Office of the Revisor of Statutes
Minnesota Administrative Rules
CHAPTER 4770, MEDICAL CANNABIS
DEPARTMENT OF HEALTH
| Part | Title |
|---|---|
| MANUFACTURERS | |
| 4770.0100 | APPLICABILITY AND PURPOSE. |
| 4770.0200 | DEFINITIONS. |
| 4770.0300 | DUTIES OF COMMISSIONER. |
| 4770.0400 | MEDICAL CANNABIS MANUFACTURER; OPERATIONS. |
| 4770.0500 | MEDICAL CANNABIS MANUFACTURER; QUALITY CONTROL; ASSURANCE PROGRAM. |
| 4770.0600 | LOCATION; DISTANCE FROM SCHOOL. |
| 4770.0700 | HOURS OF OPERATION; ACCESS. |
| 4770.0800 | ADVERTISING AND MARKETING. |
| 4770.0850 | PACKAGING AND LABELING. |
| 4770.0900 | MONITORING AND SURVEILLANCE REQUIREMENTS. |
| 4770.1000 | ALARM SYSTEM REQUIREMENTS. |
| 4770.1100 | TRANSPORTATION OF MEDICAL CANNABIS. |
| 4770.1200 | DISPOSAL OF MEDICAL CANNABIS AND PLANT MATERIAL. |
| 4770.1300 | MANDATORY SIGNAGE. |
| 4770.1400 | PERSONNEL IDENTIFICATION SYSTEM. |
| 4770.1500 | CLOSURE OF OPERATIONS; DEREGISTRATION. |
| 4770.1600 | RECORD KEEPING; REQUIREMENTS. |
| 4770.1700 | MEDICAL CANNABIS MANUFACTURER; PRODUCTION REQUIREMENTS. |
| 4770.1800 | INVENTORY. |
| 4770.1900 | MEDICAL CANNABIS LABORATORY APPROVAL. |
| 4770.2000 | MEDICAL CANNABIS LABORATORY APPROVAL; APPLICATION AND APPROVAL. |
| 4770.2100 | MEDICAL CANNABIS LABORATORY APPROVAL; INSPECTION AND COMPLIANCE. |
| 4770.2200 | MEDICAL CANNABIS LABORATORY APPROVAL; DUTY TO NOTIFY. |
| 4770.2300 | MEDICAL CANNABIS LABORATORY APPROVAL; APPEAL OF ADMINISTRATIVE DECISION. |
| 4770.2400 | MEDICAL CANNABIS LABORATORY APPROVAL; VARIANCES. |
| 4770.2700 | MEDICAL CANNABIS MANUFACTURER; FINANCIAL EXAMINATIONS; PRICING REVIEWS. |
| 4770.2800 | INCORPORATION BY REFERENCE. |
MANUFACTURERS
4770.0100 APPLICABILITY AND PURPOSE.
Parts 4770.0200 to 4770.2700 establish the criteria and procedures to be used by the commissioner for the registration and oversight of a medical cannabis manufacturer.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.0200 DEFINITIONS.
Subp. 2.
Acceptable performance or acceptable results.
"Acceptable performance" or "acceptable results" means analytical test results generated by a laboratory using methods as specified in part 4770.2000 that are acceptable and allowed by the approved provider.
Subp. 3.
Approval.
"Approval" means acknowledgment by the commissioner that a laboratory has the policies, personnel, validation procedures, and practices to produce reliable data in the analysis of analytes and contaminants described in part 4770.1900.
Subp. 4.
Approved provider.
"Approved provider" means a provider of performance testing samples that the commissioner has determined:
B.
calculates the number of standard deviations of the mean allowed using the results of all laboratories submitting test results after the exclusion of outlying values; and
C.
allows a range of standard deviations of the mean no less stringent than the range allowed by the general requirements for the competency of reference material producers in ISO Guide 34.
Subp. 5.
Audit.
"Audit" means a financial review by an independent certified public accountant that includes select scope engagement or other methods of review that analyze operational or compliance issues.
Subp. 6.
Batch.
"Batch" means a specific quantity of medical cannabis that is uniform and intended to meet specifications for identity, strength, purity, and composition, and that is manufactured, packaged, and labeled during a specified time period according to a single manufacturing, packaging, and labeling batch record.
Subp. 7.
Batch number.
"Batch number" means a unique numeric or alphanumeric identifier assigned to a batch by a manufacturing facility when the batch is first planted. The batch number must contain the manufacturing facility number and a sequence to allow for inventory and traceability.
Subp. 8.
Biosecurity.
"Biosecurity" means a set of preventative measures designed to reduce the risk of transmission of:
Subp. 9.
Certified financial audit.
"Certified financial audit" means the annual financial audit required under Minnesota Statutes, section 152.37, subdivision 2.
Subp. 10.
Commissioner.
"Commissioner" means the commissioner of the Department of Health or the commissioner's designee.
Subp. 11.
Disqualifying felony offense.
"Disqualifying felony offense" has the meaning given in Minnesota Statutes, section 152.22, subdivision 3.
Subp. 12.
Distribute or distribution.
"Distribute" or "distribution" means the delivery of medical cannabis to a patient, the patient's parent or legal guardian, or the patient's registered caregiver that is packaged in a suitable container appropriately labeled for subsequent administration to or use by a patient who is participating in the registry program and who is authorized to receive medical cannabis.
Subp. 13.
Distribution facility.
"Distribution facility" means any building or grounds of a medical cannabis manufacturer where the sale and distribution of medical cannabis are authorized.
Subp. 14.
Diversion.
"Diversion" means the intentional transfer of medical cannabis to a person other than a patient, the patient's designated registered caregiver, or the patient's parent or legal guardian if the parent or legal guardian is listed on the registry verification.
Subp. 15.
Field of testing.
"Field of testing" means the combination of product type and analyte for which a laboratory has applied or received approval by the commissioner.
Subp. 16.
Financial interest.
"Financial interest" means any actual or future right to ownership, investment, or compensation arrangement in a medical cannabis manufacturer with another person, either directly or indirectly, through business, investment, or spouse, parent, or child relationship. Financial interest does not include ownership of investment securities in a publicly held corporation that is traded on a national exchange or over-the-counter market, provided the investment securities held by the person or the person's spouse, parent, or child, in the aggregate, do not exceed one percent ownership in the medical cannabis manufacturer.
Subp. 17.
Health care practitioner.
"Health care practitioner" has the meaning given in Minnesota Statutes, section 152.22, subdivision 4.
Subp. 18.
Inspection.
"Inspection" means an on-site evaluation of laboratory facilities, records, personnel, equipment, methodology, and quality assurance practices by the commissioner for compliance with this chapter.
Subp. 19.
International Standards Organization or ISO.
The "International Standards Organization" or "ISO" means an independent, nongovernmental membership organization and the largest developer of voluntary international standards.
Subp. 20.
Laboratory managing agent.
"Laboratory managing agent" means a person, as defined in Minnesota Statutes, section 326.71, subdivision 8, who is legally authorized to direct the activities of the laboratory and commit sufficient resources to comply with parts 4770.1900 to 4770.2400.
Subp. 21.
Laboratory.
"Laboratory" means a fixed-based or mobile structure, a person, corporation, or other entity, including a government or tribal entity, that examines, analyzes, or tests samples.
Subp. 23.
Laboratory technical manager.
"Laboratory technical manager" means a person who is scientifically responsible to ensure the achievement and maintenance of quality and analytical standards or practice and who is in a supervisory, lead worker, or similarly named position within an organization.
Subp. 24.
Manufacturing or manufacture.
"Manufacturing" or "manufacture" means the process of converting harvested cannabis plant material into medical cannabis.
Subp. 25.
Manufacturing facility.
"Manufacturing facility" means any secured building, space, grounds, and physical structure of a medical cannabis manufacturer for the production, manufacturing, and distribution of medical cannabis and where access is restricted to designated employees of a medical cannabis manufacturer and escorted visitors.
Subp. 26.
Medical cannabis.
"Medical cannabis" has the meaning given in Minnesota Statutes, section 152.22, subdivision 6.
Subp. 27.
Medical cannabis manufacturer or manufacturer.
"Medical cannabis manufacturer" or "manufacturer" has the meaning given in Minnesota Statutes, section 152.22, subdivision 7.
Subp. 28.
Medical cannabis product.
"Medical cannabis product" has the meaning given in Minnesota Statutes, section 152.22, subdivision 8.
Subp. 29.
Medical cannabis waste.
"Medical cannabis waste" means medical cannabis that is returned, damaged, defective, expired, or contaminated.
Subp. 30.
Parent or legal guardian.
"Parent or legal guardian" has the meaning given in Minnesota Statutes, section 152.27, subdivision 5.
Subp. 31.
Patient.
"Patient" has the meaning given in Minnesota Statutes, section 152.22, subdivision 9.
Subp. 32.
Plant material.
"Plant material" means any cannabis plant, cutting, trimming, or clone that has roots or that is cultivated with the intention of growing roots.
Subp. 33.
Plant material waste.
"Plant material waste" means plant material that is not used in the production of medical cannabis in a form allowable under Minnesota Statutes, section 152.22, subdivision 6.
Subp. 34.
Production or produce.
"Production" or "produce" means:
(1) cultivating or harvesting plant material;
(2) processing or manufacturing; or
(3) packaging of medical cannabis.
Subp. 35.
Proficiency testing sample or PT sample.
"Proficiency testing sample" or "PT sample" means a sample obtained from an approved provider to evaluate the ability of a laboratory to produce an analytical test result meeting the definition of acceptable performance. The concentration of the analyte in the sample is unknown to the laboratory at the time of analysis.
Subp. 36.
Registered designated caregiver.
"Registered designated caregiver" has the meaning given in Minnesota Statutes, section 152.22, subdivision 11.
Subp. 37.
Registry program.
"Registry program" has the meaning given in Minnesota Statutes, section 152.22, subdivision 12.
Subp. 38.
Registry verification.
"Registry verification" has the meaning given in Minnesota Statutes, section 152.22, subdivision 13.
Subp. 39.
Restricted access area.
"Restricted access area" means a building, room, or other contiguous area on the premises where plant material is grown, cultivated, harvested, stored, packaged, or processed for sale under control of the medical cannabis manufacturer, and where no person under the age of 21 is permitted.
Subp. 40.
Sufficient cause to believe.
"Sufficient cause to believe" means grounds asserted in good faith that are not arbitrary, irrational, unreasonable, or irrelevant and that make the proposition asserted more likely than not, provided the grounds are based on at least one of the following sources:
A.
facts or statements supplied by a patient, the patient's parent or legal guardian, the patient's designated registered caregiver, or an employee or agent of a medical cannabis manufacturer;
B.
reports from an approved laboratory that indicate concerns with the chemical or bacterial composition of the medical cannabis;
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.0300 DUTIES OF COMMISSIONER.
Subpart 1.
Interagency agreements.
The commissioner may enter into any interagency agreements with other state agencies for technical services or other assistance related to the regulatory or inspection duties of a medical cannabis manufacturer and the registry program.
Subp. 2.
Notice to law enforcement.
If the commissioner has sufficient cause to believe that there is a threat to public safety, then the commissioner must notify local law enforcement agencies of any conditions that pose a threat to public safety, including:
Subp. 3.
Inspection of medical cannabis manufacturer.
A medical cannabis manufacturer is subject to reasonable inspection by the commissioner under Minnesota Statutes, section 152.29, subdivision 1. For purposes of this part, "reasonable inspection" means unannounced inspections by the commissioner of all:
B.
physical locations of the medical cannabis manufacturer, its manufacturing facility, and distribution facilities;
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.0400 MEDICAL CANNABIS MANUFACTURER; OPERATIONS.
Subpart 1.
Operating documents.
Under Minnesota Statutes, section 152.29, subdivision 1, the operating documents of a medical cannabis manufacturer must describe operational and management practices, including:
D.
types and quantities of medical cannabis products that are produced at the manufacturing facility;
O.
plans for responding to a security breach at a manufacturing or distribution facility, or while medical cannabis is in transit to a manufacturing or distribution facility;
Subp. 2.
Prohibited activities.
A.
A person may not own and operate a manufacturing facility unless the person is registered as a medical cannabis manufacturer by the commissioner under Minnesota Statutes, section 152.25.
B.
A medical cannabis manufacturer and its employees, agents, or owners may not:
(1)
produce or manufacture medical cannabis in any location except in those areas designated in the registration agreement;
(2)
sell, deliver, transport, or distribute medical cannabis or medical cannabis products from any location except its manufacturing facility or its distribution facility;
(5)
deliver or transport medical cannabis to any location except its distribution facilities and a laboratory approved by the commissioner;
Subp. 3.
Criminal background checks.
A medical cannabis manufacturer is prohibited from employing any person who has a disqualifying felony offense as shown by a Minnesota criminal history background check or a federal criminal history background check performed by the Bureau of Criminal Apprehension under Minnesota Statutes, section 152.29, subdivision 1.
Subp. 4.
Conflict of interest; health care practitioner activity restrictions.
A medical cannabis manufacturer may not:
B.
accept or solicit any form of remuneration from a health care practitioner who certifies qualifying conditions for patients; or
C.
offer any form of remuneration from a health care practitioner who certifies qualifying conditions for patients.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.0500 MEDICAL CANNABIS MANUFACTURER; QUALITY CONTROL; ASSURANCE PROGRAM.
Subpart 1.
Quality control program.
A medical cannabis manufacturer must develop and implement a written quality assurance program that assesses the chemical and microbiological composition of medical cannabis. Assessment includes a profile of the active ingredients, including shelf life, and the presence of inactive ingredients and contaminants. A medical cannabis manufacturer must use these testing results to determine appropriate storage conditions and expiration dates.
Subp. 2.
Sampling protocols.
A medical cannabis manufacturer must develop and follow written procedures for sampling medical cannabis that require the manufacturer to:
A.
conduct sample collection in a manner that provides analytically sound and representative samples;
C.
describe all sampling and testing plans in written procedures that include the sampling method and the number of units per batch to be tested;
Subp. 3.
Sampling; testing levels.
A medical cannabis manufacturer must:
A.
develop acceptance criteria for all potential contaminants based on the levels of metals, microbes, or other contaminants that the manufacturer uses in cultivating and producing medical cannabis. The testing levels are subject to approval by the commissioner;
B.
conduct sampling and testing using acceptance criteria that are protective of patient health. The sampling and testing results must ensure that batches of medical cannabis meet allowable health risk limits for contaminants;
C.
reject a medical cannabis batch that fails to meet established standards, specifications, and any other relevant quality-control criteria;
D.
develop and follow a written procedure for responding to results indicating contamination. The procedure must include destroying contaminated medical cannabis and determining the source of contamination; and
E.
retain documentation of test results, assessment, and destruction of medical cannabis for at least five years.
Subp. 4.
Quality assurance program; stability testing.
A.
The quality assurance program must include procedures for performing stability testing of each product type produced to determine product shelf life that addresses:
(1)
sample size and test intervals based on statistical criteria for each attribute examined to ensure valid stability estimates;
B.
Stability studies must include:
(2)
medical cannabis testing in the same container-closure system in which the drug product is marketed; and
(3)
testing medical cannabis for reconstitution at the time of dispensing, as directed in the labeling, and after the samples are reconstituted.
C.
If shelf-life studies have not been completed before July 1, 2015, a medical cannabis manufacturer may assign a tentative expiration date, based on any available stability information. The manufacturer must concurrently conduct stability studies to determine the actual product expiration date.
D.
After the manufacturer verifies the tentative expiration date, or determines the appropriate expiration date, the medical cannabis manufacturer must include that expiration date on each batch of medical cannabis.
E.
Stability testing must be repeated if the manufacturing process or the product's chemical composition is changed.
Subp. 5.
Reserve samples.
A.
A medical cannabis manufacturer must retain a uniquely labeled reserve sample that represents each batch of medical cannabis and store it under conditions consistent with product labeling. The reserve sample must be stored in the same immediate container-closure system in which the medical cannabis is marketed, or in one that has similar characteristics. The reserve sample must consist of at least twice the quantity necessary to perform all the required tests.
B.
A medical cannabis manufacturer must retain the reserve for at least one year following the batch's expiration date.
Subp. 6.
Retesting.
If the commissioner deems that public health may be at risk, the commissioner may require the manufacturer to retest any sample of plant material or medical cannabis.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.0600 LOCATION; DISTANCE FROM SCHOOL.
Under Minnesota Statutes, section 152.29, paragraph (j), a medical cannabis manufacturer may not operate within 1,000 feet of an existing public or private school. The medical cannabis manufacturer must measure the distance between the closest point of the manufacturing or distribution facility property lines to the closest point of the school's property lines.
For purposes of this part, "public or private school" means any property operated by a school district, charter school, or accredited nonpublic school for elementary, middle, or secondary school, or secondary vocation center purposes.
"Accredited nonpublic school" means any nonpublic school accredited by an accrediting agency recognized by the Minnesota nonpublic education council under Minnesota Statutes, section 123B.445, excluding home schools.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.0700 HOURS OF OPERATION; ACCESS.
Subpart 1.
Limiting hours of operation.
The commissioner may limit the hours of operation of a manufacturing facility if there is sufficient cause to believe that limiting the hours of operation protects public safety.
Subp. 2.
Restricted access areas.
A medical cannabis manufacturer must use an electronic controlled access system to limit entrance to all restricted access areas of its manufacturing facility and its distribution facilities.
B.
A medical cannabis manufacturer must immediately submit stored controlled-access-system data to the commissioner upon the commissioner's request.
C.
Restricted access areas must be identified with a sign that states: "Do Not Enter -- Restricted Access Area -- Access Limited to Authorized Personnel Only."
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.0800 ADVERTISING AND MARKETING.
Subpart 1.
Permitted marketing and advertising activities.
A medical cannabis manufacturer may:
A.
display the manufacturer's business name and logo on medical cannabis labels, signs, Web site, and informational material provided to patients. The name or logo must not include:
(4)
medical symbols that bear a reasonable resemblance to established medical associations. Examples of established medical organizations include the American Medical Association or American Academy of Pediatrics. The use of medical symbols is subject to approval by the commissioner;
Subp. 2.
Marketing and advertising activities; commissioner approval required.
A.
A medical cannabis manufacturer must request and receive the commissioner's written approval before beginning marketing or advertising activities that are not specified in subpart 1.
B.
The commissioner has 30 calendar days to approve marketing and advertising activities submitted under this subpart.
Subp. 3.
Inconspicuous display.
A medical cannabis manufacturer must arrange displays of merchandise, interior signs, and other exhibits to prevent public viewing from outside the manufacturing facility and distribution facility.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.0850 PACKAGING AND LABELING.
Subpart 1.
Medical cannabis packaging.
The medical cannabis manufacturer must package all medical cannabis intended for distribution according to the following standards:
A.
In addition to the requirements in Minnesota Statutes, section 152.29, subdivision 3, paragraph (c), clause (5), medical cannabis containers must be:
B.
Medical cannabis packaging must not bear a reasonable resemblance to any commercially available product.
C.
Medical cannabis packaging must be packaged to minimize its appeal to children and must not depict images other than the medical cannabis manufacturer's business name logo.
Subp. 2.
Medical cannabis trade names.
The medical cannabis manufacturer's medical cannabis trade names must comply with the following standards and are subject to approval by the commissioner:
B.
any name that is identical to, or confusingly similar to, the name of an existing noncannabis product is prohibited;
C.
any name that is identical to, or confusingly similar to, the name of an unlawful product or substance is prohibited; and
D.
any name that contains language that suggests using medical cannabis for recreational purposes or for a condition other than a qualifying medical condition is prohibited.
Subp. 3.
Labeling.
A.
A medical cannabis manufacturer must ensure that all medical cannabis that is distributed is labeled with the following information:
(3)
the name of the patient's parent or legal guardian, if listed on the registry verification, if applicable;
(5)
the name and address of the medical cannabis manufacturer where the medical cannabis was manufactured;
(9)
all ingredients of the product shown with common or usual names, including any colors, artificial flavors, and preservatives, listed in descending order by predominance of weight;
(11)
a notice with the statement, including capitalization: "This product has not been analyzed or approved by the United States Food and Drug Administration. There is limited information on the side effects of using this product, and there may be associated health risks. Do not drive or operate heavy machinery when under the influence of this product. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN."; and
(12)
a notice with the statement: "This medical cannabis is for therapeutic use only. Diversion of this product is unlawful and may result in the revocation of the patient's registration."
B.
Labeling text must not include any false or misleading statements regarding health or physical benefits to the patient.
C.
A package may contain multiple labels if the information required by this part is not obstructed.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.0900 MONITORING AND SURVEILLANCE REQUIREMENTS.
Subpart 1.
24-hour closed-circuit television.
A medical cannabis manufacturer must operate and maintain in good working order a closed-circuit television (CCTV) surveillance system on all of its premises, which must operate 24 hours per day, seven days per week, and visually record:
B.
all areas that might contain plant material and medical cannabis, including all safes and vaults;
E.
any parking lot, which must have appropriate lighting for the normal conditions of the area under surveillance.
Subp. 2.
Camera specifications.
Cameras must:
A.
capture clear and certain identification of any person entering or exiting a manufacturing facility or distribution facility;
C.
have an embedded date-and-time stamp on all recordings that must be synchronized and not obscure the picture; and
Subp. 3.
Video recording specifications.
A.
A video recording must export still images in an industry standard image format, including .jpg, .bmp, and .gif.
B.
Exported video must be archived in a proprietary format that ensures authentication and guarantees that the recorded image has not been altered.
C.
Exported video must also be saved in an industry standard file format that can be played on a standard computer operating system.
Subp. 4.
Additional requirements.
The manufacturer must maintain all security system equipment and recordings in a secure location to prevent theft, loss, destruction, corruption, and alterations.
Subp. 5.
Retention.
The manufacturer must ensure that 24-hour recordings from all video cameras are:
D.
retained longer, as needed, if the manufacturer is given actual notice of a pending criminal, civil, or administrative investigation, or other legal proceeding for which the recording may contain relevant information.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.1000 ALARM SYSTEM REQUIREMENTS.
A.
A medical cannabis manufacturer must install and maintain a professionally monitored security alarm system that provides intrusion and fire detection of all:
B.
For purposes of this part, a security alarm system means a device or series of devices that summons law enforcement personnel during, or as a result of, an alarm condition. Devices may include:
(1)
hardwired systems and systems interconnected with a radio frequency method such as cellular or private radio signals that emit or transmit a remote or local audio, visual, or electronic signal;
(8)
a failure notification system that provides an audio, text, or visual notification of any failure in the surveillance system.
C.
A manufacturer's security alarm system and all devices must continue to operate during a power outage.
D.
The commissioner must have the ability to access a medical cannabis manufacturer's security alarm system.
E.
The manufacturer's security alarm system must be inspected and all devices tested annually by a qualified alarm vendor.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.1100 TRANSPORTATION OF MEDICAL CANNABIS.
Subpart 1.
Transportation of medical cannabis and plant material; when authorized.
Subp. 2.
Transporting medical cannabis.
A.
Before transporting medical cannabis, a medical cannabis manufacturer must:
(3)
maintain all transport manifests for at least five years and make them available upon request of the commissioner.
B.
The transport manifest must be signed by an authorized medical cannabis manufacturer employee upon departure from the manufacturing facility and by an authorized medical cannabis manufacturer employee upon receipt at a distribution facility.
Subp. 3.
Transportation of medical cannabis; vehicle requirements.
A.
A manufacturer must ensure that:
C.
If an emergency requires stopping the vehicle, the employee must notify 911 and complete an incident report form provided by the commissioner.
D.
Under no circumstance may any person other than a designated manufacturer employee have actual physical control of the motor vehicle that is transporting the medical cannabis.
E.
A medical cannabis manufacturer must staff all transport motor vehicles with a minimum of two employees. At least one employee must remain with the motor vehicle at all times that the motor vehicle contains medical cannabis.
F.
Each employee in a transport motor vehicle must have communication access with the medical cannabis manufacturer's personnel, and have the ability to contact law enforcement through the 911 emergency system at all times that the motor vehicle contains medical cannabis.
G.
An employee must carry the employee's identification card at all times when transporting or delivering cannabis and, upon request, produce the identification card to the commissioner or to a law enforcement officer acting in the course of official duties.
H.
A medical cannabis manufacturer must not leave a vehicle that is transporting medical cannabis unattended overnight.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.1200 DISPOSAL OF MEDICAL CANNABIS AND PLANT MATERIAL.
Subpart 1.
Medical cannabis take-back.
A medical cannabis manufacturer must accept at no charge unused, excess, or contaminated medical cannabis. A manufacturer must:
Subp. 2.
Medical cannabis and plant material waste.
A medical cannabis manufacturer must store, secure, and manage medical cannabis waste and plant material waste in accordance with all applicable federal, state, and local regulations.
A.
The manufacturer must dispose of medical cannabis waste by incineration at a waste-to-energy facility according to federal and state law.
C.
Before transport, the manufacturer must render plant material waste unusable and unrecognizable by grinding and incorporating the waste with a greater quantity of nonconsumable, solid wastes including:
(5)
vegetative wastes generated from industrial or manufacturing processes that prepare food for human consumption;
Subp. 3.
Liquid and chemical waste disposal.
The medical cannabis manufacturer must dispose of all liquid and chemical product waste generated in the process of cultivating, manufacturing, and distributing medical cannabis in accordance with all applicable federal, state, and local regulations.
Subp. 4.
Waste-tracking requirements.
The medical cannabis manufacturer must use forms provided by the commissioner to maintain accurate and comprehensive records regarding waste material that accounts for, reconciles, and evidences all waste activity related to the disposal of medical cannabis waste and plant material waste.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.1300 MANDATORY SIGNAGE.
A.
A medical cannabis manufacturer must post a sign in a conspicuous location at each entrance of the manufacturing facility that reads "PERSONS UNDER TWENTY-ONE YEARS OF AGE NOT PERMITTED IN RESTRICTED ACCESS AREAS."
B.
A medical cannabis manufacturer must post a sign in a conspicuous location at each entrance of the premises that reads "THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE."
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.1400 PERSONNEL IDENTIFICATION SYSTEM.
Subpart 1.
Identification system.
A medical cannabis manufacturer must use a personnel identification system that controls and monitors individual employee access to restricted access areas within the manufacturing facility and distribution facility and that meets the requirements of this part and part 4770.0700.
Subp. 3.
Visitor pass required.
A visitor must wear a visitor pass issued by the medical cannabis manufacturer that is visible at all times.
Subp. 4.
Employee identification card on person and visible at all times.
A medical cannabis manufacturer employee must keep the employee's identification card visible at all times when on the premises of the medical cannabis manufacturer and when transporting medical cannabis to a distribution facility.
Subp. 5.
Termination of employment.
Upon termination of an employee, a medical cannabis manufacturer must obtain and destroy the terminated employee's identification card.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.1500 CLOSURE OF OPERATIONS; DEREGISTRATION.
Subpart 1.
Notice.
A medical cannabis manufacturer shall notify the commissioner at least six months before the closure of the manufacturing facility and its distribution facilities.
Subp. 2.
Procedures.
If a medical cannabis manufacturer ceases operation, the commissioner must verify the remaining inventory of the manufacturer and seize all plant material, plant material waste, and medical cannabis. The commissioner must ensure that any plant material, plant material waste, and medical cannabis is destroyed by incineration at a waste-to-energy facility.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.1600 RECORD KEEPING; REQUIREMENTS.
A.
A medical cannabis manufacturer must maintain for at least five years complete, legible, and current records, including:
(3)
the item number, product name and description, and quantity of medical cannabis sold or otherwise distributed;
(5)
the quantity and form of medical cannabis maintained by the manufacturer at the manufacturing facility on a daily basis; and
B.
A medical cannabis manufacturer must maintain records that reflect all financial transactions and the financial condition of the business. The following records must be maintained for at least five years and made available for review, upon request of the commissioner:
(1)
purchase invoices, bills of lading, transport manifests, sales records, copies of bills of sale, and any supporting documents, to include the items or services purchased, from whom the items were purchased, and the date of purchase;
(4)
records of all financial transactions, including contracts and agreements for services performed or services received;
(10)
records of all samples sent to a testing laboratory and the quality assurance test results; and
(11)
records of any theft, loss, or other unaccountability of any medical cannabis or plant material.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.1700 MEDICAL CANNABIS MANUFACTURER; PRODUCTION REQUIREMENTS.
Subpart 1.
Cultivation and processing.
A.
Only a registered medical cannabis manufacturer is authorized to produce and manufacture medical cannabis.
B.
All phases of production must take place in designated, restricted access areas that are monitored by a surveillance camera system in accordance with part 4770.0900.
C.
All areas must be compartmentalized based on function, and employee access must be restricted between compartments.
D.
The production process must be designed to limit contamination. Examples of contamination include mold, fungus, bacterial diseases, rot, pests, nonorganic pesticides, and mildew.
E.
Each production area must have an open aisle for unobstructed access, observation, and inventory of each plant group.
G.
The manufacturer must maintain a record at the facility of all crop inputs for at least five years. The record must include the following:
H.
At the time of planting, all plants must be tracked in a batch process with a unique batch number that must remain with the batch through final packaging.
I.
A manufacturer must record any removal of plants from the batch on a record maintained at the manufacturing facility for at least five years.
Subp. 2.
Production of medical cannabis.
A.
The commissioner must approve the manufacturer's use of any hydrocarbon-based extraction process. Examples of a hydrocarbon-based extraction process include the use of butane, ethanol, hexane, and isopropyl alcohol.
B.
Medical cannabis must be prepared, handled, and stored in compliance with the sanitation requirements in this part.
D.
A manufacturer must ensure that the cannabinoid content of the medical cannabis it produces is homogenous.
Subp. 3.
General sanitation requirements.
A manufacturer must take all reasonable measures and precautions to ensure that:
A.
any employee who has a communicable disease does not perform any tasks that might contaminate plant material or medical cannabis;
B.
hand-washing facilities are:
(3)
equipped with effective hand-cleaning and sanitizing preparations and sanitary towel service or electronic drying devices;
C.
all employees working in direct contact with plant material and medical cannabis must use hygienic practices while on duty, including:
(2)
washing hands thoroughly in a hand-washing area before starting work and at any other time when the hands may have become soiled or contaminated;
D.
litter and waste are routinely removed and the operating systems for waste disposal are routinely inspected;
E.
floors, walls, and ceilings are constructed with a surface that can be easily cleaned and maintained in good repair to inhibit microbial growth;
F.
lighting is adequate in all areas where plant material and medical cannabis are processed, stored, or sold;
G.
screening or other protection against the entry of pests is provided, including that rubbish is disposed of to minimize the development of odor and the potential for the waste becoming an attractant, harborage, or breeding place for pests;
I.
toxic cleaning compounds, sanitizing agents, and other potentially harmful chemicals are identified and stored in a separate location away from plant material and medical cannabis and in accordance with applicable local, state, or federal law;
J.
all contact surfaces, utensils, and equipment used in the production of plant material and medical cannabis are maintained in a clean and sanitary condition are cleaned and sanitized as frequently as necessary to protect against contamination;
N.
plant material and medical cannabis that could support the rapid growth of undesirable microorganisms are isolated to prevent the growth of those microorganisms.
Subp. 4.
Storage.
A.
A manufacturer must store plant material and medical cannabis during production, transport, and testing to prevent diversion, theft, or loss, including ensuring:
(1)
plant material and medical cannabis are returned to a secure location immediately after completion of the process or at the end of the scheduled business day; and
(2)
the tanks, vessels, bins, or bulk containers containing plant material or medical cannabis are locked inside a secure area if a process is not completed at the end of a business day.
B.
A manufacturer must store all plant material and medical cannabis production, transport, and testing, and all saleable medical cannabis:
(2)
in storage areas that are free from infestation by insects, rodents, birds, and other pests of any kind.
C.
To prevent degradation, a manufacturer must store all plant material and medical cannabis in production, transport, and testing, and all saleable medical cannabis under conditions that will protect it against physical, chemical, and microbial contamination and deterioration of the product and its container.
D.
A manufacturer must maintain a separate secure storage area for medical cannabis that is returned, including medical cannabis that is outdated, damaged, deteriorated, mislabeled, or contaminated, or whose containers or packaging have been opened or breached, until the returned medical cannabis is destroyed. For purposes of this part, a separate, secure storage area includes a container, closet, or room that can be locked or secured.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.1800 INVENTORY.
Subpart 1.
Controls and procedures.
A medical cannabis manufacturer must establish inventory controls and procedures for conducting inventory reviews and comprehensive inventories of plant material and medical cannabis to prevent and detect any diversion, theft, or loss in a timely manner.
Subp. 2.
Reliable and ongoing supply.
A medical cannabis manufacturer must provide a reliable and ongoing supply of medical cannabis as required by Minnesota Statutes, section 152.29, subdivision 2.
Subp. 3.
Initial inventory.
A medical cannabis manufacturer must maintain a real-time record of its inventory of plant material and medical cannabis to include:
Subp. 4.
Waste inventory.
The medical cannabis manufacturer must maintain a record of its inventory of all medical cannabis waste and plant material waste for disposal.
Subp. 5.
Reconciliation.
At the close of business each day, a medical cannabis manufacturer must reconcile all:
Subp. 6.
Scales.
All scales used to weigh usable plant material for purposes of this chapter must be certified in accordance with the International Organization for Standardization (ISO), ISO/IEC Standard 17025, which is incorporated by reference.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.1900 MEDICAL CANNABIS LABORATORY APPROVAL.
Subpart 1.
Commissioner's authority.
The commissioner must approve any medical cannabis laboratory that tests medical cannabis for a registered medical cannabis manufacturer under Minnesota Statutes, section 152.25, subdivision 1, paragraph (d). A medical cannabis laboratory may seek approval to use specific procedures to test the allowable product types and analytes according to parts 4770.1900 to 4770.2400, which specify the commissioner's requirements authorized by Minnesota Statutes, section 152.29, subdivision 1, paragraph (b).
Subp. 2.
Eligibility.
The commissioner may only approve a medical cannabis laboratory that tests under a contract with a medical cannabis manufacturer that can demonstrate its eligibility under this subpart. The laboratory must:
A.
operate using proper laboratory equipment under a quality assurance system and test product types for analytes listed in the commissioner's list in subpart 3;
Subp. 3.
Commissioner list of approved cannabis labs.
A.
The commissioner must publish a list of approved cannabis laboratories in the State Register and on the department's medical cannabis program Web site at least annually.
Subp. 4.
Commissioner's approved medical cannabis product types.
The commissioner's approved product types include:
Subp. 5.
Commissioner's analyte list.
A.
The commissioner must maintain a list of analytes that laboratories must be able to test for. The analyte categories include:
B.
The commissioner must publish the analyte list in the State Register and on the department's medical cannabis program Web site.
C.
The commissioner must review the analyte list and publish a notice of any analyte updates in the State Register and on the department's medical cannabis program Web site at least every six months.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.2000 MEDICAL CANNABIS LABORATORY APPROVAL; APPLICATION AND APPROVAL.
Subpart 1.
Application requirements.
A.
A laboratory must apply for the commissioner's approval on a form provided by the commissioner.
B.
A laboratory must also submit the following items:
(1)
a signed and notarized attestation:
(a)
declaring any conflict of interest, actual or perceived, relating to its direct or indirect financial interests in any medical cannabis manufacturer form; and
(6)
demonstration of laboratory capability and acceptable performance through a combination of:
(c)
documented and acceptable proficiency testing samples from an approved provider, where available;
(8)
the name and educational qualifications of at least one technical manager responsible for the laboratory achieving and maintaining the quality and analytical standards of practice.
C.
A mobile laboratory is considered a separate laboratory and is subject to all requirements of parts 4770.1900 to 4770.2300. In addition to the requirements of subpart 1, a mobile laboratory must:
(1)
submit a vehicle identification number, license plate number, or other uniquely identifying information to the commissioner when applying for approval; and
(2)
designate which fields of testing, equipment, and personnel are associated with the mobile laboratory.
Subp. 2.
Application requirements; commissioner's evaluation.
A.
The commissioner must evaluate completed applications using the following criteria.
(1)
A laboratory must operate formal management systems under the International Organization for Standardization (ISO). The ISO/IEC 17025, General Requirements for the Competency of Testing and Calibration Laboratories, includes technical and management system requirements which are incorporated by reference in part 4770.2800.
(2)
A laboratory seeking initial or renewal medical cannabis laboratory approval after December 31, 2016, must be accredited to Standard ISO/IEC 17025:2005, which is incorporated by reference.
(3)
A laboratory must specify one or more fields of testing for which it seeks approval. A laboratory must be approved for at least one field of testing to test medical cannabis for a medical cannabis manufacturer.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.2100 MEDICAL CANNABIS LABORATORY APPROVAL; INSPECTION AND COMPLIANCE.
Subpart 1.
Laboratory inspection and reports.
A.
The commissioner may inspect a lab without prior notice at any time during normal business hours to verify compliance with parts 4770.1900 to 4770.2200. The commissioner may inspect:
B.
If the commissioner has sufficient cause to believe that a laboratory's proficiency, execution, or validation of analytical methodologies are deficient, the commissioner may require and a laboratory must obtain third-party validation and ongoing monitoring of the laboratory. The laboratory must pay for all costs associated with the commissioner-ordered third-party validation.
C.
An approved laboratory must provide reports to the commissioner regarding chemical compositions, microbial compositions, dosages, and noncannabis drug interactions under Minnesota Statutes, section 152.25, as requested by the commissioner.
D.
An approved laboratory must provide reports to the medical cannabis manufacturer on forms provided by the commissioner.
Subp. 2.
Laboratory approval requirements.
A.
An approved laboratory may not misrepresent its approval on any document or marketing material.
Subp. 3.
Rescinding approval.
A.
The commissioner may rescind an approved cannabis laboratory's approval if the commissioner determines the laboratory has failed to:
(5)
submit copies of inspection and corrective reports issued by the approved ISO/IEC 17025 accreditation body, as requested by the commissioner;
(7)
provide the medical cannabis manufacturer with reports compliant with the commissioner's designated test report format.
B.
A laboratory must return its approval letter to the commissioner immediately if the commissioner rescinds the laboratory's approval.
C.
The commissioner's decision to rescind approval of an approved medical cannabis laboratory is a final agency decision.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.2200 MEDICAL CANNABIS LABORATORY APPROVAL; DUTY TO NOTIFY.
Subpart 1.
Operational changes.
B.
A laboratory that notifies the commissioner of an operational change under item A must include in the notice written results of proficiency testing samples or demonstrations of capability analyzed after the reported change.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.2300 MEDICAL CANNABIS LABORATORY APPROVAL; APPEAL OF ADMINISTRATIVE DECISION.
A.
The commissioner must notify a laboratory in writing the reason for the decision to deny or rescind laboratory approval under part 4770.2100.
B.
A laboratory has 30 days from the commissioner's notice of denial or notice of rescinded approval to appeal the decision. A request to appeal must:
C.
The commissioner must notify a laboratory of the commissioner's acceptance or denial of an appeal request, in writing, within 60 days of receiving the request. The commissioner's decision is a final agency decision.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.2400 MEDICAL CANNABIS LABORATORY APPROVAL; VARIANCES.
The commissioner may grant a variance from parts 4770.1900 to 4770.2200. To request a variance, a laboratory must indicate in writing:
C.
alternate measures that the laboratory will take if the commissioner grants its request for variance;
E.
data that the laboratory will provide to ensure analytical results of equal or better reliability, if applicable.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.2700 MEDICAL CANNABIS MANUFACTURER; FINANCIAL EXAMINATIONS; PRICING REVIEWS.
A.
A medical cannabis manufacturer must maintain financial records in accordance with generally accepted accounting principles and, upon request, must provide any financial records to the commissioner.
B.
The commissioner shall request an additional audit of the medical cannabis manufacturer, of the same time period, if the commissioner finds one or more of the following:
(1)
credible evidence or allegations of financial reporting irregularities not revealed in the annual certified financial audit; or
(2)
reasonable cause to believe there are operational or compliance concerns involving financing, budgeting, revenues, sales, or pricing.
History:
39 SR 1080
Published Electronically:
February 20, 2015
4770.2800 INCORPORATION BY REFERENCE.
The International Organization for Standardization (ISO), ISO/IEC Standard 17025, is incorporated by reference, is not subject to frequent change, and is made a part of this rule where indicated. ISO/IEC Standard 17025 is published by the International Organization for Standardization, located at 1, ch. de la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland. ISO/IEC Standard 17025 is available in the office of the commissioner of health and can be found online at www.isoiec17025.com or www.iso.org.
History:
39 SR 1080
Published Electronically:
February 20, 2015
Official Publication of the State of Minnesota
Revisor of Statutes