

A certification issued for an individual eighteen (18) to twenty-five (25) years old shall meet the following conditions: A. The debilitating condition is confirmed by two practitioners from separate practices after an in-person consultation (this isn’t required if the person is homebound or had an identification card before the age of 18); and, B. One of the practitioners shall be a physician (MD/DO).

2.8.10

A certification issued for a minor (under the age of 18) may only be issued by a physician (MD/DO).

2.8.11

A registered practitioner is prohibited from the following: A. Referring patients to a specific medical cannabis establishment; B. Referring patients to a specific caregiver; C. Advertising in medical cannabis establishments; and, D. Issuing a written certification for a qualifying patient while holding a financial interest in any medical cannabis establishment.

2.8.12

A registered practitioner shall conduct the evaluation, consultation, diagnosis, and certification processes under this part in a manner consistent with all 35

professional and medical standards of care, including the rules of professional conduct adopted by the practitioner’s respective board of licensure, and document all information related to those processes in the patient’s records.

2.8.13

After a registered practitioner issues a written certification to a qualifying patient, he/she may assist that patient in applying for a registry identification card via the Department’s Licensing Portal.

2.9

Practitioner Registration.

2.9.1

Practitioners shall register annually with the Department to participate in the medical cannabis program for purposes of issuing written certifications on behalf of qualifying patients.

2.9.2

The collaborating physician (MD/DO), for both physician assistants and certified nurse practitioners, shall be registered with the Department in order for the physician assistant or nurse practitioner in collaboration with that physician (MD/DO) to subsequently register with the Department.

2.9.3

In order to register with the Department, the practitioner (i.e., applicant) shall submit the following to the Department: A. Evidence of unrestricted licensure in Mississippi by the Mississippi State Board of Medical Licensure; Mississippi State Board of Nursing; or Mississippi State Board of Optometry; B. Issue date and expiration date of licensure in Mississippi; C. Area of specialty; D. Physical address of practice; E. Current telephone number and email address; F. Evidence of completion of continuing medical education approved by the Department; G. A waiver, signed and dated by the practitioner, allowing, and authorizing the Department to fully communicate with the Mississippi State Board of Medical Licensure, Mississippi State Board of Nursing; or Mississippi State Board of Optometry and receive licensure information; and, H. An attestation that the applicant has no direct or indirect financial interest in 36

any licensed medical cannabis establishment.

2.9.4

Practitioner Registration may be suspended or revoked for the following: A. The practitioner provided false information to the Department; and/or B. The practitioner is the subject of disciplinary action from the Mississippi State Board of Medical Licensure, Mississippi State Board of Nursing, or Mississippi State Board of Optometry.

2.10

Requirements of Practitioners Participating in the Medical Cannabis Program.

2.10.1

Practitioners shall complete eight (8) hours of initial training related to the use of medical cannabis in order to enroll in the program. Annual training in the amount of five (5) hours related to the use of medical cannabis shall also be completed in order to annually renew participation in the program. All training shall be approved by the Department. Failure to meet these training requirements will negatively impact a practitioner’s ability to participate in the Program.

2.10.2

Practitioners are prohibited from sharing office space with a medical cannabis establishment.

2.10.3

Participation in the program does not negate the authority of the Mississippi State Board of Medical Licensure, Mississippi State Board of Nursing or Mississippi State Board of Optometry to investigate practitioners and freely communicate with the Department should those instances occur. Practitioners registered with the Program agree to the additional regulatory requirements related to the MS Medical Cannabis Act and the rules contained in this Part. Practitioners participating in the Program agree that MSDH is authorized to freely communicate with the practitioner’s professional licensing board if violations are alleged.

2.10.4

Practitioners shall utilize the Prescription Monitoring Program in order to complete an assessment of the patient prior to issuing an initial or renewal certification qualifying his/her condition for the medical cannabis program.

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2.10.5

All patients shall be advised of their freedom of choice as to the medical cannabis dispensary they wish to utilize. Evidence of this shall be maintained in the patient’s medical record.

2.10.6

In addition to the requirements set forth in this Part, practitioners shall also follow the rules, regulations, and policies set forth by the Mississippi State Board of Medical Licensure, Mississippi State Board of Nursing, or the Mississippi State Board of Optometry in order to maintain an unrestricted license from the respective licensing boards.

2.10.7

A certifying practitioner may determine that a patient no longer meets the requirements related to a debilitating medical condition; no longer believes that the patient receives therapeutic benefit from the use of medical cannabis; or does not believe the patient is using the medical cannabis for medical purposes. The practitioner shall notify the Department of that determination and intent to terminate the physician certification. Termination of physician certification renders the patient identification card null and void.

2.10.8

Notification of termination of practitioner certification to the Department and patient shall include, but isn’t limited to: 1. The practitioner’s identification number issued by the MS Medical Cannabis Program; 2. The patient’s identification number issued by the MS Medical Cannabis Program; 3. The reason the certification is being revoked; 4. The date of revocation; 5. The signature of the practitioner; 6. The date of notification to the Department; 7. The date of notification to the patient; and, 8. The official letterhead and/or email account of the practitioner.

2.11

Advertising Restrictions for Registered Practitioners.

2.11.1

Advertising for cannabis certification(s) shall be professional in nature and may not be designed in such a way as to suggest that patients will obtain certification 38

regardless of their condition or compliance with the requirements of the Act, or in any way that entices minors.

2.11.2

A practitioner or affiliated clinic/entity shall not publish or cause to be published any advertisement that: A. Contains false or misleading statements about medical cannabis or about the Program; B. Uses colloquial terms to refer to medical cannabis, including but not limited to pot, weed, dope or grass; C. States or implies the health care practitioner is endorsed by the Department or by the Program, including use of the Department’s Medical Cannabis Program logo; D. Includes images of cannabis in its plant or leaf form or of cannabis-smoking paraphernalia; or E. Contains medical symbols that could reasonably be confused with symbols of established medical associations or groups.

2.11.3

A practitioner found by the Department to have violated this Part is prohibited from certifying that patients have a qualifying medical condition for purposes of patient participation in the Program. The Department’s decision that a practitioner has violated this subdivision is a final decision of the Department which may be appealed by an aggrieved party in accordance with Subpart 11 of this Part.

Source:

Miss. Code Ann. §§ 41-137-1 – 41-137-67.

Subpart 3

MEDICAL CANNABIS ESTABLISHMENT LICENSES, BACKGROUND CHECKS, & WORK PERMITS

3.1

Application for Medical Cannabis Establishment License.

3.1.1

An application and all required documentation shall be completed by the applicant and submitted to the Department using the Department’s Online Licensing Portal.

3.1.2

At a minimum, an application for licensure as a medical cannabis establishment shall include the following: 39

1. The names and other required information for all individuals and legal entities who are applicants; 2. The proposed physical location of the cannabis facility; 3. A map or sketch of the premises proposed for licensure, including the defined boundaries of the premises and a scaled floorplan sketch of all enclosed areas with clear identification of the main entrance, walls, all areas of ingress and egress, and all limited access areas. This map shall provide accurate measurements that allow the Department, at a minimum, to determine the precise main entrance location in reference to the rest of the premises. This map shall also clearly identify the distinct areas utilized for commercial cannabis activities (i.e., cultivation activities, processing activities, storage, etc.). This map shall identify all locations of security cameras, exterior lighting, secure access areas and fencing; 4. If the application is based on proposed construction not completed at the time of application, the applicant shall submit construction plans for the proposed building which will be the basis for the application investigation. These plans shall, at a minimum, provide accurate measurements that allow the Department to determine the precise main entrance location in reference to the rest of the building. If the application is based on an existing building, photos of the interior, exterior and the surrounding property should be submitted at the time of application; 5. An operating plan that demonstrates the following at a minimum: 1. The applicant’s organization chart; 2. Job descriptions and minimum qualifications for each position; 3. An explanation of whether the applicant has experience operating businesses in highly-regulated industries, including but not limited to the cannabis industry under the laws of Mississippi or any other state or jurisdiction within the United States; 4. Employee training plan; and 5. Hours of operation. 6. Standard Operating Procedures that demonstrate at a minimum how the applicant’s proposed premises and business will comply with applicable laws and rules regarding: A. Security; B. Employment practices adhering to state and federal law;

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C. Record-keeping systems; D. Preventing diversion of cannabis and/or cannabis products; E. Types and quantities of cannabis products that will be produced at the facility; F. Methods of cultivation or processing of cannabis and/or cannabis products, as applicable based on category of license applied for; G. Inventory control and tracking; H. Procedures for proper labeling and packaging; I. Transportation of cannabis and/or cannabis products, as applicable based on category of license applied for; J. Waste disposal; and, K. Recall of cannabis and/or cannabis products; 7. If the municipality or county where the proposed cannabis facility will be located has enacted zoning restrictions, a sworn attestation by the applicant certifying that the proposed cannabis facility is in compliance with the restrictions; 8. If the municipality or county where the proposed cannabis facility will be located requires a local registration, license, or permit, then the applicant shall include a copy of such registration, license or permit issued to the applicant with the application submitted to the Department. If construction is still underway at the time of application, then the applicant shall include a signed attestation containing the following information: A. A list of all local requirements not yet obtained; B. Anticipated dates that the applicant will obtain each location registration, license and/or permit; C. An attestation that acknowledges that the applicant is aware of the outstanding need for local registrations, licenses and/or permits and will provide delinquent documents within 10 business days of their receipt as a condition of licensure; 9. The names and other required information for all persons and/or entities who directly or indirectly own ten percent (10%) or more of the medical cannabis establishment applicant entity;

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10. If the applicant is a business entity, the names and other required information for each principal officer and board member of the medical cannabis establishment applying for licensure; 11. Fingerprint cards or electronic fingerprints collected by a live scan (or like) vendor for any person who directly or indirectly owns ten percent (10%) or more of the medical cannabis establishment applicant in order to perform a criminal background check to determine whether a disqualifing felony offense is present. The signed and notarized Background Check Affidavit for each applicant should also be submitted at the time of application; and, 12. Other information that may be required by the Department.

3.1.3

All information and documents required by the Department including but not limited to the following shall accompany an application for licensing as a cannabis testing entity: A. Initial applications for regular and/or provisional licensing as a cannabis testing entity shall require: 1. The legal name of the prospective cannabis testing entity; 2. The physical address of the prospective cannabis testing entity’s facility, which shall not be within one thousand (1,000) feet of the nearest property boundary line of a school, church, or child care facility which exists or has acquired necessary real property for the operation of such facility before the date of the cannabis testing facility application unless the proposed entity has received approval from the school, church or child care facility and received the applicable waiver from the entity that licenses or accredits any such school or child care facility, provided that the main point of entry of the cannabis testing facility is not located within five hundred (500) feet of the nearest property boundary line of any school, church or child care facility; 3. The name of each owner, principal officer, board member, and lab director of the proposed cannabis testing entity; 4. An attestation that the information provided to the Department to apply for a cannabis testing entity license is true and correct; 5. The signatures of the owners of the cannabis testing entity and the technical laboratory director and the date each signed; 6. For each owner: a. An attestation signed and dated by the owner that the owner has not been 42

convicted of an excluded felony offense; b. An attestation signed and dated by the owner that the owner does not have a direct or indirect familial or financial relationship with or interest in a cannabis dispensary, cannabis cultivation entity, cannabis processing entity, cannabis disposal entity or cannabis research entity; c. An attestation signed and dated by the owner pledging not to divert cannabis to any individual who or entity that is not allowed to possess cannabis; and, 7. Verification for each principal officer or board member that they are at least twenty-one (21) years of age. 8. Verification for each principal officer or board member that they are at least twenty-one (21) years of age; 9. A valid certificate of accreditation, issued by an accreditation body, as defined in this Chapter, that attests to the laboratory’s competence to perform testing, including all the required analytes for the relevant test methods: a. Cannabinoids; b. Heavy metals; c. Microbial impurities; d. Mycotoxins; e. Residual pesticides; f. Residual solvents and processing chemicals; g. Terpenoids (if performed); and, h. Foreign Material; 10. A copy of the cannabis testing facility’s most recent assessment by the laboratory’s accreditation body, the laboratory’s responses to any findings of non-compliance with standards or recommendations, and the corrective actions taken by the laboratory to address the findings or recommendations; 11. Laboratory standard operating procedures for all testing methods; 12. Laboratory test method verification and validation documentation for all testing methods, including final data reports approved by the laboratory director, validation material package inserts and all supporting data including instrument raw data and calculation tools; 13. Laboratory standard operating procedures for security measures; 43

14. Laboratory standard operating procedures for the sampling of cannabis or cannabis products; 15. Laboratory standard operating procedures for the transportation of cannabis or cannabis products; 16. Laboratory standard operating procedures for the reporting of test results for cannabis or cannabis products; 17. Laboratory standard operating procedures for the disposal of samples, digestates, leachates and extracts or other sample preparation products; 18. Testing staff initial and/or ongoing demonstration of capability for all applicable tests. 19. All completed proficiency testing. For new applications, a testing entity shall successfully analyze one set of proficiency testing samples for all required analytes prior to being licensed. B. In addition to the above, applications for renewal of a cannabis testing entity license shall also include: 1. A valid certificate of accreditation, issued by an accreditation body, as defined in this Part, that attests to the laboratory’s competence to perform testing, including all the required analytes for the relevant test methods: a. Cannabinoids; b. Heavy metals; c. Microbial impurities; d. Mycotoxins; e. Residual pesticides; f. Residual solvents and processing chemicals; g. Foreign Material; h. Terpenoids, if performed. 2. A copy of the cannabis testing entity’s most recent assessment by the laboratory's accreditation body, the laboratory's responses to any findings of non-compliance with standards or recommendations, and the corrective actions taken by the laboratory to address the findings or recommendations; 3. Any new or updated laboratory standard operating procedures for all testing methods; 4. Any new or updated laboratory test method verification and validation documentation for all testing methods, including final data reports approved 44

by the laboratory director, validation material package inserts and all supporting data including instrument raw data and calculation tools; 5. Any new or updated laboratory standard operating procedures for security measures; 6. Any new or updated laboratory standard operating procedures for the sampling of cannabis or cannabis products; 7. Any new or updated laboratory standard operating procedures for the transportation of cannabis or cannabis products; 8. Any new or updated laboratory standard operating procedures for the reporting of test results for cannabis or cannabis products; 9. Any new or updated laboratory standard operating procedures for the disposal of samples, digestates, leachates and extracts or other sample preparation products; and, 10. Testing staff initial demonstration of capability for all applicable tests.

3.1.4

The Department will review an application for licensure to determine if it is complete. An application will not be considered complete if the applicant does not provide all information required by the application form, the full application and license fees have not been paid, or all of the additional information required under these rules is not submitted. If items are missing/require correction/require additional information, the Department will send notification to the applicant that the application has been returned for action and provide a description of the requisite information. The applicant will need to resubmit an amended application and/or supporting documents for a license if the application is returned for action.

3.1.5

Upon review, the Department may return an application for action, an applicant will have three opportunities for correction. If an applicant is unable to present a complete and correct application, as determined by the Department, after these three attempts, the application will be denied. Upon denial, if the entity chooses to apply again, a new application and supporting documents meeting the requirements of this Part shall be submitted.

3.1.6

Once all required information is received and the fees have been paid, the Department will send notification to the applicant that it has received a completed application. Once the application has been deemed complete, the Department will 45

review the application and issue a determination within thirty (30) days of receiving the completed application. Applications will be processed in the order in which a completed application is filed by the applicant. Review will be initiated based on the order in which a complete application is filed; however, the duration of the review will depend upon the information provided by the applicant.

3.2

Categories and Fees.

3.2.1

Categories of Medical Cannabis Establishment Licenses. The following categories of medical cannabis establishment licenses may be issued by the Department consistent with the Mississippi Medical Cannabis Act: A. Cannabis Cultivation License. Establishments licensed as cannabis cultivation facilities/entities or micro-cultivation facilities may engage in the following commercial cannabis activities: acquisition and possession of medical cannabis, production of cannabis (e.g., grow, cultivate, harvest, dry, cure, trim) in accordance with the rules contained in this Part; storage of cannabis and/or raw pre-roll cannabis products; packaging and labeling of cannabis and/or cannabis products; production of raw pre-roll cannabis products, the sale of cannabis and raw pre-roll cannabis products to medical cannabis establishments authorized by this Part or medical cannabis dispensaries licensed by MDOR. Additionally, establishments licensed as micro-cultivation facilities/entities shall meet the ownership requirement established in Miss. Code § 41-137-35(12). B. Cannabis Processing License. Establishments licensed as cannabis processing facilities/entities or micro-processing facilities may engage in the following commercial cannabis activities: acquisition of cannabis from licensed cultivation and/or micro-cultivation facilities/entities; possession of cannabis with the intent to manufacture cannabis products; manufacture of cannabis products from unprocessed cannabis and/or a cannabis extract; storage of cannabis and/or cannabis products, packaging and labeling of cannabis and/or cannabis products, the sale of cannabis products to medical cannabis establishments authorized by this Part or medical cannabis dispensaries licensed by MDOR. Additionally, establishments licensed as micro-processing facilities/entities shall meet the ownership requirement established in Miss. Code § 41-137-35(12). C. Cannabis Transportation License. Establishments licensed as cannabis transportation entities in accordance with the rules in this Part may engage in the transportation (e.g., transfer) and storage of cannabis and/or cannabis products to other licensed medical cannabis establishments authorized by this Part and/or medical cannabis dispensaries licensed by MDOR. 46

D. Cannabis Disposal License. Establishments licensed as cannabis disposal entities may engage in the following commercial cannabis activities: disposal or destruction of medical cannabis, cannabis products, and/or cannabis waste. E. Cannabis Testing Facility License. Establishments licensed as medical cannabis testing facilities/entities may engage in the following commercial cannabis activities: collection and transportation of medical cannabis test samples, testing of medical cannabis test samples for purposes of analyzing the safety and potency of cannabis and cannabis products. F. Cannabis Research License. Establishments licensed as medical cannabis research facilities/entities may engage in the following commercial cannabis activities: acquisition of cannabis or cannabis products from licensed cannabis cultivation facilities and licensed cannabis processing facilities in order to research cannabis, develop best practices for specific medical conditions, develop medicines and provide commercial access for medical use.

3.2.2

License Fees. The following nonrefundable fees are required at the time of initial application and renewal: A. Micro-cultivators. 1. Tier 1 (canopy of 1,000 square feet or less) - one-time application fee of $1,500.00. Annual license fee of $2,000.00. 2. Tier II (canopy of more than 1,000 square feet but not more than 2,000 square feet) - one-time application fee of $2,500.00. Annual license fee of $3,500.00. B. Cultivators. 1. Tier I (canopy of not less than 2,000 square feet but not more than 5,000 square feet) – one-time application fee of $5,000.00. Annual license fee of $15,000.00. 2. Tier II (canopy of not less than 5,000 square feet but not more than 15,000.00 square feet) – one-time application fee of $10,000.00. Annual license fee of $25,000.00. 3. Tier III (canopy of not less than 15,000 square feet but not more than 30,000 square feet) – one-time application fee of $20,000.00. Annual license fee of $50,000.00. 4. Tier IV (canopy of not less than 30,000 square feet but not more than 60,000 square feet) - one time application fee of $30,000.00. Annual license fee of

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$75,000.00. 5. Tier V (canopy of not less than 60,000 square feet but not more than 100,000 square feet) – one time application fee of $40,000.00. Annual license fee of $100,000.00. 6. Tier VI (canopy of not less than100,000 square feet but no more than 150,000 square feet with up to two locations) – one time application fee $60,000.00. Annual license fee of $150,000.00. C. Micro-Processors. 1. Tier 1 (processes less than two thousand (2,000) pounds of dried biomass annually) - one-time application fee of $2,000.00. Annual license fee of $3,500.00. 2. Tier II (processes not less than two thousand (2,000) pounds but not more than three thousand (3,000) pounds of dried biomass annually) - one-time application fee of $2,500.00. Annual license fee of $5,000.00. D. Processors (processes no less than three thousand (3,000) pounds of dried biomass annually) - one time application fee of $15,000.00. Annual license fee of $20,000.00. E. Transportation Entity. One time application fee of $5,000.00. Annual license fee of $7,500.00. F. Waste Disposal Entity. One-time application fee of $5,000.00. Annual license fee of $7,500.00. G. Testing Entity. One-time application fee of $10,000.00. Annual license fee of $15,000.00. H. Research Entity. One-time application fee of $10,000.00. Annual license fee of $15,000.00.

3.2.3

All application and license fees shall be paid in a manner set forth by the Department.

3.2.4

The one-time application fee and license fee shall be paid in order for an initial application to be determined complete and move forward in the Department’s review.

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3.2.5

A fee for a status change from provisional license to regular license is not required. The application and license fees shall be paid as stated in Rule 3.2.2.

3.2.6

Should fees be returned to the Department as insufficient; the Department will cease the application review process. The applicant will be notified of the activity and the application will be denied at that time. If a license has been issued when the Department is notified of insufficient funds associated with the payment of fee, the medical cannabis establishment will be notified, and its license will be suspended until the fee payments are remedied. Remediation of the insufficient funds shall occur within thirty (30) days.

3.3.

Background Checks.

3.3.1

Fingerprinting and criminal history record checks are required for each applicant applying to obtain a medical cannabis work permit.

3.4

Licensure: Regular and Provisional

3.4.1

A license, issued by the Department, shall be obtained for each medical cannabis establishment prior to the commencement of any commercial cannabis activities authorized by this Part and the Mississippi Medical Cannabis Act. Activities outside of the authority granted to medical cannabis establishments by virtue of these rules, licensure and registration with the Department and the Mississippi Medical Cannabis Act may be considered suspected illegal activities and reported to proper authorities as such.

3.4.2

All operational medical cannabis establishments shall be currently licensed and registered by the Department and adhere to all regulations set forth by the Department.

3.4.3

To be licensed and registered by the Department, cannabis testing entities shall be accredited as defined in this Part.

3.4.4

To be licensed and registered by the Department, cannabis testing entities shall test at least one analyte required by the Department.

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3.4.5

To maintain an active license and registration certificate, cannabis testing entities shall maintain accreditation, as defined in this Part.

3.4.6

Any loss of accreditation status by a cannabis testing entity will result in immediate revocation of the license and registration of the cannabis testing facility.

3.4.7

Any cannabis testing entity that has a license revoked for failure to maintain accreditation, as defined in this Part, may file a written petition to the Department to reinstate the cannabis testing entity’s license once the cannabis testing entity submits proof of accreditation, as defined in this Part. A reinstatement of a license is required prior to the cannabis testing entity resuming cannabis testing operations.

3.4.8

A medical cannabis establishment shall not be within 1,000 feet of the nearest property boundary line of a school, church or child care facility that exists or has acquired necessary real property for the operation of such facility before the date of the medical cannabis establishment application unless the entity has received approval from the school, church or child care facility and received the applicable waiver from their licensing agency, provided that the main point of entry of the cannabis establishment is not located within five hundred (500) feet of the nearest property boundary line of any school, church or child care facility.

3.4.9

Regular Licensure. A license shall be issued for the specific business/entity identified on the application, and is valid only for the owner, premises and name designated on the application and Department issued license and the location for which it is issued. Upon issuance of a license, the licensee may begin operations; provided that it may not commence cultivating, producing or dispensing cannabis or cannabis products until it receives a written notice authorizing commencement from the Department, following the Department’s initial inspection to determine compliance with this Part.

3.4.10

Provisional Licensure. Within its discretion, the Department may issue a provisional license when a temporary condition of non-compliance with the regulations contained in this Part exists. A provisional license shall be issued only if the Department is satisfied that preparations are being made to qualify for a regular license and that the health and safety of patients and the public will not be 50

endangered. The Department identifies opportunities for diversion, such as a lack of plant/package tags and insufficient security measures, as dangers to the health and safety of patients and the public.

3.4.11

A provisional license may be issued when the following conditions exist: A. Prior to the medical cannabis establishment’s start date of operations and subsequent to meeting the licensure requirements for the development of all required standard operating procedures. The license issued under this provision shall be valid until the issuance of a regular license but shall generally not exceed four (4) months following date of issuance, whichever may be sooner. B. When a temporary issue of non-compliance with these regulations exists that does not endanger the health and safety of patients and the public (at the discretion of the Department). The license issued under this provision shall be valid until the issues of non-compliance are remedied and evidence of compliance is submitted to the Department. The license issued under this provision shall be valid until the issuance of a regular license but shall generally not exceed four (4) months following date of issuance, whichever may be sooner.

3.4.12

Upon acceptance of a license issued by the Department to operate as a medical cannabis establishment pursuant to this Part and the Medical Cannabis Act, the licensee shall: A. Post the license or permit in a location in the medical cannabis establishment that is conspicuous; B. Comply with the provisions of the Act and the rules and regulations contained in this Part; C. Comply with directives of the Department including time frames for corrective actions specified in inspection reports, audit reports, notices, orders, warnings, and other directives issued by the Department in regard to the license holder’s medical cannabis business or in response to community emergencies; D. Be subject to the administrative, civil, injunctive, and criminal remedies authorized in law for failure to comply with rules in this Part or a directive of the Department, including time frames for corrective actions specified in inspection reports, audit reports, notices, orders, warnings, and other directives; and, E. Bear the financial responsibility for all compliance and inventory tracking 51

obligations and responsibilities set forth in Mississippi statutes and rules in this Part.

3.4.13

Licensees shall register with the Mississippi Department of Revenue for tax purposes.

3.5

Oversight and Inspections.

3.5.1

The physical location of medical cannabis establishments, all general business (inclusive of employee records) of the establishments, all financial records of the establishments, and vehicles utilized to transport cannabis and/or cannabis products (which requires a cannabis transportation entity license) are subject to reasonable inspection by the Department.

3.5.2

The Department shall conduct at least one on-site inspection of all medical cannabis establishments. Inspections by the Department may be scheduled or unannounced but generally shall occur during the reported hours of operation included in the licensee’s operating plan submitted as a requisite component of the application for licensure.

3.5.3

Cannabis testing facilities are subject to inspection by the Department during business hours, including but not limited to, inspection of the physical cannabis testing facility, interviews of personnel, review, inspection, and audit of records and documents related to the analyses of dispensary samples to verify compliance with this Part.

3.5.4

Medical cannabis licensees shall cooperate with the Department during any inspections, requests to resolve complaints, requests for information/data, etc. in order to verify compliance with this Part, the Mississippi Medical Cannabis Act and any subsequent versions of the rules and regulations in this Part and the Act.

3.5.5

If the Department discovers what it reasonably believes to be criminal activity or other violations of Mississippi law during an inspection, the Department may refer the matter to appropriate Mississippi state or local law enforcement or regulatory authorities for further investigation.

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3.6

Authority Relating to Inspections and Investigations; Administration of Provisions of Program.

3.6.1

Except for license information concerning licensed patients, the Department may share confidential information to assist other agencies in ensuring compliance with applicable laws, rules, and regulations.

3.7

Term of License.

3.7.1

Regular licenses issued by the Department under this Part are valid for one year from the date of issuance.

3.8

Renewal of Licensure.

3.8.1

Regular licenses issued by the Department under this Part require annual renewal.

3.8.2

The Department shall send notification to each licensee of the duty to renew at least sixty (60) days prior to the expiration date of an active license. Notification will be to the email address of the primary contact person designated by the licensee on its application or latest renewal, as applicable.

3.8.3

License Renewal Process. A. A license issued under this Part may be renewed annually if the medical cannabis establishment: 1. Submits to the Department a renewal application in the manner prescribed by the Department within thirty (30) days prior to the expiration date on the license that includes as applicable: a. Copy of current Certificate of Good Standing from the Mississippi Secretary of State’s Office; b. New, updated or revised service agreements; c. Any new or updated Standard Operating Procedures; d. Updated and/or revised diagram of the licensee’s premises; e. Copy of licensee’s current insurance policy; f. Updated vehicle information (transportation and disposal licensees); 2. Continues to meet all the requirements of this Part; and,

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3. Submits proof that the licensee remains in compliance with all requisite local permits and licenses; and, 4. Submits the renewal fee for the license to the Department as required in Rule 3.2.2. B. Before renewing a license, the Department may require further information and documentation and may conduct additional background checks to determine that the licensee continues to meet the requirements of this Part. C. A licensee whose license is not renewed shall cease all operations immediately upon expiration of the license, schedule a close out inspection with the Department, and destroy all cannabis and cannabis products in the licensee’s possession in a manner approved by the Department.

3.8.4

At the time of renewal, the licensee shall ensure that all material changes to the required plans and/or standard operating procedures have been communicated in writing to the Department.

3.8.5

An inspection by the Department within sixty (60) days prior to expiration of a license issued under this Part may be required at the Department’s discretion for renewal of the license.

3.8.6

A license may be suspended, revoked, and shall not be renewed by the Department if: A. Outstanding fines are owed to the Department; B. An owner has been convicted of a disqualifying felony; C. The medical cannabis establishment has not engaged in licensed activity at the licensed premises for a period of one (1) year, unless the medical cannabis establishment submits evidence of reasonable justification, including without limitation death, illness, natural disaster, or other circumstances beyond the medical cannabis establishment’s control; D. Renewal will result in any person having a direct or indirect ownership or economic interest of greater than ten percent (10%) in more than one (1) Mississippi cannabis cultivation entity license; more than one (1) Mississippi cannabis processing entity license; and more than five (5) Mississippi cannabis dispensary licenses;

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E. The licensed entity owes delinquent taxes. Applicants who have completed an agreed upon payment plan and/or are following an agreed upon payment plan are not considered to be delinquent; F. The licensed entity no longer meets all eligibility requirements for the issuance of a medical cannabis establishment license; G. The licensed entity does not meet regulatory requirements set by the Department; and/or, H. The licensed entity provides of misleading, incorrect, false or fraudulent information.

3.8.7

The application for renewal of a medical cannabis establishment license may be denied after consideration by the Department of the licensee’s demonstrated history of violations of the rules in this Part. The number and severity of violations will be considered by the Department.

3.8.8

If the license of a medical cannabis establishment expires (by date), isn’t renewed, or is suspended or revoked, operations of that establishment that are authorized by rules and regulations in this Part and the MS Medical Cannabis Act must cease as instructed by the Department.

3.9

Procedure for Termination of License.

3.9.1

Licensees who permanently abandon the licensed premises or otherwise permanently cease all activities relating to the operation of a medical cannabis establishment under its license, whether a result of revocation, voluntary surrender or other reasons, shall follow the following procedures for terminating the license: A. Provide written notice of abandoning the licensed premises or ceasing operations at least forty-eight (48) hours in advance to the Department stating the reason for surrender of the license; name(s) and contact information of the person(s) responsible for closing of all business operations; and the address where business records will be retained. B. Provide the Department with a full accounting of all cannabis plants, cannabis and cannabis products located within the licensed premises; and, C. Destroy all cannabis plants, cannabis and cannabis products in its possession as instructed by the Department.

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The annual licensing fee paid at the time of application is non-refundable. No portion of the annual licensing fee shall be returned to the licensee.

3.10

Transfer of Ownership Requirements.

3.10.1

A licensee may transfer ownership interests, including without limitation partial ownership, only after the application for a transfer of an ownership interest has been approved by the Department.

3.10.2

An application for the transfer of ownership interests in a medical cannabis establishment shall: 1. Be completed on forms and/or a system made available by the Department; 2. Be submitted to the Department; and, 3. Contain all required supplemental information provided by the person or entity seeking to assume an ownership interest, similar to that which is required in an application for a cannabis cultivation license, to demonstrate compliance with all applicable requirements for licensure, including but not limited to fingerprinting and background check requirements.

3.10.3

The Department may revoke or suspend a license upon discovery of any effort or attempt to transfer an ownership interest in a license without complying with the requirements of this Part.

3.10.4

All information and documents required by the Department, including but not limited to, the following must accompany an application for change of ownership for a cannabis testing entity: 1. The legal name of the cannabis testing entity; 2. The name of each principal officer and board member of the cannabis testing entity; 3. An attestation that the information provided to the Department regarding the change of ownership for a cannabis testing entity is true and correct; 4. The signatures of the owners of the cannabis testing entity and the technical laboratory director and the date each signed; 5. For each owner:

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A. An attestation signed and dated by the owner that the owner has not been convicted of an excluded felony offense; B. An attestation signed and dated by the owner that the owner does not have a direct or indirect familial or financial relationship with or interest in a dispensary, cannabis cultivation entity, cannabis processing entity, cannabis disposal entity or cannabis research entity; and, C. An attestation signed and dated by the owner pledging not to divert cannabis to any individual or entity that is not allowed to possess cannabis; 6. Verification for each principal officer or board member that they are at least twenty-one (21) years of age.

3.11

Work Permit Licenses.

3.11.1

A medical cannabis establishment representative as defined in this Part shall register for and obtain a work permit license issued by the Department before the individual may work for, volunteer at, or maintain his/her ownership interest of ten percent (10%) or greater, whether direct or indirect, in a medical cannabis establishment licensed by the Department.

3.11.2

To be eligible to obtain a work permit, an individual shall be at least twenty-one (21) years of age.

3.11.3

An applicant for an initial work permit or renewal of a work permit shall complete a fingerprint-based background check of the Mississippi Central Criminal Database and the Federal Bureau of Investigation Criminal History Database and shall not have a disqualifying felony offense.

3.11.4

A work permit license shall be valid for five (5) years from the date of issuance by the Department.

3.11.5

A medical cannabis work permit shall be the property of the licensed individual and non-transferrable.

3.11.6

Anyone holding a valid work permit shall provide written notification to the 57

Department within ten (10) business days of a name change.

3.11.7

All applicants for a Work Permit shall complete the application required by the Department and include all documentation set forth in this Part, pay the appropriate nonrefundable application and fingerprinting/background fees to the Department, and be approved as a valid work permit license-holder by the Department prior to beginning work at/for a medical cannabis establishment licensed by the Department or the MDOR.

3.11.8

All information and documents required by the Department, including but not limited to, the following shall accompany an initial or renewal application for a medical cannabis work permit: A. Current photograph, meeting the following requirements: 1. Clear, color photograph of the head and top of shoulders (headshot); 2. In a .jpg, .png, or .gif digital image format; 3. Taken in the last six (6) months to reflect the applicant’s appearance; 4. Taken in front of a plain white or off-white background; 5. Taken in full-face view directly facing the camera at eye level with nothing obscuring the face; 6. With a neutral facial expression and both eyes open; 7. No hat or head covering that obscures the hair or hairline, unless worn daily for a religious purpose. Full face shall be visible, and the head covering shall not cast any shadows on the face; 8. Shall not be digitally enhanced to change the appearance of the applicant (e.g., use of “filters”); 9. Other photo requirements as specified by the Department; B. Copy of a current driver’s license or state-issued ID card issued by the state department of motor vehicles; C. Copies of all current state issued professional licenses; D. Authorization for the Department to perform a criminal history records check; E. An attestation that the information provided to the Department to apply for a medical cannabis establishment employee work permit and registration is true and correct; 58

F. Fees as required by the Department.

3.11.9

Application and Permit Fees: Initial and Renewal. The following nonrefundable fees are due and payable at the time of initial registration for a work permit and at the time of renewal of such permit: A. Medical Cannabis Work Permit registration fee of $25.00. B. Fingerprinting and Department background records check fee(s) in addition to the work permit registration fee. C. All payments shall be made through the Department’s electronic payment system(s) found on the Department’s website.

3.11.10

Medical cannabis establishments shall not employ any person who has been convicted of a disqualifying felony offense as defined in this Part.

3.11.11

The Department may deny an application for registration or renewal of a work permit for any of the following reasons: A. Failure to provide the information required in this Part; B. Failure to meet the requirements set forth in this Part; C. Provision of misleading, incorrect, false or fraudulent information; D. Failure to pay all applicable fees as required; and/or, E. Any other grounds that serve the purposes of this Part.

3.11.12

If the Department denies an application for registration or renewal of a work permit, the Department shall notify the applicant in writing of the Department’s decision, including the reason for denial.

3.11.13

If an individual does not complete the continuing education required by this Part, the Department may revoke the individual’s work permit or suspend the work permit until such time as the education requirements are completed.

3.11.14

The Department may fine, suspend or revoke the work permit issued by the Department for a violation of any rules and/or regulations in this Part or any

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disqualifying felony offense.

3.11.15

A medical cannabis work permit applicant or registered permit-holder aggrieved by a decision of the Department denying, suspending or revoking registration of a medical cannabis work permit or imposing a fine or other penalty, the applicant permit-holder may file an administrative appeal in writing with the Department within twenty (20) days of receipt of the initial notice of the decision. If an applicant permit-holder fails to appeal within twenty (20) days of receipt of the initial notice, the Department’s decision becomes final.

3.11.16

The hearing decision of the Department on the denial of an application for registration or renewal of a work permit, or the revocation or suspension of a work permit, is a final decision of the Department. Any person or entity aggrieved by a final decision of the Department under the provisions of this Part may petition for judicial review of the decision as provided in Miss. Code § 41-137-59.

Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67.

Subpart 4

Operational & Recordkeeping Requirements

4.1

General.

4.1.1

All medical cannabis establishments, including cannabis testing facility laboratory operations, shall be physically located within the State of Mississippi.

4.1.2

Licensed medical cannabis establishments may produce and possess usable medical cannabis in an amount reasonably necessary to meet the demand for and needs of qualifying patients as demand and needs may be determined by the Department. At a minimum, the Department will utilize the following data sources to make such determinations: patient registry, medical cannabis establishment licensing data, and data produced by the statewide seed-to-sale system.

4.1.3

Cannabis processing entities that process edible cannabis products shall also comply with any and all Department regulations for Mississippi Food Manufacture and Sale with fees and inspection schedules associated with risk level 4 for the related manufactured food permit. 60

4.1.4

Commencement of Operations. Medical cannabis licensees shall notify the Department (in a format approved by the Department) of their intent to commence operations for which authority is granted by the licensure status, along with the date of the commencement. Notification to the Department shall include, but is not limited to: A. Verification of an operational alarm and video surveillance system meeting requirements in Rules 4.5.2 and 4.5.3; B. Verification of secure locks throughout the facility; C. Verification of implementation of biosecurity measures; D. Verification of access controls throughout the facility; E. Verification of initial inventory of cannabis and/or cannabis products; F. Verification of functional operation capacity; G. Verification of employment records (at the time); and, H. Verification of connection to the state’s seed-to-sale system.

4.1.5

A medical cannabis licensee that fails to maintain operations for any reason for more than six (6) months from the date of licensure after it has commenced business activities shall be notified in writing and given thirty (30) days from the date of notification from the Department to submit a written explanation why it so failed and, if it plans on continuing to operate as a licensee, a description of how it will correct the problem and prevent it from occurring again.

4.1.6

Licensed medical cannabis establishments shall only purchase, grow, cultivate, and use cannabis that is grown, cultivated, processed, and dispensed in this state. No medical cannabis that is grown, cultivated or processed in this state shall be transported outside of this state. No cannabis product shall be brought into the State of Mississippi for the purpose of converting, transforming, chemically engineering, or otherwise altering it into a compound or substance which would constitute cannabis and/or a cannabis product under this Part.

4.1.7

Medical cannabis establishments shall not acquire, possess, store, grow, cultivate, harvest, manufacture, produce, or transport cannabis or cannabis products for any person or entity other than those authorized by this Part.

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4.2

Personnel.

4.2.1

An individual shall not begin work at a medical cannabis establishment until after he or she obtains a work permit license issued by the Department. An individual is required to renew his or her permit every five (5) years.

4.2.2

Medical cannabis establishments shall complete a criminal history background check on each employee to verify that the employee does not have a disqualifying felony.

4.2.3

Medical cannabis establishments shall ensure that any and all persons who are employed by, volunteer for, and/or engaged in activities or operations under the direction of the licensee are qualified to perform their assigned duties.

4.2.4

All employees of a medical cannabis establishment shall be entered into the state’s seed-to-sale system within seven (7) calendar days of employment by the licensed entity.

4.2.5

A cannabis testing entity shall not employ an individual who also is employed or has ownership at any other medical cannabis establishment other than a licensed cannabis transportation entity. Further, when a cannabis testing entity owns a transport entity or any part thereof, the transport entity cannot have any ownership that creates a conflict of interest.

4.2.6

Test samples shall only be collected and transported by qualified lab employees Test samples shall not be transported between facilities in the same vehicle at the same time as any other cannabis product (e.g. retail-ready cannabis products) due to the potential for cross-contamination.

4.2.7

Cannabis testing entities shall employ a full-time supervisor or management employee who shall be responsible for the following: A. Overseeing and directing the scientific methods of the cannabis testing facility; B. Ensuring that the cannabis testing facility achieves and maintains a cannabis 62

testing facility quality assurance program; and, C. Providing ongoing and appropriate training to cannabis testing facility employees. D. To be considered qualified, the supervisor or management employee shall have at minimum: 1. A doctoral degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university; 2. A master’s degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university, plus at least 2 years of full-time practical experience; 3. A bachelor’s degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university, plus at least 4 years of full-time practical experience; or 4. A bachelor’s degree in any field from an accredited college or university, plus at least 8 years of full-time practical experience, four (4) years of which shall have been in a supervisory or management position.

4.2.8

Cannabis testing entities shall employ a full-time analyst who, at minimum shall have: A. Earned a master’s degree or a bachelor’s degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university; or B. Completed two (2) years of college or university education that included coursework in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university, plus at least 3 years of fulltime practical experience; and C. Demonstrated the analyst’s ability to perform a preparation and/or analytical method through: 1. A documented training program that includes a training checklist that is signed by the trainer and the analyst; and 2. A documented attestation that the analyst has read and understands the methods Standard Operating Procedure. D. Demonstrated an initial display of competency prior to analyzing any compliance sample. An initial display of competency for a method includes: 1. Obtaining quality control samples from an outside source or preparing the 63

samples using stock standards that are prepared independently from those used in instrument calibration. 2. Preparing four (4) aliquots at the concentration specified, or if unspecified, to a concentration of one (1) to four (4) times the LOQ for low-concentration analytes either concurrently or over a period of days. For higher-concentration analytes (such as potency), the concentration may be greater than four (4) times the LOQ. 3. Analyzing the aliquots either concurrently or over a period of days. 4. Using all results, assess the results against established and documented method acceptance criteria. E. Complete a continuing demonstration of competency annually thereafter for all methods performed. One of the following options shall be performed and documented: 1. Another initial demonstration of competency (as described above), or 2. Participation in a proficiency test study offered by an ISO/IEC 17043 proficiency test provider (if available); or 3. Analysis of one (1) sample of clean matrix that is fortified with a known quantity of the target analyte, with the result compared to method acceptance criteria. F. If an analyst has not run a specific analysis within one calendar year, he or she shall successfully complete an initial display of competency for this analysis and shall not run such analysis until competency has been demonstrated. G. If a method Standard Operating Procedure is significantly amended, an analyst must be retrained on the procedure, and the training documented.

4.2.9

Cannabis testing facilities entities shall employ designated sample collector who, at minimum, shall have: 1.

Documented attestation that the designated sample collector has read and understands the Sampling Standard Operating Procedure;

2. A documented sampling training program that includes principles, procedures, and policies of sampling and was provided by a qualified instructor who has demonstrated competency in performing the sampling methods referenced with all training documented on a training checklist for each sample matrix type that will be collected; 64

3. At least 8 hours of documented field training on various sampling techniques with a qualified instructor; 4. Documentation of an initial demonstration of capability (IDOC) through the comparison of replicate samples within a defined Relative Standard Deviation (%RSD) or the comparison of a sample collected to that of one collected by personnel with an existing IDOC within a defined RPD; 5. Thereafter, continuing demonstration of capability (CDOC) is required annually. The cannabis testing entity shall have a documented procedure for performing the CDOC. The cannabis testing entity shall retain documentation verifying CDOC for each designated sample collector and make this documentation available to the Department upon request; and, 6. If the Sampling SOP is significantly amended, all designated sample collectors shall be retrained on the procedure, and the training documented.

4.2.10

A cannabis testing entity must maintain a master of list of all controlled quality system documents and a signature log that includes the names, initials and signatures for all individuals who are responsible for signing or initialing any cannabis testing entity record.

4.2.11

Each licensed medical cannabis establishment is required to create an identification badge for its representatives/employees. This badge shall be conspicuously worn by all representatives /employees at all times while they are on the licensed premises or during transport of cannabis and/or cannabis products. Representatives/employees shall also maintain a copy of the Department issued work permit on their person while present at a medical cannabis establishment.

4.2.12

Within thirty (30) calendar days of the date of hire, licensed medical cannabis establishments shall ensure all employees are trained in at least the following for a minimum of eight (8) hours of initial training and five (5) hours of annual training: A. The rules and regulations contained in this Part; B. The use of security measures and controls that have been adopted by the facility for the prevention of diversion, inversion, theft, or loss of cannabis and/or cannabis products;

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C. Proper use of the statewide seed-to-sale system; D. Response to an emergency, including severe weather, fire, natural disasters, and unauthorized intrusions; and, E. The facility’s safety and sanitation procedures.

4.2.13

Medical cannabis licensees shall take reasonable measures and precautions to ensure the following measures for personnel: A. Disease control. Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of cannabis, cannabis products, components, contact surfaces, or packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected, unless conditions such as open lesions, boils, and infected wounds are adequately covered (e.g., by an impermeable cover). Personnel shall be instructed to report such health conditions to their supervisors. B. Cleanliness. All persons working in direct contact with cannabis, cannabis products, components, contact surfaces, and packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of cannabis or cannabis products. The methods for maintaining cleanliness include: 1. Wearing outer garments suitable to the operation in a manner that protects against allergen cross-contact and against the contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials; 2. Maintaining adequate personal cleanliness; 3. Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate handwashing facility before starting work, after each absence from the workstation, and at any other time when the hands may have become soiled or contaminated; 4. Removing all unsecured jewelry and other objects that might fall into cannabis, cannabis products, components, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which cannabis, cannabis products, or components are manipulated by hand. If such hand jewelry cannot be removed, it may be covered by gloves or material which can be maintained in an intact, clean, and 66

sanitary condition and which effectively protects against the contamination by these objects of the cannabis, cannabis products, components, contact surfaces, or packaging materials; 5. Maintaining gloves, if they are used in handling cannabis, cannabis products, or components, in an intact, clean, and sanitary condition; 6. Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints; 7. Storing clothing or other personal belongings in areas other than where cannabis, cannabis products, or components are exposed or where equipment or utensils are washed; 8. Confining the following to areas other than where cannabis, cannabis products, or components may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco; and 9. Taking any other necessary precautions to protect against allergen cross contact and against contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials with microorganisms or foreign substances (including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin). C. Responsibility for ensuring compliance by individuals with the requirements of this subchapter shall be clearly assigned to supervisory personnel who have the education, training, or experience (or a combination thereof) necessary to supervise the production of clean and safe cannabis and/or cannabis products.

4.2.14

Licensees shall not permit the consumption of cannabis and/or cannabis products on its licensed premises or by employees during working hours.

4.2.15

Contractors and Other Authorized Visitors. A. Contractors and other authorized visitors permitted access to a licensee’s premises who will not handle cannabis plants, cannabis or cannabis products, including but not limited to electricians, plumbers, engineers and alarm technicians, do not require an individual identification card issued by the licensed medical cannabis establishment. B. A contractor may enter a limited access area only if wearing a visitor identification badge, signed in and recorded on a visitor entry log and

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prevented from accessing cannabis plants, cannabis or cannabis products. 1. If the contractor is working in an area with immediate access to cannabis plants, cannabis or cannabis products, a licensee or employee shall supervise the contractor at all times. 2. If the contractor is working in an area in which locked doors, compartments or other physical security measures prevent the contractor from accessing cannabis plants, cannabis or cannabis products, a licensee or employee shall take reasonable precautions to ensure that the contractor remains in such areas and does not attempt to gain access to cannabis plants, cannabis or cannabis products. C. At all times while in a limited access area, the contractor shall display in a conspicuous place on their person a visitor identification badge. 1. The visitor identification badge shall display an identifying mark, which may be a clearly identifiable letter, number or symbol or combination thereof. 2. The visitor identification badge may be displayed on a sticker, a card on a lanyard, a card pinned to the clothing of the visitor, or by other effective means. D. A visitor entry log shall include, at a minimum: 1. The date and time of the visitor’s entry; 2. The date and time of the visitor’s departure; 3. The full name of the visitor; 4. The identifying number of the visitor’s state- or federally-issued identification; 5. The identifying mark on the visitor identification badge; 6. The individual identification card number of the person who will accompany the contractor, if required, while the contractor is in the limited access areas of the premises; and, 7. The purpose for which the contractor is accessing the limited access area(s). E. Any incident of noncompliance with the licensee’s authorized conduct that occurred while the contractor or visitor was in a limited access area of the premises shall be reported in writing to the Department within twenty-four (24) hours, including all information required by the visitor entry log.

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4.3

Facility and Grounds.

4.3.1

Medical cannabis establishments may be located in any area in a municipality or county that is zoned as agricultural or industrial or for which agricultural or industrial use is otherwise authorized or not prohibited, provided that it being there does not violate any other provision of this Part.

4.3.2

Medical cannabis establishments may be located in any area in a municipality or county that is zoned as commercial or for which commercial use is otherwise authorized or not prohibited, provided that the municipality or county has authorized the entity to be located in such area and that it being there does not violate any other provision of this chapter. The municipality or county may authorize this by granting a variance to an existing zoning ordinance or by adopting a change in the zoning ordinance that allows for those entities to be located in specific commercial areas.

4.3.3

A municipality or county may require a medical cannabis establishment to obtain a local license, permit or registration to operate, and may charge a reasonable fee for the local license, permit or registration, provided that this fee is consistent with fees charged to businesses that are not involved in the cannabis industry.

4.3.4

No individuals may reside at the same address and/or live on the same property where a medical cannabis establishment is located. Should a prospective owner of a medical cannabis establishment reside on an adjoining property, a separate address for the medical cannabis establishment shall be obtained from the county (e.g., 123 County Road and 123 A County Road). The medical cannabis establishment shall have a separate, independent address from any residential premises.

4.4

Facility Construction and Design.

4.4.1

All commercial cannabis activities shall take place in indoor, enclosed, locked and secure facilities with controls over environmental conditions such as humidity, temperature, and light and that preclude unfiltered air exchange with the outdoors. Condition changes outside of the facility should not significantly alter or affect environmental conditions inside the facility Outdoor cultivation of

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cannabis and processing of cannabis products are prohibited. “Home grow” of cannabis is prohibited.

4.4.2

Indoor, enclosed, and secure facilities. All operations and activities shall take place within a building or secure structure that meets all state and local electrical, fire, plumbing and building codes and specification(s) in addition to the following requirements: A. Has a complete roof enclosure supported by connecting permanent walls, constructed of solid materials extending from the ground to the roof; that: 1. Provides a sealed environment that prevents unfiltered air exchange with the outdoors; 2. Provides control over the environment (i.e., temperature, humidity, light, carbon dioxide levels, etc.); and, 3. Protects commercial cannabis activities from all external elements; B. Is secure against unauthorized entry; C. Has a foundation, slab, or equivalent base to which the floor is securely attached; D. Has commercial-grade door locks on all external doors that are locked at all times; E. Restricts access to only authorized personnel to locked and secure areas identified with signage and daily records of entry and exit; F. Plumbing is adequate to carry sufficient quantities of water to locations through the facility and convey sewage and waste from the facility without cross-contamination of potable water and waste; G. Water supplies should be sufficient for commercial cannabis activities; H. Toxic cleaning compounds, sanitizing agents, solvents, and pesticides shall be identified and stored in a manner that is in accordance with applicable local, state or federal law, rule, or regulation; and, I. A pest control management plan shall be implemented on the premises; J. Biosecurity measures shall be implemented and adhered to at all times.

4.4.3

Cannabis facilities shall be constructed in such a manner that: A. Ensure floors, walls, and ceilings may be adequately cleaned, kept clean, and

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kept in good repair; B. Prevent drip or condensate from fixtures, ducts, and pipes from contaminating cannabis, cannabis products, components, contact surfaces, or packaging materials; and C. Ensure Aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating cannabis, cannabis products, components, contact surfaces, or packaging materials with clothing or personal contact; D. Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where cannabis, cannabis products, or components are examined, produced, packed, or stored and where equipment or utensils are cleaned; E. Provide shatter-resistant light bulbs, fixtures, skylights, or other glass suspended over exposed cannabis, cannabis products, or components in any step of preparation, or otherwise protect against contamination in case of glass breakage; F. Provide adequate ventilation or control equipment to minimize dust, odors, and vapors (including steam and noxious fumes) in areas where they may cause allergen cross contact or contaminate cannabis, cannabis products, or components; G. Ensure fans and other air blowing equipment are located and operate in a manner that minimizes the potential for allergen cross-contact and for contaminating cannabis, cannabis products, components, contact surfaces, and packaging materials; and, H. Provide adequate screening or other protection against pests.

4.4.4

The perimeter of all licensed medical cannabis establishments shall be designed and maintained to discourage theft and diversion of cannabis and/or cannabis products. In addition to any local zoning requirements, all cannabis licensees shall: 1. Maintain adequate lighting to facilitate video surveillance at all times (24 hours per day/7 days per week); 2. Have landscaping that prevents the concealment of any person(s) from sight or video surveillance;

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3. Have fencing that ensures secure perimeter access and points of entry onto the premises including but not limited to around the grounds and that all stages of commercial cannabis activities are inaccessible to and hidden from view of the public. Licensed testing entities are exempt from this requirement. 4. Post signage in a conspicuous location at each entrance of the cannabis cultivation facility that reads “PERSONS UNDER 21 YEARS OF AGE NOT PERMITTED ON THESE PREMISES”; and, 5. Post signage in a conspicuous location at each entrance of the cannabis facility that reads “THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE”.

4.4.5

Cannabis cultivation licensees shall maintain physical access to their stock of cannabis plant(s) for safe and easy observation and inventory of each plant group. Aisles shall be open and accessible so as to allow inspection of the plants by the Department and shall provide a safe means for access and viewing of plants if plants are located/placed on an upper rack.

4.4.6

Separation of Functions. If a medical cannabis establishment is licensed as a cultivation entity and processing entity with both functions in the same physical space, there shall be physical separation between the two by connecting permanent walls, constructed of solid materials extending from the ground to the roof with separate means of entrance and exit.

4.5

Security and Surveillance.

4.5.1

Licensees shall designate a security manager with responsibility for overall facility security to include, but not limited to: adherence to security requirements; conducting semiannual audits of security measures to identify areas of needed improvements/corrective actions; employee training on security measures and controls; and, prevention of diversion/theft of cannabis and/or cannabis products.

4.5.2

Alarm Systems. All licensees and locations shall have alarm systems that meet the following: 1. Upon unauthorized entry, or attempted unauthorized entry, the alarm system shall transmit a signal directly to a central protection company or a law

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enforcement agency that has legal authority to respond. A designated employee of the licensee shall also be notified; 2. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas; 3. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing cannabis (of any type or stage of growth) and any room used for cannabis production operations and activities of any type; 4. Be equipped with failure notification systems to notify the licensee and law enforcement of any failure in the alarm system; and, 5. Have the ability to remain operational during a power outage.

4.5.3

Video Surveillance. All licensees and locations shall have video surveillance that meets the following: 1. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas, and parking areas; 2. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing cannabis (of any type or stage of growth), and any room used for cannabis production operations and activities of any type; 3. Digital archiving capabilities for a minimum of (120) days; 4. On-site and off-site monitoring capabilities; 5. At least one on-site display monitor, of at least twelve inches, connected to the system at all times shall be available; 6. Have the date and time embedded on all surveillance recordings without significantly obscuring the picture; and, 7. Use cameras that are capable of recording in both high and low lighting conditions. 8. Have the ability to remain operational during a power outage. 9. Licensing entities should undertake a vulnerability assessment of their standby power systems, to include: all system components and hazards likely to impact the facility, conduct a detailed accounting of what electrical devices are and are not supplied by the backup power, identify systems that should 73

not go down during a power outage event. 10. Licensees should have a backup power system/generator for backup power supply for up to a minimum of forty-eight (48) hours for portions of the facility that should be supplied with standby power during a power interruption. Licensees should have a safe and secure location for a digital backup archiving system in the facility located in a locked and secure area to prevent any unauthorized access or theft of video/recording system monitors or video footage.

4.5.4

Upon request, licensees shall make all information related to security alarm systems and video surveillance, monitoring, and recordings available to the Department within the timeframe requested.

4.5.5

Licensed medical cannabis establishments shall notify local law enforcement and the Department of any theft, robbery, break-in, or security breach that occurs on the premises, no later than twenty-four (24) hours after the licensee first becomes aware of the event. Notice to the Department shall include at minimum a description of any property that was stolen or destroyed, and the quantity of any usable cannabis that was stolen.

4.6

Health and Safety Standards.

4.6.1

General. A. Each licensee shall ensure that all cannabis and cannabis products it dispenses are safe for use or consumption by registered patient cardholders. B. Each licensee shall comply with State and county health, safety, and sanitation laws and regulations and will be subject to unannounced inspections to confirm that no health or safety concerns are present which may contaminate the cannabis or cannabis products.

4.6.2

General Sanitation Requirements. All medical cannabis establishment licensees shall maintain sanitary conditions at their respective facilities and locations that include the following: 1. Any employee who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial 74

contamination for whom there is a reasonable possibility of contact with cannabis and/or cannabis products shall be excluded from any operations which may be expected to result in such contamination until the condition is resolved. 2. Hand-washing areas that are adequate and convenient to employees. Hand washing or sanitizing areas shall include running water at a suitable temperature and a sanitary towel service or suitable drying device. 3. Any person working in direct contact with cannabis and/or cannabis products shall: 1. Maintain adequate personal cleanliness; 2. Wash hands and exposed portions of his or her arms thoroughly in an adequate hand-washing area before starting work and at any other time when the hands may have become soiled or contaminated, including but not limited to: a. Any time after handling possibly soiled equipment or utensils; b. After leaving the initial room in which he or she was working, and before resuming work in any room, including the initial room; D. Litter and waste shall be properly removed so they do not contribute to potential sources of contamination in areas where cannabis plants or products are located; E. Floors, walls, and ceilings shall be adequately cleaned and kept in good repair; and, F. There shall be adequate screen or other protection against the entry of pests.

4.6.3

Sanitary Operations. A. General maintenance. Buildings, fixtures, and other physical facilities shall be maintained in a clean and sanitary condition and shall be kept in repair adequate to prevent cannabis or cannabis products from becoming contaminated. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against allergen cross-contact and against contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials. B. Substances used in cleaning and sanitizing; storage of toxic materials. Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable microorganisms and shall be safe 75

and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means, including purchase of these substances under a letter of guarantee or certification or examination of these substances for contamination. Only the following toxic materials may be used or stored in a medical cannabis production center: 1. Those required to maintain clean and sanitary conditions; 2. Those necessary for use in laboratory testing procedures; 3. Those necessary for facility and equipment maintenance and operation; and, 4. Those necessary for use in the facility’s operations. C. Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified and stored in a manner that protects against contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials. D. Pest control. Pests shall not be allowed in any area of a production center. Guard, guide, or pest-detecting dogs may be allowed in some areas of a production center if the presence of the dogs is unlikely to result in contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials. Effective measures shall be taken to exclude pests from the production and storage areas and to protect against the contamination of cannabis, cannabis products, or components on the premises by pests. The use of pesticides to control pests in the production center is permitted only under precautions and restrictions that will protect against the contamination of cannabis, cannabis products, components, contact surfaces, and packaging materials. E. Sanitation of contact surfaces. All contact surfaces, including utensils and contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against allergen cross-contact and against contamination of cannabis, cannabis products, or components. 1. Contact surfaces used for producing and storing cannabis or low-moisture cannabis products or components shall be in a clean, dry, sanitary condition before use. When the surfaces are wet cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use. 2. In wet processing, when cleaning is necessary to protect against allergen cross contact or the introduction of microorganisms into cannabis, cannabis products, or components, all contact surfaces shall be cleaned and sanitized before use and after any interruption during which the 76

contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and contact surfaces of the equipment shall be cleaned and sanitized as necessary. 3. Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) shall be stored, handled, and disposed of in a manner that protects against allergen cross-contact and against contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials. F. Sanitation of non-contact surfaces. Noncontact surfaces of equipment used in the operation of a production center shall be cleaned in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of cannabis, cannabis products, components, contact surfaces, and packaging materials. G. Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized portable equipment with contact surfaces and utensils shall be stored in a location and manner that protects contact surfaces from allergen cross-contact and from contamination.

4.6.4

Sanitary Facilities and Controls. Each medical cannabis establishment shall be equipped with adequate sanitary facilities and accommodations including: A. Water supply. The water supply shall be adequate for the operations intended and shall be derived from an adequate source. Any water that contacts cannabis, cannabis products, components, contact surfaces, or packaging materials shall be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the production of cannabis and cannabis products, for the cleaning of equipment, utensils, and packaging materials, or for employee sanitary facilities; B. Plumbing. Plumbing shall be of adequate size and design and adequately installed and maintained to: 1. Carry adequate quantities of water to required locations throughout the facility; 2. Properly convey sewage and liquid disposable waste from the facility; 3. Avoid constituting a source of contamination to cannabis, cannabis products, components, water supplies, equipment, or utensils or creating

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an unsanitary condition; 4. Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and 5. Provide that there is not backflow from, or cross-connection between, piping systems that discharge wastewater or sewage and piping systems that carry water for cannabis or cannabis product production; C. Sewage disposal. Sewage shall be disposed of into an adequate sewerage

system or disposed of through other adequate means; D. Toilet facilities. Licensees shall provide employees with adequate, readily

accessible toilet facilities. Toilet facilities shall be kept clean and shall not be a potential source of contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials; E. Hand-washing facilities. Licensees shall provide hand-washing facilities

designed to ensure that an employee’s hands are not a source of contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature; and rubbish disposal. Rubbish shall be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of cannabis, cannabis products, components, contact surfaces, packaging materials, water supplies, and ground surfaces.

4.6.5

Each production area designated and/or used for commercial cannabis activities shall be maintained free of debris.

4.6.6

Potable water sources shall be utilized in processing/ manufacturing of cannabis and/or cannabis products.

4.7

Extraction/Processing.

4.7.1

Cannabis processing licensees may utilize chemical extraction processes using a nonhydrocarbon-based, or other solvent such as water, vegetable glycerin, vegetable oils, animal fats, steam distillation, food-grade ethanol. Nonhydrocarbon-based solvents shall be food grade.

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4.7.2

Cannabis processing licensees may use chemical extraction processes using hydrocarbon-based solvents that are at least ninety-nine percent (99%) purity.

4.7.3

Extraction processes shall take place in an environment with proper ventilation, controlling all sources of ignition where a flammable atmosphere is, or could be, present.

4.7.4

Cannabis processing licensees are prohibited from using pressurized canned flammable fuel such as butane intended for use in outdoor/camp like activities, handheld torch devise, refillable cigarette letters, etc.

4.7.5

Cannabis processing licensees using carbon dioxide shall have equipment and facilities approved by local fire code officials, if applicable.

4.7.6

Manufacturing processes using flammable gas or flammable liquid shall have leak or gas detection measures, or both.

4.8

Storage of Cannabis and/or Cannabis Products.

4.8.1

Storage of cannabis, cannabis products, and components shall be under conditions that will protect against allergen cross-contact and against biological, chemical (including radiological), and physical contamination of cannabis, cannabis products, or components as well as against deterioration of the cannabis, cannabis product, or component and the container.

4.9

General Recordkeeping Requirements.

4.9.1

Medical cannabis establishments shall participate in and utilize the state’s seedto-sale system for inventory control and tracking purposes. All associated costs for their participation are the financial responsibility of the medical cannabis establishments.

4.9.2

Medical cannabis establishments are required to maintain the following for a minimum period of five (5) years:

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1. All books and records necessary to fully account for each business transaction conducted under its license; 2. A copy of each transportation manifest for each transport of cannabis and/or cannabis products shall be maintained (a separate license as a cannabis transportation entity is required if cannabis is being transported); 3. Employment records; 4. Record of all pesticides and chemical applications to cannabis and/or cannabis products; and, 5. Records of any theft, loss, or other unaccountability of any cannabis and/or cannabis products.

4.9.3

Records of all pesticides and chemical applications to cannabis plants and/or cannabis products shall include the following: 1. The date of application; 2. The name of the individual making the application; 3. The product that was applied; 4. The section, including the square footage, that receives the application; 5. The amount of product that was applied; and, 6. A copy of the label of the product that was applied.

4.9.4

All records shall be maintained on-site or electronically (virtually) and available for Department review at the address of the licensee.

4.9.5

All cannabis plants, cannabis and cannabis products shall be physically inventoried on a weekly basis and records maintained for a minimum of five (5) years. Any removal, including but not limited to disposal or destruction, of cannabis plants, cannabis or cannabis products shall be recorded.

4.10

Employment Records.

4.10.1

A medical cannabis establishment shall keep an individual employment record for all employees, including, but not limited to: 1. Full legal name and any nicknames;

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2. Detailed job description; 3. Record of all training received or acquired by the employee; 4. Dates of employment; 5. Records of days and hours worked; 6. Records of time worked; and, 7. Any disciplinary actions taken.

4.10.2

Employment records shall be maintained, either electronically or in hard copy, for at least five (5) years after the employee’s last date of employment with the cannabis cultivation facility.

4.10.3

Licensees shall ensure, document, and provide to the Department upon request, documentation that each medical cannabis establishment representative, as defined by this Part, meets the requirements of the Mississippi Medical Cannabis Act, and Department regulations.

4.11

Statewide Seed-to-Sale System and Inventory Control.

4.11.1

Licensees shall use the Department-designated seed-to-sale system directly for inventory tracking or may use an approved third-party integrator for interface into the Department-designated seed-to-sale system.

4.11.2

Licensees shall identify an employee with primary responsibility for seed-to-sale tracking (e.g., seed-to-sale system administrator).

4.11.3

Licensees shall ensure that all reporting into the Department approved statewide seed-to-sale system is clear, accurate, and transparent.

4.11.4

Licensees shall ensure its inventories are properly tagged and labeled in any manner which is compatible with the state seed-to-sale tracking program for tracking purposes and such tags may include bar codes, RFID tags, NFC tags, or other equivalent system for assigning unique numbers to cannabis plants, products, and packages:

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A. Tags shall contain the legal name and correct license number of the licensed medical cannabis establishment. B. Prior to a cannabis plant reaching a point where it is able to support the weight of a tag (8 inches in height), a tag may be securely fastened to the stalk or other similarly situated position approved by the Department. The tag shall remain affixed for the entire life of the plant until disposal. C. Cannabis shall be continuously and properly tagged (individually or as packages) at all stages of production, including all cultivation phases and/or production steps. D. Mother plants shall be tagged before any cuttings or clones are generated therefrom. Cuttings or clones taken from the mother plant for a plant batch shall be recorded in the state seed-to-sale program as being derived from that mother plant’s tag. E. If a tag is destroyed, stolen, or falls off of a cannabis plant or package, the licensee shall ensure a new tag is placed on the cannabis plant or package and the change is properly reflected in the State seed-to-sale system. F. Licensees shall not reuse any tags that have already been affixed to any cannabis plant or cannabis products. G. Each wholesale package of cannabis and/or cannabis products shall have a tag during storage and transfer and may only contain one batch of cannabis and/or cannabis products. This is inclusive of packages awaiting testing. H. Prior to transfer, licensees shall ensure that each immature plant batch is assigned a package tag in accordance with seed-to-sale system protocol and the rules in this Part. I. Licensees’ inventory shall have a tag properly affixed to all cannabis and/or cannabis products during storage and transfer in one of the following manners: A. Individual units of cannabis product(s) shall be individually affixed with a tag; B. Cannabis products may only be combined in a single wholesale package using one tag if all units are from the same production batch. C. If any cannabis and/or cannabis products are removed from a wholesale package, each individual unit or new wholesale package shall be separately tagged.

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4.11.5

All locations related to the commercial production of cannabis and cannabis products shall be distinguishable in the statewide seed-to-sale system. Locations identified in the system shall be designed and labeled in accordance with the licensee’s approved site plan and in a manner that identifies the position of inventory within the facility at all times.

Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67.

Subpart 5

PRODUCT TESTING AND SAFETY

5.1

General.

5.1.1

Cannabis testing entities shall test for cannabis-related analytes for which they are licensed and registered by the Department.

5.1.2

Cannabis testing entities shall develop and implement an employee training program to ensure competency of cannabis testing entity employees for their assigned function and shall document each employee’s qualifications.

5.1.3

Licensees shall not treat or otherwise adulterate a cannabinoid product, concentrate, cannabinoid extract, or extract with any non-cannabinoid additive that would increase potency, toxicity or addictive potential, or that would create an unsafe combination, with caffeine or other chemical that may increase carcinogenicity or cardiac effects.

5.1.4

All edible cannabis products shall be homogenized to ensure uniform disbursement of cannabinoids throughout the product(s).

5.1.5

Every medical cannabis establishment licensee shall comply with the testing requirements for cannabis and cannabis products in this Part.

5.2

Batch Requirements.

5.2.1

A medical cannabis establishment shall separate each harvest batch of usable medical cannabis into no larger than twenty-five pound (25 lb) harvest batch packages for testing purposes.

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5.2.2

Notwithstanding Rule 5.2.1 of this section, a medical cannabis establishment may combine harvest batch packages for purposes of test sampling if intended for use by a licensed processing entity to make a cannabinoid concentrate or extract

5.2.3

A medical cannabis establishment may not combine harvest batch packages for purposes of sampling and testing for THC or CBD.

5.2.4

A medical cannabis establishment shall assign each harvest and production batch a unique batch number as defined in this Part and that unique batch number shall be: A. Documented and maintained in the licensee’s records for at least two years and available to the Department upon request; B. Provided to the individual responsible for taking samples; and C. Included on the batch label.

5.3

Sample Size, Handling, Storage and Disposal.

5.3.1

An employee of a licensed testing facility will obtain and analyze test samples only from usable medical cannabis. Cannabis products shall be sampled and tested in final form in accordance with the rules in this Part.

5.3.2

Sampling shall be conducted on-site at the cannabis cultivation or processing entity. Testing entity personnel shall have access to the entire batch for the purposes of sampling.

5.3.3

Sampling Requirements for Mandatory Testing. A. All samples must be collected, stored, and transported in a way that mitigates contamination and degradation. B. Sampling of each harvest batch or production batch shall be conducted with representative samples such that there is assurance that all harvest or process lots are adequately assessed for contaminants and that the cannabinoid profile is consistent throughout.

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C. For mandatory harvest/production batch sampling, the total batch weight or count to be sampled shall be verified by the testing licensee. A testing licensee shall not pull samples for mandatory testing if there is reasonable belief the full batch is not present for sampling. D. A representative sample shall be taken from each container or area holding the harvest/production batch, from the top, middle, and bottom of the total contents. E. The sampling shall be video-recorded, with the batch number stated verbally or in writing on the video at the beginning of the video and a visible time and date indication on the video recording footage. A facility employee must be present but not involved nor assisting with the sampling. The video recordings shall be maintained for 90 calendar days.

5.3.4

The maximum harvest batch package is twenty-five pounds (25 lbs). For harvest batch sampling a licensed testing entity shall take a minimum of fifteen (15) sample increments of half a gram (0.5 g) each. Additional increments may be collected to ensure that the samples obtained are representative and sufficient to perform required testing.

5.3.5

The production batch for infused cannabis products (edible, non-edible liquids, non-edible solids) shall not contain more than 150,000 units. For infused and edible cannabis products, the test sample collected by a licensed testing entity for product testing shall comply with the minimum number of units set forth below based upon the production batch size. Additional increments may be collected to ensure that the samples obtained are representative. A. 3 units for a production batch of up to 100 units. B. 6 units for a production batch of 101 to 500 units. C. 9 units for a production batch of 501 to 1000 units. D. 12 units for a production batch of 1001 to 5000 units. E. 15 units for a production batch of 5001 to 10,000 units. F. 20 units for a production batch 10,001 to 35,000 units. G. 30 units for a production batch of 35,001 to 100,000 units. H. 50 units for a production batch of 100,001 to 150,000 units.

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5.3.6

For a cannabis concentrate, each sample increment taken by a licensed testing entity for product testing shall be one-quarter gram (0.25 g). The test sample collected by a licensed testing entity for product testing shall comply with the minimum number of increments set forth below based upon the production batch size. Additional increments may be collected to ensure that the samples obtained are representative. A. 12 increments for a production batch of 1 to 2 pounds. B. 15 increments for a production batch of 2.01 to 3 pounds. C. 18 increments for a production batch of 3.01 to 4 pounds. D. 23 increments for a production batch of 4.01 to 10 pounds. E. 30 increments for a production batch greater than 10 pounds.

5.3.7

A production batch of raw or infused pre-rolls shall contain no more than 150,000 units. The test sample collected by a licensed testing entity for product testing shall comply with the minimum number of increments relative to the batch size as set forth below. Additional increments may be collected at the discretion of the licensed testing entity to ensure that the samples obtained are representative. Each sample increment consists of one packaged unit. A. 2 units for a production batch of up to 50 units. B. 3 units for a production batch of 51 to 100 units. C. 4 units for a production batch of 101 to 500 units. D. 8 units for a production batch of 501 to 1500 units. E. 12 units for a production batch of 1501 to 3000 units. F. 20 units for a production batch of 3001 to 10,000 units. G. 30 units for a production batch of 10,001 units- 35,000 units. H. 50 units for a production batch of 35,001 units – 150,000 units.

5.3.8

A production batch of inhalable concentrate products shall contain no more than 150,000 units. The test sample collected by a licensed testing entity for product testing shall comply with the minimum number of increments relative to the batch size as set forth below. Additional increments may be collected at the discretion of the licensed testing entity to ensure that the samples obtained are representative. Each sample increment consists of one packaged unit.

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A. 2 units for a production batch of up to 50 units. B. 3 units for a production batch of 51 to 100 units. C. 4 units for a production batch of 101 to 500 units. D. 8 units for a production batch of 501 to 1500 units. E. 12 units for a production batch of 1501 to 3000 units. F. 20 units for a production batch of 3001 to 10,000 units. G. 30 units for a production batch of 10,001 units- 35,000 units. H. 50 units for a production batch of 35,001 units – 150,000 units.

5.3.9

A licensed testing entity shall not do any of the following: A. Desiccate samples; B. Test compliance samples without homogenization where required by the rules in this Part; or C. Select only the most desirable material from a batch or sample for testing; or D. Manipulate samples in any way that would alter the sample integrity or homogeneity of the sample. All sample increments must have the same genesis.

5.3.10

Only qualified employees/representatives of a licensed testing entity may collect and transport test samples and shall follow the testing entity’s accredited sampling and transportation policies and procedure when collecting samples for testing. A. A licensed testing entity shall prepare medical cannabis sampling policies and procedures that contain all of the information necessary for collecting and transporting samples from usable medical cannabis in a manner that does not endanger the integrity of the sample for any analysis required by this rule. These policies and procedures shall be appropriate to the matrix being sampled. B. Care shall be taken to avoid contamination of the non-sampled material. Sample containers shall be free of analytes of interest and appropriate for the analyses requested. C. A sufficient sample size shall be taken for analysis of all requested tests and

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the quality control performed by the testing laboratory for these tests. D. A licensed testing entity shall comply with any recording requirements for samples and subsamples in the policies and procedures and at a minimum: 1. Record the location of each sample and subsample taken. 2. Subsamples collected from the same batch shall be combined into a single sample by a laboratory prior to testing. 3. Subsamples and samples collected from different batches may not be combined. 4. Field duplicates may not be combined with the primary samples. 5. Assign a field identification number for each sample, subsample and field duplicate that have an unequivocal link to the laboratory identification number. 6. Assign a unique identification number for each test batch. 7. Have a documented system for uniquely identifying the samples to be tested to ensure there can be no confusion regarding the identity of such samples at any time. This system shall include identification for all samples, subsamples, preservations, sample containers, tests, and subsequent extracts or digestates. 8. Place the licensed testing entity identification code as a durable mark on each sample container. 9. Enter a unique sample identification number into the laboratory records. This number shall be the link that associates the sample with related laboratory activities such as sample preparation. In cases where the sample collector and analyst are the same individual, or the laboratory pre-assigns numbers to sample containers, the unique identification number may be the same as the field identification code. E. The test sample(s) shall be transported in one or more sealed containers and not be accessible while in transit. F. The vehicle a testing facility employee uses to transport medical cannabis test samples shall not bear markings or other indication that it is carrying cannabis or a cannabis product. G. All test samples shall be transported by a qualified employee of a licensed testing facility and shall not be transported in the same vehicle as other products. H. An employee of the medical cannabis establishment from which a test sample 88

is being collected shall be physically present to observe the testing facility employee collect the test sample and ensure that the sample increments are taken from throughout the batch. I. No employee of the medical cannabis establishment from which a test sample is being collected shall assist the testing facility employee nor touch the harvest and/or production batch package or sampling equipment while the testing facility employee is obtaining the test sample. J. After test samples have been selected, both the employee of the medical cannabis establishment having the test samples collected and the employee of the testing facility shall sign and date the chain of custody form, attesting to the following sample information: 1. Product name; 2. Weight of product; 3. All products and test samples are correctly identified in the statewide seed-to-sale system; and, 4. If the test sample is obtained for a retest, the testing facility confirms that it is not accepting a test sample that is prohibited from being retested. K. The medical cannabis establishment from which the test sample is collected shall enter in the statewide seed-to-sale system the test sample that is collected by a licensed testing facility, including the date and time the test sample is collected and transferred. L. When a test sample is collected from a medical cannabis establishment for testing, that licensee shall quarantine the product that is undergoing the testing from any other product at the facility. The quarantined product may not be packaged, transferred, or sold until passing test results are entered into the statewide monitoring system. M. Any cannabis or cannabis product collected for testing shall not be transferred or sold to any person or entity other than the licensee from whom the sample was collected. This provision does not apply to a testing facility that engages another testing facility to perform certain safety tests on a subcontracted basis. N. A testing facility may collect additional sample material from the same licensee from which the original sample was collected for the purposes of completing the required safety tests as long as the requirements of this Rule are met.

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5.3.11

An approved testing entity shall store each test sample under the appropriate conditions to protect the physical and chemical integrity of the sample. A. Analyzed test samples consisting of cannabis or cannabis-derived product shall be appropriately segregated, controlled, and held in a controlled access area pending destruction or other disposal. B. Any portion of a cannabis or cannabis-derived test sample that is not destroyed during analysis shall be: 1. Returned to the licensed producer who provided the sample under chain of custody; or 2. Destroyed in accordance with the disposal requirements of this Part.

5.3.12

A testing entity shall maintain the documentation required in these rules for at least five years and shall provide that information to the Department upon request.

5.4

Testing Requirements and Standards.

5.4.1

Testing Requirements for Cannabis and Cannabis Products. A. All sample increments collected must be homogenized prior to sample analyses, notwithstanding foreign material testing. B. Every harvest batch of cannabis flower shall be tested for the following prior to sale or distribution to a qualified patient or caregiver: 1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; 8. Foreign material in accordance with Rule 5.4.10 of this Part. C. Every production batch of raw pre-rolls shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver, for the

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following prior to sale or transfer: 1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; 8. Foreign material in accordance with Rule 5.4.10 of this Part. D. Every production batch of cannabinoid concentrate, and extract shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer: 1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; 8. Foreign material in accordance with Rule 5.4.10 of this Part. 9. A processing entity is exempt from testing concentrates for solvents under this Rule if the processing entity: a. Did not use any solvent listed in Appendix A, Table 2 1; and, b. Solvents in Used a mechanical extraction process to separate cannabinoids from the cannabis; or c. Used only water, animal fat or vegetable oil as a solvent to separate the cannabinoids from the cannabis. E. Every production batch of infused cannabis products shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer: 91

1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; 8. Foreign material in accordance with Rule 5.4.10 of this Part; and 9. Homogeneity. 10. Final form edible cannabis products shall meet the following additional requirements: a. Produced and sold with a standardized concentration of cannabinoids not to exceed ten milligrams (10 mg) of total tetrahydrocannabinol (THC) per serving with an allowable variance of ±10% when testing. b. Must demonstrate uniform disbursement of cannabinoids throughout the product when sampled and tested. 11. Infused non-edible products and beverages are exempt from water activity and moisture content testing. F. Every production batch of Kief shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer: 1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; and 8. Foreign material in accordance with Rule 5.4.10 of this Part; and G. Every production batch of infused pre-rolls and inhalable compound 92

concentrate products shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer: 1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; and 8. Foreign material in accordance with Rule 5.4.10 of this Part. H. Testing Standards: All compliance testing requirements by product type are summarized in Appendix D and all compliance testing requirements by final packaging are summarized in Appendix E.

5.4.2

Standards for Testing Microbiological Contaminants. A. Medical cannabis and medical cannabis products required to be tested for microbiological contaminants shall be sampled using appropriate aseptic technique and tested by a Mississippi licensed and registered cannabis testing entity for microbial impurities. B. The cannabis testing entity shall report the result of the microbial impurities testing by indicating “pass” or “fail” on the Certificate of Analysis. C. All cannabis products shall be deemed to have passed the microbial impurities testing if all of the following conditions are met: 1. Total coliform is not detected above 100 colony forming units/gram. 2. Shiga toxin-producing Escherichia coli is not detected in 1 gram; 3. Salmonella spp. is not detected in 1 gram; and 4. Pathogenic Aspergillus species A. fumigatus, A. flavus, A. niger, and A. terreus are not detected in 1 gram. 5. Total Yeast and Mold is not detected above 10,000 colony-forming units/gram. D. Microbial impurities testing shall include an optimized incubation period for 93

all plating-based methods used to report total coliform and total yeast and mold results. E. If the sample fails microbial impurities testing, the batch from which the sample was collected fails microbial impurities testing and shall not be released for retail sale. F. The testing entity shall follow the protocol or product instructions provided by the equipment manufacturer, including any enrichment steps. If enrichment is recommended but not required, the enrichment shall be performed. G. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.3

Standards for Testing Pesticides A. Medical cannabis and medical cannabis products required to be tested for pesticides shall be tested by a Mississippi licensed, and registered cannabis testing entity approved for the analytes listed in Appendix A, Table 1. B. The cannabis testing entity shall report whether any Residual Pesticides are detected above the limit of detection (LOD) and shall report the result of the testing in ppms on the Certificate of Analysis. The cannabis testing facility shall indicate “pass” or “fail” on the Certificate of Analysis. C. A batch fails pesticide testing if a cannabis testing entity detects the presence of a pesticide above the action levels listed in Appendix A, Table 1 in a sample: 1. During an initial test where no reanalysis is requested; or 2. Upon reanalysis as described in Rule 5.5.1 of this Part.

5.4.4

Standards for Testing Solvents. A. Medical cannabis products required to be tested for solvents shall be tested by a Mississippi licensed, and registered cannabis testing entity approved for the analytes listed in Appendix A, Table 1. B. The cannabis testing entity shall report the result of the residual solvents testing in ppm on the Certificate of Analysis and indicate “pass” or “fail” on the Certificate of Analysis. C. A batch fails solvent testing if a cannabis testing entity, during an initial test where no reanalysis is requested or upon reanalysis as described in section 94

5.5 of this Part: 1. Detects the presence of a solvent above the action level listed in Appendix A, Table 1; or 2. Calculates a RPD of more than twenty percent (20%) between the field primary result of the sample and the field duplicate result.

5.4.5

Standards for Testing Water Activity and Moisture Content. A. Medical cannabis and medical cannabis products required to be tested for water activity and moisture content shall be tested by a currently Mississippi licensed and registered cannabis testing entity. If a sample has a water activity rate of more than 0.65 aw the sample fails except for an edible infused cannabis product. B. An edible cannabis-infused product fails water activity testing if the water activity rate of more than 0.85 aw. C. Non-edible infused products are not subject to water activity testing. D. The cannabis testing entity shall report the result of the water activity test on the COA and indicate “pass” or “fail” on the COA. E. If a sample has a moisture content of more than fifteen percent (15%), the sample fails. The cannabis testing entity shall report the result of the moisture content on the COA and indicate “pass” or “fail” on the COA. F. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.6

Standards for Potency (THC and CBD) Testing. A. In the preparation of samples intended for potency analysis, the testing entity may not adulterate or attempt to manipulate the total potency of the sample by any means, including by the addition of trichomes that were removed during the grinding and homogenization process. B. All flower material used for potency testing shall be representative of the product used by the end consumer and homogenized in such a way that it is representative of the way a consumer would be using the product. Kief shall not be reintroduced to the flower sample during the homogenization process. C. A licensed cannabis testing entity shall test for the following at a minimum when testing medical cannabis and medical cannabis products for potency 95

without any corrective factor taken for moisture content: 1. Delta-8- tetrahydrocannabinol; 2. Delta-8- tetrahydrocannabinolic acid; 3. Delta-9-tetrahydrocannabinol; 4. Delta-9-tetrahydrocannabinolic acid; 5. Cannabidiol (CBD); 6.

Cannabidiolic acid (CBDA);

7. THC content; 8. Cannabinol (CBN); and 9. Any other cannabinoid determined by the department. D. A cannabis testing entity shall establish a limit of quantitation of 1.0 mg/g or lower for all cannabinoids analyzed and reported. E. A cannabis testing entity shall report the result of the cannabinoid testing on the Certificate of Analysis, including, at minimum: 1. A percentage for THC, THCA, CBD, and CBDA. The dry-weight percent shall be calculated using the below equation: Dry-weight percent cannabinoid = wet-weight percent cannabinoid/(1 − percent moisture/100); 2. A percentage for Total THC and Total CBD, if applicable; 3. Milligrams per gram (mg/g) if by dry-weight or milligrams per milliliter (mg/mL) if by volume for THC, THCA, CBD, and CBDA; 4. Milligrams per gram (mg/g) if by dry-weight or milligrams per milliliter (mg/mL) if by volume for Total THC and Total CBD, if applicable; 5. Total cannabinoid concentration shall be calculated for concentration expressed in weight: Total cannabinoid concentration (mg/g) = (cannabinoid acid form concentration (mg/g) x 0.877) + cannabinoid concentration (mg/g); 6. Milligrams per package for THC and CBD; 7. Milligrams per package for Total THC and Total CBD, if applicable; 8. Milligrams per serving for THC and CBD, if any; 9. Milligrams per serving for Total THC and Total CBD, if any and if applicable;

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10. For edible cannabis products, the cannabis testing entity shall also report, the concentration in milligrams per serving (mg/serving) and milligrams per package (mg/package). 11. The results of all other cannabinoids analyzed on the COA both as a percentage and in either milligrams per gram (mg/g) if by weight or milligrams per milliliter (mg/mL) if by volume. 12. The sample shall be deemed to have passed the cannabinoid testing if the amount of THC does not exceed the limits below: a. Cannabis flower or trim potency ≤ 30% total THC; b. Cannabis tinctures, oils or concentrates ≤ 60% total THC. F. A cannabis testing entity shall report the test results and indicate an overall “pass” or “fail” for the cannabinoid testing on the Certificate of Analysis. G. Total THC, and/or Total CBD claimed to be present on a label shall not be considered inaccurate if the difference in percentage on the certificate of analysis is plus or minus 10.0%. H. A production batch of cannabinoid concentrate or extract fails potency testing if, based on an initial test where no reanalysis is requested or upon reanalysis, the amount of THC, as calculated pursuant to Rule 5.4.6 of this Part, between samples taken from the batch exceeds twenty percent (20%) RSD. I. The testing facility shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.7

Standards for Testing for Heavy Metals. A. Medical cannabis and medical cannabis products shall be tested by a current Mississippi licensed and registered cannabis testing entity for the metals listed in Appendix A. B. A cannabis testing entity shall report the result of the heavy metals test on the Certificate of Analysis and indicate “pass” or “fail” on the COA. C. A batch fails metals testing if a cannabis testing entity, during an initial test where no reanalysis is requested or upon reanalysis as described in section 5.5 of this Part detects the presence of metals above the action level listed in Appendix A, Table 1. D. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

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5.4.8

Standards for Mycotoxin Testing. A. Medical cannabis and medical cannabis products shall be tested by a Mississippi licensed and registered cannabis testing entity for the following mycotoxins: Aflatoxin B1, B2, G1, and G2 Ochratoxin A. B. A batch shall be deemed to have passed mycotoxin testing if both the following conditions are met: 1. Total of aflatoxin B1, B2, G1, and G2 does not exceed 20 µg/kg of substance, and 2. Ochratoxin A does not exceed 20 µg/kg of substance. C. A cannabis testing entity shall report the result of the mycotoxin testing on the Certificate of Analysis and indicate “pass” or “fail” on the COA. D. A batch fails mycotoxin testing if a cannabis testing entity, during an initial test where no reanalysis is requested or upon reanalysis as described in section 5.5 of this Part detects the presence of mycotoxins above the action level listed in Appendix A, Table 1. E. The testing facility shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.9

Standards for Terpenoid Testing. A. Terpene analysis is not required. However, if terpene content is listed on product packaging or label, a terpene analysis from a Mississippi licensed and registered cannabis testing entity shall be performed to confirm the product label. B. A cannabis testing facility shall report the result of the terpenoid testing on the COA both as a percentage and in either milligrams per gram (mg/g) if by weight or milligrams per milliliter (mg/mL) if by volume. C. The terpenoid testing results on the label of any one terpenoid claimed to be present shall not be considered inaccurate if the difference in percentage on the COA is plus or minus 10.0%. D. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.10

Standards for Foreign Material Testing. 98

A. Medical cannabis and medical cannabis products shall be tested by a Mississippi licensed and registered cannabis testing entity to determine whether foreign material is present. B. A cannabis testing entity shall report the result of the foreign material test by indicating “pass” or “fail” on the COA. C. A cannabis testing entity shall perform foreign material testing on the total representative sample prior to sample homogenization. D. When the licensed testing entity performs foreign material testing, at minimum, it shall do all of the following: 1. Examine both the exterior and interior of the dried flower sample and; 2. Examine the exterior of the cannabis product sample. E. The sample shall be deemed to have passed the foreign material testing if the presence of foreign material does not exceed: 1. One-fourth (1/4) of the total sample area covered by sand, soil, cinders, or dirt; 2. One-fourth (1/4) of the total sample area covered by mold; 3. One (1) insect fragment, 1 hair, or 1 count mammalian excreta per 3.0 grams; or 4. One-fourth (1/4) of the total sample area covered by an embedded foreign material. F. If the sample fails foreign material testing, the batch from which the sample was collected fails foreign material testing and shall not be released for retail sale. G. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion.

5.4.11

Standards for Homogeneity Testing. A. Infused cannabis products must be homogenous, with the THC and CBD content evenly distributed throughout. B. Infused cannabis products shall only be considered homogenous if the concentration of total THC and/or CBD in milligrams per serving for three (3) units from the batch is +/- 15% of the stated THC/CBD per serving. C. Each type of infused product shall be tested every six (6) months and any time the manufacturing process or ingredient(s) change. 99

D. An infused cannabis product that fails homogeneity testing shall not be released for retail sale. All subsequent production batches of the failed item type shall undergo homogeneity testing until three (3) consecutive batches pass. E. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion. F. The processor shall maintain copies of the test results for each product type for at least one (1) year after the specific item is discontinued.

5.4.12

If a testing entity is not accredited for the full scope of state-required tests, the testing facility will need to subcontract with another Department-licensed testing facility for the relevant tests needed. All subcontracted testing shall be documented in the seed-to-sale system and be transferred using appropriate transport processes and chain of custody.

5.4.13

If a testing entity performs research and development testing, the laboratory shall comply with these rules. A. Punitive action shall not be taken against a licensed medical cannabis establishment for conducting research and development testing when permitted. B. The Department may publish guidance for research and development testing that shall be followed by all licensed medical cannabis establishments. C. Research and development testing is only permitted BEFORE compliance testing for all analytes except Terpenes, which shall always be ordered as an R&D test. D. All research and development testing shall be fully completed and reported into the seed-to-sale system by the testing entity BEFORE the final compliance testing can be ordered by the licensee. E. Research and development testing shall not replace the Department’s required safety compliance testing.

5.4.14

The Department shall take immediate disciplinary action, including sanctions, fines, or both, against any testing entity that falsifies records or fails to comply with the provisions of this Part.

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5.4.15

A testing entity shall comply with random compliance checks at the request of the Department. The Department or its authorized agents may collect a random sample of a medical cannabis product from a testing entity or designate another testing entity to collect a random sample of a medical cannabis product in a secure manner to test that sample for compliance pursuant to these Rules.

5.5

Failed Test Samples.

5.5.1

If a sample fails any initial test, the cannabis testing entity that did the testing may reanalyze the sample. If the sample passes, another cannabis testing entity shall resample the batch and confirm that result in order for the batch to pass testing.

5.5.2

If a sample fails a test or a reanalysis under Rule 5.5.1of this Chapter, the batch: A. May be remediated or sterilized in accordance with this subchapter; or B. If it is not or cannot be remediated or sterilized under this rule, it shall be destroyed in a manner specified by the Department.

5.5.3

If a cultivation entity is permitted under this Part to sell or transfer a harvest batch that has failed a test, the cultivation entity shall notify the processing entity to whom the harvest batch is sold or transferred of the failed test within twenty-four (24) hours of receipt of the COA.

5.5.4

Failed Microbiological Contaminant Testing. A. If a sample from a batch of usable medical cannabis fails microbiological contaminant testing, the batch may be used to make a cannabinoid concentrate or extract if the processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent, or a CO2 closed loop system. B. If a sample from a batch of a cannabinoid concentrate or extract fails microbiological contaminant testing, the batch may be further processed, if the processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent, or a CO2 closed loop system. C. A batch that is sterilized in accordance with subsection (A) or (B) of this rule shall be sampled and tested in accordance with this Chapter and must be tested, if not otherwise required for that product, for microbiological 101

contaminants, solvents and pesticides. D. A batch that fails microbiological contaminant testing after undergoing a sterilization process in accordance with subsection (A) or (B) of this rule shall be destroyed in a manner specified by the Department.

5.5.5

Failed Solvent Testing. A. If a sample from a batch fails solvent testing, the batch may be remediated using procedures that would reduce the concentration of solvents to less than the action level. B. A batch that is remediated in accordance with subsection (A) of this rule shall be sampled and tested in accordance with this Chapter and shall be tested if not otherwise required for that product under this Chapter, for solvents and pesticides. C. A batch that fails solvent testing that is not remediated or that if remediated fails testing shall be destroyed in a manner specified by the Department.

5.5.6

Failed Water Activity Testing and Moisture Testing. A. If a sample from a batch of usable medical cannabis fails for water activity or moisture activity, the batch from which the sample was taken may: 1. Be used to make a cannabinoid concentrate or extract; or 2. Continue to dry or cure. B. A batch that undergoes additional drying or curing as described in subsection (A) of this rule shall be sampled and tested in accordance with this Part.

5.5.7

Failed pesticide testing. If a sample from a batch fails pesticide testing, the batch may not be remediated and shall be destroyed in a manner permitted under this Part and/or approved by the Department.

5.5.8

Failed Potency Testing. A. Usable medical cannabis that fails potency testing under Rule 5.4.7 of this Part may be repackaged in a manner that enables the item to meet the standard in Rule 5.4.7 of this Part. B. Usable medical cannabis that is repackaged in accordance with this section 102

shall be sampled and tested in accordance with these Rules.

5.5.9

Failed Remediation. A. If a sample fails a test after undergoing remediation or sterilization as permitted under this rule, the batch shall be destroyed in a manner approved by the Department. B. A cultivation or processing entity shall inform a cannabis testing facility prior to samples being taken that the batch has failed a test and is being retested after undergoing remediation or sterilization. C. A cultivation or processing entity shall, as applicable: 1. Have detailed procedures for sterilization processes to remove microbiological contaminants and for reducing the concentration of solvents. 2. Document all sampling, testing, sterilization, remediation and destruction that are a result of failing a test under these rules. D. A cannabis or cannabis product batch may only be remediated twice. If the batch fails after a second remediation attempt and the second retesting, the entire batch shall be destroyed in a manner approved by the Department. E. Within one (1) business day of completing the required analyses of a representative sample obtained from a remediated cannabis or cannabis product batch, the cannabis testing entity shall upload the COA information into the seed-to-sale system.

5.6

Tentative Identification of Compounds.

5.6.1

Tentatively Identified Compounds (TICs) are compounds detected in a sample using gas chromatography mass spectrometry that are not among the target analytes for the residual solvent analysis.

5.6.2

The Department may initiate an investigation of a cultivation or processing entity upon receipt of a TICs report from a cannabis testing entity and may require a cultivation or processing entity to submit samples for additional testing, including testing for analytes that are not required by these rules, at the cultivation or processing entity’s expense.

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5.7

Certificate of Analysis (COA).

5.7.1

The cannabis testing entity shall generate a Certificate of Analysis for each representative sample that the cannabis testing entity analyzes.

5.7.2

The cannabis testing entity shall ensure that the COA contains the results of all required analyses performed for the representative sample.

5.7.3

The cannabis testing entity shall, within three (3) business day of completing all analyses of a sample, upload the COA into the seed-to-sale system. Passed test results shall be in the Department’s seed-to-sale system for a batch to be released for immediate processing, packaging, and labeling for transfer or sale in accordance with these Rules.

5.7.4

The cannabis testing entity shall not release to any person any cumulative or individual test results prior to completing all analyses and providing the COA to the Department.

5.7.5

The COA shall contain, at minimum, the following information: A. The term “Regulatory Compliance Testing” in font no smaller than 14point, which shall appear in the upper-right corner of each page of the COA. No text or images shall appear above the term “Regulatory Compliance Testing” on any page of the COA. B. The cannabis testing entity’s name, premises address, and license number; cultivator’s, or processor’s name, premises address, and license number; C. Batch number of the batch from which the sample was obtained. For cannabis and cannabis products that are already packaged at the time of sampling, the labeled batch number on the packaged cannabis and cannabis products shall match the batch number on the COA; D. Sample identifying information, including matrix type and unique sample identifiers; E. Sample history, including the date collected, the date received by the cannabis testing entity, and the date(s) of sample analyses and corresponding testing results; F. A picture of the sample of cannabis and cannabis products. If the sample 104

is pre-packaged, the picture shall include an unobstructed image of the packaging; G. For dried flower samples, the total weight of the batch in grams and the total weight of the representative sample in grams; H. For cannabis product or pre-rolls samples, the total unit count of both the representative sample and the total batch size; I. Measured of the cannabis and cannabis products; J. The analytical methods, analytical instrumentation used, and corresponding Limits of Detection (“LOD)” and Limits of Quantitation (“LOQ”); K. An attestation on the COA from the cannabis testing entity supervisory or management employee that all LQC samples required by this Part were performed and met the acceptance criteria; and, L. Analytes detected during the analyses of the sample that are unknown, unidentified, or injurious to human health if consumed, if any.

5.7.6

The cannabis testing entity shall report test results for each representative sample on the COA as follows: Indicate an overall “pass” or “fail” for the entire batch; A. When reporting qualitative results for each analyte, the cannabis testing entity shall indicate “pass” or “fail”; B. When reporting quantitative results for each analyte, the cannabis testing entity shall use the appropriate units of measurement as required under this Part; C. When reporting results for each test method, the cannabis testing entity shall indicate “pass” or “fail”; D. When reporting results for any analytes that were detected below the analytical method LOQ, indicate “<LOQ”, notwithstanding cannabinoid results; E. When reporting results for any analytes that were not detected or detected below the LOD, indicate “ND”; and, F. Indicate “NT” for any test that the cannabis testing entity did not perform.

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5.7.7

The cannabis testing entity supervisory or management employee shall validate the accuracy of the information contained on the COA and sign and date the COA.

5.7.8

The cannabis testing entity supervisory or management employee may request to amend a COA to correct minor errors and upload into the seed-to-sale system.

5.8

Post-Testing Sample Requirements.

5.8.1

The cannabis testing entity shall retain the reserve sample, consisting of any portion of a sample that was not used in the testing process. The reserve sample shall be kept at minimum, for forty-five (45) business days after the analyses, after which time it may be destroyed and denatured to the point the material is rendered unrecognizable and unusable.

5.8.2

The cannabis testing entity shall securely store the reserve sample in a manner that prohibits sample degradation, contamination, and tampering.

5.8.3

The cannabis testing entity shall provide the reserve sample to the Department upon request.

5.9

Transportation of Samples.

5.9.1

Qualified employees of a licensed cannabis testing entity are responsible for the collection and transportation of testing samples. Only qualified employees of a licensed cannabis testing entity shall collect and transport medical cannabis test samples. Medical cannabis test samples shall not be transported in the same vehicle with any other usable cannabis or cannabis products.

5.9.2

Licensed cannabis testing entities that transport medical cannabis test samples shall also comply with all applicable rules and regulations set forth in Subpart 7 of this Part.

5.9.3

Qualified employees/representatives of a licensed cannabis testing entity shall utilize an electronic inventory management system to create and maintain 106

transportation manifests documenting all transport of medical cannabis and medical cannabis products throughout the State of Mississippi.

5.9.4

When transporting medical cannabis test samples, all cannabis testing entities and their employees/representatives shall provide copies of the inventory manifests to each originating and receiving medical cannabis establishment at the time the product changes possession.

5.9.5

The copy of the inventory manifest to be left with the originating medical cannabis establishment shall include, at a minimum: A. The license number, business name, address, and contact information of the originating medical cannabis establishment; B. A complete inventory of the medical cannabis test samples to be transported, including the quantities by weight or unit of each type of medical cannabis and medical cannabis products and the batch number(s); C. The date of transportation and the approximate time of departure; D. Printed names, signatures, and identification card numbers of testing entity personnel accompanying the transport; E. The license number(s), business name(s), address(es), and contact information for all end point recipients.

5.9.6

The copy of the inventory manifest to be left with the receiving medical cannabis establishment shall include, at a minimum: A. The license number, business name, address, and contact information for the receiving medical cannabis establishment; B. The license number, business name, address, and contact information of the originating medical cannabis establishment; C. A complete inventory of the medical cannabis test samples delivered to the receiving medical cannabis establishment, including the quantities by weight or unit of each type of medical cannabis test sample and the batch number(s); D. The date and estimated time of arrival; E. The printed names, signatures, and identification card numbers of the personnel accompanying the transport; and F. The printed names, titles, and signatures of any personnel accepting delivery 107

on behalf of the receiving medical cannabis establishment.

5.9.7

Transportation manifests should reflect a complete chain of custody of all medical cannabis test samples being transported, including all instances in which the medical cannabis test samples are stored.

5.9.8

Originating and receiving licensed entities shall maintain copies of transportation manifests and inventory records logging the quantity of medical cannabis test samples received for at least three (3) years from the date of receipt.

5.9.9

A transportation manifest shall not be altered after departing from the originating medical cannabis establishment’s premises, except for the addition of the printed names, titles, and signatures of any personnel accepting delivery on behalf of the receiving cannabis testing entity.

5.10

Quality Assurance Measures for Cannabis Testing Entities.

5.10.1

The cannabis testing entity shall develop and implement a Quality Assurance (QA) program to assure the reliability and validity of the analytical data produced by the cannabis testing entity. The QA program shall, at minimum, include a written QA manual that addresses the following: A. Quality control procedures; B. Cannabis testing entity organization and employee responsibilities, including good laboratory practice (GLP);

training

C. QA objectives for measurement data; D. Traceability of data and analytical results; E. Instrument maintenance, calibration procedures, and frequency; F. Performance and system audits, G. Corrective action procedures; H. Steps to change processes when necessary; I. Record retention and document control; J. Test procedure standardization; and K. Method validation;

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and

L. Chain of custody protocols; M. Premise and sample security; N. Sample handling, including sample receipt, identification, rejection, storage and destruction; O. Contingency plans for data that is not within control limits, or is otherwise unacceptable for analysis; and P. Disposal of cannabis and laboratory waste.

5.10.2

The supervisory or management cannabis testing entity employee shall annually review, amend if necessary, and approve the QA program and manual both when they are created and when there is a change in methods, testing entity equipment, or the supervisory or management testing entity employee.

5.10.3

The cannabis testing entity’s standard operating procedures for testing methods shall include the following: A. The name of the testing method; B. A list of all analytes used in the testing method; C. The applicable matrix or matrices; D. Sample receipt and acceptance; E. Method sensitivity; F. Potential interferences; G. Analytical instrument and equipment used; H. Consumable supplies, reagents, and standards; I. Sample preservation and hold time; J. Type, frequency, and acceptable criteria for quality control samples; K. Type, frequency, and acceptable criteria for calibration standards; L. Procedures for analyzing batch samples; M. Data quality assessment and acceptance criteria; N. Calibration of results; and, O. Reagent solution and reference material preparation.

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P. Current step-by-step instructions with sufficient detail to perform the assay to include equipment operation and any abbreviated versions used by a testing analyst.

5.10.4

Each cannabis testing entity shall maintain a consumables log or inventory for all reagents, reference standards and media purchased and received. All reagents and reference standards, including any working standards, must be: A. Labeled to indicate identity, batch number, date received or prepared, expiration date, and where applicable, concentration or purity, and date opened; B. Stored under appropriate conditions to minimize degradation or deterioration of the material; C. Within their expiration or re-qualification dates at the time of use; and, D. Documented on records for each analysis.

5.10.5

Each cannabis testing entity shall calibrate and maintain its equipment as specified below, and the calibration, verification and/or check and maintenance must be documented. A. Trend testing space temperatures and humidity daily using NIST-certified temperature devices. Record corrective action if temperatures are out-ofrange. B. Check autoclaves performance with bioindicator monthly and use heatindicating tape with each cycle. C. Check automatic Pipettes or Micropipettors and Pipette Tips dispensing accuracy and precision quarterly and calibrate annually. D. Check balances daily with a documented zero before use and service and recalibrate annually. E. Inspect Biosafety cabinet airflow with each use and have certified annually. F. Clean blenders as required by manufacturer after each homogenization of submitted cannabis or cannabis products. G. Verify centrifuge speeds and temperatures daily and have certified annually. H. Calibrate conductivity monthly.

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I. Trend freezer and refrigerator temperatures daily using NIST-certified temperature devices. Record corrective action if temperatures are out-ofrange. J. Inspect glassware for chemistry cannabis testing entity with each use for cleanliness, chips, and etching with each use. Use class A when specified by the approved method and keep certificate of conformance per each piece of class A glassware. If class B or class A without a certificate of conformance, perform verification check upon purchase or prior to first use. K. Inspect glassware for microbiological cannabis testing entity with each use for cleanliness, chips, and etching. L. Trend incubator temperatures daily using NIST-certified temperature devices. Record corrective action if temperatures are out-of-range. M. Trend water bath temperatures daily using NIST-certified temperature devices. Record corrective action if temperatures are out-of-range. N. Trend Laminar Flow Hoods daily and service annually. O. Clean Microscope optics and stage daily and check alignment with each use. Service annually. P. Follow Microwave digestors manufacturer’s instructions. Q. Check Muffle furnaces temperature accuracy at least annually. R. Standardize pH meters with at least 2 buffer solutions daily before use. S. Check Spectrophotometers wavelength. T. Check Timers and stop watches at least annually. U. Certify reference weights annually. V. Follow Analytical Instrumentation manufacturer’s instructions for cleaning and maintenance and document all cleaning, calibrations, maintenance, and repairs. W. Maintain all service records for the life of equipment.

5.10.6

The cannabis testing entities shall develop, implement, and validate test methods for the analyses of samples as follows: A. To the extent practicable, methods shall compart with the following guidelines: B. The Bacteriological Analytical Manual (BAM), 2019, which is incorporated by reference, includes no future editions or amendments, and is available at 111

https://www.fda.gov/food/laboratory-methods-food/bacteriologicalanalytical-manualbam; C. AOAC Official Methods of Analysis, 21st Edition, 2019, which is incorporated by reference, includes no future editions or amendments, and is available at https://www.aoac.org/official-methods-of-analysis-21st-edition2019; and D. To the extent practicable, methods shall be validated in accordance with the following guidelines: 1. AOAC - Appendix J: Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces, 2012, which is incorporated by reference, includes no future editions or amendments, and is available at http://www.eoma.aoac.org/app_j.pdf; 2. AOAC - Appendix K: Guidelines for Dietary Supplements and Botanicals, 2013, which is incorporated by reference, includes no future editions or amendments, and is available at http://www.eoma.aoac.org/app_k.pdf; 3. ICH – Validation of Analytical Procedures: Text and Methodology Q2(R1) 2005, which is incorporated by reference, includes no future editions or amendments, and is available at https://database.ich.org/sites/default/files/Q2_R1__Guideline.pdf or Unofficial version of the Rules in 9 A.A.C. 17, effective September 8, 2022 Page 115 https://www.fda.gov/regulatory-information/search-fdaguidance-documents/q2-r1- validation-analytical-procedures-text-andmethodology. E. Method validation should, at a minimum, verify accuracy, precision, analytical sensitivity, analytical specificity, limit of detection, limit of quantification, reportable range and the identification of interfering substances. F. Methods adopted from a matrix specific standard method, inclusivity and exclusivity do not require a comprehensive reassessment, provided that there were no modifications to the methods, including, but not limited to, all of the following: 1. Referenced media. 2. Primers. 3. Probes. 4. Antibodies. 112

5. Critical chemistries that were not modified. 6. Microbial methods shall include environmental monitoring and quality control of all buffers, media, primers, and incubators. G. The licensed laboratory shall generate a validation report for each test method. Each validation report shall include the following information: 1. Instrument calibration data, if any; 2. Raw data, including instrument raw data scanned as a PDF, for each test method, if any; 3. Cannabis reference materials or certified reference material results; 4. Data and calculations pertaining to LOD and LOQ determinations, if any; 5. Quality Control Sample report; 6. Worksheets, forms, pictures, or copies of laboratory notebook pages H. The laboratory director shall review, approve, sign, and date the validation report for each test method. I. Validations shall be submitted to the agency for approval with an acceptable and graded external proficiency test by a third party, where all required analytes are shown to have passed. J. Upon new test methods or altered test methods being used in the laboratory, the new validation report shall be submitted to the Department within 5 business days.

5.11

Cannabis Testing Entity Quality Control Samples.

5.11.1

The cannabis testing entity shall use Quality Control samples (QC) and adhere to good, approved laboratory practice (“GLP”) in the performance of each analysis according to the specifications of this Part.

5.11.2

The cannabis testing entity shall analyze QC samples in the same manner as the cannabis testing entity analyzes cannabis and cannabis products samples.

5.11.3

The cannabis testing entity shall use at least one negative control, one positive control, and one cannabis testing entity replicate sample in each analytical batch for each target organism during microbial testing. If one of the controls

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produces unexpected results, the samples shall be re- prepped and reanalyzed with a new set of controls.

5.11.4

If the result of the microbial analyses is outside the specified acceptance criteria in Appendix A, Table 2, the cannabis testing entity shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria. Microbiology Culture Methods – Qualitative and Quantitative The quality control (QC) samples that are required for culturing of cannabis and cannabis products using qualitative and quantitative methods are included in Appendix A, Table 2. Molecular Assays/Methods The QC samples that are required for molecular (i.e., polymerase chain reaction (PCR), gel electrophoresis and probe-based qPCR with or without melting curve analyses) analysis of cannabis and cannabis products are listed in Appendix A, Table 3. PCR positive DNA controls are used to verify that the PCR master mix and reagents were prepared correctly to produce amplification of the target nucleic acid. This type of positive control is analyzed with each PCR run. A PCR run is defined as a group of samples that are analyzed at the same time under the same amplification conditions, using the same PCR master mix, and in the same thermocycler. A PCR run may contain more than one extracted sample batches. A PCR run with multiple assays must have a DNA positive control for each assay. Inhibition controls are used to verify that interfering constituents from a cannabis form, which may be carried over during isolation of nucleic acids or organisms during sample processing, do not inhibit the PCR. Because cannabis forms are constantly changing, inhibition positive controls must be performed in every extracted sample. PCR DNA negative controls are used to verify that the PCR master mix and reagents were prepared correctly to produce amplification of the target nucleic acid. This type of negative control is analyzed with each PCR run. A PCR run is defined as a group of samples that are analyzed at the same time under the same amplification conditions, using the same PCR master mix, and in the same thermocycler. A PCR run may contain more than one extracted sample batches. 114

A PCR run with multiple assays must have a DNA negative control for each assay to verify that the amplification conditions are working properly. No template controls are used to verify no contaminating nucleic acid has been introduced into the master mix. These controls are prepared when template is added to the master mix. They are prepared as separate PCR reactions to which aliquots of molecular-grade water or buffer are added to the master mix in place of target nucleic acid or sample. A negative result with this control indicates that the master mix and final processing reagents are not contaminated. This type of negative control is analyzed with each PCR run. A PCR run is defined as a group of samples that are analyzed at the same time under the same amplification conditions, using the same PCR master mix, and in the same thermocycler. A PCR run may contain more than one extracted sample batch. A PCR run with multiple assays must have not template controls for each assay to verify that the sterility of the assays. One duplicate sample is required per run. A duplicate sample is subjected to all of the same steps as the original sample. For qualitative analyses, if the duplicate sample does not equal the sample result, the sample and its duplicate must be reanalyzed. Consideration should also be given to possibility of re-preparing and reanalyzing all associated samples. For quantitative analyses, if the RPD of the sample and duplicate is greater than 100, the parent sample and duplicate sample must be reanalyzed. Consideration should also be given to possibility of repreparing and reanalyzing all associated samples. When data are accepted, the result for the sample portion designated as the “original sample” is reported.

5.11.5

Chemistry – Analytical, Organic and Inorganic (Metals). Quality control must be performed for each analytical, organic and metal chemistry method. Each cannabis testing entity shall maintain sufficient raw data records to ensure the QC was performed at the frequency specified. ‘Bracketing’ of QC samples, rotating from across the calibration curve range, is required. QC samples must follow the first twenty (20) samples after an initial calibration, every twenty (20) samples thereafter, and at the end of testing samples. This would also apply to a continuing calibration. Initial Calibration

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A. Samples results must be associated with an acceptable initial calibration. If the initial calibration is not acceptable, corrective actions must be performed and all associated samples re-analyzed. B. No sample results are to be reported nor data qualified for a failed initial calibration. C. Samples must be analyzed under an initial calibration that was performed no more than one month prior. D. The following items are required elements of an initial calibration: 1. The details of the initial calibration procedures including calculations, integrations, acceptance criteria, and associated statistics must be included or referenced in the method SOP. When initial calibration procedures are referenced in the method SOP, then the referenced material must be retained by the cannabis testing entity and be available for review; 2.

Sufficient raw data records must be retained to permit reconstruction of the initial calibration (e.g., calibration date, method, instrument, analysis date, each analyte name, and analyst or technician’s initials or signature; concentration and response, calibration curve or response factor; or unique equation or coefficient used to reduce instrument responses to concentration);

3. The cannabis testing entity must use the most recent initial calibration analyzed prior to the analytical batch; 4. Standards used for calibration must be traceable to an international or national standard, when commercially available; and 5.

The cannabis testing entity must have a written procedure addressing removal and replacement of calibration standards.

E. The lowest calibration standard must be at or below the lowest concentration for which quantitative data are to be reported without qualification. F. The highest calibration standard shall be at or above the highest concentration for quantitative data are to be reported without qualification. G. Sample results must be quantitated from the initial calibration and may not be quantitated from any continuing calibration verification. H. Criteria for the acceptance of an initial calibration must be established including any calculations (e.g., relative error, relative standard deviation). 1. R2 ≥ 0.990, and 116

2. Curve recovery of ±20% (and ±30% for the lowest point) for all points must be maintained. I. The cannabis testing entity must use and document a measure of relative error in the calibration as specified in the method SOP. Initial Calibration Verification A. All initial calibrations must be verified with a standard obtained from a second manufacturer or a separate lot prepared independently by the same manufacturer. B. Initial calibration verification is performed by analyzing a test solution of known analyte concentration(s) after initial calibration and prior to sample analysis. C. In general, the check must be ± 20% (± 30% for the lowest point) of the known value. Some individual methods may require tighter tolerances (±10% of the known value). Continuing Calibration Verification A. The validity of the initial calibration must be verified prior to sample analyses by a continuing calibration verification with each analytical batch. B. A CCV is performed by analyzing a test solution of known analyte concentration(s) prior to sample testing on each testing day and continued periodically during the analytical batch run, no less frequently than once after each set of 20 samples, and at the end of each run. C. The CCV must be a standard that is from the same vendor/lot that is used for the calibration curve. D. In general, the check must be ± 20% (and ± 30% for the lowest point) of the known value. E. Calibration must be verified for each compound, element, or other discrete chemical analyte, except for multi-component analytes where a representative chemical, related substance or mixture can be used. F. Instrument continuing calibration verification must be performed at the beginning and end of each analytical batch, and at the frequency defined in the method. G. Sufficient raw data records must be retained to permit reconstruction of the continuing instrument calibration verification (e.g., method, instrument, analysis date, each analyte name, concentration and response, calibration

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curve or response factor, or unique equations or coefficients used to convert instrument responses into concentrations). H. Continuing calibration verification records must explicitly connect the continuing calibration verification data to the initial calibration. I.

If the continuing instrument calibration verification results obtained are outside the established acceptance criteria, the following steps must be taken: 1. If a cause for the calibration verification failure is identified that impacts only the calibration verification sample (e.g., a missed autosampler injection), then analysis may proceed if a second calibration verification sample is analyzed immediately and the result is within acceptance criteria. Samples analyzed previously must be considered valid if bracketed by a passing calibration verification sample. The cause for the failure of the first calibration verification result must be documented; and 2. If the cause for the calibration verification failure is not identifiable or has impacted other samples, then corrective action must be performed and documented. Prior to analyzing samples, the cannabis testing entity must demonstrate acceptable performance after corrective action with calibration verification or a new initial calibration must be performed. Samples analyzed prior to the calibration verification failure must be reanalyzed.

J.

Data associated with an unacceptable calibration verification must not be reported with a qualifier. Qualifying the data is not an acceptable approach.

Low Level Continuing Calibration Verification A. A LLCCV will be run at the end of each analytical batch. B. The measured value must be within ± 30 % of the prepared value. C. The cannabis testing facility entity shall prepare and analyze at least one of each of the following QC samples for each analytical batch: 1. Negative Control, Method Blank; and 2. Positive Control, Laboratory Control Sample (LCS); 3. Matrix spike sample; 4. Duplicate matrix spike sample; and 5. Duplicate sample. D. The required QC is summarized in Appendix 2, Table 4. Negative Control – Method Blank (MB) 118

A. A method blank must be analyzed at a minimum of one (1) per preparation batch. B. The MB must be processed along with and under the same conditions as the associated samples to include all steps of the preparation and analytical procedure. C. The MB is used to assess the samples in the preparation batch for possible contamination during the preparation and processing steps. D. The measured concentration of each analyte in the MB or LRB must be < LOQ or MRL. E. Procedures must be in place to determine if a MB or LRB is contaminated. While the goal is to have no detectable contaminants, each method blank must be critically evaluated as to the nature of the interference and the effect on the analysis of each sample within the batch. F. The source of contamination must be investigated and measures taken to minimize or eliminate the problem and affected samples reprocessed if the concentration of a targeted analyte in the blank is at or above the LOQ, if the blank contamination otherwise affects the sample results as per the method requirements or the individual project data quality objectives, and a blank is determined to be contaminated. Samples associated with a contaminated blank must be evaluated as to the best corrective action for the samples (e.g., reprocessing or data qualifying codes). In all cases, the corrective action must be documented. G. Any affected samples associated with a contaminated MB or LRB must be reprocessed for analysis. Positive Control – Laboratory Control Sample (LCS) A. The LCS is used to evaluate the performance of the total analytical system, including all preparation and analysis steps. B. The LCS must be carried through the entire sample preparation process and analyzed. C. The LCS must be spiked with all target analytes at a mid-level concentration in the curve. D. The LCS must be analyzed at a minimum of one (1) per preparation batch. E. The LCS is a quality system matrix, known to be free of analytes of interest, spiked with known concentrations of analytes that are within the calibration range.

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1. A laboratory control sample (LCS) may be used in place of a continuing calibration verification (CCV) (but not as a replacement for a failing CCV) for methods where the calibration goes through the same process as the LCS. Note that the more stringent acceptance criteria must be met. 2. The matrix spike may be used in place of this control as long as the acceptance criteria are as stringent as for the LCS. 3. The lab may use commercially available or pre-prepared standards (separate from calibrators) for QC. F. All analyte concentrations must be within the calibration range of the methods. G. The individual LCS must be compared to the acceptance criteria stated in the standard operating procedure. The results of the individual batch LCS are calculated in percent recovery or other appropriate statistical technique that allows comparison to established acceptance criteria. The cannabis testing entity must document the calculation. H. When the acceptance criteria for the positive control are exceeded, those sample results must be investigated, and a corrective action implemented. Matrix Spikes and Matrix Spike Duplicates A. Analyze an actual sample with a known amount of standard added (matrix spike. MS). A second portion of the actual sample used to prepare the MS that is spiked and processed in the same manner as the MS (matrix spike duplicate, MSD). 1. For potency testing, a “representative matrix” may be used to prepare the MS/MSD. 2. MS/ MSD shall be spiked at a midlevel concentration with the target analytes. B. Calculate the relative percent difference (RPD) between first sample and replicate. The calculations must be documented, and the target value must be close to the first value and have a RPD of less than 20%. C. Matrix-specific QC samples indicate the effect of the sample matrix on the precision and accuracy of the results generated using the selected method. The information from these controls is sample/matrix specific and would not normally be used to determine the validity of the entire batch. D. For methods that include one (1) to twenty (20) targets, spike all components.

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E. For methods with more than twenty (20) targets, randomly spike at least sixteen (16) components. Sample Duplicate A. Analyze the same sample twice, using two separate preparations. The sample should be chosen at random and run together on the same analytical run. B. Calculate the relative percent difference (RPD) between first sample and replicate. Calculations must be documented, and the target value must be close to the first value and have a RPD of less than twenty percent (20%). Variability may be introduced during sample preparation. To account for this, if more than one staff member is prepping samples, each staff must also prepare and analyze a sample matrix duplicate for each set of prepared samples.

5.11.6

Physical Chemistry. Water Activity: A. Sample Duplicates. Analyze the same sample twice, using two separate preparations. The sample should be chosen at random and run together on the same analytical run. Calculate the relative percent difference (RPD) between first sample and replicate. Calculations must be documented, and the target value must be close to the first value and have a RPD of less than twenty percent (20%). Variability may be introduced during sample preparation. To account for this, if more than one staff member is prepping samples, each staff must also prepare and analyze a sample matrix duplicate for each set of prepared samples. B. Calibration. If the aw instrument is being used in a single location at the same temperature (61°C) and humidity (65% relative humidity), calibrate if it has been more than seven consecutive days since the last calibration. If the aw instrument is physically moved from one location to another, calibrate immediately following the move and prior to analyzing samples. If the aw instrument has been cleaned, then calibrate immediately following the cleaning. Follow any other calibration procedures listed in a consensus method and manufacturer’s instructional manual. C. Monitor temperature and humidity daily or on day of use and keep a record of the check.

5.12

Required Formulas.

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5.12.1

The cannabis testing entity shall prepare and analyze at least one of each of the following QC samples for each analytical batch: A. Method Blank; and B. Laboratory control sample (LCS); and C. Matrix spike sample; and D. Duplicate matrix spike sample.

5.12.2

The cannabis testing entity shall analyze, at minimum, a continuing calibration verification (“CCV”) sample prior to sample testing on each testing day and continued periodically during the analytical batch run no less frequently than once after each set of twenty (20) samples and at the end of each run. The CCV shall be a standard that is not from the same vendor/lot that is used for the calibration curve.

5.12.3

If the result of the chemical analyses is outside the specified minimum acceptance criteria in Appendix A, Table 3, the cannabis testing entity shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.

5.12.4

A cannabis testing entity shall use the following calculation for determining Relative Percentage Difference (RPD): RPD = (|Num1-Num2|/ Num1+Num2)/2 x 100 Where: Num1= Original Number Num2= Second Number

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5.12.5

A cannabis testing entity shall use the following calculation for determining Relative Standard Deviation (RSD):

5.12.6

For calculating both RPD and RSD if any results are less than the LOQ, the absolute value of the LOQ is used in the equation.

5.12.7

If any analyte is detected above any action level, as described in this Part, the sample shall be re-prepped and reanalyzed in replicate within another analytical batch.

5.12.8

For quantitative analyses, the re-prepped sample and its associated replicate shall meet the acceptance criteria of RPD ≤20%.

5.12.9

For qualitative analyses, the re-prepped sample and its associated replicate results shall concur.

5.12.10

If any quality control sample produces a result outside of the acceptance criteria, the cannabis testing entity cannot report the result and the entire batch cannot be released for retail sale. The cannabis testing entity shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.

5.12.11

If the cannabis testing entity determines that the result is a false-positive or a false- negative, the Department may ask for the cannabis testing entity to resample or re-test.

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5.12.12

The cannabis testing entity shall compile and generate one LQC sample report for each analytical batch that includes LQC acceptance criteria, measurements, analysis date, and matrix.

5.13

Limits of Detection (LOD) and Limits of Quantitation (LOQ) for Quantitative Analyses.

5.13.1

The cannabis testing entity shall calculate the LOD for chemical method analyses according to any of the following methods: A. Signal-to-noise ratio of between 3:1 and 2:1; B. Standard deviation of the response and the slope of calibration curve using a minimum of seven (7) spiked blank samples calculated as follows: LOD = (3.3 x standard deviation of the response)/slope of the calibration curve; or C. A method published by the United States Food and Drug Administration (USFDA) or the United States Environmental Protection Agency (USEPA).

5.13.2

The cannabis testing entity shall calculate the LOQ for chemical method analyses according to any of the following methods: A. Signal-to-noise ratio of 10:1, at minimum; B. Standard deviation of the response and the slope using a minimum of seven

(7) spiked Blank samples calculated as follows: LOQ = (10 × standard deviation of the response)/slope of the calibration curve; or C. A method published by the USFDA or the USEPA.

5.14

Cannabis Testing Entity Data Package.

5.14.1

The cannabis testing entity shall compile and generate one data package for each representative sample that the cannabis testing facility analyzes. A. All data generated during the testing of a test sample, except data generated by automated data collection systems, is recorded directly, promptly, and legibly in ink. All data shall be annotated with the date of entry and signed or initialed by the person recording the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such

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change, and shall be dated and signed or initialed at the time of the change. B. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in an entry shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or initialed at the time of the change. A corrective action report shall accompany such change and shall be made available to the department, a non-profit producer, and a manufacturer upon their request for up to two years after the analysis is completed. C. For each final result reported, an approved testing entity shall verify that: 1. Any calculations or other data processing steps were performed correctly; 2. The data meet any data quality requirements such as for accuracy, precision, linearity, etc.; 3. Any reference standards used were of the appropriate purity and within their expiration or requalification dates; 4. Any volumetric solutions were properly standardized before use; and, 5. Any test or measuring equipment used has been properly tested, verified, and calibrated, and is within its verification or calibration period.

5.14.2

The cannabis testing entity shall provide requested data packages to the Department immediately upon request.

5.15

Required Proficiency Testing.

5.15.1

A cannabis testing entity shall participate in a proficiency testing program for all methods available from an organization that operates in conformance with the requirements of ISO/IEC 17043 at least once every six (6) months.

5.15.2

The cannabis testing entity shall annually, successfully participate in a proficiency testing program for each test method performed for the below: A. Cannabinoids; B. Heavy metals; C. Microbial impurities ; D. Mycotoxins; E. Residual pesticides; 125

F. Residual solvents and processing chemicals; G. Foreign Material; and H. Terpenoids, if performed.

5.15.3

The cannabis testing entity shall report all analytes available by the proficiency testing program provider and for which the licensee is required to test under the rules in this Part.

5.15.4

The cannabis testing entity shall participate in the proficiency testing program by following the cannabis testing entity’s existing SOPs for testing cannabis and cannabis products.

5.15.5

The cannabis testing entity shall rotate the proficiency testing program among the cannabis testing entity employees who perform the test methods.

5.15.6

Cannabis testing entity employees who participate in a proficiency testing program shall sign the corresponding analytical reports or attestation statements to certify that the proficiency testing program was conducted in the same manner as the cannabis testing entity tests of cannabis and cannabis products.

5.15.7

A supervisory or management cannabis testing entity employee shall review and verify the accuracy of results reported for all proficiency testing program samples analyzed.

5.15.8

The cannabis testing entity shall request the proficiency testing program provider to send results concurrently to the Department, if available, or the cannabis testing entity shall provide the proficiency testing program results to the Department within three (3) business days after the cannabis testing entity receives notification of their test results from the proficiency testing program provider.

5.16

Proficiency Testing Performance.

5.16.1

The cannabis testing entity shall be deemed to have successfully participated in a proficiency testing program for an analyte tested in a specific method if the test 126

results demonstrate a “satisfactory” or otherwise proficient performance determination by the proficiency testing program provider.

5.16.2

The cannabis testing entity may not report test results for analytes that are deemed by the proficiency testing program provider as “unacceptable,” “questionable,” “unsatisfactory”, or otherwise deficient. Testing with the deficient method shall stop immediately upon receiving deficient proficiency testing results.

5.16.3

The cannabis testing entity may resume reporting test results for analytes that were deemed “unacceptable,” “questionable,” “unsatisfactory”, or otherwise deficient, only if both of the following conditions are met: A. The cannabis testing entity satisfactorily remedies the cause of the failure for each analyte; and B. The cannabis testing entity submits to the Department a written corrective action report demonstrating how the cannabis testing entity has fixed the cause of the failure.

5.16.4

The cannabis testing entity shall immediately perform a follow-up proficiency test on any method associated with a deficient report until the testing entity obtains an acceptable result for all analytes.

5.16.5

The Department shall take immediate disciplinary action against any cannabis testing entity that is unable to successfully participate in a proficiency program for any available method/analyte every six (6) months.

5.17

Cannabis Testing Entity Audits.

5.17.1

The cannabis testing entity shall conduct an internal audit at least once per year or in accordance with the ISO/IEC 17025 accrediting body’s requirement, whichever is more frequent.

5.17.2

The internal audit shall include all the components required by the ISO/IEC 17025 internal-audit standards.

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5.17.3

Within three (3) business days of completing the internal audit, the cannabis testing entity shall submit the results of the internal audit to the Department.

5.17.4

A cannabis testing entity shall contract with an independent, third-party auditor certified to conduct on-site audits at least annually or in accordance with ISO/IEC 17025 accrediting body’s requirements standards.

5.17.5

Within three (3) business days of receiving the accrediting body on-site audit findings, the cannabis testing facility shall submit the report to the Department.

5.17.6

The Department reserves the rights to perform additional audits as needed and without advance notice.

5.18

Recalls.

5.18.1

The Department may issue public notice of a medical cannabis recall if, in its judgment, any particular cannabis and/or cannabis product presents a threat to the health and safety of qualifying patients. All medical cannabis establishments are responsible for complying with recall notices. Recalled items shall be immediately pulled from production or inventory and held until such time as the Department determines the item is safe, may be remediated, or shall be destroyed.

Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67.

Subpart 6

PACKAGING AND LABELING

6.1

General Requirements.

6.1.1

Licensees shall not sell, or otherwise transfer cannabis and/or cannabis products to other medical cannabis establishments licensed by the Department and/or MDOR that are not packaged and labeled in accordance with these regulations.

6.1.2

Medical cannabis establishments receiving a sale or transfer from another medical cannabis establishment shall refuse to accept or shall return to the medical cannabis establishment transferring cannabis and/or cannabis products, any cannabis and/or cannabis products that are not packaged and labeled in accordance with these

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regulations. The medical cannabis establishment that sold or otherwise transferred the nonconforming cannabis and/or cannabis products shall accept such return.

6.1.3

Medical cannabis establishments shall document any such return, nonacceptance, or disposal, and such documentation shall include at a minimum: 1. The license number, name, contact information, and address of the medical cannabis establishment that sold or otherwise transferred the nonconforming cannabis and/or cannabis products; 2. A complete inventory of the cannabis and/or cannabis products to be returned or disposed, including the batch number; 3. The reason for the nonacceptance, return, or disposal; and, 4. The date of the nonacceptance, return, or disposal.

6.1.4

The following packaging requirements apply to all usable medical cannabis (retailready) being transferred to or sold to a medical cannabis dispensary for sale to a qualified patient and/or caregiver. Packaging and labelling, meeting the following requirements, shall be in place when transferred or sold to a medical cannabis dispensary: 1. Labels, packages, and containers shall not be attractive to minors and shall not contain any content that reasonably appears to target children, including toys, cartoon characters, or any color scheme, image, graphic, or feature that might reasonably be expected to make the product label, package, or container entice or appealing to children. 2. Packages should be designed to minimize appeal to children and shall not depict images other than the business name and logo of the medical cannabis establishment. 3. Packaging shall contain a label that reads: “Keep out of reach of children”. 4. All usable medical cannabis and cannabis products shall be packaged in childresistant containers at the point of sale or other transfer to a patient, a patient's parent, or legal guardian if patient is a minor, or a caregiver. 5. Packages and labels shall not contain product names related to candy or candies or any spellings thereof (e.g., kandy, kandies, etc.) or feature images that look like candy. 6. No cannabis and/or cannabis products shall be intentionally or knowingly packaged or labeled to cause a reasonable patient confusion as to whether the 129

medical cannabis or medical cannabis product is a trademarked product or any commercially available candy, snack, baked good or beverage. 7. Packages and labels shall not make any claims or statements that the medical cannabis or medical cannabis products provide health or physical benefits to the patient. 8. Shall not contain the logo of the Department or any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead any person to believe the product has been endorsed, manufactured, or used by any state, county, or municipality or any agency thereof. 9. Cannabis products that have a potency of over thirty percent (30%) total THC shall be labeled as “extremely potent”. 10. Edible cannabis products shall be labeled in a manner which indicates the number of servings of THC in the product and include a statement that the product’s potency was tested with an allowable variance of plus or minus 10%. Potency of all products shall test +/- 10% of label claim or be repackaged to meet actual concentration. The single serving size shall also be included on the label. All edible cannabis product shall be labeled. 11. Usable medical cannabis shall include the following on the label: a. Name of the cannabis and/or cannabis product; b. Batch number of the cannabis and/or cannabis product; c. Unique identifier number created by the seed to sale system; d. Net quantity or weight of contents; e. The length of time it typically takes for the product to take affect; f. Disclosure of ingredients and possible allergens; g. A nutritional fact panel (applicable to cannabis products meant to be ingested); h. The total amount of THC and CBD in the product as verified by the cannabis testing facility; i. Terpenoid profile in the product as verified by the cannabis testing facility (if applicable); j. A notice of the potential harm caused by consuming medical cannabis; and, k. For edible cannabis products, when practicable, the Mississippi standard symbol indicating the product contains cannabis. This symbol is required

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on packaging as of July 1, 2023. The required symbol will be available for download from the Department.

6.1.5

All usable medical cannabis and/or cannabis products shall be in compliant packaging upon entering the medical cannabis dispensary space.

6.1.6

All labeling shall be in plain font that can be easily read.

6.1.7

All labeling on topical products shall also state “For Topical Application – Do Not Eat or Smoke”.

6.1.8

Labels and packaging for food containing cannabis shall comply with all applicable requirements in existing Mississippi law, rules and regulations.

6.1.9

In addition to the labeling requirements in this Part, all usable (retail-ready) cannabis and/or cannabis products shall be packaged to meet the following: 1. Packaging shall be opaque and light resistant. The Department does not specify package coloring. 2. Packing shall fully enclose the product so that it cannot be seen from outside the packaging. 3. Packaging shall protect the product from contamination; 4. Not impart any toxic or deleterious substance to the medical cannabis product; 5. Shall be in child-resistant packages or containers; and, 6. Shall be in a resealable package or container that meets the effectiveness specifications outlined in 16 CFR 1700.15, to the extent that such laws, rules, regulations do not conflict with the Mississippi Medical Cannabis Act, if the product contains more than one serving.

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6.1.10

All cannabis and/or cannabis products sold or transferred between cannabis cultivation facilities and/or cannabis processing facilities shall be labeled (in addition to the required seed-to-sale tagging), and the label shall contain, at a minimum, the following information: 1. Name and license number of the cultivator/grower or processor/manufacturer who is selling or otherwise transferring the medical cannabis or medical cannabis product; 2. The batch number of the medical cannabis or medical cannabis product; 3. Date of harvest or production; and, 4. Unique identifier number generated by the seed-to-sale system.

Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67.

Subpart 7

TRANSPORTATION

7.1

General Requirements.

7.1.1

Cannabis transportation entities shall comply with any and all motor vehicle laws in the State of Mississippi.

7.1.2

All employees shall possess a valid, unrestricted driver’s license issued by the State of Mississippi and a valid work permit issued by the Department. The cannabis transportation entity shall also issue each employee an identification badge, with picture. All documents referenced in this Rule shall be in the employee’s possession when in a vehicle transporting cannabis and/or cannabis products.

7.1.3

A cannabis transportation entity shall be responsible for any and all cannabis and/or cannabis products within its custody, control, or possession.

7.1.4

A cannabis transportation entity may transport cannabis and/or cannabis products to medical cannabis establishments during the hours of 5:00 a.m. until 9:00 p.m.

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7.1.5

Prior to the transport of cannabis and/or cannabis products, the cannabis transportation entity shall ensure a trip plan has been created for each transportation event. At a minimum, a trip plan shall include the following: 1. Names of employees transporting the cannabis and/or cannabis products; 2. State issued work permits of the employees transporting the cannabis and/or cannabis products; 3. Date and start time of the transport; 4. Physical location of the originating medical cannabis establishment; 5. Physical location of the receiving medical cannabis establishment; 6. A description of the cannabis and cannabis products to be transported to include: quantities by weight or unit of each type of cannabis and/or cannabis products contained in the transport, along with the unique identifying numbers issued by the seed to sale system for each item; 7. Any anticipated stops during the trip, including the locations of the stop and arrival and departure time from the location; 8. The anticipated route of transportation; 9. Any and all instances in which cannabis and/or cannabis products are stored at cannabis transportation entity’s facilities; and, 10. Estimated date and time of arrival at the receiving medical cannabis establishment. 11. The make, model, color and license plate number of the vehicles transporting cannabis and/or cannabis products.

7.1.6

A copy of the trip plan shall be provided to the originating medical cannabis establishment and maintained by the cannabis transportation entity. A copy of the applicable trip plan shall be kept in the vehicle during transport.

7.1.7

A cannabis transportation entity may make reasonable deviations from the anticipated routes identified on the trip plan when needed (for example, unanticipated mandatory detours for construction, traffic accidents, etc.). All deviations shall be reflected in the transportation entity’s vehicle GPS system at all times.

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7.1.8

Should a cannabis transportation entity possess cannabis and/or cannabis products outside of the approved transportation hours, the licensee shall immediately go to its facility and store the cannabis and/or cannabis products in accordance with the rules in this Part.

7.1.9

To maintain the independence required, cannabis transportation entities are prohibited from the following activities related to the medical cannabis program: 1. Growing/cultivating cannabis; 2. Manufacturing/processing cannabis and/or cannabis products; 3. Retail sales of cannabis and/or cannabis products; 4. The resale of cannabis and/or cannabis products to other entities and medical cannabis establishments; 5. Transportation, storage, and/or delivery of cannabis and/or cannabis products to entities who are not licensed by the Department as medical cannabis establishments or the MDOR as cannabis dispensaries; and, 6. Provision of cannabis and/or cannabis products directly to qualifying patients and/or caregivers as defined in this Part.

7.1.10

A cannabis transportation entity shall have inventory tracking processes and procedures in place that include, but are not limited to, the following: 1. Prior to the transport of cannabis and/or cannabis products, the originating medical cannabis establishment shall provide the transporter with a copy of the inventory/transportation manifest generated from the seed-to-sale system. At a minimum, the manifest shall include the following: a. License number of the originating medical cannabis establishment; b. Name and contact information of the originating medical cannabis establishment; c. License number of the receiving medical cannabis establishment; d. Name and contact information of the receiving medical cannabis establishment; e. Physical address of the receiving medical cannabis establishment where cannabis and/or cannabis products are being delivered;

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f. Quantities by weight or unit of each type of cannabis and/or cannabis products contained in the transport, along with the unique identifying numbers issued by the seed-to-sale system for each item; g. The date of transport to include the time of departure and approximate arrival time; h. Names and work permit numbers issued by the Department of the individuals accompanying the transport; i. The make, model, color, and license plate number of the vehicles providing transport of cannabis and/or cannabis products.

7.1.11

An inventory/transportation manifest shall be included with each transport.

7.1.12

An inventory/transportation manifest shall not be altered after departing the originating medical cannabis establishment. Such manifest made be made available to law enforcement, if requested.

7.1.13

There shall not be any passenger or operator in a vehicle transporting cannabis and/or cannabis products that is not employed by the cannabis transportation entity while cannabis and/or cannabis products are present.

7.1.14

Transportation of Cannabis or Cannabis Products to Retail Dispensary Locations. A. Cannabis and/or cannabis products that have undergone and passed regulatory compliance testing and have an accompanying COA may be transferred to one or more licensed dispensaries via a licensed cannabis transportation entity. B. Cannabis that has not been transported to a licensed dispensary for retail sale within twelve (12) months of the date on the COA shall be destroyed or retested by the licensee in possession thereof. Retesting pursuant to this subsection shall only be conducted if the cannabis has not been modified in any way.

7.2

Vehicle Requirements.

7.2.1

Prior to use, a licensed cannabis transportation entity shall submit to the Department the license plate numbers, proof of insurance, and vehicle 135

identification numbers for each vehicle being used to transport cannabis or cannabis-infused products.

7.2.2

Vehicles used to transport cannabis and/or cannabis products shall be insured at or above the legal requirements in Mississippi.

7.2.3

Vehicles used to transport cannabis and/or cannabis products shall be equipped with the following: 1. An alarm system; 2. A global positioning system (GPS) to monitor location, routes, etc. at all times with the ability to grant the Department and/or state and local law enforcement access to the system; and, 3. Locked storage container as defined in Rule 1.2.73.

7.2.4

With the exception of test samples, all vehicles used to transport cannabis and/or cannabis products shall meet one of the following requirements for video surveillance or staffing required during transport of cannabis and/or cannabis products: 1. Staffed with a minimum of two (2) employees when a vehicle contains cannabis and/or cannabis products. At least one (1) employee shall remain with the vehicle any time it contains cannabis and/or cannabis products; or 2. Utilize video surveillance of the vehicle (meeting video surveillance requirements in Rule 7.3.5) to include: a. Installation of video cameras in the interior of vehicles transporting cannabis and/or cannabis products; and, b. Video surveillance of the interior of the vehicle, particularly the locked storage areas where cannabis and/or cannabis products are located.

7.2.5

All vehicles used for the purpose of transporting cannabis and/or cannabis products shall be maintained in a sanitary condition.

7.2.6

A vehicle transporting cannabis and/or cannabis products shall not bear any markings to indicate the vehicle contains cannabis or bear the name or logo of the medical cannabis establishment. 136

7.3

Storage Requirements – During and Outside of Transport.

7.3.1

A transporter shall not transport cannabis and/or cannabis product(s) unless it is first packed in a cannabis container by the originating medical cannabis establishment.

7.3.2

A cannabis container for transport shall be: 1. Sealable and sealed during transport; 2. Locked during transport; 3. Clearly labeled as medical cannabis and/or medical cannabis product; 4. Maintained in a locked and secure storage compartment that is part of the vehicle or a locked storage container with a separate key or combination lock.

7.3.3

A transporter shall not open a cannabis container. Once a cannabis container is packed and sealed for delivery, only the following may open a cannabis container: 1. The originating medical cannabis establishment; 2. The medical cannabis establishment intended for delivery; 3. Local, State, or federal law enforcement; 4. An employee of the Department or the MDOR.

7.3.4

Cannabis and/or cannabis-products shall be transported so it is not visible or recognizable from outside the vehicle.

7.3.5

If a cannabis transportation entity is required to store cannabis and/or cannabis products, the storage location shall, at a minimum, meet the following requirements: 1. Approved by the Department during the application process as part of the cannabis transportation entity’s license; 2. Be secure, enclosed with permanent walls, and controls for temperature and relative humidity to ensure storage in a manner that prevents the cannabis and cannabis products from becoming adulterated.;

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3. Be locked at all times; 4. Be accessible only to specifically identified employees of the cannabis transportation entity; 5. Have an alarm system that meets the following: a. Upon attempted unauthorized entry, the alarm system shall transmit a signal directly to a central protection company or a law enforcement agency that has a legal authority to respond. A designated employee of the cannabis transportation entity shall also be notified. b. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas; c. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing a safe, and any room used to store cannabis and/or cannabis products; d. Be equipped with failure notification systems to notify the transporter and law enforcement of any failure in the alarm system; and, e. Have the ability to remain operational during a power outage. 6. Have continuous, uninterrupted video surveillance that meets the following: A. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas, and parking areas; B. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing a safe, and any room used to store cannabis and/or cannabis products; C. Digital archiving capabilities for a minimum of (120) days; D. On-site and off-site monitoring capabilities; E. Have the date and time embedded on all surveillance recordings without significantly obscuring the picture; and, F. Use cameras that are capable of recording in both high and low lighting conditions.

7.3.6

Upon request, a medical cannabis establishment shall make all information related to security alarm systems and video surveillance, monitoring, and recordings available to the Department within the timeframe requested. 138

Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67.

Subpart 8

WASTE DISPOSAL

8.1.1

Cannabis disposal entities shall also comply with all applicable rules and regulations in this Part to include, but not limited to, licensure and registration as a cannabis transportation entity if the cannabis disposal entity transports cannabis and/or cannabis products.

8.1.2

All employees shall possess a valid, unrestricted driver’s license issued by the State of Mississippi and a valid work permit issued by the Department. The cannabis disposal entity shall also issue each employee an identification badge, with picture. All documents referenced in this Rule shall be in the employee’s possession when in a vehicle transporting cannabis and/or cannabis products.

8.1.3

A cannabis disposal entity shall be responsible for any and all cannabis and/or cannabis products within its custody, control, or possession.

8.1.4

Unless specifically licensed by the Department to do so, cannabis disposal entities are prohibited from the following activities related to the medical cannabis program: 1. Growing/cultivating cannabis; 2. Manufacturing/processing cannabis and/or cannabis products; 3. Retail sales of cannabis and/or cannabis products; 4. The resale of cannabis and/or cannabis products to other entities and medical cannabis establishments; 5. Transportation, storage, and delivery of cannabis and/or cannabis products (outside of the purposes of disposal and/or destruction of cannabis waste); and, 6. Provision of cannabis and/or cannabis products directly to qualifying patients and/or caregivers as defined in this Part.

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8.1.5

If a cannabis disposal entity is required to store cannabis and/or cannabis products, the storage location shall, at a minimum, meet the following requirements: 1. Cannabis and/or cannabis products shall be stored at location licensed by the Department as part of the cannabis disposal entity’s license; 2. Be secure and enclosed with permanent walls; 3. Be locked at all times; 4. Be accessible only to specifically identified employees of the cannabis transportation entity; 5. Have an alarm system that meets the following: A. Upon attempted unauthorized entry, the alarm system shall transmit a signal directly to a central protection company or a law enforcement agency that has a legal authority to respond. A designated employee of the cannabis transportation entity shall also be notified; B. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas; C. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing a safe, and any room used to store cannabis and/or cannabis products; D. Be equipped with failure notification systems to notify the transporter and law enforcement of any failure in the alarm system; and, E. Have the ability to remain operational during a power outage. 6. Have continuous, uninterrupted video surveillance that meets the following: A. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas, and parking areas; B. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing a safe, and any room used to store cannabis and/or cannabis products; C. Digital archiving capabilities for a minimum of (120) days; D. On-site and off-site monitoring capabilities; E. Have the date and time embedded on all surveillance recordings without significantly obscuring the picture; and, 140

F. Use cameras that are capable of recording in both high and low lighting conditions.

8.1.6

All cannabis waste designated for disposal shall be properly weighed and recorded in the state’s seed-to-sale system at the following points at minimum: 1. On-site at the medical cannabis establishment for which the cannabis disposal entity is providing services; and, 2. At the final destination where disposal/destruction occurs.

8.1.7

Cannabis waste shall be disposed of either via a process which renders the waste unusable and unrecognizable through physical destruction or a recycling process that the waste disposal facility is authorized by Mississippi law to carry out.

8.1.8

The disposal/destruction of cannabis waste shall be done under video surveillance by video surveillance and made available to the Department upon request.

8.1.9

Medical cannabis and/or cannabis products shall be rendered unusable by grinding and incorporating the cannabis waste with other ground materials, so the resulting mixture is at least fifty percent 50% non-cannabis waste by volume. This includes compostable mixed waste and non-compostable mixed waste meeting the requirements below.

8.1.10

Grinding and incorporating the cannabis waste into compostable mixed waste until it is unusable and unrecognizable: Cannabis waste to be disposed of as compost or in another organic waste method may be mixed with the following types of waste materials: 1. Food waste; 2. Yard waste; 3. Vegetable based grease oils; 4. Agricultural Materials; 5. Biodegradable products and paper; 6. Clean wood; 141

7. Fruits and vegetables; or 8. Plant matter. 9. Bokashi or other compost activators; or, 10. Other materials or methods approved by the Department that will render the cannabis waste unusable and unrecognizable.

8.1.11

Grinding and incorporating the cannabis waste into non-compostable mixed waste until it is unusable and unrecognizable: Cannabis waste to be disposed of in a landfill or another disposal method, such as incineration, may be mixed with the following types of waste materials: 1. Paper waste; 2. Cardboard waste; 3. Plastic waste; 4. Soil; 5. Nonrecyclable plastic; 6. Broken glass; 7. Sawdust; or 8. Other materials or methods approved by the Department that will render the cannabis waste unusable and unrecognizable.

8.1.12

Licensure and/or permitting may also be required through the Mississippi Department of Environmental Quality for cannabis disposal entities as well as local permitting, dependent upon the location of the cannabis disposal entity.

Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67.

Subpart 9

ADVERTISING AND MARKETING

9.1

Prohibition Against Advertising and Marketing.

9.1.1

Medical cannabis establishments licensed by the Department pursuant to this Part, and/or entities acting on their behalf, are prohibited from advertising and marketing in any media, including but not limited to: A. Broadcast or electronic media: 142

1. Radio 2. Television 3. Unsolicited internet pop-up advertising 4. Social media B. Print media: 1. Newspaper C. Other forms: 1. Mass text/messaging communications. 2. Mass email communications. 3. Medical cannabis or medical cannabis products shall not be displayed in windows or public view. 4. Advertisement in any manner that can be viewable or otherwise perceived as a public space, including, but not limited to, adopt a highway signs, and electronic interstate signs. 5. Solicited/paid patient and/or caregiver reviews/testimonies/endorsements. 6. Solicited/paid practitioner reviews/testimonies/endorsements.

9.1.2

Licensees shall not engage in advertising that contains any statement or illustration that: A. Depicts the actual consumption of cannabis or cannabis products; B. Promotes the overconsumption of cannabis or cannabis products; C. Makes any health, medicinal, or therapeutic claims about cannabis or cannabis products; D. Makes safety claims of any type; E. Includes the image of a cannabis leaf or bud; or F. Includes any image designed or likely to appeal to minors, including cartoons, toys, animals, or children or any other likeness, images, characters, or phrases that are designed in any manner to be appealing to children and/or youth.

9.2

Branding Requirements. 143

9.2.1

Medical cannabis establishments licensed by the Department pursuant to this Part are permitted to participate in branding activities as described in Rules 9.2.2 and 9.2.3 in order to publicize their businesses. Additionally, the business name and contact information of all licensed medical cannabis establishments will be made available by the Department through a public website.

9.2.2

Permissible branding activities include: 1. Establishment of a website and/or social media presence that provides general information on the licensed entity’s contact information, retail dispensing locations, and a list of products available.; 2. Listings in business directories (inclusive of phone books, cannabis-related or medical publications);. 3. Display of cannabis in company logos and other branding activities; and, 4. Sponsorships of health or not-for-profit charity or advocacy events.

9.2.3

Branding shall not target minors, pregnant women, breastfeeding women, or promote non-medical use of cannabis.

9.2.4

Branding, in the form of business signage, for all licensed medical cannabis establishments is subject to local zoning and permitting requirements.

9.3

Use of Inducements.

9.3.1

Licensees may utilize inducements to assist qualified patients. Inducements shall not persuade or influence the use of medical cannabis outside of practitioner recommendations and/or limitations or the amounts allowed by the Mississippi Medical Cannabis Act. Examples of inducements include, but are not limited to: 1. The use of discount cards; 2. The use of coupons; 3. The use of “punch cards” to offer discounts/free products; 4. Promotion of sales/discounts on medical cannabis of any type; 5. The use of “buy one, get one” discount approaches; and, 6. The use of any type of “daily deal”, “weekly deal”, “monthly deal”, etc.

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9.3.2

Any medical cannabis and medical cannabis products that are part of an inducement program as defined in Rule 9.3.1, remain subject to seed-to-sale tracking requirements, any practitioner limitation included on the qualified patient’s written certification, and MMCEU allotment limitations set forth in the Mississippi Medical Cannabis Act.

9.4

Education Regarding the Risks and Benefits of Medical Cannabis.

9.4.1

Education on the risks and benefits of the use of medical cannabis between a registered practitioner and/or medical cannabis establishment and a qualified patient, caregiver, parent, or legal guardian is permissible. This education is not considered advertising or marketing.

9.4.2

Education on the risks and benefits of the use of medical cannabis between a registered practitioner and/or medical cannabis establishment and a qualified patient, caregiver, parent, or legal guardian can also include written or video educational materials that are inclusive of the medical cannabis establishment’s brand.

9.4.3

Education provided to a qualified patient, caregiver, parent, or legal guardian by a registered practitioner and/or medical cannabis establishment that includes instruction/direction on the safe use of medical cannabis and/or medical cannabis products is permissible.

9.4.4

Except as otherwise provided in this Part the use of pictures and/or images of cannabis and/or cannabis products shall be limited to patient education materials.

9.4.5

A registered practitioner or medical cannabis establishment may provide educational materials about cannabis to qualifying patients and/or their designated caregivers, parents and/or legal guardians. Educational materials shall adhere to the following: A. Information about the potential risks and side effects of medical cannabis use, including the risk of poisoning and the number for the closest poison control center shall be included; B. Information to assist in the selection of cannabis, describing the potential 145

differing effects of various strains of cannabis, as well as various forms and routes of administration, purported effectiveness of various methods, and the differences in the anticipated time frames for the forms to take affect may be included; C. Materials offered to registered qualifying patients and their personal caregivers to enable them to track the strains used and their associated effects may be included; D. Information on tolerance, dependence, and withdrawal may be included; E. Information regarding substance abuse signs and symptoms, as well as referral information for substance abuse treatment programs; and, F. Other warnings, instructions, and/or directions on the safe use of medical cannabis and/or medical cannabis products which the registered practitioner and/or medical cannabis establishment deems appropriate.

Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67.

Subpart 10

VARIANCE REQUESTS

10.1.1

Through a variance, the Department may waive provisions of this Part on its own initiative or by request from licensed medical cannabis establishments. The Department shall not consider Variance Requests related to provisions that are purely statutory.

10.1.2

Requests for variance from the rules of any provision of this Part shall be made in writing and will be granted or denied by the State Health Officer. Variance Requests shall include: 1. A list of each rule for which a variance is requested, with citation to the specific rule(s); 2. An explanation of why the rule cannot be met at the time of the request or why meeting the rule would impose an undue burden on the licensed medical cannabis establishment; and, 3. The requested relief. Denial of variance requests shall be issued by the Department in writing and shall include the specific reasons for the denial.

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10.1.3

The Variance Request shall be submitted by the primary contact of the licensed medical cannabis establishment in a format approved by the Department.

10.1.4

Variance Requests are not guaranteed for approval and will not be approved to circumvent any relevant rule, regulation or standards promulgated under the Act or any portion thereof. The medical cannabis establishment making the Variance Request should continue to meet Department-published rules in this Part while the Request is under consideration and pending.

Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67.

Subpart 11

ENFORCEMENT AND PENALTIES

11.1

Suspension or Revocation of License, Fines or Other Penalties.

11.1.1

The Department may take the following actions against licensees, alone or in combination, in any case in which it finds that a licensee has failed to comply with the requirements established by the Mississippi Medical Cannabis Act and/or the rules, regulations or standards promulgated in furtherance of such act: A. Impose monetary penalties; B. Issue an Administrative Hold; C. Suspend a license; D. Revoke a license; E. Accept the voluntary surrender of a license; F. Confiscate or seize cannabis plants, cannabis and/or cannabis products; G. Order destruction of cannabis plants, cannabis and/or cannabis products; H. Recall cannabis and/or cannabis products; or I. Accept the voluntary surrender of cannabis plants, cannabis and/ cannabis products. The schedule of disciplinary actions included as APPENDIX B to this Part shall be used when administratively disciplining medical cannabis establishments for violating statutory and/or regulatory requirements. The Department reserves the right to increase penalties based on aggravating circumstances and/or the medical cannabis establishment’s history of violations and corrective actions.

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11.1.2

Suspension. In addition to the schedule of disciplinary actions included as APPENDIX B to this Part, the Department may suspend the license of a medical cannabis establishment if necessary to protect public health, safety, or welfare. A suspension shall not exceed a period longer than six (6) months. A medical cannabis establishment may continue to possess and cultivate cannabis as otherwise authorized to do so under its license during a suspension, but it may not dispense, transfer or sell cannabis.

11.1.3

The Department may seize, destroy, confiscate or place an administrative hold on any cannabis plants, cannabis and/or cannabis products under, but not limited to, the following circumstances: A. Failure to log and/or tag in the seed-to-sale system; B. Alteration of cannabis and/or cannabis products in a manner that fails to comply with this Part; C. Failure to package and label in accordance with this Part in general and Section 11 specifically; D. Such items are cultivated, harvested, manufactured or transferred in a manner, or otherwise in a form, not compliant with the rules/regulations in this Part or the Mississippi Medical Cannabis Act Use; or E. Improper use, handling, storage, transport, transfer or other possession of such items.

11.1.4

Administrative Holds. The Department may order an administrative hold of cannabis plants, cannabis and/or cannabis products to prevent destruction of evidence, diversion or other threats to public safety, while permitting a licensee to retain its inventory pending further investigation, pursuant to the following procedure: A. If during an investigation or inspection of a licensee, an employee or agent of the Department develops reasonable grounds to believe certain cannabis plants, cannabis or cannabis products constitute evidence of acts in violation of the rules/regulations in this Part, the Mississippi Medical Cannabis Act or constitute a threat to the public health or safety, the Department may issue a notice of administrative hold of any such cannabis plants, cannabis or cannabis products. The notice of administrative hold shall provide a documented description of the cannabis plants, cannabis and/or cannabis products subject to the administrative hold and a concise statement regarding

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the reasons for issuing the administrative hold. B. The Department will identify the cannabis plants, cannabis and/or cannabis products subject to the administrative hold in the seed-to-sale system. The licensee shall continue to comply with all inventory tracking requirements of the seed-to-sale system. C. The licensee shall completely and physically segregate the cannabis plants, cannabis and/or cannabis products subject to the administrative hold in a limited access area of the licensed premises under investigation, where it shall be safeguarded by the licensee. D. While the administrative hold is in effect, the licensee is prohibited from selling, giving away, transferring, transporting or destroying the cannabis plants, cannabis and/or cannabis products subject to the administrative hold, except as otherwise authorized by this Part. E. While the administrative hold is in effect, the licensee must safeguard the cannabis plants, cannabis and/or cannabis products subject to the administrative hold, must maintain the licensed premises in reasonable condition according to health, safety and sanitary standards, and must fully comply with all security requirements, including but not limited to all surveillance, lock and alarm requirements in this Part. F. Nothing herein shall prevent a licensee from voluntarily surrendering cannabis plants, cannabis and/or cannabis products that is subject to an administrative hold, except that the licensee shall follow the procedure authorized by the Department to complete the voluntary surrender. G. Nothing herein shall prevent a licensee from the continued possession, cultivation or harvesting of the cannabis plants, cannabis and/or cannabis products subject to the administrative hold. H. At any time after the initiation of the administrative hold, the Department may lift the administrative hold or seek other appropriate relief.

11.1.5

Notice. At the time of denial of an application for licensure or the imposition of any monetary penalty and prior to imposition of non-monetary sanctions, suspension or revocation of a license, written notice of the contemplated action shall be given to the applicant or licensee specifying the reason(s) for the proposed action and shall notify the licensee of the right to a hearing on the matter. The Department shall provide its initial notice of denial, suspension, revocation, fine or other sanction by personal delivery, mailing by certified mail, signature 149

required, or by electronic mail to the applicant or licensee, at the address on record with the Department.

11.1.6

Request for an Administrative Appeal/Hearing. The Mississippi State Department of Health will provide to a licensee/aggrieved party an opportunity for a prompt and fair appeal process when the licensee/aggrieved party is dissatisfied with an administrative decision imposing fines and/or other penalties/sanctions, denial, suspension, or revocation of a license and wishes to appeal the administrative decision. A. Upon written request by the licensee/aggrieved party and within twenty (20) days of receipt of the initial notice of administrative action, the licensee/aggrieved party may file a request for an appeal which is handled through the means of an administrative hearing with the Department. Once a licensee/aggrieved party requests an appeal, the State Health Officer shall be notified by the Department and shall appoint a qualified Hearing Officer within thirty (30) days to set a date, time and place for the administrative hearing convenient for all parties. B. If the licensee/aggrieved party fails to appeal the initial notice within the prescribed time, the decision becomes final and cannot be further appealed. C. A court reporter shall attend and transcribe the proceeding. D. Hearings before a Hearing Officer are considered confidential and are not open to the public. E. An informal review may be granted for any situation, but is not required before seeking an administrative appeal, and if requested, does not toll the time limit to request an appeal/administrative hearing. F. The parties may continue to attempt to resolve issues informally once the formal appeals process has begun. G. The licensee/aggrieved party shall be entitled to legal representation at the hearing at his/her own expense but may also choose to represent himself/herself. The burden shall be on the licensee/aggrieved party at the hearing to prove that the Department’s decision was: (a) arbitrary or capricious; (b) unsupported by evidence; (c) beyond the power of the Department to make; or (d) violated a statutory or constitutional right of the aggrieved party. H. A continuance for an administrative hearing may only be requested by a showing of good cause and may be granted at the discretion of the Hearing Officer. A request for a continuance shall be made within ten (10) days of the 150

date for which it is needed unless it is due to an emergency. 1. Within thirty (30) calendar days of the hearing, or such period as determined during the hearing, written findings of fact together with a recommendation from the Hearing Officer shall be forwarded to the State Health Officer for review. The State Health Officer may adopt, modify, or reject the Hearing Officer’s recommendation or decide what, if any, action is to be taken on the matter. The decision by the State Health Officer will be made within fourteen (14) calendar days of receipt of the recommendation from the Hearing Officer and will be considered the Final Decision or Final Order by the Department. 2.

Written notice of the decision shall be provided to the licensee/aggrieved party at the address on record with the Department. Licensee/aggrieved party has a duty to update his/her address as necessary to receive correspondence in a timely manner.

3. Appeal of the Department’s Final Order shall be accomplished as provided by the appropriate statute. 4. If the licensee/aggrieved party fails to appeal the Final Order within the prescribed time, the decision becomes final and cannot be further appealed. 5. For the Rules and Procedures for State Level Administrative Hearings refer to APPENDIX C of this Part.

11.2

Appeal of Final Decisions or Orders.

11.2.1

Any person or entity who disagrees with or is aggrieved by the Final Decision or Final Order of the Department concerning the imposition of fine(s) and/or other sanction(s), including but not limited to, denial of an application for licensure, suspension, or revocation of a license may appeal same in the circuit court of the county in which he/she resides. If the aggrieved party is a nonresident of this state, he/she may appeal to the Circuit Court of the First Judicial District of Hinds County, Mississippi. The appeal shall be filed no later than twenty (20) calendar days after the issuance of the Final Decision or Order by the Department.

11.2.2

The review by the circuit court shall be based on the record made before the Department. Before filing an appeal petition in circuit court, the appellant shall obtain from the Department an estimate of the cost to prepare the entire record of the Department and shall pay to the Department the amount of the estimate. The circuit court shall dismiss with prejudice any petition filed where it is shown 151

that the petitioner failed to pay prior to filing the petition the estimated cost for preparation of the record. On appeal to the circuit court, appellant shall have the burden of proving that the decision of the Department was: (a) arbitrary or capricious; (b) unsupported by substantial evidence; (c) beyond the power of the administrative agency to make; or (d) violated some statutory or constitutional right of the licensee/aggrieved party.

11.2.3

Any person or entity aggrieved by the decision of the circuit court may appeal to the Mississippi Supreme Court.

11.2.4

If a medical cannabis establishment is allowed to continue to operate during the appeal process, it will remain under the regulation of the Department and will be subject to all current licensure regulations to include, but not limited to, inspection of the facility, review of facility and/or records, submission of all required or requested documents, and payment of all applicable fees and/or monetary penalties. However, the medical cannabis establishment may not dispense, transfer or sell cannabis during this period.

11.2.5

A cannabis testing entity may continue to possess cannabis under its license during a suspension but shall not receive, transfer or test cannabis during the suspension period.

Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67.

152

APPENDIX A Table 1 Key to Table 1: •

CAS Number = Chemical Abstract Services Registry number

•

CFU = Colony-forming unit, a method to estimate the number of viable bacteria or fungal cells in a sample. A. Microbial Contaminants Analyte

Total coliform

Maximum Allowable Contaminants

Required Action

100 CFU/g

Use to make a concentrate or extract if the processing method effectively sterilizes the batch and retested or destroy

Shiga toxin- producing Escherichia coli

Detectable in 1 gram

Destroy

Salmonella spp.

Detectable in 1 gram

Destroy

Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger, and Aspergillus terreus

Inhalable: Detectable in 1 gram

Cannabis product, except a cannabis Mycotoxins: Aflatoxin B1, B2, product intended for topical application, G1, and G2 Ochratoxin A prepared from an extract or concentrate of medical cannabis

Total Mold and Yeast

10,000 CFU/g

153

Use to make a concentrate or extract if the processing method effectively sterilizes the batch and retest or destroy

Destroy

Use to make a concentrate or extract if the processing method effectively sterilizes the batch and retest or destroy

B. Heavy Metals Maximum Allowable Concentration (ppm) Analyte

Inhaled Flower

Inhaled Concentrates

Other

Arsenic

0.4

0.2

1.5

Cadmium

0.4

0.2

0.5

Lead

1.0

0.5

0.5

Mercury

0.2

0.1

3.0

Total Chromium

1.2

0.6

2.0

Nickel

1.0

0.5

N/A

Copper

N/A

3.0*

N/A

Required Action

Remediate and retest, or Destroy *Copper is required for vaping products only

C. Residual Solvents

Analyte CAS Number Acetone 67-64-1 Acetonitrile 75-05-8 Benzene 71-43-2 Butanes (measured as the 106-97-8 and 75cumulative residue of n-butane 28-5, and isobutane) respectively Chloroform 67-66-3

Maximum Allowable Concentration 1,000 ppm 410 ppm 2 ppm 5,000 ppm 60 ppm

Dichloromethane

75-09-2

600 ppm

Ethanol

64-17-5

5,000 ppm

Ethyl Acetate

141-78-6

5,000 ppm

Ethyl Ether

60-29-7

5,000 ppm

Heptane 142-82-5 Hexanes (measured as the cumulative residue of n-hexane, 2110-54-3, 107methylpentane, 383-5, and methylpentane, 2,279-29-8 dimethylbutane, and 2,3dimethylbutane) Isopropyl Acetate 108-21-4 Methanol

5,000 ppm

290 ppm

5,000 ppm

67-56-1

3,000 ppm

154

Required Action

Remediate and retest, or Destroy

Pentanes (measured as the 109-66-0, 78-78cumulative residue of n-pentane, 4, and 463-82-1 iso- pentane, and neo- pentane) 2-Propanol (IPA) 67-63-0 Propane 74-98-6 Toluene

108-88-3

Xylenes (measured as the cumulative residue of 1,2dimethylbenzene, 1,3dimethylbenzene, and 1,4dimethylbenzene, And the non-xylene, ethyl benzene) Dimethylbenzene, and 1,4dimethylbenzene, and the nonxylene, ethyl benzene)

5,000 ppm 5,000 ppm 5,000 ppm 890 ppm

1330-20-7 (9547-6,10838-3, and 106423, and 100-41-4)

2,170 ppm

D. Pesticides, Fungicides, Growth Regulators

Analyte Abamectin

CAS Number 71751-41-2

Maximum Allowable Concentration 0.5 ppm

Acephate

30560-19-1

0.4 ppm

Acequinocyl Acetamiprid Aldicarb Azoxystrobin Bifenazate Bifenthrin Boscalid Carbaryl Carbofuran Chlorantraniliprole Chlorfenapyr Chlormequat chloride

57960-19-7 135410-20-7 116-06-3 131860-33-8 149877-41-8 82657-04-3 188425-85-6 63-25-2 1563-66-2 500008-45-7 122453-73-0 7003-89-6

2.0 ppm 0.2 ppm 0.4 ppm 0.2 ppm 0.2 ppm 0.2 ppm 0.4 ppm 0.2 ppm 0.2 ppm 0.2 ppm 1.0 ppm 0.2 ppm

Chlorpyrifos Clofentezine Cyfluthrin Cypermethrin Daminozide DDVP (Dichlorvos)

2921-88-2 74115-24-5 68359-37-5 52315-07-8 1596-84-5 62-73-7

0.2 ppm 0.2 ppm 1.0 ppm 1.0 ppm 1.0 ppm 0.1 ppm

155

Required Action

Destroy

Diazinon

333-41-5

0.2 ppm

Dimethoate Ethoprophos Etofenprox Etoxazole Fenoxycarb Fenpyroximate Fipronil Flonicamid Fludioxonil Hexythiazox Imazalil Imidacloprid Kresoxim-methyl Malathion Metalaxyl Methiocarb Methomyl

60-51-5 13194-48-4 80844-07-1 153233-91-1 72490-01-8 134098-61-6 120068-37-3 158062-67-0 131341-86-1 78587-05-0 35554-44-0 138261-41-3 143390-89-0 121-75-5 57837-19-1 2032-65-7 16752-77-5

0.2 ppm 0.2 ppm 0.4 ppm 0.2 ppm 0.2 ppm 0.4 ppm 0.4 ppm 1.0 ppm 0.4 ppm 1.0 ppm 0.2 ppm 0.4 ppm 0.4 ppm 0.2 ppm 0.2 ppm 0.2 ppm 0.4 ppm

Methyl parathion

298 -00 - 0

0.2 ppm

Myclobutanil

88671-89-0

0.2 ppm

Naled Oxamyl Paclobutrazol

300-76-5 23135-22-0 76738-62-0

0.5 ppm 1.0 ppm 0.4 ppm

Permethrins (measured as the cumulative residue of cis- and trans-isomers)

52645-531(54774-45-7 and 51877-74-8)

0.2 ppm

Phosmet Piperonyl_butoxide Prallethrin Propiconazole Propoxur

732-11-6 51-03-6 23031-36-9 60207-90-1 114-26-1

0.2 ppm 2.0 ppm 0.2 ppm 0.4 ppm 0.2 ppm

Pyrethrins (measured as the cumulative residue of pyrethrin 1, cinerin 1 and jasmolin 1)

8003-34-7(12121-1, 25402-06-6, and 4466-14-2)

1.0 ppm

Pyridaben Spinosad Spiromesifen

96489-71-3 168316-95-8 283594-90-1

0.2 ppm 0.2 ppm 0.2 ppm

156

Destroy

Spirotetramat

203313-25-1

0.2 ppm

Spiroxamine Tebuconazole Thiacloprid Thiamethoxam Trifloxystrobin

118134-30-8 107534-96-3 111988-49-9 153719-23-4 141517-21-7

0.4 ppm 0.4 ppm 0.2 ppm 0.2 ppm 0.2 ppm

E. Potency Labeling

Analyte

Required Action

Tetrahydrocannabinolic acid (THC-A) Delta-9- tetrahydrocannabinol (Δ9- Label claim is not within ±10 % of THC) tested value

Revise label as necessary

Cannabidiolic acid (CBD-A) Cannabidiol (CBD) Terpenoids (primary and secondary)

Label claim is not within ±10 % of tested value

Revise label as necessary

F. Moisture Content and Water Activity Testing Measurement

Allowable Measurement

Required Action

Water activity

˃ 0.65 Aw

Destroy

Moisture content

˃ than 15%

Remediate and retest

157

Table 2

Quality Control Sample

Acceptance Criteria

Frequency

Positive control

Produces expected result, positive result

Per Batch

Negative control

Produces expected result, negative result

Per Batch

Duplicate sample

Results shall concur

Per Run

Analyst or technician Quantitative Performance Plate count comparisons monthly

Within 10% for all analysts

Monthly

Table 3 Quality Control Sample

Positive control

Negative control

Laboratory replicate sample

Acceptance Criteria

Corrective Action Re-prep and reanalyze the entire analytical batch, once. If problem persists, locate and Produces expected result, remedy the source of unexpected result, then repositive result prep samples and reanalyze with a new set of controls. Re-prep and reanalyze the entire analytical batch, once. If problem persists, locate and Produces expected result, remedy the source of unexpected result, then renegative result prep samples and reanalyze with a new set of controls. Reanalyze sample and associated replicate sample once. If problem persists, re-prep samples and reanalyze.

Sample results shall concur

158

Table 4 Quality Control Sample

Method Blank Sample

Laboratory Control Sample

Duplicate Sample

Matrix Spike Sample/Matrix Spike Duplicate

CCV

Acceptance Criteria

Corrective Action

Not to exceed LOQ

Reanalyze entire analytical batch once. If method blank is still greater than the LOQ for any analyte, locate the source of contamination then re-prep samples and reanalyze.

RPD ≤20%

Reanalyze the entire analytical batch, once. If problem persists, re-prep samples and reanalyze or re-run the initial calibration curve.

RPD ≤20%

Reanalyze sample and associated replicate sample once. If problem persists, re-prep samples and reanalyze.

RPD ≤20%

Reanalyze sample and associated matrix spike sample once. If problem persists, re-prep samples and reanalyze.

Reanalyze all samples that followed the last CCV RPD ≤20% except for that met the acceptance criteria. If CCV still lowest point, which can be fails, re-run the initial calibration curve and all ±30% samples in the analytical sequence.

159

APPENDIX B SCHEDULE OF DISCIPLINARY ACTIONS Violation

Penalty

Unit of Measurement

Failure of an employee to possess an active work permit

$5,000

Each employee found without an active work permit.

Employment of person under the age of 21

$5,000

Each employee found under the age of 21.

Failure to assist Department during recall of product

$5,000

Each directive from the Department regarding recall.

Failure to comply with security requirements

$5,000

Each security deficiency related to Rules in this Part.

On-site use of cannabis by employee(s) of medical cannabis establishment

$5,000

Each employee using cannabis on premises of the medical cannabis establishment.

Failure to sufficiently maintain records

$10,000

Each deficiency/finding related to recordkeeping to Rules in this Part.

Unlawful acquisition, transfer, purchase or sale of cannabis and/or cannabis product(s)

$10,000

Each instance of acquisition, transfer, purchase or sale.

$10,000 and/or one-week Failure to accurately track inventory suspension and/or destruction of product Falsification of records

Each untagged plant, package and/or batch at the time of the Department’s finding.

Each instance of falsification of $10,000 and/or one week records required under Rules in suspension this Part.

Refusal to permit access by Department Two-week suspension staff as required by law

Instance/Occurrence documented at the time of requested access.

Threat against law enforcement and/or Department staff

Two-week suspension

Instance/Occurrence documented at the time of the threat.

Revocation

Cultivation activities that would include (but not limited to) any planting, drying, harvesting, and/or packaging during the dates of suspension and any administrative appeal.

Cultivation activities during a license suspension period

160

Revocation

Activities related to processing during the dates of suspension and any administrative appeals.

Transportation activities during a license suspension period

Revocation

Transportation activities that would include during the dates of suspension and any administrative appeal.

Disposal/Destruction activities during a license suspension period

Revocation

General penalty for any violation/infraction not specifically listed in this Table

$5,000

Processing activities during a license suspension period

161

Any disposal activities during the dates of suspension and any administrative appeal. Each instance and/or finding to be specifically identified by the Department.

APPENDIX C RULES AND PROCEDURES FOR ADMINISTRATIVE HEARINGS 1. Hearing Officer: The Hearing Officer shall be appointed by the State Health Officer or his/her designee. The Hearing Officer shall preside at the hearing, shall be charged with maintaining order at the hearing, and shall rule on all questions of evidence and procedure in accordance with the provisions of these rules. 2. Appearance by Licensee/Aggrieved party: The licensee/aggrieved party shall appear at the date and time set for the hearing, and failure to do so without reasonable notice to the Department may result in admission of the charges and adverse action taken against the licensee. 3. Representation by Counsel: The licensee/aggrieved party may, but is not required to be, represented by counsel at the hearing at his/her own expense and shall have the right to crossexamine all witnesses, present evidence, written or oral, on his/her own behalf, and to refute any testimony or evidence presented by the Department. 4. Confidentiality of Hearings: Administrative hearings before a Hearing Officer are considered confidential and are not open to the public. 5. Rules of Evidence and Discovery: Formal rules of evidence and procedure, including Discovery, do not apply in administrative hearings; however, the rules of evidence may be used as a guide during the hearing. A record of the hearing shall be made by a court reporter. 6. Attendance of Witnesses: The licensee/aggrieved party or counsel for the Department may make a written request to the Hearing Officer at least ten (10) days prior to the hearing to ensure the attendance of a witness or the production of documents through the issuance of an administrative subpoena. The issuance of the subpoena shall be at the discretion of the Hearing Officer. 7. Order of Proceedings: The Department shall present its case first, followed by the licensee/aggrieved party, and any rebuttal evidence by either party. At the request of either party, all prospective witnesses shall be excluded from the proceedings except while actually testifying. 8. Standard of Proof: In order for the Department’s decision to be overturned, the Hearing Officer shall find that the regulatory violation and/or disciplinary action is (a) arbitrary or capricious; 162

(b) unsupported by substantial evidence; (c) beyond the power of the administrative agency to make; or (d) violated some statutory or constitutional right of the aggrieved party. 9. Recommendation and Final Decision/Final Order: Within thirty (30) days of the hearing, or such period as determined at the hearing considering the amount of testimony and evidence and the complexity of the issues, the Hearing Officer shall submit his/her “Findings of Fact, Conclusions of Law and Recommendation” to the State Health Officer, outlining the proof presented and containing his/her recommendation to the State Health Officer as to the appropriate action to be taken. The State Health Officer shall issue his/her Final Order adopting, modifying, or rejecting the Recommendation within fourteen (14) days of receipt of the recommendation. This Final Order becomes the final appealable order of the Mississippi State Department of Health as to those proceedings. 10. Appeal of the Department’s Final Order shall be accomplished as provided by the appropriate statute. 11. Any person or entity who disagrees with or is aggrieved by the Final Decision or Final Order of the Department concerning the imposition of fine(s) and/or other sanction(s). suspension, or revocation of a license may appeal same in the circuit court of the county in which he/she resides. If the aggrieved party is a nonresident of this state, he/she may appeal to the Circuit Court of the First Judicial District of Hinds County, Mississippi. The appeal shall be filed no later than twenty (20) calendar days after the issuance of the Final Decision or Order by the Department. 12. Any person or entity aggrieved by the decision of the circuit court may appeal to the Mississippi Supreme Court. 13. If the licensee/aggrieved party fails to appeal the Final Order within the prescribed time, the decision becomes final and cannot be further appealed. Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67.

163

APPENDIX D Medical Cannabis Testing Requirements by Product Type Product Type

Potency

Pesticides &Chemical Residue

Bud/Flower, Shake/Trim or Raw Pre-roll

✓

✓

✓

✓

Non-Solvent Concentrate*

✓

✓

✓

✓

✓

Concentrate or Kief Infused Beverages

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

Infused Non-Edible Solids

✓

✓

✓

✓

✓

✓

✓

✓

Infused Edible

✓

✓

✓

✓

✓

✓

✓

✓

Inhalable Concentrates, Infused Pre-Roll or Other Compound Concentrate Products***

✓

✓

✓

✓

✓

✓

✓

Residual Solvents

Heavy Metals

* Extraction using ice water, rosin press or dry ice ** Moonrock, Caviar joint, tarantula, etc.

164

Microbiological Water Impurities Activity

✓

Foreign Matter

Homogeneity

✓

APPENDIX E Product Type

Description

Test Sample Packaging

Cannabis Flower

Loose cannabis flower whole or ground.

Batch can be packaged after passing compliance testing.

Samples must be in final form. Raw and Infused Pre-roll products

Cannabis flower loaded, rolled and ready for consumption.

Pre-roll lots in their entirety must be rolled prior to testing and shall be stored in a manner to ensure general sanitary practices and product stability. Remainder of the batch can be packaged after passing compliance testing. Samples shall be in the cartridge or container.

Oil for Vaporization

Pre-filled vape cartridges and prefilled Remainder of the batch shall be stored in a manner to ensure general disposable pens. sanitary practices and product stability. Remainder of the batch can be packaged after passing compliance testing. Samples shall be in final form.

Topicals

All products intended for topical use. Some examples are balms, lotions, and body oils.

Remainder of the batch shall be stored in a manner to ensure general sanitary practices and product stability. Remainder of the batch can be packaged after passing compliance testing.

Wax, Shatter, Resin

Concentrated cannabis extracted using a solvent. Some examples are budder, crumble, sauce, shatter, crystals, and crumble.

Samples shall be in final form. Remainder of the batch shall be stored in a manner to ensure general sanitary practices and product stability. Remainder of the batch can be packaged after passing compliance testing.

Product Type

Description

Test Sample Packaging

Includes: •

Gel-based foods, Water- Soluble Edibles, Tablets, Capsules, Solid Chocolates, and Lozenges

Any cannabis edible product that is intended to be chewed and relies upon a gelling agent such as, but not limited to, gelatin, agar, or pectin to maintain its shape or texture. Some examples are fruit chews, gummies, and chewable gel capsules.

•

Tablets, capsules, and lozenges.

•

Edible products which are intended to be dissolved in water before consumption. Some examples are dissolving powders and effervescent tablets.

Samples shall be in final form. Remainder of the batch shall be stored in a manner to ensure general sanitary practices and product stability. Remainder of the batch can be packaged after passing compliance testing.

Samples shall be in final form. Oral Liquids

Homogeneous oral liquids including tinctures, oral solutions, syrups, and oral emulsions.

Remainder of the batch shall be stored in a manner to ensure general sanitary practices and product stability. Remainder of the batch can be packaged after passing compliance testing. Samples shall be in final form.

Beverages

All beverages and syrups.

Remainder of the batch shall be stored in a manner to ensure general sanitary practices and product stability. Remainder of the batch can be packaged after passing compliance testing. 166

167