Medical Marijuana Facility Inspection Checklist
This inspection checklist guide will help applicants may use this checklist in preparation for the Initial Inspection conducted by the Department of Cannabis Regulation.
MaintainX
07/19/2022
Medical Marijuana Facility Inspection Checklist
This inspection checklist guide will help applicants may use this checklist in preparation for the Initial Inspection conducted by the Department of Cannabis Regulation.
Provider/DBA:
Facility Address:
Associated License(s):
Inspection Date:
Provider owned (Y/N)
Valid Permission Form (Y/N/Na)
License type(s):
Provider(s) contact information:
Local Ordinance Jurisdiction:
Inspecting agent(s):
Inspection type:
Names/Title of representatives present for inspection:
Tax Status:
Canopy Tier Level:
Canopy Max Square Footage:
Canopy Square Footage at Inspection:
Complaints received:
Persons of Interest
Requirement
The department may not license a person under this section if the person or an individual with a financial interest in the person:
has a felony conviction or a conviction for a drug offense;
is in the custody of or under the supervision of the department of corrections or a youth court;
has been convicted of a violation under 50-46-331;
has failed to:
pay any taxes, interest, penalties, or judgments due to a government agency
stay out of default on a government-issued student loan;
pay child support; or
remedy an outstanding delinquency for child support or for taxes or judgments owed to a government agency
Notes/Deficiencies/Corrections (if any):
Advertising
Requirement
Persons with licenses and individuals with valid registry identification cards may not advertise marijuana or marijuana-related products in any medium, including electronic media.
A listing in a directory of businesses authorized under this part is not advertising for the purposes of this section.
A licensee may have a website but may not:
include prices on the website; or
actively solicit customers or out-of-state consumers through the website
A licensee who violates the advertising restrictions imposed under 50-46-341 is subject to:
a written warning for the first violation;
a 5-day license suspension or a $500 fine for a second violation;
a 5-day license suspension or a $1,000 fine for a third violation;
a 30-day license suspension or a $2,500 fine for a fourth violation; and
a license revocation for a fifth violation.
Prohibited activities include:
the use of any written or verbal statements, photos, symbols, or depictions of marijuana or marijuana products, on any medium accessible to the general public; or
the use of vocabulary or prices on any medium accessible to the general public that leads a reasonable person to believe that the term or prices used identifies or describes marijuana or marijuana products.
A licensee may use the phrase "DPHHS Montana Medical Marijuana Program Licensed Provider" in its signage, on a website homepage, or on its promotional materials.
Notes/Deficiencies/Corrections (if any):
General Facility
Requirement
No portion of the property used for cultivation of marijuana or manufacture of marijuana-infused products or marijuana concentrate may be shared with or rented or leased to another provider, marijuanainfused products provider, testing laboratory, or registered cardholder.
No portion of a registered premises used to manufacture a marijuana-infused product or marijuana concentrate may be shared with, rented, or leased to another provider, marijuana-infused products provider, testing laboratory, or registered cardholder.
A provider or marijuana-infused products provider:
A provider, marijuana-infused products provider, dispensary, or testing laboratory license or an endorsement for chemical manufacturing is a privilege that the state may grant to an applicant and is not a right to which an applicant is entitled. In making a licensing decision, the department shall consider:
The department or state laboratory, as applicable, may deny a license if the applicant's proposed registered premises:
is situated within a zone of a city, town, or county where an activity related to the medical use of marijuana is prohibited by ordinance or resolution, a certified copy of which has been filed with the department
will adversely affect the welfare of the people residing in or of retail businesses located in the vicinity.
The department or state laboratory, as applicable, may deny a license or endorsement if the applicant's proposed registered premises or testing laboratory
is not approved by local building, health, or fire officials
is within 500 feet of and on the same street as a building used exclusively as a church, synagogue, or other place of worship or as a school or postsecondary school other than a commercially operated school. This distance must be measured in a straight line from the center of the nearest entrance of the place of worship or school to the nearest entrance of the licensee's premises
The department may not approve a license for a provider, marijuana-infused products provider, or dispensary if a local government has adopted an ordinance or resolution prohibiting the operation of dispensaries or storefront businesses as allowed under 50-46-328
A provider or marijuana-infused products provider may not:
Renewal applications must be submitted at least 30 calendar days prior to the expiration date of the license
A licensee:
may not operate until on or after the effective date of the license
must display proof of licensure in a prominent place on the registered premises.
A licensee must clearly identify all limited access areas at a registered premises.
Licensees must ensure that licensee's employees wear a department-issued identification badge in a clearly visible manner on the outermost layer of clothing while working on behalf of the licensee.
A licensee must maintain a daily log of all visitor activity on a registered premises. The log must contain the visitor's first and last name and date of visit.
A licensee must post signs inside the registered premises in a conspicuous location that read:
"No Minors Permitted on This Premises Except When Accompanied By An Adult"
"No On-Site Consumption of Marijuana Except by Registered Cardholders"
A licensee is responsible for the security of all marijuana items on a registered premises, in transit, and under the supervision of any licensee or licensee employee until the marijuana item is sold.
A licensee must have a written security plan maintained on the registered premises that safeguards against theft, diversion, or tampering of marijuana items both on the registered premises and during transit.
Commercial grade, nonresidential door locks must be installed on every external door and gate of a registered premises.
A licensee must ensure general sanitary requirements are met on a registered premises to include:
hand-washing facilities
proper and timely removal of all litter and waste
toilet facilities that are maintained in a sanitary condition and good repair.
A licensee must use a licensed weighing device pursuant to 30-12-203, MCA and ARM 24.351.101 whenever marijuana items are:
packaged for sale by weight
bought and sold by weight
weighed for entry into the inventory tracking system.
A licensee must establish written emergency procedures to be followed in case of a fire, chemical spill, or other emergency at all registered premises.
A marijuana employee permit is required for any employee of a licensee prior to working.
The marijuana employee permit must always be carried when performing work on behalf of a licensee in a clearly visible manner on the outermost layer of clothing
A licensee must notify the department as soon as reasonably practical but in no case more than 24 hours following the theft of marijuana items or money from the registered premises.
Notes/ Deficiencies/ Corrections (if any):
Cultivation
Requirement
The department shall license providers and marijuana-infused products providers according to a tiered canopy system.
A micro tier canopy license allows for a canopy of up to 250 square feet at one registered premises.
A tier 1 canopy license allows for a canopy of up to 1,000 square feet at one registered premises. A minimum of 500 square feet must be equipped for cultivation.
A tier 2 canopy license allows for a canopy of up to 2,500 square feet at up to two registered premises. A minimum of 1,100 square feet must be equipped for cultivation
A tier 3 canopy license allows for a canopy of up to 5,000 square feet at up to three registered premises. A minimum of 2,600 square feet must be equipped for cultivation.
A tier 4 canopy license allows for a canopy of up to 7,500 square feet at up to four registered premises. A minimum of 5,100 square feet must be equipped for cultivation.
A tier 5 canopy license allows for a canopy of up to 10,000 square feet at up to five registered premises. A minimum of 7,750 square feet must be equipped for cultivation
A tier 6 canopy license allows for a canopy of up to 13,000 square feet at up to five registered premises. A minimum of 10,250 square feet must be equipped for cultivation.
A tier 7 canopy license allows for a canopy of up to 15,000 square feet at up to five registered premises. A minimum of 13,250 square feet must be equipped for cultivation
A tier 8 canopy license allows for a canopy of up to 17,500 square feet at up to five registered premises. A minimum of 15,250 square feet must be equipped for cultivation
A tier 9 canopy license allows for a canopy of up to 20,000 square feet at up to six registered premises. A minimum of 17,775 square feet must be equipped for cultivation.
A provider or marijuana-infused products provider who has reached capacity under the provider's existing license may apply to advance to the next licensing tier. The department:
The department's application for the canopy system must require evidence that the provider is able to successfully cultivate the minimum amount of space allowed for the tier and sell the amount of marijuana produced by the minimum cultivation level.
A registered cardholder who has elected not to use the system of licensed providers and marijuanainfused products providers may possess up to 4 mature plants, 4 seedlings, and the amount of usable marijuana allowed by the department by rule.
If two or more registered cardholders share a residence and have elected not to use the system of licensed providers and marijuana-infused products providers, the cardholders may have a maximum of 8 mature plants, 8 seedlings, and the amount of usable marijuana allowed by the department by rule. The limits in this subsection (1)(b)(ii) apply regardless of the location of the plants and seedlings.
A provider or marijuana-infused products provider may have the canopy allowed by the department for the provider or marijuana-infused products provider. The canopy allotment is a cumulative total for all of the provider's or marijuana-infused products provider's registered premises and may not be interpreted as an allotment for each premises.
A registered cardholder, provider, or marijuana-infused products provider may not cultivate marijuana or manufacture marijuana concentrates or marijuana-infused products for use by a registered cardholder in a manner that is visible from the street or other public area
The following provisions apply to a licensee's canopy space:
a licensee must not exceed the total canopy allowed by the department for cultivation of marijuana.
A licensee must establish written standard operating procedures to produce marijuana. The licensee must maintain those procedures on the registered premises and make them available for department inspection at all times. The standard operating procedures must include:
when and how all pesticides or other chemicals are to be applied during the production process;
water usage and waste water disposal;
the waste disposal plan
In addition to other records required by these rules, a licensee must maintain on the registered premises:
the material safety data sheet for all pesticides, fertilizers, or other agricultural chemicals used in the production of marijuana;
the original label or a copy thereof for all pesticides, fertilizers, or other agricultural chemicals used in the production of marijuana; and
a log of all pesticides, fertilizers, or other agricultural chemicals used in the production of marijuana.
A licensee may not cultivate hemp or engage in hemp manufacturing at a registered premises
Notes/ Deficiencies/ Corrections (if any):
MIPP
Requirement
A provider or marijuana-infused products provider: (c)may not contract or otherwise arrange for another party to process the provider's or marijuana-infused products provider's marijuana into marijuana-infused products or marijuana concentrates
A person licensed as a marijuana-infused products provider shall:
prepare marijuana-infused products at a registered premises; and
use equipment that is used exclusively for the manufacture and preparation of marijuana-infused products.
A marijuana-infused products provider:
may cultivate marijuana only for the purpose of making marijuana-infused products;
may not enter into a contract or other arrangement to provide services through the provider's commercial kitchen or chemical extraction facilities to another marijuana-infused products provider; and
may not provide a cardholder with marijuana in a form that may be used for smoking unless the marijuana-infused products provider is also a licensed provider.
All registered premises on which marijuana-infused products are manufactured must meet any applicable standards set by a local board of health for a retail food establishment as defined in 50-50-102.
Marijuana-infused products may not be considered a food or drug for the purposes of Title 50, chapter 31.
A registered cardholder, provider, or marijuana-infused products provider may not cultivate marijuana or manufacture marijuana concentrates or marijuana-infused products for use by a registered cardholder in a manner that is visible from the street or other public area.
In addition to any other penalty provided by law, the department shall revoke a license issued under this part if the licensee: (c) operates a carbon dioxide or hydrocarbon extraction system without obtaining a chemical manufacturing endorsement
A licensee may not cultivate hemp or engage in hemp manufacturing at a registered premises.
To produce marijuana-infused products or engage in chemical manufacturing, a licensee must:
ensure the registered premises and equipment are maintained in a clean and sanitary condition for product preparation purposes;
use equipment, counters, and surfaces for processing that are food grade, do not react adversely with any solvent being used, reduce the potential for development of microbials, molds and fungi, and can be easily cleaned;
maintain detailed instructions for making each infused product, concentrate, or extract;
conduct necessary safety checks prior to commencing processing; and
create written detailed operating procedures for:
cleaning all equipment, counters, and surfaces thoroughly;
proper handling and storage of any solvent, gas, or other chemical used in processing or on the registered premises;
proper disposal of any waste produced during processing;
training licensee employees on how to use the system and handle and store the solvents and gases safely
A licensee with a chemical manufacturing endorsement must:
only use hydrocarbon-based solvents that are at least 99 percent pure, except when using solvents outlined in (3);
only use nonhydrocarbon-based solvents that are food grade;
work in an environment with proper ventilation, controlling all sources of ignition where a flammable atmosphere is or may be present;
use only potable water and ice made from potable water in processing;
process in a fully enclosed room;
use a professional grade closed loop extraction system designed to recover the solvents;
have equipment and facilities used in processing approved for use by the local fire code official;
have an emergency eye-wash station in any room in which chemical manufacturing is occurring;
have all applicable material safety data sheets readily available;
establish written emergency procedures to be followed in case of a fire, chemical spill, or other emergencies at all registered premises.
A licensee with a chemical manufacturing endorsement may use:
a mechanical extraction process;
a chemical extraction process using a nonhydrocarbon-based or other solvent, such as water, vegetable glycerin, vegetable oils, animal fats, isopropyl alcohol or ethanol
a chemical extraction process using the solvent carbon dioxide, provided that the process: (i) does not involve the use of heat over 180 degrees Fahrenheit; and (ii) uses a professional grade closed-loop carbon dioxide gas extraction system where every vessel is rated to a minimum of six hundred pounds per square inch
A licensee with a chemical manufacturing endorsement may not use:
class I solvents;
pressurized canned flammable fuel intended for use in camp stoves, handheld torch devices, refillable cigarette lighters, and similar products; or
denatured alcohol
A licensee may not treat or otherwise alter a marijuana item with any noncannabinoid additive that would increase potency, toxicity, or addictive potential that would create an unsafe combination with other psychoactive substances.
All licensees using solvent-based or solvent-free extraction processes authorized under this rule must obtain a chemical manufacturing endorsement.
a provider or marijuana-infused products provider shall: (a)prior to selling marijuana or marijuana-infused products, submit samples to testing laboratories pursuant to 50-46-311, 50-46-326, and related administrative rules;
A provider or marijuana-infused products provider:
may sell only marijuana the provider has cultivated or marijuana products derived from marijuana the provider has cultivated
may not open a dispensary before obtaining the required license or before the department has completed the inspection required under this part.
a provider or marijuana-infused products provider may not sell marijuana or marijuana-infused products until the marijuana or products have been tested by a testing laboratory or the department of agriculture and met the requirements of this section.
A licensee may not:
give marijuana items as a prize, premium or consideration for a lottery, contest, game of chance or game of skill, or competition of any kind;
sell or transfer any marijuana item through a drive-up window;
treat or otherwise alter usable marijuana, consisting of dried leaves and flowers, with the intent of altering the color, appearance, weight, or smell
A licensee may not sell hemp flower as defined by 80-18-101, MCA.
A licensee may only sell hemp cannabidiol (CBD) products sourced from hemp produced and sold by a producer who is licensed by a state or tribe with a USDA-approved hemp production plan.
In addition to any other penalty provided by law, the department shall revoke a license issued under this part if the licensee:
A licensee may not:
sell more than the daily or monthly purchase limit of usable marijuana to a cardholder.
For each marijuana sale or transfer to a registered cardholder, the licensee or licensee employee must:
verify the registered cardholder's eligibility and daily and monthly purchase limits. (i) A licensee may not complete a sale that exceeds a registered cardholder's daily or monthly purchase limit.
record in the seed-to-sale tracking system at the time of sale or transfer: (i) the quantity of each item sold or transferred to a registered cardholder; (ii) the price before tax; and (iii) the date of the sale or transfer to a registered cardholder
A provider is not permitted to sell or transfer to a registered cardholder, marijuana items that have a failed quality assurance test.
Notes/ Deficiencies/ Corrections (if any):
Labels
Prior to marijuana items being sold or transferred to a registered cardholder the container holding the usable marijuana items must have a label that has the following information:
licensee business or trade name and licensee registration number;
date of harvest of marijuana or date the marijuana item was manufactured;
name of strain or marijuana item (common or usual name);
net weight or volume in U.S. customary and metric units;
concentration by weight or volume of THC, THCA, CBD, and CBDA;
unique identification number.
Labels must include a consumer warning that states:
"For use by Montana Medical Marijuana Program registered cardholders only. Keep out of reach of children.";
"It is illegal to drive a motor vehicle while under the influence of marijuana."
"This product is not approved by the U.S. Food and Drug Administration (FDA) to treat, cure, or prevent any disease."
If the marijuana item has passed required testing, the licensee must include on the label: "This Product Has Been Tested and Meets the Quality Assurance Requirements of the State of Montana."
Additional labeling requirements for marijuana topicals, ointments, suppositories, and other marijuana products not intended to be administered orally must include:
"DO NOT EAT" in bold capital letters
a list of ingredients in descending order or predominance by weight or volume used to process the product.
Additional labeling requirements for edible marijuana products and tinctures must include:
"BE CAUTIOUS" in bold capital letters, followed by "This product can take up to two hours or more to take effect";
if the marijuana item is perishable, a statement that the marijuana item must be refrigerated or kept frozen;
list of potential major food allergens;
a "contains" statement to summarize the major food allergen information at the end of or immediately adjacent to the ingredient list; or (e) a statement of the appropriate major food allergen in parenthesis within the ingredient list after the common or usual name of the ingredient derived from that major food allergen.
Additional labeling requirements for marijuana concentrates and extracts must include:
"DO NOT EAT" in bold capital letters;
extraction method and solvent.
Labels required by these rules must:
be placed on the container and on any packaging, that is used to display marijuana items for sale or transfer to a registered cardholder;
be in no smaller than eight point Times New Roman, Helvetica, or Arial font;
be in English; and
be unobstructed and conspicuous.
Licensees may use a peel-back or accordion label with the required information if the peel-back or accordion label can be easily identified by a registered cardholder as containing important information.
A label may not:
contain any untruthful or misleading statements
contain any untruthful or misleading statements
be attractive to minors. For the purpose of this rule, "attractive to minors" means packaging, labeling and marketing that features:
If a marijuana item is placed in a package that is being reused, the old label or labels must be removed and it must have a new label or labels
Exit packaging must contain a label that reads: "Keep out of the reach of children."
Containers or packaging for usable marijuana items must protect the product from contamination and must not impart any toxic or deleterious substance to the product.
Marijuana items for final sale to a consumer must be:
packaged in a container that is child-resistant as defined in ARM 37.107.110; and
labeled in accordance with ARM 37.107.401
Tracking
A provider or marijuana-infused products provider shall: (c)participate as required by the department by rule in a seed-to-sale tracking system established by the department pursuant to 50-46-304
A licensee must have a department inventory tracking system account activated and functional prior to operating or exercising any privileges of the license and must maintain an active account while licensed.
An individual entering data into the inventory tracking system may only use that individual's inventory tracking system account.
A licensee must ensure:
all inventory tracking system users are up to date on inventory tracking system user training requirements; and
any data that is entered into the inventory tracking system in error is corrected.
A licensee and any designated inventory tracking system user must enter data into the inventory tracking system that accounts for all inventory tracking activities.
A licensee is accountable for all actions inventory tracking system users take while logged into the inventory tracking system
A licensee is responsible for the accuracy of all information entered into the inventory tracking system.
If a licensee loses access to the inventory tracking system, the licensee must keep and maintain comprehensive records detailing all tracking inventory activities that were conducted during the loss of access
Once access is restored, all inventory tracking activities that occurred during the loss of access must be entered into the inventory tracking system.
A licensee must document when access to the inventory tracking system was lost and when it was restored.
A licensee must use the department's selected inventory tracking system as the primary inventory and record keeping system.
Each individual marijuana plant that reaches a height of twelve inches must be issued a unique identification number in the inventory tracking system, which follows the plant through all phases of production and final sale to a registered cardholder.
All marijuana items, test batches, harvest lots, and process lots must be issued a unique identification number in the inventory tracking system.
Unique identification numbers cannot be reused
Each marijuana plant, marijuana item, test batch, harvest lot, and process lot that has been issued a unique identification number must have a physical tag placed on it with the unique identification number.
The tag must be legible and placed in a position that can be clearly read and must be kept free from dirt and debris.
Licensees must use unique identification tags provided by the department.
All on-premises and in-transit marijuana item inventories must be reconciled in the inventory tracking system at the close of business each day
Licensees must record in the seed-to-sale tracking system:
wet weight of all harvested marijuana plants immediately after harvest
information for marijuana items by unit count;
weight per unit of a product;
weight and disposal of post-harvest waste materials;
theft or loss of marijuana items
Testing
a provider or marijuana-infused products provider shall:(a) prior to selling marijuana or marijuanainfused products, submit samples to testing laboratories pursuant to 50-46-311, 50-46-326, and related administrative rules.
A provider or marijuana-infused products provider shall submit material that has been collected in accordance with a sampling protocol established by the state laboratory by rule. The protocol must address the division of marijuana and marijuana-infused products into batch sizes for testing. Each batch must be tested in the following categories:
A provider may request that the laboratory resample the failed batch or lot for repeat testing within seven calendar days of receiving notice from the laboratory of any failed testing and resampled analyses must be completed by the laboratory within 30 days of receiving the request from the provider
Failed harvest lots or test batches may be remediated as long as the remediation method does not impart any substance or effect to the usable marijuana, marijuana concentrates, or marijuana-infused products that may have a toxic or deleterious effect on the health of the consumer.
Remediation methods used on specific lots or batches of marijuana or marijuana-infused products that have failed initial quality assurance testing must be disclosed to the state laboratory and to the Medical Marijuana Program prior to remediation.
No remediated harvest lots or test batches may be sold or transferred until the completion and successful passage of all quality assurance testing, and the results certified in a certificate of analysis, as required in these rules and Montana statute.
With the exception of moisture analysis or residual solvent screening, a remediated sample from a failed harvest lot or test batch that fails quality assurance testing cannot be remediated again and the harvest lot or test batch must be destroyed. Harvest lots or test batches that fail initial quality assurance testing for moisture analysis or residual solvent screening may be remediated and retested a maximum of two times.
a provider must submit for testing a sample of every test batch from a harvest lot of marijuana and process lots of marijuana-infused products, extracts, and concentrates intended for use by a registered cardholder prior to selling or transferring the marijuana item to a registered cardholder
Usable marijuana lots consisting of dried leaves and flowers must be tested for the following: (a) cannabinoid profile;
moisture analysis
moisture analysis
foreign matter screening;
microbiological screening;
and pesticides screening
Marijuana concentrate and extract lots must be tested for the following:
cannabinoid profile;
microbiological screening;
residual solvents screening; and
pesticides screening
Marijuana-infused products must be tested for the following:
cannabinoid profile; and
microbiological screening.
Providers must adhere to testing requirements for all marijuana and marijuana products intended for sale or transfer to cardholders.
Usable marijuana, including trim and manicure must be tested for:
pesticides;
moisture content;
cannabinoid profile/potency;
microbiological;
mycotoxin
filth and foreign matter; and heavy metals (random testing).
Marijuana extract and concentrate that is intended for direct sale or transfer to cardholders must be tested for:
pesticides
cannabinoid profile/potency
microbiological
mycotoxin
heavy metals (random testing); and
heavy metals (random testing); and
Source: MaintainX (Community Member)