On August 4, 2014, the Minnesota Department of Health published the first draft of rules for the two persons/companies who are chosen as Minnesota’s two medical marijuana manufacturers. Below are some frequently asked questions regarding the new rules, which will be codified as Chapter 4770.*
What is the Purpose of Chapter 4770?
To provide the commissioner with provisions to enforce relating to the registration and oversight of a medical cannabis manufacturer.
What are Some of the Key Definitions in the Rules?
“Batch:” a specific quantity that is uniform and intended to meet specifications for identity, strength, purity, composition, and that is manufactured, packaged and labeled during a specified time period according to a single manufacturing, packaging, and labeling batch record.
“Batch Number:” 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.
“Biosecurity:” a set of preventative measures designed to reduce the risk of transmission of infectious diseases in crops, quarantined pests, invasive alien species, and living modified organisms.
“Cannabis Waste:” Any part of the cannabis plant that is not usable, or plant material that cannot be processed into a form allowable under Minnesota Statutes, section 152.22, subdivision 6.
“Distribute” or “Distribution:” The delivery of medical cannabis to a patient, parent or legal guardian, or registered care giver 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.
“Distribution Facility:” Any building or grounds of a medical cannabis manufacturer where the sale and distribution of medical cannabis are authorized and the production of medical cannabis is prohibited. A distribution facility may be part of a manufacturing facility and any distribution facility not on the same property as a manufacturing facility is prohibited form performing any production activities.
“Service Area:” One of two regions of the state, based on geographic need for patient access, in which a medical cannabis manufacturer is located and includes either all even-numbered congressional districts or all odd-numbered congressional districts.
What are the Duties of the Commissioner Under the New Medical Marijuana Law?
- Enter into any interagency agreements related to the regulatory or inspection duties of a medical cannabis manufacturer and the registry program,
- Notify local law enforcement of any conditions that pose a threat to public safety,
- Inspection of medical cannabis manufacturer,
- Collect fees,
- Annually review price costing by a medical cannabis manufacturer.
What Operating Documents Does the Manufacturer Need?
The operating documents of a medical cannabis manufacturer must describe:
- All operational and management practices and must address record keeping,
- Security measures,
- Unauthorized entrance into areas containing medical cannabis,
- Types and quantities of medical cannabis products that are produced at the manufacturing facility,
- Methods of planting (seed or clones), harvesting, drying and storage of medical cannabis,
- Estimated quantity of waste material to be generated and disposal plans,
- Quantity and method for disposal method for all crop inputs used for cannabis plant production,
- Employee training methods for the specific phases of production;
- Biosecurity measures used in cannabis plan production and in medical cannabis production;
- Response strategies to reconcile discrepencies in accounting of product inventories;
- Sampling stragety and quality testing for labeling purposes;
- Medical cannabis packaging and labeling procedures;
- Procedures for the mandatory and voluntary recall of medical cannabis, and
- Response plans for measures to be taken in the event of a security breach at a manufacturing or distribution facility, or while medical cannabis is in route to a manufacturing or distribution facility.
Are There Prohibited Activities in the New Rules?
Yes. No one can operate a manufacturing facility unless licensed. In addition, a medical manufacturer and its employees may not manufacture in any location that is not the designated location, sell or deliver cannabis from any location other than the manufacturing facility or distribution facility, grow medical cannabis outside of Minnesota, sell or distribute cannabis to any person not allowed under the statue, deliver or transport cannabis to anywhere excepted to the distribution facility or laboratory, sell cannabis not properly packaged, or consume or permit consumption on the grounds of the facilities.
Does the Manufacturer Have to Conduct Criminal Background Checks on Potential Employees and are There Any Offenses that Prohibit Employment?
Yes and yes. A manufacturer must perform a criminal background check and if the applicant has a record of a violation of a state or federal controlled substance law that is a felony under Minnesota law, or would be a felony if committed in Minnesota, they are prohibited from employment with the manufacturer.
Can a Health Care Practitioner Have an Economic Interest in a Medical Cannabis Manufacturer?
No. A manufacturer is prohibited from allowing a health care practitioner to hold a direct or indirect economic interest in the medical cannabis manufacturer. A health care practitioner also cannot serve on the board of directors or as an employee. A manufacturer cannot offer remuneration to a health care practitioner or allow a health care practitioner to advertise with the medical cannabis manufacturer in any capacity.
Are There Requirements for Sampling and Stability Testing?
Yes. A manufacturer must conduct sample collection in a manner that provides sound representative samples, document every sampling event, describe sampling and testing plans in written procedures, and ensure random samples are taken in an amount necessary, are labeled and submitted for testing.
What Kind of Quality Control Testing is Required by a Manufacturer?
A manufacturer must conduct sampling and testing with acceptance criteria that is sufficient to assure that batches of medical cannabis meet appropriate acceptance levels and appropriate rejection levels.
What Happens if a Batch Fails Quality Control Testing
A manufacturer must reject medical cannabis failing to meet established standards or specifications and any other relevant quality control criteria.
How Does Stability Testing Work?
A manufacturer must follow a written testing program designed to assess the stability characteristics of medical cannabis. The results of the stability testing must be used in determining appropriate storage conditions and expiration dates.
The written program must include: sample size and test intervals, storage conditions for samples retained for testing, reliable, meaningful and specific test methods, testing of the drug product in the same container-closure system as that in which the drug product is marketed, and testing of medical cannabis for reconstitution at the time of dispensing.
Will There be Limited Hours of Operation for the Manufacturer?
Yes. A manufacturer shall restrict access to the manufacturing facility and the commissioner shall limited the hours of operation of a manufacturing facility if there is sufficient cause to believe that limited the hours of operation protects public safety.
Are There Monitoring and Surveillance Requirements?
Yes. A manufacturing facility must operate and maintain on the premises a closed-circuit television surveillance system on a twenty-four hour, seven days per week basis that visually records and monitors all building entrances and exits, and other areas to be determined.
What Are the Surveillance Camera Specifications?
The manufacturer must install day/night camera in outdoor areas and in interior areas with low light. The manufacturer must ensure the cameras are in good working order and must install additional lighting to ensure picture clarity and brightness.
The recording device must be a digital video recorder that displays a date and time stamp on all recorded video, has the capability to produce a video disc directly from the DVR unit, remain operational during a power outage, and allow for the exporting of still images.
How Long do Security Recordings Have to be Maintained?
The manufacturer must retain the recordings for 90 days and an additional 90 days if the storage is off site. In addition, the recording system for the security cameras must be located in a locked, tamper-proof compartment.
Can All Employees Have Access to the Surveillance Equipment?
No. Access to the surveillance areas shall be limited to persons that are essential to surveillance operations.
What are the Alarm System Requirements?
A manufacturer must install and use a professionally monitored robbery and burglary alarm system that provides coverage of all facility entrances and exits, rooms with exterior windows, rooms with exterior walls, roof hatches, skylights, and storage rooms.
The alarm system must be equipped with a duress alarm, panic alarm, holdup alarm, automatic voice dialer, failure notification system and the ability to remain operational during a power outage.
What Happens if Manufacture or Distribution Facility Has to Close?
Medical cannabis manufacturer shall notify the commissioner at least six months before the closure of the manufacturing facility and distribution facilities.
What are the Recordkeeping Requirements?
Medical cannabis manufacture shall maintain for seven years complete and current books and records. These books and records shall include the date of each sale or distribution to a distribution facility, the name address and registration number of the distribution facility, the item number, product name, and quantity of cannabis and cannabis infused product’s registered by the department and sold or otherwise distributed to the dispensary, the price charged and the amount received for the medical cannabis from the medical cannabis manufacture, if the distribution was for a purpose other than sale, the reason for the distribution, the quantity and form of medical Cannabis maintained by the medical cannabis manufacture at the manufacturing facility on a daily basis, and the amount of plants being grown at the manufacturing facility on a daily basis.
In addition the manufacturers must have records that reflect all financial transactions in the financial condition of the business. These records must also be maintained for seven years. The financial records should include purchase invoices, bank statements, accounting and tax records, records of all financial transactions, all employee records, soil amendments, production records, records of each batch of extracts or cannabis infused products made, truck transportation records, inventory records, records of all samples sent to an independent testing lab, all samples provided to any person for any purpose and records of any theft, loss, or other unaccountability of any cannabis, medical cannabis or plant material.
Transporting and Disposing of Cannabis
What are the Guidelines for Transporting Medical Cannabis?
Before transportation of medical cannabis, a manufacturer must complete a shipping manifest on a form prescribed by the commissioner, securely transmit a copy of the shipping manifest to the commission before the close of business the day before transport, maintain all shipping manifests, transport it in a locked, safe and secure storage compartment. In addition, any motor vehicle transporting cannabis must travel directly from the manufacturing facility to the dispensary facility or to a testing laboratory and is prohibited from making any stops in between (with exceptions).
All delivery times and routes must be random and all transport motor vehicles must be staffed 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.
Each employee must have access to a secure form of communication with personnel at the cultivation facility and the ability to contact law enforcement and an employee must carry his or her employee identification card at all times when transporting cannabis.
How is medical cannabis implant material disposed of?
Cannabis waste must be stored, secured, locked, and managed in accordance with the manufactures operating documents. Any disposal of hazardous waste and chemical waste must be conducted in accordance with federal, state and local laws
In addition a manufacturing facility shall maintain a traceability system that documents the rendering and disposal of the Cannabis.
The various disposal methods are rendering unusable, incinerating, or composting.
What Signage is Mandatory at the Manufacturing Facility?
The manufacturer shall post a sign in a conspicuous location at each entrance of the manufacturing to facility that reads “persons under 21 years of age not permitted on these premises.” There must also be a sign at each entrance of the premises that reads “these premises are under constant video surveillance.”
In addition any employee shall keep their employee identification card visible at all times when on the property and during the transportation of cannabis. A visitor shall keep a visitor pass issued by the medical cannabis manufacture visible at all times.
What does the Manufacturer Need for Employee Identification System?
An employee identification card must contain the name of the cardholder, the date of issuance of expiration, alphanumeric identification number that is unique to the holder; and a current photograph of the cardholder.
If the employee is terminated the manufacturer must immediately seize the terminated employees identification card. If an identification card is lost or stolen the manufacturer shall immediately report the loss, theft, or destruction of an employee identification card to the commissioner and to local law enforcement agency.
Production and Distribution
What are the Manufacturers Production Requirements?
Manufacturer must have a reliable and ongoing supply. Reliable and ongoing supply means a three month supply of cannabis plant material and other materials as determined by the commissioner.
What are the Distribution Protocols?
Security which includes traceable entry, cameras and lobby and inside distribution area, panic button, signage about security, and backup battery in case power cut or out.
Transportation which includes staff requirements, secure transport, and schedules.
Inventory control which includes ordering, receiving/delivery conditions, audits, discrepancies, waste, storage conditions, and daily distribution logs.
Distribution which includes software, patient ID confirmation, patient registry look up, patient profile, labeling requirements, sales, returns, and accountability.
Support staff which includes, pharmacist, technician, duties/expectations, qualifications/criminal background checks, policies and procedures, and training.
Expectations, unprofessional conduct which includes Hipa H I PPA, OSHA OSHA, Diversion, compromising security, accessories to illegal drug traffic, violation of any law, rule, regulation or ordinance, involving kickbacks, discrimination, and maintain sanitary and clean distribution center.
Lastly a distribution center must have software which includes distribution, accountability, updates, upgrades, security, backups, Internet access, and inventory control.
Laboratory Approval Program
What is the Medical Cannabis Laboratory Approval Program?
The manufacturer must contract with a laboratory for the purposes of testing medical cannabis manufactured as to content, contamination, and consistency to verify the medical cannabis meets the statutory requirements. The laboratory must meet Minnesota Department of Health approval.
What Does the Laboratory do with the Results of any Testing?
The results are sent to the commissioner and the commissioner shall maintain and publish a list of all analytes available for approval. The category of analytes include, cannabinoid profile, metals, pesticide residues and plant growth regulators, microbiological contaminants and mycotoxins, and residual solvents.
The list of analytes are reviewed every 6 months and any updates are published in the State Register and posted on the program’s website. The commissioner shall publish the notification of changes and review comments on the changes no less than 30 days from the date the list is published.
What are the Requirements for the Approval Program?
First, make the request to be approved by the commissioner and is encouraged to operate formal management systems in accordance to International Organization for Standardization (ISO). If the approval is sought after December 31, 2016, the laboratory must be accredited to Standard ISO/IEC 17025:2005, General Requirements for the Competency of Testing and Calibration Laboratories, of the ISO.
What Information must a Laboratory Application Contain?
The laboratory must specify the field of testing for which it seeks approval and any application must include the legal name and legal status of the laboratory, the physical location, postal mailing address, the owner, the names and telephone numbers and email of a designated contact person and the director, along with the name of a managing agent and a technical manager.
The following items must also be included:
- Notarized attestation that the laboratory is independent from the manufacturer,
- Quality assurance manual,
- Standard operating procedures,
- Sample handling, receipt and acceptance procedures and policies,
- Demonstration of laboratory capability,
- Method validation procedures for testing methods,
- Name and educational qualifications for at least one technical manager,
- Copy of the lab’s ISO/IEC 17025:2005 Certificate and Scope of Accreditation (on or before 12/31/16),
- Copy of the lab’s most recent assessment report.
Can the Laboratory be Mobile?
Yes. But, a mobile laboratory has additional requirements with its application. Those requirements are to submit a vehicle identification number, license plate number, or other uniquely identifying information. In addition, a mobile laboratory must designate which fields of testing, equipment and personnel are associated with the mobile laboratory.
Can an Approval be Rescinded?
Yes. The commissioner can rescind approval for an approved cannabis laboratory if the commissioner determines one or more of the following reasons exist: failure to comply with or misrepresentation of application materials, nonconformance with the applicable laws, rules, standards, policies, and procedures, history of repeated nonconformance or complaints regarding the analysis of medical cannabis, failure to allow the commission to perform physical inspection of the facilities, and failure to provide the manufacturer with timely reports compliant with the commissioner’s designated rest report format.
If My Laboratory Application is Denied or Rescinded, do I Have Any Recourse?
Although the approval or denial of a laboratory application is considered a final decision of the commissioner, it is subject to judicial review under the Administrative Procedure Act.
Can I Withdrawal After Given Approval?
Yes. However, you must notify the commissioner in writing.
Are Their Ongoing Requirements of the Laboratory After Approval?
Yes. The laboratory must notify the commissioner of any changes in its name, location, owner, and contact information, among other things.
*NOTE: This FAQ is based on the Rules as they were revised on July 31, 2014. These Rules are subject to change and may have changed since the publication of this article.