Minnesota Administrative Rules
Agency 144 - Health Department
Chapter 4770 - MEDICAL CANNABIS
Part 4770.1700 - MEDICAL CANNABIS MANUFACTURER; PRODUCTION REQUIREMENTS

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.

F. Biosecurity measures must be in effect and documented according to part 4770.0400, subpart 1.

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.

J. The batch number must be displayed on the label of the medical cannabis.

A. A manufacturer cultivating plants intended to become dried raw cannabis must follow practices and procedures that minimize the risk of chemical contamination or adulteration of the medical cannabis.

B. A manufacturer may only apply a pesticide in the cultivation of medical cannabis if the pesticide has been:

B. A manufacturer may use rooting hormones or cloning gels only during the propagation phase of the plant life cycle.

C. A manufacturer must store all crop input stocks in their original containers with their original labels intact. The manufacturer must ensure that packaged fertilizers and containers of diluted or prepared fertilizer remain labeled with information as required in Minnesota Statutes, section 18C.215, at all times.

D. The manufacturer must apply, store, and dispose of crop inputs, rinsate, and containers according to label instructions and all other applicable laws and regulations.

E. If an audit sample tested under part 4770.3035 shows the presence of a crop input not permitted under this subpart, the batch and any finished good produced from the batch are adulterated and must be disposed of as medical cannabis waste under part 4770.1200, subpart 2. The use of pesticides not permitted under this part is presumptively classified as a serious violation under Minnesota Statutes, sections 144.989 to 144.993.

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.

C. A manufacturer must maintain appropriate temperatures and conditions that will protect plant material and medical cannabis against physical, chemical, and microbial contamination or deterioration of the product or its container.

D. A manufacturer must ensure that the cannabinoid content of the medical cannabis it produces is homogenous.

E. Prior to distributing new finished goods to customers, a manufacturer must obtain the commissioner's approval. The commissioner shall:

F. The manufacturer must submit a definition of each finished good to the commissioner to include in the registered finished goods list before a batch sample may be tested.

G. Pre-rolls must not contain more than 1.0 gram of dried raw cannabis each.

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:

C. all employees working in direct contact with plant material and medical cannabis must use hygienic practices while on duty, including:

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;

H. any buildings, fixtures, and other facilities are maintained in a sanitary condition;

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;

K. the manufacturing facility water supply is sufficient for necessary operations;

L. plumbing size and design meets operational needs and all applicable state and local laws;

M. employees have accessible toilet facilities that are sanitary and in good repair; and

N. plant material and medical cannabis that could support the rapid growth of undesirable microorganisms are isolated to prevent the growth of those microorganisms.

A. A manufacturer must store plant material and medical cannabis during production, transport, and testing to prevent diversion, theft, or loss, including ensuring:

B. A manufacturer must store all plant material and medical cannabis during production, transport, and testing, and all saleable medical cannabis:

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.