Those long-awaited proposed revisions to the Mississippi Department of Health’s medical cannabis program regulations dropped last Thursday afternoon. Thankfully, the department released a red-lined version, highlighting exactly what they are proposing to change and add to the existing regulatory framework. And goodness is there a lot of red! The department is accepting comments from the public until October 2, 2023, via this form.

No “summary” can capture all the proposed changes, as many delve fairly deep into the technical side of operating a medical cannabis business. So, if you are operating in Mississippi’s program or working with and advising those who are, I implore you to spend the time necessary to review the 200-plus-page document and to submit comments in a timely manner. I suspect many will see some of the proposed changes as steps in the right direction, designed to encourage well-established and experienced operators with ample resources to maintain sophisticated operations and compliance programs, while many will view some of the proposals as means to hamper a medical cannabis program that needs all the momentum it can get. 

However these proposals are perceived, I hope the following is a good starting point at scratching the surface of the proposed changes that may prove most impactful if adopted. Also, keep in mind that these proposed regulations generally only govern “medical cannabis establishments,” which the regulations define to include every licensee under the program other than dispensaries. The department of revenue regulates dispensaries.

Notable Definition Adds and Changes

• Definitions for the following previously undefined terms:
  • “Additive”
  • “Adverse Health Event”
  • “Adverse Weather Event”
  • “Botanically Derived Compounds”
  • “Cannabis Facility”
  • “Commercial Cannabis Activity”
  • “Certificate of Analysis”
  • “Contaminant”
  • “Final Form”
  • “Harvest Batch Package”
  • “Homogeneity”
  • “Homogenization”
  • “Identification Badge”
  • “Industrial Hemp”
  • “Infused Pre-Roll”
  • “Infusion”
  • “Ingredient”
  • “Inhalable Compound Concentrate Products”
  • “Kief”
  • “Manicure Batch”
  • “Non-Cannabis Waste”
  • “Plant Batch”
  • “Production Batch”
  • “Raw Pre-Roll”
  • “Research and Development Testing”
  • “Sanitize”
  • “Scope of Practice”
  • “Tincture”
  • “Topical Cannabis Product”
  • “Total CBD”
  • “Total THC”
  • “Total Yeast and Mold Count”
• More clarity on what information must be included with a “batch number,” depending on the type of product.
• Expanded definition of “biosecurity measures.” Pay attention: The department is placing lots of emphasis on biosecurity and environmental factors pertinent to grow operations in this set of proposed regulations.
• Expressly excluding the term “industrial hemp” from the term “cannabis” as that term is defined by Mississippi’s Hemp Cultivation Act, and excluding from the definition of “cannabis products”, “cannabis flower”.
• Further clarifying (1) what the term “cannabis waste” encompasses, adding that unusable sugar leaves, flower, bud, or any other unusable plant material containing trichomes or having a delta 9 THC concentrate level of greater than .3% on dry weight basis, and (2) that only a licensed cannabis disposal entity can dispose of cannabis waste.
• Removing from the definition section the term “chronic pain.”
• Specifically identifying kief, hashish, bubble hash, oil, and wax as “concentrates.”
• Proposed changes to the evaluation of what constitutes having an “economic interest” in a licensed medical cannabis business’s operation.
• Adding to the definition of “indoor cannabis cultivation” to include “a sealed, controlled environment that prevents unfiltered air exchange with the outdoors, provides control of environmental conditions such as humidity, temperature, light, carbon dioxide levels, and either requires use of artificial light exclusively or a rate above twenty-five (25) watts per square foot. Condition changes outside of the cultivation facility shall not alter or significantly affect environmental conditions inside the facility.”
• Expanding the definition of “medical cannabis establishment representative” to include an owner having a 10% or greater economic interest in the establishment and “independent contractors who perform services for a medical cannabis establishment if the establishment controls what will be done and how it will be done, including independent contractors and volunteers. 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 business establishment.”

Practitioner/Patient/Caregiver Proposed Changes

• Practitioners would have the option of renewing patient cards via telehealth if that practitioner previously evaluated the registered cardholder in-person.
• Specifying what information ID card applicants between the ages of 18-25 must submit with application.
• Changing language governing possession and purchase limits for resident cardholders, notably eliminating “rolling [ ] day period” language and describing periods as per week and per 30 days.
• Expanding what information a non-resident must provide to obtain a non-resident ID card in Mississippi.
• Clarifying that the department may approve and issue a non-resident card twice during any 365-day period, for a maximum each period of 15 days from the date of issuance.
• Expanding steps a practitioner must take before issuing a practitioner certification and expanding what is encompassed by a bona fide practitioner-patient relationship.
• Recordkeeping requirements imposed on practitioners with respect to patient certifications.
• New section imposing advertising restrictions on practitioners:
  • Any practitioner advertisements must be professional, not entice minors, and not suggest certification is attainable regardless of condition.
  • Practitioner advertisements cannot:
    • Contain false or misleading statements about medical cannabis or about the program;
    • Use colloquial terms to refer to medical cannabis, including, but not limited to, pot, weed, dope or grass;
    • State or imply the healthcare practitioner is endorsed by the department or by the program, including use of the department’s medical cannabis program logo;
    • Include images of cannabis in its plant or leaf form or of cannabis-smoking paraphernalia; or
    • Contain medical symbols that could reasonably be confused with symbols of established medical associations or groups.
  • Registered practitioners or entities acting on their behalf, are prohibited from advertising and marketing in any media, including, but not limited to:
    • Broadcast or electronic media:
      • Television
      • Unsolicited internet pop-up advertising
      • Social media
    • Print media:
    • Other forms:
      • Mass text/messaging communications
      • Mass email communications
      • Medical cannabis or medical cannabis products shall not be displayed in windows or public view
      • Advertisement in any manner that can be viewable or otherwise perceived as a public space, including, but not limited to, adopt-a- highway signs or electronic interstate signs
      • Solicited/paid patient and/or caregiver reviews/testimonies/endorsements
  • 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.

Proposed Changes to Business Licensing, Background Checks, and Work Permits

• Clarifying that map/sketch of premises must illustrate locations of security cameras, exterior lighting, secure access areas, and fencing.
• If application is based on an existing building, the applicant must submit photos of the interior, exterior, and surrounding property.
• The applicant’s operating plan must include:
  • An organization chart;
  • Operating personnel’s job descriptions and minimum qualifications;
  • Explanation of whether the applicant has experience working in highly regulated industries, such as the cannabis industry;
  • Employee training plan; and
  • Hours of operation.
• Applications must include additional information about individuals or entities having 10% or more ownership in the entity.
• More clarity that anyone with a direct or indirect ownership interest of 10% or more must provide adequate fingerprinting information for background checks.
• For the proficiency testing component of a testing entity application, these applicants must have successfully analyzed one set of proficiency testing samples for all required analytes prior to being licensed.
• Clarifies that licensed testing facilities can engage in transportation of test samples.
• Clarifies that a medical cannabis establishment, despite receiving a license, cannot “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.”
• While department inspections can be unannounced, they generally shall only occur during reported hours of operation.
• More detail about what must be submitted during the license renewal process, within 30 days prior to the license expiration date.
• Nonrenewal prior to the expiration date requires immediate stoppage operations, scheduling of a close-out inspection with the department, and destruction of all cannabis and cannabis products in the licensee’s possession.
• The department may conduct an inspection of the licensee’s facility within 60 days of the license expiration.
• Sets forth a process for licensees who permanently abandon or otherwise permanently cease activities on the premises related to the operation of a medical cannabis establishment.
• All “medical cannabis establishment representatives” (defined above) must obtain a work permit.

Operational and Recordkeeping Requirements

• No medical cannabis licensee, not just cultivators, may allow operations to stop for more than a six-month period after business activities (changed from “production”) commence.
• Medical cannabis licensees must ensure that all employees, volunteers, and others engaged in activities under their direction are “qualified to perform their assigned duties.”
• While testing facilities and transportation entities may share employees and ownership, such ownership cannot create conflicts.
• “Qualified lab employees only shall collect and transport samples for testing, etc. Transport of non-lab samples such as retail products or products between facilities shall not occur in the same vehicle at the same time due to potential cross-contamination issues.”
• Additional qualification criteria for a testing entity’s full-time analyst.
• New proposed regulation requiring testing facility to employ designated sample collector having certain, stated qualifications and training.
• Additional recordkeeping requirements for testing facilities.
• New proposed measures and precautions imposed on any medical cannabis licensee, including disease control and cleanliness, and a requirement that these licensees have supervisory personnel assigned to ensure compliance with those measures and precautions.
• New rules governing contractors and other authorized visitors to medical cannabis establishments.
• New rules regarding the condition that licensees must keep their premises to avoid contamination, including equipment storage, litter control, yard and weed maintenance, drainage, and water treatment.
• New details about what the scope of “indoor, enclosed, locked, and secure” means with respect to cannabis facilities: “no unfiltered air exchange with the outdoors and provides control of environmental conditions such as humidity, temperature, light, and odor. Condition changes outside of the facility should not alter or significantly affect environmental conditions inside the facility.”
  • The structure for all medical cannabis activities must take place in a building that is sealed and prevents unfiltered air exchange with the outdoors, provides control over outside environment (e.g.,temperature, humidity, light, carbon dioxide levels), and protects operations from all external elements.
• No outdoor processing allowed.
• New rules governing sanitation operations for cultivating, processing, and storage of cannabis and cannabis products.
• Additional specifications regarding construction of facilities, including measures to ensure indoor components can be adequately cleaned and repaired; avoid obstruction of aisles and working spaces; prevent drip and condensation from air exchange and other HVAC components; provide adequate lighting throughout the facility; provide shatter-resistant lighting in areas where cannabis and cannabis products are present; provide adequate ventilation and control equipment to minimize dust, odors, and vapors; ensure fans and other air-blowing equipment do not promote allergen cross-contact or contamination; and provide adequate screening and protection against pests.
• Removal of video surveillance requirement for destruction of plant waste;
• Requirement that video surveillance system be able to operate during power outage;
• New specifications regarding the secure perimeter fencing of medical cannabis facilities.
• All licensees must have their SOPs on-site for security; employment practices adhering to state and federal law; recordkeeping, diversion and/or inversion protection; types and quantities of cannabis products to be produced and cultivated; methods of cultivation; processing methods; integrated pest management plan; inventory control and tracking, labeling and packaging procedures; transportation of cannabis and cannabis products; waste disposal; and recall procedures.
• SOPs must also address:
  • Selection, weighing, and measuring of ingredients and the determination of finished yield are reviewed by a second individual;
  • Major equipment, transfer lines, containers and tanks used for processing, holding, or filling are identified to indicate contents, batch identification, stage of processing, and control status;
  • Appropriate measures to prevent contamination with microorganisms, chemicals, filth, or other extraneous material;
  • In-process controls to ensure product uniformity, integrity (for example, in-process batch weights), accurate fill of mixing containers, and adequacy of mixing;
  • Theoretical yield for a production batch is compared with the actual yield;
  • Storage and handling of packaging materials that are intended to come into direct contact with the product prevent mix-ups and microbiological or chemical contamination; and
  • Finished product packages bear permanent, meaningful, unique batch numbers.
• New comprehensive rules governing sanitation operations, which address contamination prevention, cleaning and toxic materials (use and storage), pest control, sanitation of contact and non-contact surfaces, water supply, plumbing, sewage disposal, toilet facilities, hand-washing facilities, equipment and utensils, quality control procedures, handling of ingredients integrated with cannabis products, manufacturing operations, and addressing contaminated processed products.
• Requiring that cuttings or clones taken from a mother plant for a plant batch must be e-recorded in the seed-to-sale program as being derived from that mother plant’s tag.
• Prior to transfer, immature plant batches must be assigned a package tag per seed-to-sale protocol.

Product Testing and Safety

• New recordkeeping requirements applicable to testing entities, including batch production and distribution records.
• Clarity that samples are to be tested only from usable cannabis products and that “retail-ready” products must be sampled and tested in “final form.”
• Final-form products, for testing/sampling, must be in retail-ready packaging.
• Sampling of product for mandatory testing must be done by testing licensee at harvest batch or production batch level so as to avoid contaminations or degradation.
• The max harvest batch package is 25 pounds, and a minimum of 15 sample increments of .5 gram each is required.
• The production batch for infused products shall not contain more than 150,000 units, with the following rules governing infused and edible products:
  • 3 units for a production batch of up to 100 units
  • 6 units for a production batch of 101 to 500 units
  • 9 units for a production batch of 501 to 1,000 units
  • 12 units for a production batch of 1,001 to 5,000 units
  • 15 units for a production batch of 5,001 to 10,000 units
  • 20 units for a production batch of 10,001 to 35,000 units
  • 30 units for a production batch of 35,001 to 100,000 units
  • 50 units for a production batch of 100,001 to 150,000 units
• Sample increments for cannabis concentrates shall be .25 grams as follows:
  • 12 increments for a production batch of 1 to 2 pounds
  • 15 increments for a production batch of 2.01 to 3 pounds
  • 18 increments for a production batch of 3.01 to 4 pounds
  • 23 increments for a production batch of 4.01 to 10 pounds
  • 30 increments for a production batch greater than 10 pounds
• A production batch of raw or infused pre-rolls shall contain no more than 150,000 units, with the following minimum number of increments (each sample increment consists of one packaged unit):
  • 2 units for a production batch of up to 50 units
  • 3 units for a production batch of 51 to 100 units
  • 4 units for a production batch of 101 to 500 units
  • 8 units for a production batch of 501 to 1,500 units
  • 12 units for a production batch of 1,501 to 3,000 units
  • 20 units for a production batch of 3,001 to 10,000 units
  • 30 units for a production batch of 10,001 to 35,000 units
  • 50 units for a production batch of 35,001 to 150,000 units
• A production batch of inhalable concentrate shall contain no more than 150,000 units, with the following minimum number of increments (each sample increment consists of one packaged unit):
  • 2 units for a production batch of up to 50 units
  • 3 units for a production batch of 51 to 100 units
  • 4 units for a production batch of 101 to 500 units
  • 8 units for a production batch of 501 to 1,500 units
  • 12 units for a production batch of 1,501 to 3,000 units
  • 20 units for a production batch of 3,001 to 10,000 units
  • 30 units for a production batch of 10,001 to 35,000 units
  • 50 units for a production batch of 35,001 to 150,000 units
• Licensed testing entities shall not desiccate samples, pre-test samples, select best or most desirable material from a batch of sample for testing, or manipulate samples in any way that would alter the sample integrity or homogeneity of the sample (all sample increments must have the same genesis, same chances of being selected, and all sampling must be random).
• Clarity on testing entity employee obligations and limitations with respect to sampling and transportation of samples and handling of samples.
• Testing of production batches of infused products, kief, and infused pre-rolls must test the following prior to sale or transfer:
  • Pesticides;
  • Water activity and moisture content;
  • THC and CBD concentration;
  • Heavy metals;
  • Mycotoxins;
  • Microbiological contaminants;
  • Terpenes, if performed;
  • Foreign material; and
  • Homogeneity.
• Final form edible products must also be produced and sold with a standardized concentration of cannabinoids not exceeding 10 mg of THC per serving with an allowable variance of ±10% when testing and demonstrate uniform disbursement of cannabinoids throughout the product when sampled and tested.
• Non-edible or beverage products are exempt from water activity and moisture content testing.
• In appendices D and E, the proposed new regulations summarize compliance testing requirements by product type and by final packaging, respectively.
• Additional criteria for testing of microbial impurities, water activity and moisture content, THC and CBD testing, heavy metals, mycotoxins, terpenoids, and foreign materials.
• New standards proposed for homogeneity testing.
• New criteria proposed for research and development testing.
• New proposed rules governing a testing entity’s transportation of samples.
• New recordkeeping requirements proposed for testing entities’ quality assurance standards and new rules proposed to govern reagents, reference standards and media, and calibration of equipment.
• New quality control sample standards proposed.
• New criteria proposed for proficiency testing.
• New rules proposed to govern cultivation and processing entities SOPs for the cultivation of cannabis and cannabis productions (e.g., formulations, processing procedures, in-process control methods, packaging procedures, procedures for operating equipment).
• New rules proposed to govern SOPs for quality control and assurance, including quality control review and disposition decisions, and recordkeeping of same.
• New rules proposed regarding returned cannabis or cannabis products, product complaints, adverse events, and recalls.
•  New rules proposed regarding remediation and reanalysis of batches.

Packaging and Labeling

• Labels of edible cannabis products must indicate number of servings of THC in the product, a statement that the product’s potency was tested with an allowable variance of plus or minus 10% (must be repackaged if tests outside of this 10% allowable variance).

Transportation

• Only cannabis or cannabis products that have passed testing and have an accompanying COA can be transported, via a licensed transportation entity, to a licensed dispensary.
• Products that haven’t been transported to a dispensary within 12 months of the COA date must be destroyed or retested, and only retested if the products have not been modified.Removes requirement that transportation entities be fully independent from other medical cannabis establishments and dispensaries

• Storage of cannabis products by a transportation entity must, in addition to existing regulations, occur in a location that has controls for temperature and relative humidity; is under conditions that protect against allergen cross-contact and against biological, chemical, and physical contamination; and that protects against deterioration of the product, component, and container.

Variance Requests

• The MDOH will not consider variance requests that relate to provisions of the Mississippi Medical Cannabis Act or that are otherwise “purely statutory.”

Enforcement and Penalties

• The MDOH proposes to broaden its menu of penal actions to include:
  • Imposing monetary penalties;
  • Issuing an administrative hold;
  • Suspending a license;
  • Revoking a license;
  • Accepting the voluntary surrender of a license;
  • Confiscating or seizing cannabis plants, cannabis and/or cannabis products;
  • Ordering destruction of cannabis plants, cannabis and/or cannabis products; recalling cannabis and/or cannabis products; or
  • Accepting the voluntary surrender of cannabis plants, cannabis and/ cannabis products.
• Proposed new regulations detail processes and decision making related to suspension of licenses, seizing/destroying/confiscating, or putting administrative hold on products; department emergency decisions and orders; and proceedings and judicial review of same.