SF 4500

as introduced - 92nd Legislature (2021 - 2022) Posted on 04/20/2022 08:09am

A bill for an act
relating to state government; establishing the Office of Cannabis Derivatives;
transferring the regulation and implementation of the medical cannabis program
to the Office of Cannabis Derivatives; transferring the regulation of industrial
hemp to the Office of Cannabis Derivatives; requiring the Office of Cannabis
Derivatives to regulate all hemp and hemp-derivative products; proposing coding
for new law as Minnesota Statutes, chapter 342; repealing Minnesota Statutes
2020, sections 18K.01; 18K.02; 18K.03; 18K.04; 18K.05; 18K.06; 18K.07; 18K.08;
18K.09; 151.72, subdivisions 1, 2, 3, 4, 6; 152.21; 152.22, subdivisions 1, 2, 3, 4,
5, 5a, 5b, 7, 8, 9, 10, 12, 13, 14; 152.24; 152.25; 152.27, subdivisions 1, 5, 6, 7;
152.28, subdivisions 2, 3; 152.29, subdivisions 2, 3a, 4; 152.30; 152.32; 152.33;
152.34; 152.35; 152.36; 152.37; Minnesota Statutes 2021 Supplement, sections
151.72, subdivision 5; 152.22, subdivisions 5c, 6, 11; 152.23; 152.26; 152.27,
subdivisions 2, 3, 4; 152.28, subdivision 1; 152.29, subdivisions 1, 3, 3b, 3c;
152.31.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [342.01] DEFINITIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Terms. new text end

new text begin For purposes of this chapter, the following terms have the
meanings given.
new text end

new text begin Subd. 2. new text end

new text begin Applicant. new text end

new text begin "Applicant" means an individual who submits an application for a
license as required under this chapter. If the applicant is an entity, applicant means the owner
or most responsible individual in charge of the entity.
new text end

new text begin Subd. 3. new text end

new text begin Commissioner. new text end

new text begin "Commissioner" means the commissioner of the Office of
Cannabis Derivatives.
new text end

new text begin Subd. 4. new text end

new text begin Consumer. new text end

new text begin "Consumer" means an individual who purchases a hemp-derived
consumable or topical product for personal consumption and not for resale.
new text end

new text begin Subd. 5. new text end

new text begin Entity. new text end

new text begin "Entity" means a corporation, joint stock company, association, limited
partnership, limited liability partnership, limited liability company, irrevocable trust, estate,
charitable organization, or other similar organization, including any such organization
participating in hemp production as a partner in a general partnership, a participant in a joint
venture, or a participant in a similar organization.
new text end

new text begin Subd. 6. new text end

new text begin Hemp. new text end

new text begin "Hemp" means the plant Cannabis sativa L. and any part of the plant,
whether growing or not, including the plant's seeds, and all the plant's derivatives, extracts,
cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a
tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.
Hemp does not include marijuana. Hemp does not include industrial hemp products.
new text end

new text begin Subd. 7. new text end

new text begin Hemp-derived consumable or topical product. new text end

new text begin "Hemp-derived consumable
or topical product" or "hemp product" means a finished product that is derived from hemp
and that contains cannabidiol or another cannabinoid, derivative, or extract of hemp and
the finished product:
new text end

new text begin (1) is a cosmetic, food, food additive, or herb;
new text end

new text begin (2) is intended for human or animal use or consumption, including consumption through
a vaporized delivery method using a liquid or oil;
new text end

new text begin (3) contains any part of the hemp plant, including naturally occurring cannabinoids,
compounds, concentrates, extracts, isolates, resins, or derivatives; and
new text end

new text begin (4) contains a tetrahydrocannabinol concentration of no more than three-tenths of one
percent on a dry weight basis.
new text end

new text begin Subd. 8. new text end

new text begin Hemp grower. new text end

new text begin "Hemp grower" means a person licensed by the commissioner
under this chapter to plant or grow raw hemp for commercial or research purposes.
new text end

new text begin Subd. 9. new text end

new text begin Hemp processor. new text end

new text begin "Hemp processor" means a person licensed by the
commissioner under this chapter to process raw hemp into hemp products for commercial
purposes.
new text end

new text begin Subd. 10. new text end

new text begin Hemp retailer. new text end

new text begin "Hemp retailer" means a person licensed by the commissioner
under this chapter to sell at the retail level hemp-derived consumable or topical products to
consumers.
new text end

new text begin Subd. 11. new text end

new text begin Industrial hemp product. new text end

new text begin "Industrial hemp product" means the intermediate
or finished product made from fibrous waste that is not intended for human or animal use
or consumption and is not usable or recognizable as medical cannabis or a hemp-derived
consumable or topical product.
new text end

new text begin Subd. 12. new text end

new text begin Label. new text end

new text begin "Label" has the meaning given in section 151.01, subdivision 18.
new text end

new text begin Subd. 13. new text end

new text begin Marijuana. new text end

new text begin "Marijuana" has the meaning given in section 152.01, subdivision
9. Marijuana does not include hemp, industrial hemp products, or hemp-derived consumable
or topical products.
new text end

new text begin Subd. 14. new text end

new text begin Medical cannabis program. new text end

new text begin "Medical cannabis program" means the program
administered in accordance with sections 342.15 to 342.29.
new text end

new text begin Subd. 15. new text end

new text begin Office. new text end

new text begin "Office" means the Office of Cannabis Derivatives.
new text end

new text begin Subd. 16. new text end

new text begin Processing. new text end

new text begin "Processing" means rendering by refinement hemp plants or hemp
plant parts from their natural or original state after harvest. Processing includes but is not
limited to decortication, devitalization, chopping, crushing, extraction, and packaging.
Processing does not include typical farm operations such as sorting, grading, baling, and
harvesting.
new text end

new text begin Subd. 17. new text end

new text begin Processing location. new text end

new text begin "Processing location" means any area, building, plant,
or facility registered with and approved by the commissioner in which a licensee converts
raw hemp into a marketable product.
new text end

new text begin Subd. 18. new text end

new text begin Raw hemp. new text end

new text begin "Raw hemp" means the whole hemp plant, whether growing or
not, or the stalk, viable seeds, unaltered flowers or leaves, or any unprocessed plant pieces
or parts of the hemp plant.
new text end

Sec. 2.

new text begin [342.02] OFFICE OF CANNABIS DERIVATIVES.
new text end

new text begin Subdivision 1. new text end

new text begin Scope. new text end

new text begin (a) The office is created to establish and implement policy and
regulations for growing, cultivating, and processing hemp for the production of hemp
products, the commercial retail sale of these products in this state, and the implementation
of the medical cannabis program under sections 342.15 to 342.29.
new text end

new text begin (b) Nothing in this chapter shall be construed to regulate the sale of industrial hemp
products or any other product with a tetrahydrocannabinol concentration of more than 0.3
percent on a dry weight basis. This paragraph does not include medical cannabis as defined
under section 342.15, subdivision 5.
new text end

new text begin (c) Nothing in this chapter shall be construed to authorize or regulate the recreational
use of marijuana unless the state or federal government enacts legislation legalizing the
adult use of recreational marijuana.
new text end

new text begin Subd. 2. new text end

new text begin Creation. new text end

new text begin The Office of Cannabis Derivatives is created with a commissioner
appointed by the governor with the advice and consent of the senate and serving at the
pleasure of the governor.
new text end

new text begin Subd. 3. new text end

new text begin Responsibilities. new text end

new text begin The office has the following powers and duties:
new text end

new text begin (1) develop, maintain, and enforce an organized system of regulation for hemp and
hemp-derived consumable or topical products;
new text end

new text begin (2) establish standards for product testing, packaging, and labeling of hemp products;
new text end

new text begin (3) issue and reissue licenses for growing and processing raw hemp for commercial
purposes;
new text end

new text begin (4) issue and reissue licenses for the retail sales of hemp-derived consumable or topical
products to consumers;
new text end

new text begin (5) inspect the premises, records, books, and other documents of license holders to ensure
compliance with all applicable laws and rules;
new text end

new text begin (6) enforce the laws and rules adopted under this chapter;
new text end

new text begin (7) authorize research and studies of the use of hemp products and medical cannabis as
defined under section 342.15, subdivision 5;
new text end

new text begin (8) establish limits on the potency of hemp-derived consumable or topical products that
can be grown and sold;
new text end

new text begin (9) implement the medical cannabis patient registry program under sections 342.15 to
342.29; and
new text end

new text begin (10) exercise other powers and authority as required by law.
new text end

new text begin Subd. 4. new text end

new text begin Rulemaking. new text end

new text begin The office may adopt rules to implement any provision in this
chapter.
new text end

Sec. 3.

new text begin [342.03] EXECUTIVE OFFICERS; EMPLOYEES.
new text end

new text begin The office shall be under the administrative control of the commissioner. The
commissioner shall serve in the unclassified service of the state civil service. On behalf of
the office, the commissioner or the commissioner's designated representative is authorized
to sign contracts and execute all instruments necessary or appropriate to carry out the
purposes of this chapter. The salary of the commissioner shall be established according to
section 15A.0815. The commissioner may appoint other professional employees who shall
serve in the unclassified service of the state civil service. All other employees shall be in
the classified civil service.
new text end

Sec. 4.

new text begin [342.04] CANNABIS ADVISORY COUNCIL.
new text end

new text begin Subdivision 1. new text end

new text begin Establishment; membership. new text end

new text begin A cannabis advisory council to the office
is established. The members of the advisory council shall include the following members:
new text end

new text begin (1) the commissioner of health or a designee;
new text end

new text begin (2) the commissioner of public safety or a designee;
new text end

new text begin (3) the commissioner of agriculture or a designee;
new text end

new text begin (4) the executive director of the board pharmacy or a designee;
new text end

new text begin (5) a representative from the League of Minnesota Cities, appointed by the league;
new text end

new text begin (6) a representative from the Association of Minnesota Counties, appointed by the
association;
new text end

new text begin (7) two patient advocates who are patients enrolled in the medical cannabis program;
and
new text end

new text begin (8) three representatives of the hemp market, appointed by the commissioner, with one
member representing hemp growers, one member representing hemp processors, and one
member representing retailers selling hemp products in this state.
new text end

new text begin Subd. 2. new text end

new text begin Organization. new text end

new text begin The advisory council shall be organized and administered as
provided in section 15.059. The advisory council shall select one of its members to serve
as chair.
new text end

new text begin Subd. 3. new text end

new text begin Duties. new text end

new text begin The advisory council shall determine its meeting times as necessary
but must meet at least quarterly to advise the commissioner and make recommendations to
the commissioner as it finds appropriate regarding the state's hemp industry. The advisory
council shall also meet at the call of the commissioner.
new text end

new text begin Subd. 4. new text end

new text begin Expiration. new text end

new text begin Notwithstanding section 15.059, the advisory council does not
expire.
new text end

Sec. 5.

new text begin [342.05] APPROVAL OF HEMP PRODUCTS.
new text end

new text begin (a) Notwithstanding any law to the contrary, a hemp product containing cannabinoids
may be sold in Minnesota through a licensed hemp retailer if the product does not contain
a concentration of more than 0.3 percent of tetrahydrocannabinol.
new text end

new text begin (b) A licensed hemp retailer located in Minnesota may only sell hemp products that are
approved for retail sale by the office and that comply with this chapter and any rules adopted
pursuant to this chapter.
new text end

new text begin (c) The office may adopt rules to limit or prohibit toxic ingredients in or additives to
hemp-derived consumable or topical products.
new text end

new text begin (d) Any hemp product that has been approved for sale by the office and meets the
requirements of this chapter is not a controlled substance under section 152.02.
new text end

Sec. 6.

new text begin [342.06] LICENSING.
new text end

new text begin Subdivision 1. new text end

new text begin Requirement; issuance; presumption. new text end

new text begin (a) A person must obtain a license
from the commissioner before:
new text end

new text begin (1) planting or growing hemp for commercial or research purposes;
new text end

new text begin (2) obtaining raw hemp materials for processing hemp to make hemp products for
commercial purposes; and
new text end

new text begin (3) selling hemp-derived consumable and topical products at the retail level to consumers
for personal consumption.
new text end

new text begin (b) To obtain a license under paragraph (a), a person must apply to the commissioner
in the form prescribed by the commissioner and must pay the annual registration and
inspection fee established by the commissioner pursuant to section 16A.1285, subdivision
2.
new text end

new text begin (c) For a license to grow hemp for commercial or research purposes, the license
application must include the name and address of the applicant and the legal description of
the land area or areas where hemp will be grown by the applicant and any other information
required under Code of Federal Regulations, title 7, part 990.
new text end

new text begin (d) For a license to process raw hemp for commercial purposes, the license application
must include the name and address of the applicant, the legal description of the processing
location, and any other information required by the commissioner.
new text end

new text begin (e) For a license to sell hemp products at the retail level, the license application must
include the name and address of the applicant, the address of the retail business, if applicable,
and any other information required by the commissioner.
new text end

new text begin (f) When an applicant has paid the fee and completed the application process to the
satisfaction of the commissioner, the commissioner shall issue a license that is valid until
December 31 of the year of application.
new text end

new text begin (g) A person licensed under this section to grow or process hemp is presumed to be
growing or processing hemp for commercial or research purposes.
new text end

new text begin Subd. 2. new text end

new text begin Background check; data classification. new text end

new text begin The commissioner must require each
first-time applicant for a license to submit to a background investigation conducted by the
Bureau of Criminal Apprehension as a condition of licensure. As part of the background
investigation, the Bureau of Criminal Apprehension must conduct criminal history checks
of Minnesota records and is authorized to exchange fingerprints with the United States
Department of Justice, Federal Bureau of Investigation for the purpose of a criminal
background check of the national files. The cost of the investigation must be paid by the
applicant. Criminal history records provided to the commissioner under this section must
be treated as private data on individuals, as defined in section 13.02, subdivision 12.
new text end

new text begin Subd. 3. new text end

new text begin Federal requirements. new text end

new text begin The applicant must demonstrate to the satisfaction of
the commissioner that the applicant has complied with all applicable federal requirements
pertaining to the processing, production, distribution, and sale of hemp.
new text end

new text begin Subd. 4. new text end

new text begin Hemp licensing data classification. new text end

new text begin (a) In addition to data classified pursuant
to section 13.41, the following data collected, created, or maintained by the commissioner
under this chapter are classified as private data, as defined in section 13.02, subdivision 12,
or nonpublic data, as defined in section 13.02, subdivision 9:
new text end

new text begin (1) nondesignated addresses provided by licensees and applicants; and
new text end

new text begin (2) data that identify the specific locations where licensees and applicants grow or
process, or will grow or process, hemp, including but not limited to legal descriptions, street
addresses, geospatial locations, maps, and property boundaries and dimensions.
new text end

new text begin (b) The commissioner may disclose data classified as private data or nonpublic data
under this subdivision if the commissioner determines that there is a substantive threat to
human health or safety or to the environment, or to aid in the law enforcement process.
new text end

new text begin Subd. 5. new text end

new text begin Hemp licensing data security and auditing. new text end

new text begin (a) The commissioner must
establish written procedures to ensure that only individuals authorized by law may access
the private data and nonpublic data identified in subdivision 4. An authorized individual's
ability to enter, update, or access data must correspond to the official duties or training level
of the individual and to the statutory authorization granting access for that purpose. All
queries and responses, including the specific purpose for which data are requested and, if
applicable, disclosed, and all actions in which data are entered, updated, accessed, shared,
or disseminated must be recorded in the data audit trail. Data contained in the audit trail are
public to the extent the data are not otherwise classified by law.
new text end

new text begin (b) The commissioner must immediately and permanently revoke the authorization of
any individual who willfully entered, updated, accessed, shared, or disseminated data in
violation of state or federal law. If an individual willfully gained access to data without
authorization by law, the commissioner must forward the matter to the appropriate
prosecuting authority for prosecution.
new text end

new text begin (c) By January 15 of each odd-numbered year, the commissioner must provide a copy
of the data audit trail required under paragraph (a) to the commissioner of administration,
the chairs and ranking members of the legislative committees and divisions with jurisdiction
over public safety and data practices, and the Legislative Commission on Data Practices
and Personal Data Privacy or its successor commission.
new text end

Sec. 7.

new text begin [342.07] TESTING REQUIREMENTS.
new text end

new text begin (a) A manufacturer of a hemp product regulated under this chapter must submit
representative samples of the product to an independent, accredited laboratory in order to
certify that the product complies with the standards adopted by the office. Testing must be
consistent with generally accepted industry standards for herbal and botanical substances
and, at a minimum, the testing must confirm that the product:
new text end

new text begin (1) contains the amount or percentage of cannabinoids that is stated on the label of the
product within a variation of plus or minus ten percent;
new text end

new text begin (2) does not contain more than trace amounts of any pesticides, fertilizers, or heavy
metals or residual solvents; and
new text end

new text begin (3) does not contain a concentration of tetrahydrocannabinol that exceeds the
concentration permitted for hemp.
new text end

new text begin (b) Upon the request of the office, the manufacturer of the product must provide the
office with the results of the testing required in this section.
new text end

Sec. 8.

new text begin [342.08] LABELING.
new text end

new text begin Subdivision 1. new text end

new text begin General. new text end

new text begin All hemp-derived consumable or topical products sold in this
state must be labeled as required by this section and rules adopted under this chapter.
new text end

new text begin Subd. 2. new text end

new text begin Content of label; hemp-derived consumable or topical products. new text end

new text begin (a) All
hemp-derived consumable or topical products sold in this state must have affixed to the
packaging or container of the product a label that contains at least the following information:
new text end

new text begin (1) the name, location, contact phone number, and website of the manufacturer of the
product;
new text end

new text begin (2) the name and address of the independent, accredited laboratory used by the
manufacturer to test the product; and
new text end

new text begin (3) an accurate statement of the amount or percentage of cannabinoids found in each
unit of the product meant to be consumed.
new text end

new text begin (b) The information in paragraph (a) may be provided:
new text end

new text begin (1) on an outer package if the immediate container that holds the product is too small
to contain the information; and
new text end

new text begin (2) through the use of a scannable barcode or matrix barcode that links to a page on the
manufacturer's website if that page contains all the information required by this section.
new text end

new text begin (c) The information required by this subdivision must be prominently and conspicuously
placed on the label or displayed on the website in terms that can be easily read and understood
by the consumer.
new text end

new text begin (d) The labeling must not contain any claim that the product may be used or is effective
for the diagnosis, prevention, treatment, or cure of a disease or that it may be used to alter
the structure or function of human or animal bodies, unless the claim has been approved by
the United States Food and Drug Administration.
new text end

Sec. 9.

new text begin [342.09] PACKAGING.
new text end

new text begin Subdivision 1. new text end

new text begin General. new text end

new text begin Any hemp-derived consumable or topical product sold in this
state must be packaged as required by this section and rules adopted under this chapter.
new text end

new text begin Subd. 2. new text end

new text begin Packaging requirements. new text end

new text begin (a) Any hemp-derived consumable or topical product
sold in this state must be:
new text end

new text begin (1) prepackaged in packaging or a container that is plain, child-resistant, tamper-evident,
and opaque; or
new text end

new text begin (2) placed in packaging or a container that is plain, child-resistant, tamper-evident, and
opaque at the final point of sale to a customer.
new text end

new text begin (b) If a hemp-derived consumable or topical product is packaged in a manner that
indicates serving sizes, the product must be packaged in one or more easily identifiable
single-serving portions.
new text end

new text begin (c) If a hemp-derived consumable or topical product is an edible product for human
consumption intended for more than a single use or containing multiple servings, the product
must be prepackaged or placed at the final point of sale in packaging or a container that is
resealable.
new text end

new text begin Subd. 3. new text end

new text begin Packaging prohibitions. new text end

new text begin (a) Hemp-derived consumable or topical products
sold in this state must not be packaged in a manner that:
new text end

new text begin (1) bears a reasonable resemblance to any commercially available product; or
new text end

new text begin (2) is designed to appeal to persons under age 21.
new text end

new text begin (b) Packaging for hemp-derived consumables or topical products must not contain or
be coated with any perfluoroalkyl substance.
new text end

Sec. 10.

new text begin [342.10] ADVERTISEMENT.
new text end

new text begin No business shall publish or cause to be published an advertisement for a hemp-derived
consumable or topical product in a manner that:
new text end

new text begin (1) contains false or misleading statements; or
new text end

new text begin (2) contains unverified claims about the health or therapeutic benefits or effects of
consuming the product.
new text end

Sec. 11.

new text begin [342.11] ENFORCEMENT.
new text end

new text begin (a) A hemp product sold under this chapter shall be considered an adulterated drug if
the hemp product:
new text end

new text begin (1) consists, in whole or in part, of any filthy, putrid, or decomposed substance;
new text end

new text begin (2) has been produced, prepared, packed, or held under unsanitary conditions where it
may have been rendered injurious to health or where it may have been contaminated with
filth;
new text end

new text begin (3) has a container that is composed, in whole or in part, of any poisonous or deleterious
substance that may render the contents injurious to health;
new text end

new text begin (4) contains any color additives or excipients that have been found by the FDA to be
unsafe for human or animal consumption; or
new text end

new text begin (5) contains an amount or percentage of cannabinoids that is different than the amount
or percentage stated on the label.
new text end

new text begin (b) A product sold under this section shall be considered a misbranded drug if the
product's labeling is false or misleading in any manner or in violation of the requirements
of this section.
new text end

new text begin (c) The office has the authority to issue cease and desist orders and to seek injunctive
relief for a violation of this section.
new text end

Sec. 12.

new text begin [342.12] FEES.
new text end

new text begin Fees collected under this chapter must be credited to the hemp account, which is hereby
established in the state treasury. Interest earned in the account accrues to the account. Funds
in the hemp account are annually appropriated to the commissioner to implement and enforce
this chapter.
new text end

Sec. 13.

new text begin [342.15] DEFINITIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Terms. new text end

new text begin For purposes of sections 342.15 to 342.29, the following terms
have the meanings given.
new text end

new text begin Subd. 2. new text end

new text begin Disqualifying felony offense. new text end

new text begin "Disqualifying felony offense" means 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, regardless of the sentence imposed, unless the
commissioner determines that the person's conviction was for the medical use of cannabis
or assisting with the medical use of cannabis.
new text end

new text begin Subd. 3. new text end

new text begin Health care practitioner. new text end

new text begin "Health care practitioner" means a Minnesota-licensed
doctor of medicine, a Minnesota-licensed physician assistant acting within the scope of
authorized practice, or a Minnesota-licensed advanced practice registered nurse who has
the primary responsibility for the care and treatment of the qualifying medical condition of
a person diagnosed with a qualifying medical condition.
new text end

new text begin Subd. 4. new text end

new text begin Health records. new text end

new text begin "Health records" means health records as defined in section
144.291, subdivision 2, paragraph (c).
new text end

new text begin Subd. 5. new text end

new text begin Medical cannabis. new text end

new text begin (a) "Medical cannabis" means any species of the genus
cannabis plant or any mixture or preparation of them, including whole plant extracts and
resins, and is delivered in the form of:
new text end

new text begin (1) liquid, including but not limited to oil;
new text end

new text begin (2) pill;
new text end

new text begin (3) vaporized delivery method with use of liquid or oil;
new text end

new text begin (4) combustion with use of dried raw cannabis; or
new text end

new text begin (5) any other method approved by the commissioner.
new text end

new text begin (b) This definition includes any part of the genus cannabis plant before being processed
into a form allowed under paragraph (a) that is possessed by a person while that person is
engaged in employment duties necessary to carry out a requirement under sections 342.15
to 342.29 for a registered manufacturer or a laboratory under contract with a registered
manufacturer. This definition also includes any hemp acquired by a manufacturer by a hemp
grower as permitted under section 342.17.
new text end

new text begin (c) Medical cannabis does not include industrial hemp products or hemp-derived
consumable or topical products.
new text end

new text begin Subd. 6. new text end

new text begin Medical cannabis manufacturer. new text end

new text begin "Medical cannabis manufacturer" or
"manufacturer" means an entity registered by the commissioner to cultivate, acquire,
manufacture, possess, prepare, transfer, transport, supply, or dispense medical cannabis,
delivery devices, or related supplies and educational materials.
new text end

new text begin Subd. 7. new text end

new text begin Medical cannabis product. new text end

new text begin "Medical cannabis product" means any delivery
device or related supplies and educational materials used in the administration of medical
cannabis for a patient with a qualifying medical condition enrolled in the registry program.
new text end

new text begin Subd. 8. new text end

new text begin Patient. new text end

new text begin "Patient" means a Minnesota resident who has been diagnosed with a
qualifying medical condition by a health care practitioner and who has otherwise met any
other requirements for patients under sections 342.15 to 342.29 to participate in the registry
program under sections 342.15 to 342.29.
new text end

new text begin Subd. 9. new text end

new text begin Patient registry number. new text end

new text begin "Patient registry number" means a unique
identification number assigned by the commissioner to a patient enrolled in the registry
program.
new text end

new text begin Subd. 10. new text end

new text begin Registered designated caregiver. new text end

new text begin "Registered designated caregiver" means
a person who:
new text end

new text begin (1) is at least 18 years old;
new text end

new text begin (2) does not have a conviction for a disqualifying felony offense;
new text end

new text begin (3) has been approved by the commissioner to assist a patient who requires assistance
in administering medical cannabis or obtaining medical cannabis from a distribution facility;
and
new text end

new text begin (4) is authorized by the commissioner to assist the patient with the use of medical
cannabis.
new text end

new text begin Subd. 11. new text end

new text begin Registry program. new text end

new text begin "Registry program" means the patient registry established
in sections 342.15 to 342.29.
new text end

new text begin Subd. 12. new text end

new text begin Registry verification. new text end

new text begin "Registry verification" means the verification provided
by the commissioner that a patient is enrolled in the registry program and that includes the
patient's name, registry number, and, if applicable, the name of the patient's registered
designated caregiver or parent, legal guardian, or spouse.
new text end

new text begin Subd. 13. new text end

new text begin Qualifying medical condition. new text end

new text begin "Qualifying medical condition" means a
diagnosis of any of the following conditions:
new text end

new text begin (1) cancer, if the underlying condition or treatment produces one or more of the following:
new text end

new text begin (i) severe or chronic pain;
new text end

new text begin (ii) nausea or severe vomiting; or
new text end

new text begin (iii) cachexia or severe wasting;
new text end

new text begin (2) glaucoma;
new text end

new text begin (3) human immunodeficiency virus or acquired immune deficiency syndrome;
new text end

new text begin (4) Tourette syndrome;
new text end

new text begin (5) amyotrophic lateral sclerosis;
new text end

new text begin (6) seizures, including those characteristic of epilepsy;
new text end

new text begin (7) severe and persistent muscle spasms, including those characteristic of multiple
sclerosis;
new text end

new text begin (8) inflammatory bowel disease, including Crohn's disease;
new text end

new text begin (9) terminal illness, with a probable life expectancy of under one year, if the illness or
its treatment produces one or more of the following:
new text end

new text begin (i) severe or chronic pain;
new text end

new text begin (ii) nausea or severe vomiting; or
new text end

new text begin (iii) cachexia or severe wasting; or
new text end

new text begin (10) any other medical condition or its treatment approved by the commissioner.
new text end

Sec. 14.

new text begin [342.16] PATIENT REGISTRY PROGRAM ESTABLISHED.
new text end

new text begin Subdivision 1. new text end

new text begin Patient registry program; establishment. new text end

new text begin (a) The commissioner shall
establish a patient registry program to evaluate data on patient demographics, effective
treatment options, clinical outcomes, and quality-of-life outcomes for the purpose of reporting
on the benefits, risks, and outcomes regarding patients with a qualifying medical condition
engaged in the therapeutic use of medical cannabis.
new text end

new text begin (b) The establishment of the registry program shall not be construed or interpreted to
condone or promote the illicit recreational use of marijuana.
new text end

new text begin Subd. 2. new text end

new text begin Commissioner duties. new text end

new text begin (a) The commissioner shall:
new text end

new text begin (1) give notice of the program to health care practitioners in the state who are eligible
to serve as health care practitioners and explain the purposes and requirements of the
program;
new text end

new text begin (2) allow each health care practitioner who meets or agrees to meet the program's
requirements and who requests to participate to be included in the registry program to collect
data for the patient registry;
new text end

new text begin (3) provide explanatory information and assistance to each health care practitioner in
understanding the nature of therapeutic use of medical cannabis within program requirements;
new text end

new text begin (4) create and provide a certification to be used by a health care practitioner for the
practitioner to certify whether a patient has been diagnosed with a qualifying medical
condition and include in the certification an option for the practitioner to certify whether
the patient, in the health care practitioner's medical opinion, is developmentally or physically
disabled and, as a result of that disability, the patient requires assistance in administering
medical cannabis or obtaining medical cannabis from a distribution facility;
new text end

new text begin (5) supervise the participation of the health care practitioner in conducting patient
treatment and health records reporting in a manner that ensures stringent security and
record-keeping requirements and that prevents the unauthorized release of private data on
individuals as defined by section 13.02;
new text end

new text begin (6) develop safety criteria for patients with a qualifying medical condition as a
requirement of the patient's participation in the program to prevent the patient from
undertaking any task under the influence of medical cannabis that would constitute negligence
or professional malpractice on the part of the patient; and
new text end

new text begin (7) conduct research and studies based on data from health records submitted to the
registry program and submit reports on intermediate or final research results to the legislature
and major scientific journals. The commissioner may contract with a third party to complete
the requirements of this clause. Any reports submitted must comply with section 342.18,
subdivision 2.
new text end

new text begin (b) The commissioner may add a delivery method under section 342.15, subdivision 5,
or add, remove, or modify a qualifying medical condition under section 342.15, subdivision
13, upon a petition from a member of the public or the task force on medical cannabis
therapeutic research or as directed by law. The commissioner shall evaluate all petitions to
add a qualifying medical condition or to remove or modify an existing qualifying medical
condition submitted by the task force on medical cannabis therapeutic research or as directed
by law and may make the addition, removal, or modification if the commissioner determines
the addition, removal, or modification is warranted based on the best available evidence
and research. If the commissioner wishes to add a delivery method under section 342.15,
subdivision 5, or add or remove a qualifying medical condition under section 342.15,
subdivision 13, the commissioner must notify the chairs and ranking minority members of
the legislative committees with jurisdiction over health and public safety policy of the
addition or removal and the reasons for its addition or removal, including any written
comments received by the commissioner from the public and any guidance received from
the task force on medical cannabis research, by January 15 of the year in which the
commissioner wishes to make the change. The change is effective on August 1 of that year
unless the legislature by law provides otherwise.
new text end

new text begin Subd. 3. new text end

new text begin Patient application. new text end

new text begin (a) The commissioner shall develop a patient application
for enrollment into the registry program. The application shall be available to the patient
and given to health care practitioners in the state who are eligible to serve as health care
practitioners. The application must include:
new text end

new text begin (1) the name, mailing address, and date of birth of the patient;
new text end

new text begin (2) the name, mailing address, and telephone number of the patient's health care
practitioner;
new text end

new text begin (3) the name, mailing address, and date of birth of the patient's designated caregiver, if
any, or the patient's parent, legal guardian, or spouse if the parent, legal guardian, or spouse
is acting as a caregiver;
new text end

new text begin (4) a copy of the certification from the patient's health care practitioner that is dated
within 90 days prior to submitting the application that certifies that the patient has been
diagnosed with a qualifying medical condition; and
new text end

new text begin (5) all other signed affidavits and enrollment forms required by the commissioner under
sections 342.15 to 342.29, including but not limited to the disclosure form required under
paragraph (c).
new text end

new text begin (b) The commissioner shall require a patient to resubmit a copy of the certification from
the patient's health care practitioner on a yearly basis and shall require that the recertification
be dated within 90 days of submission.
new text end

new text begin (c) The commissioner shall develop a disclosure form and require, as a condition of
enrollment, all patients to sign a copy of the disclosure. The disclosure must include:
new text end

new text begin (1) a statement that, notwithstanding any law to the contrary, the commissioner, or an
employee of any state agency, may not be held civilly or criminally liable for an injury, loss
of property, personal injury, or death caused by any act or omission while acting within the
scope of office or employment under sections 342.15 to 342.29; and
new text end

new text begin (2) the patient's acknowledgment that enrollment in the patient registry program is
conditional on the patient's agreement to meet the requirements of sections 342.15 to 342.29.
new text end

new text begin Subd. 4. new text end

new text begin Registered designated caregiver. new text end

new text begin (a) The commissioner shall register a
designated caregiver for a patient if the patient requires assistance in administering medical
cannabis or obtaining medical cannabis from a distribution facility and the caregiver has
agreed, in writing, to be the patient's designated caregiver. As a condition of registration as
a designated caregiver, the commissioner shall require the person to:
new text end

new text begin (1) be at least 18 years of age;
new text end

new text begin (2) agree to only possess the patient's medical cannabis for purposes of assisting the
patient; and
new text end

new text begin (3) agree that if the application is approved, the person will not be a registered designated
caregiver for more than six registered patients at one time. Patients who reside in the same
residence shall count as one patient.
new text end

new text begin (b) The commissioner shall conduct a criminal background check on the designated
caregiver prior to registration to ensure that the person does not have a conviction for a
disqualifying felony offense. Any cost of the background check shall be paid by the person
seeking registration as a designated caregiver. A designated caregiver must have the criminal
background check renewed every two years.
new text end

new text begin (c) Nothing in sections 342.15 to 342.29 shall be construed to prevent a person registered
as a designated caregiver from also being enrolled in the registry program as a patient and
possessing and using medical cannabis as a patient.
new text end

new text begin Subd. 5. new text end

new text begin Parent, legal guardian, or spouse. new text end

new text begin A parent, legal guardian, or spouse of a
patient may act as the caregiver to the patient without having to register as a designated
caregiver. The parent, legal guardian, or spouse shall follow the requirements in sections
342.15 to 342.29. Nothing in sections 342.15 to 342.29 limits any legal authority of a parent,
legal guardian, or spouse for the patient under any other law.
new text end

new text begin Subd. 6. new text end

new text begin Patient enrollment. new text end

new text begin (a) After receipt of a patient's application, application fees,
and signed disclosure, the commissioner shall enroll the patient in the registry program and
issue a registry verification to the patient and patient's registered designated caregiver or
parent, legal guardian, or spouse, if applicable. The commissioner shall approve or deny a
patient's application for participation in the registry program within 30 days after the
commissioner receives the patient's application and application fee. A patient's enrollment
in the registry program shall only be denied if the patient:
new text end

new text begin (1) does not have certification from a health care practitioner that the patient has been
diagnosed with a qualifying medical condition;
new text end

new text begin (2) has not signed and returned to the commissioner the disclosure form required under
subdivision 3, paragraph (c);
new text end

new text begin (3) does not provide the information required;
new text end

new text begin (4) has previously been removed from the registry program for violations of section
342.20 or 342.24; or
new text end

new text begin (5) provides false information.
new text end

new text begin (b) The commissioner shall give written notice to a patient of the reason for denying
enrollment in the registry program.
new text end

new text begin (c) Denial of enrollment into the registry program is considered a final decision of the
commissioner and is subject to judicial review under the Administrative Procedure Act
pursuant to chapter 14.
new text end

new text begin (d) A patient's enrollment in the registry program may only be revoked upon the death
of the patient or if a patient violates a requirement under section 342.20 or 342.24.
new text end

new text begin (e) The commissioner shall develop a registry verification to provide to the patient, the
health care practitioner identified in the patient's application, and the manufacturer. The
registry verification shall include:
new text end

new text begin (1) the patient's name and date of birth;
new text end

new text begin (2) the patient registry number assigned to the patient; and
new text end

new text begin (3) the name and date of birth of the patient's registered designated caregiver, if any, or
the name of the patient's parent, legal guardian, or spouse if the parent, legal guardian, or
spouse is acting as a caregiver.
new text end

new text begin Subd. 7. new text end

new text begin Notice requirements. new text end

new text begin Patients and registered designated caregivers shall notify
the commissioner of any address or name change within 30 days of the change. A patient
or registered designated caregiver is subject to a $100 fine for failure to notify the
commissioner of the change.
new text end

Sec. 15.

new text begin [342.17] COMMISSIONER DUTIES.
new text end

new text begin Subdivision 1. new text end

new text begin Medical cannabis manufacturer registration. new text end

new text begin (a) The commissioner
shall register two in-state manufacturers for the production of all medical cannabis within
the state. A registration agreement between the commissioner and a manufacturer is
nontransferable. The commissioner shall register new manufacturers or reregister the existing
manufacturers by December 1 every two years using the factors described in this subdivision.
The commissioner shall accept applications after December 1, 2014, if one of the
manufacturers registered before December 1, 2014, ceases to be registered as a manufacturer.
The commissioner's determination that no manufacturer exists to fulfill the duties under
sections 342.15 to 342.29 is subject to judicial review in Ramsey County District Court.
Data submitted during the application process are private data on individuals or nonpublic
data as defined in section 13.02 until the manufacturer is registered under this section. Data
on a manufacturer that is registered are public data unless the data are trade secret or security
information under section 13.37.
new text end

new text begin (b) As a condition for registration, a manufacturer must:
new text end

new text begin (1) supply medical cannabis to patients; and
new text end

new text begin (2) comply with sections 342.15 to 342.29.
new text end

new text begin (c) The commissioner shall consider the following factors when determining which
manufacturer to register:
new text end

new text begin (1) the technical expertise of the manufacturer in cultivating medical cannabis and
converting the medical cannabis into an acceptable delivery method under section 342.15,
subdivision 5;
new text end

new text begin (2) the qualifications of the manufacturer's employees;
new text end

new text begin (3) the long-term financial stability of the manufacturer;
new text end

new text begin (4) the ability to provide appropriate security measures on the premises of the
manufacturer;
new text end

new text begin (5) whether the manufacturer has demonstrated an ability to meet the medical cannabis
production needs required by sections 342.15 to 342.29; and
new text end

new text begin (6) the manufacturer's projection and ongoing assessment of fees on patients with a
qualifying medical condition.
new text end

new text begin (d) If an officer, director, or controlling person of the manufacturer pleads or is found
guilty of intentionally diverting medical cannabis to a person other than allowed by law
under section 342.24, subdivision 1, the commissioner may decide not to renew the
registration of the manufacturer, provided the violation occurred while the person was an
officer, director, or controlling person of the manufacturer.
new text end

new text begin (e) The commissioner shall require each medical cannabis manufacturer to contract with
an independent laboratory to test medical cannabis produced by the manufacturer. The
commissioner shall approve the laboratory chosen by each manufacturer and require that
the laboratory report testing results to the manufacturer in a manner determined by the
commissioner.
new text end

new text begin Subd. 2. new text end

new text begin Revocation or nonrenewal of a medical cannabis manufacturer
registration. new text end

new text begin If the commissioner intends to revoke or not renew a registration issued under
this section, the commissioner must first notify in writing the manufacturer against whom
the action is to be taken and provide the manufacturer with an opportunity to request a
hearing under the contested case provisions of chapter 14. If the manufacturer does not
request a hearing by notifying the commissioner in writing within 20 days after receipt of
the notice of proposed action, the commissioner may proceed with the action without a
hearing. For revocations, the registration of a manufacturer is considered revoked on the
date specified in the commissioner's written notice of revocation.
new text end

new text begin Subd. 3. new text end

new text begin Temporary suspension proceedings. new text end

new text begin The commissioner may institute
proceedings to temporarily suspend the registration of a medical cannabis manufacturer for
up to 90 days by notifying the manufacturer in writing if any action by an employee, agent,
officer, director, or controlling person of the manufacturer:
new text end

new text begin (1) violates sections 342.15 to 342.29 or the rules adopted under those sections;
new text end

new text begin (2) permits, aids, or abets the commission of any violation of state law at the
manufacturer's location for cultivation, harvesting, manufacturing, packaging, and processing
or at any site for distribution of medical cannabis;
new text end

new text begin (3) performs an act contrary to the welfare of a registered patient or registered designated
caregiver; or
new text end

new text begin (4) obtains or attempts to obtain a registration by fraudulent means or misrepresentation.
new text end

new text begin Subd. 4. new text end

new text begin Notice to patients. new text end

new text begin Upon the revocation or nonrenewal of a manufacturer's
registration under subdivision 2 or implementation of an enforcement action under section
342.24, subdivision 1, that may affect the ability of a registered patient, a registered
designated caregiver, or a registered patient's parent, legal guardian, or spouse to obtain
medical cannabis from the manufacturer subject to the enforcement action, the commissioner
shall notify in writing each registered patient and the patient's registered designated caregiver
or registered patient's parent, legal guardian, or spouse about the outcome of the proceeding
and information regarding alternative registered manufacturers. The notice must be provided
two or more business days prior to the effective date of the revocation, nonrenewal, or other
enforcement action.
new text end

new text begin Subd. 5. new text end

new text begin Range of compounds and dosages; report. new text end

new text begin The commissioner shall review
and publicly report the existing medical and scientific literature regarding the range of
recommended dosages for each qualifying condition and the range of chemical compositions
of any plant of the genus cannabis that will likely be medically beneficial for each of the
qualifying medical conditions. The commissioner shall make the information available to
patients with qualifying medical conditions and update the information annually. The
commissioner may consult with the independent laboratory under contract with the
manufacturer or other experts in reporting the range of recommended dosages for each
qualifying medical condition, the range of chemical compositions that will likely be medically
beneficial, and any risks of noncannabis drug interactions. The commissioner shall consult
with each manufacturer on an annual basis on medical cannabis offered by the manufacturer.
The list of medical cannabis offered by a manufacturer shall be published on the Department
of Health website.
new text end

new text begin Subd. 6. new text end

new text begin Reports. new text end

new text begin (a) The commissioner shall provide regular updates to the Task Force
on Medical Cannabis Therapeutic Research and to the chairs and ranking minority members
of the legislative committees with jurisdiction over health and human services, public safety,
judiciary, and civil law regarding: (1) any changes in federal law or regulatory restrictions
regarding the use of medical cannabis or hemp; and (2) the market demand and supply in
this state for products made from hemp that can be used for medicinal purposes.
new text end

new text begin (b) The commissioner may submit medical research based on the data collected under
sections 342.15 to 342.29 to any federal agency with regulatory or enforcement authority
over medical cannabis to demonstrate the effectiveness of medical cannabis for treating a
qualifying medical condition.
new text end

Sec. 16.

new text begin [342.18] HEALTH CARE PRACTITIONER DUTIES.
new text end

new text begin Subdivision 1. new text end

new text begin Health care practitioner duties. new text end

new text begin (a) Prior to a patient's enrollment in
the registry program, a health care practitioner shall:
new text end

new text begin (1) determine, in the health care practitioner's medical judgment, whether a patient suffers
from a qualifying medical condition and, if so determined, provide the patient with a
certification of that diagnosis;
new text end

new text begin (2) advise patients, registered designated caregivers, and parents, legal guardians, or
spouses who are acting as caregivers of the existence of any nonprofit patient support groups
or organizations;
new text end

new text begin (3) provide explanatory information from the commissioner to patients with qualifying
medical conditions, including disclosure to all patients about the experimental nature of
therapeutic use of medical cannabis; the possible risks, benefits, and side effects of the
proposed treatment; and the application and other materials from the commissioner; and
provide patients with the Tennessen warning as required by section 13.04, subdivision 2;
and
new text end

new text begin (4) agree to continue treatment of the patient's qualifying medical condition and report
medical findings to the commissioner.
new text end

new text begin (b) Upon notification from the commissioner of the patient's enrollment in the registry
program, the health care practitioner shall:
new text end

new text begin (1) participate in the patient registry reporting system under the guidance and supervision
of the commissioner;
new text end

new text begin (2) report health records of the patient to the commissioner throughout the ongoing
treatment of the patient in a manner determined by the commissioner and in accordance
with subdivision 2;
new text end

new text begin (3) determine, on a yearly basis, if the patient continues to suffer from a qualifying
medical condition and, if so, issue the patient a new certification of that diagnosis; and
new text end

new text begin (4) otherwise comply with all requirements developed by the commissioner.
new text end

new text begin (c) A health care practitioner may conduct a patient assessment to issue a recertification
as required under paragraph (b), clause (3), via telehealth, as defined in section 62A.673,
subdivision 2.
new text end

new text begin (d) Nothing in this section requires a health care practitioner to participate in the registry
program.
new text end

new text begin Subd. 2. new text end

new text begin Data. new text end

new text begin Data collected on patients by a health care practitioner and reported to
the patient registry are health records under section 144.291 and are private data on
individuals under section 13.02, but may be used or reported in an aggregated, nonidentifiable
form as part of a scientific, peer-reviewed publication of research conducted under section
342.17 or in the creation of summary data, as defined in section 13.02, subdivision 19.
new text end

new text begin Subd. 3. new text end

new text begin Advertising restrictions. new text end

new text begin (a) A health care practitioner shall not publish or
cause to be published any advertisement that:
new text end

new text begin (1) contains false or misleading statements about medical cannabis or the medical
cannabis registry program;
new text end

new text begin (2) uses colloquial terms to refer to medical cannabis, such as pot, weed, or grass;
new text end

new text begin (3) states or implies the health care practitioner is endorsed by the Department of Health,
the Office of Cannabis Derivatives, or the medical cannabis registry program;
new text end

new text begin (4) includes images of cannabis in its plant or leaf form or of cannabis-smoking
paraphernalia; or
new text end

new text begin (5) contains medical symbols that could reasonably be confused with symbols of
established medical associations or groups.
new text end

new text begin (b) A health care practitioner found by the commissioner to have violated this subdivision
is prohibited from certifying that patients have a qualifying medical condition for purposes
of patient participation in the registry program. The commissioner's decision that a health
care practitioner has violated this subdivision is a final decision of the commissioner and
is not subject to the contested case procedures in chapter 14.
new text end

Sec. 17.

new text begin [342.19] MANUFACTURER OF MEDICAL CANNABIS DUTIES.
new text end

new text begin Subdivision 1. new text end

new text begin Manufacturer; requirements. new text end

new text begin (a) A manufacturer may operate eight
distribution facilities, which may include the manufacturer's single location for cultivation,
harvesting, manufacturing, packaging, and processing but is not required to include that
location. The commissioner shall designate the geographical service areas to be served by
each manufacturer based on geographical need throughout the state to improve patient
access. A manufacturer shall not have more than two distribution facilities in each
geographical service area assigned to the manufacturer by the commissioner. A manufacturer
shall operate only one location where all cultivation, harvesting, manufacturing, packaging,
and processing of medical cannabis shall be conducted. This location may be one of the
manufacturer's distribution facility sites. The additional distribution facilities may dispense
medical cannabis and medical cannabis products but may not contain any medical cannabis
in a form other than those forms allowed under section 342.15, subdivision 5, and the
manufacturer shall not conduct any cultivation, harvesting, manufacturing, packaging, or
processing at the other distribution facility sites. Any distribution facility operated by the
manufacturer is subject to the requirements applying to the manufacturer under sections
342.15 to 342.29, including but not limited to security and distribution requirements.
new text end

new text begin (b) A manufacturer may acquire hemp grown in this state from a hemp grower and may
acquire hemp products produced by a hemp processor. A manufacturer may manufacture
or process hemp and hemp products into an allowable form of medical cannabis under
section 342.15, subdivision 5. Hemp and hemp products acquired by a manufacturer under
this paragraph are subject to the same quality control program, security and testing
requirements, and other requirements that apply to medical cannabis under sections 342.15
to 342.29 and Minnesota Rules, chapter 4770.
new text end

new text begin (c) A medical cannabis manufacturer shall contract with a laboratory approved by the
commissioner, subject to any additional requirements set by the commissioner, for purposes
of testing medical cannabis manufactured or hemp or hemp products acquired by the medical
cannabis manufacturer as to content, contamination, and consistency to verify the medical
cannabis meets the requirements of section 342.15, subdivision 5. The cost of laboratory
testing shall be paid by the manufacturer.
new text end

new text begin (d) The operating documents of a manufacturer must include procedures for:
new text end

new text begin (1) the oversight of the manufacturer and procedures to ensure accurate record keeping;
new text end

new text begin (2) the implementation of appropriate security measures to deter and prevent the theft
of medical cannabis and unauthorized entrance into areas containing medical cannabis; and
new text end

new text begin (3) the delivery and transportation of hemp between hemp growers and manufacturers
and for the delivery and transportation of hemp products between hemp processors and
manufacturers.
new text end

new text begin (e) A manufacturer shall implement security requirements, including requirements for
the delivery and transportation of hemp and hemp products, protection of each location by
a fully operational security alarm system, facility access controls, perimeter intrusion
detection systems, and a personnel identification system.
new text end

new text begin (f) A manufacturer shall not share office space with, refer patients to, or have any financial
relationship with a health care practitioner.
new text end

new text begin (g) A manufacturer shall not permit any person to consume medical cannabis on the
property of the manufacturer.
new text end

new text begin (h) A manufacturer is subject to reasonable inspection by the commissioner.
new text end

new text begin (i) For purposes of sections 342.15 to 342.29, a medical cannabis manufacturer is not
subject to the Board of Pharmacy licensure or regulatory requirements under chapter 151.
new text end

new text begin (j) A medical cannabis manufacturer may not employ any person who is under 21 years
of age or who has been convicted of a disqualifying felony offense. An employee of a
medical cannabis manufacturer must submit a completed criminal history records check
consent form, a full set of classifiable fingerprints, and the required fees for submission to
the Bureau of Criminal Apprehension before an employee may begin working with the
manufacturer. The bureau must conduct a Minnesota criminal history records check and
the superintendent is authorized to exchange the fingerprints with the Federal Bureau of
Investigation to obtain the applicant's national criminal history record information. The
bureau shall return the results of the Minnesota and federal criminal history records checks
to the commissioner.
new text end

new text begin (k) A manufacturer may not operate in any location, whether for distribution or
cultivation, harvesting, manufacturing, packaging, or processing, within 1,000 feet of a
public or private school existing before the date of the manufacturer's registration with the
commissioner.
new text end

new text begin (l) A manufacturer shall comply with reasonable restrictions set by the commissioner
relating to signage, marketing, display, and advertising of medical cannabis.
new text end

new text begin (m) Before a manufacturer acquires hemp from a hemp grower or hemp products from
a hemp processor, the manufacturer must verify that the hemp grower or hemp processor
has a valid license issued by the commissioner under this chapter.
new text end

new text begin (n) Until a state-centralized, seed-to-sale system is implemented that can track a specific
medical cannabis plant from cultivation through testing and point of sale, the commissioner
shall conduct at least one unannounced inspection per year of each manufacturer that includes
inspection of:
new text end

new text begin (1) business operations;
new text end

new text begin (2) physical locations of the manufacturer's manufacturing facility and distribution
facilities;
new text end

new text begin (3) financial information and inventory documentation, including laboratory testing
results; and
new text end

new text begin (4) physical and electronic security alarm systems.
new text end

new text begin Subd. 2. new text end

new text begin Manufacturer; production. new text end

new text begin (a) A manufacturer of medical cannabis shall
provide a reliable and ongoing supply of all medical cannabis needed for the registry program
through cultivation by the manufacturer and through the purchase of hemp from hemp
growers.
new text end

new text begin (b) All cultivation, harvesting, manufacturing, packaging, and processing of medical
cannabis must take place in an enclosed, locked facility at a physical address provided to
the commissioner during the registration process.
new text end

new text begin (c) A manufacturer must process and prepare any medical cannabis plant material or
hemp plant material into a form allowable under section 342.15, subdivision 5, before
distribution of any medical cannabis.
new text end

new text begin Subd. 3. new text end

new text begin Manufacturer; distribution. new text end

new text begin (a) A manufacturer shall require that employees
licensed as pharmacists pursuant to chapter 151 be the only employees to give final approval
for the distribution of medical cannabis to a patient. A manufacturer may transport medical
cannabis or medical cannabis products that have been cultivated, harvested, manufactured,
packaged, and processed by that manufacturer to another registered manufacturer for the
other manufacturer to distribute.
new text end

new text begin (b) A manufacturer may distribute medical cannabis products whether or not the products
have been manufactured by that manufacturer.
new text end

new text begin (c) Prior to distribution of any medical cannabis, the manufacturer shall:
new text end

new text begin (1) verify that the manufacturer has received the registry verification from the
commissioner for that individual patient;
new text end

new text begin (2) verify that the person requesting the distribution of medical cannabis is the patient,
the patient's registered designated caregiver, or the patient's parent, legal guardian, or spouse
listed in the registry verification using the procedures described in section 152.11, subdivision
2d;
new text end

new text begin (3) assign a tracking number to any medical cannabis distributed from the manufacturer;
new text end

new text begin (4) ensure that any employee of the manufacturer licensed as a pharmacist pursuant to
chapter 151 has consulted with the patient to determine the proper dosage for the individual
patient after reviewing the ranges of chemical compositions of the medical cannabis and
the ranges of proper dosages reported by the commissioner. For purposes of this clause, a
consultation may be conducted remotely by secure videoconference, telephone, or other
remote means if the employee providing the consultation is able to confirm the identity of
the patient and the consultation adheres to patient privacy requirements that apply to health
care services delivered through telehealth. A pharmacist consultation under this clause is
not required if a manufacturer is distributing medical cannabis to a patient according to a
patient-specific dosage plan established with that manufacturer and is not modifying the
dosage or product being distributed under that plan and the medical cannabis is distributed
by a pharmacy technician;
new text end

new text begin (5) properly package medical cannabis in compliance with the United States Poison
Prevention Packing Act regarding child-resistant packaging and exemptions for packaging
for elderly patients, and label distributed medical cannabis with a list of all active ingredients
and individually identifying information, including:
new text end

new text begin (i) the patient's name and date of birth;
new text end

new text begin (ii) the name and date of birth of the patient's registered designated caregiver or, if listed
on the registry verification, the name of the patient's parent or legal guardian, if applicable;
new text end

new text begin (iii) the patient's registry identification number;
new text end

new text begin (iv) the chemical composition of the medical cannabis; and
new text end

new text begin (v) the dosage; and
new text end

new text begin (6) ensure that the medical cannabis distributed contains a maximum of a 90-day supply
of the dosage determined for that patient.
new text end

new text begin (d) A manufacturer shall require an employee of the manufacturer who is transporting
medical cannabis or medical cannabis products to a distribution facility or to another
registered manufacturer to carry identification showing that the person is an employee of
the manufacturer.
new text end

new text begin (e) A manufacturer shall distribute medical cannabis in dried raw cannabis form only
to a patient age 21 or older or to the registered designated caregiver, parent, legal guardian,
or spouse of a patient age 21 or older.
new text end

new text begin Subd. 4. new text end

new text begin Transportation of medical cannabis; staffing. new text end

new text begin (a) A medical cannabis
manufacturer may staff a transport motor vehicle with only one employee if the medical
cannabis manufacturer is transporting medical cannabis to either a certified laboratory for
the purpose of testing or a facility for the purpose of disposal. If the medical cannabis
manufacturer is transporting medical cannabis for any other purpose or destination, the
transport motor vehicle must be staffed with a minimum of two employees as required by
rules adopted by the commissioner.
new text end

new text begin (b) Notwithstanding paragraph (a), a medical cannabis manufacturer that is only
transporting hemp for any purpose may staff the transport motor vehicle with only one
employee.
new text end

new text begin Subd. 5. new text end

new text begin Distribution to recipient in a motor vehicle. new text end

new text begin A manufacturer may distribute
medical cannabis to a patient, registered designated caregiver, or parent, legal guardian, or
spouse of a patient who is at the distribution facility but remains in a motor vehicle if:
new text end

new text begin (1) distribution facility staff receive payment and distribute medical cannabis in a
designated zone that is as close as possible to the front door of the distribution facility;
new text end

new text begin (2) the manufacturer ensures that the receipt of payment and distribution of medical
cannabis are visually recorded by a closed-circuit television surveillance camera at the
distribution facility and provides any other necessary security safeguards;
new text end

new text begin (3) the manufacturer does not store medical cannabis outside a restricted access area at
the distribution facility, and distribution facility staff transport medical cannabis from a
restricted access area at the distribution facility to the designated zone for distribution only
after confirming that the patient, designated caregiver, or parent, guardian, or spouse has
arrived in the designated zone;
new text end

new text begin (4) the payment and distribution of medical cannabis take place only after a pharmacist
consultation takes place, if required under subdivision 3, paragraph (c), clause (4);
new text end

new text begin (5) immediately following distribution of medical cannabis, distribution facility staff
enter the transaction in the state medical cannabis registry information technology database;
and
new text end

new text begin (6) immediately following distribution of medical cannabis, distribution facility staff
take the payment received into the distribution facility.
new text end

new text begin Subd. 6. new text end

new text begin Disposal of medical cannabis plant root balls. new text end

new text begin Notwithstanding Minnesota
Rules, part 4770.1200, subpart 2, item C, a manufacturer is not required to grind root balls
of medical cannabis plants or incorporate them with a greater quantity of nonconsumable
solid waste before transporting root balls to another location for disposal. For purposes of
this subdivision, "root ball" means a compact mass of roots formed by a plant and any
attached growing medium.
new text end

new text begin Subd. 7. new text end

new text begin Report. new text end

new text begin Each manufacturer shall report to the commissioner on a monthly basis
the following information on each individual patient for the month prior to the report:
new text end

new text begin (1) the amount and dosages of medical cannabis distributed;
new text end

new text begin (2) the chemical composition of the medical cannabis; and
new text end

new text begin (3) the tracking number assigned to any medical cannabis distributed.
new text end

Sec. 18.

new text begin [342.20] PATIENT DUTIES.
new text end

new text begin (a) A patient shall apply to the commissioner for enrollment in the registry program by
submitting an application as required in section 342.16 and an annual registration fee as
determined under section 342.26.
new text end

new text begin (b) As a condition of continued enrollment, a patient shall agree to:
new text end

new text begin (1) continue to receive regularly scheduled treatment for a qualifying medical condition
from the patient's health care practitioner; and
new text end

new text begin (2) report changes in the patient's qualifying medical condition to the patient's health
care practitioner.
new text end

new text begin (c) A patient shall only receive medical cannabis from a registered manufacturer but is
not required to receive medical cannabis products from only a registered manufacturer.
new text end

Sec. 19.

new text begin [342.21] LIMITATIONS.
new text end

new text begin (a) Nothing in sections 342.15 to 342.29 permits any person to engage in and does not
prevent the imposition of any civil, criminal, or other penalties for:
new text end

new text begin (1) undertaking any task under the influence of medical cannabis that would constitute
negligence or professional malpractice;
new text end

new text begin (2) possessing or engaging in the use of medical cannabis:
new text end

new text begin (i) on a school bus or van;
new text end

new text begin (ii) on the grounds of any preschool or primary or secondary school;
new text end

new text begin (iii) in any correctional facility; or
new text end

new text begin (iv) on the grounds of any child care facility or home day care;
new text end

new text begin (3) vaporizing or combusting medical cannabis pursuant to section 342.15, subdivision
5:
new text end

new text begin (i) on any form of public transportation;
new text end

new text begin (ii) where the vapor would be inhaled by a nonpatient minor child or where the smoke
would be inhaled by a minor child; or
new text end

new text begin (iii) in any public place, including any indoor or outdoor area used by or open to the
general public or a place of employment as defined under section 144.413, subdivision 1b;
and
new text end

new text begin (4) operating, navigating, or being in actual physical control of any motor vehicle,
aircraft, train, or motorboat or working on transportation property, equipment, or facilities
while under the influence of medical cannabis.
new text end

new text begin (b) Nothing in sections 342.15 to 342.29 requires the medical assistance and
MinnesotaCare programs to reimburse an enrollee or a provider for costs associated with
the medical use of cannabis. Medical assistance and MinnesotaCare shall continue to provide
coverage for all services related to treatment of an enrollee's qualifying medical condition
if the service or services are covered under chapter 256B or 256L.
new text end

Sec. 20.

new text begin [342.22] DATA PRACTICES.
new text end

new text begin (a) Government data in patient files maintained by the commissioner and the health care
practitioner, and data submitted to or by a medical cannabis manufacturer, are private data
on individuals, as defined in section 13.02, subdivision 12, or nonpublic data, as defined in
section 13.02, subdivision 9, but may be used for purposes of complying with chapter 13
and complying with a request from the legislative auditor or the state auditor in the
performance of official duties. The provisions of section 13.05, subdivision 11, apply to a
registration agreement entered between the commissioner and a medical cannabis
manufacturer under section 342.17.
new text end

new text begin (b) Not public data maintained by the commissioner may not be used for any purpose
not provided for in sections 342.15 to 342.29 and may not be combined or linked in any
manner with any other list, dataset, or database.
new text end

new text begin (c) The commissioner may execute data-sharing arrangements with the commissioner
of agriculture to verify licensing, inspection, and compliance information related to hemp
growers and hemp processors under this chapter.
new text end

Sec. 21.

new text begin [342.23] PROTECTIONS FOR REGISTRY PROGRAM PARTICIPATION.
new text end

new text begin Subdivision 1. new text end

new text begin Presumption. new text end

new text begin (a) There is a presumption that a patient enrolled in the
registry program under sections 342.15 to 342.29 is engaged in the authorized use of medical
cannabis.
new text end

new text begin (b) The presumption may be rebutted by evidence that conduct related to use of medical
cannabis was not for the purpose of treating or alleviating the patient's qualifying medical
condition or symptoms associated with the patient's qualifying medical condition.
new text end

new text begin Subd. 2. new text end

new text begin Criminal and civil protections. new text end

new text begin (a) Subject to section 342.21, the following
are not violations under this chapter:
new text end

new text begin (1) use or possession of medical cannabis or medical cannabis products by a patient
enrolled in the registry program or possession by a registered designated caregiver or the
parent, legal guardian, or spouse of a patient if the parent, legal guardian, or spouse is listed
on the registry verification;
new text end

new text begin (2) possession, dosage determination, or sale of medical cannabis or medical cannabis
products by a medical cannabis manufacturer, employees of a manufacturer, a laboratory
conducting testing on medical cannabis, or employees of the laboratory; and
new text end

new text begin (3) possession of medical cannabis or medical cannabis products by any person while
carrying out the duties required under sections 342.15 to 342.29.
new text end

new text begin (b) Medical cannabis obtained and distributed pursuant to sections 342.15 to 342.29 and
associated property is not subject to forfeiture under sections 609.531 to 609.5316.
new text end

new text begin (c) The commissioner, the commissioner's staff, the commissioner's agents or contractors,
and any health care practitioner are not subject to any civil or disciplinary penalties by the
Board of Medical Practice, the Board of Nursing, or any business, occupational, or
professional licensing board or entity solely for participation in the registry program under
sections 342.15 to 342.29. A pharmacist licensed under chapter 151 is not subject to any
civil or disciplinary penalties by the Board of Pharmacy when acting in accordance with
sections 342.15 to 342.29. Nothing in this section affects a professional licensing board
from taking action in response to violations of any other section of law.
new text end

new text begin (d) Notwithstanding any law to the contrary, the commissioner, the governor of
Minnesota, or an employee of any state agency may not be held civilly or criminally liable
for any injury, loss of property, personal injury, or death caused by any act or omission
while acting within the scope of office or employment under sections 342.15 to 342.29.
new text end

new text begin (e) Federal, state, and local law enforcement authorities are prohibited from accessing
the patient registry under sections 342.15 to 342.29, except when acting pursuant to a valid
search warrant.
new text end

new text begin (f) Notwithstanding any law to the contrary, neither the commissioner nor a public
employee may release data or information about an individual contained in any report,
document, or registry created under sections 342.15 to 342.29 or any information obtained
about a patient participating in the program, except as provided in sections 342.15 to 342.29.
new text end

new text begin (g) No information contained in a report, document, or registry or obtained from a patient
under sections 342.15 to 342.29 may be admitted as evidence in a criminal proceeding
unless independently obtained or in connection with a proceeding involving a violation of
sections 342.15 to 342.29.
new text end

new text begin (h) Notwithstanding section 13.09, any person who violates paragraph (e) or (f) is guilty
of a gross misdemeanor.
new text end

new text begin (i) An attorney may not be subject to disciplinary action by the Minnesota Supreme
Court or the Lawyers Professional Responsibility Board for providing legal assistance to
prospective or registered manufacturers or others related to activity that is no longer subject
to criminal penalties under state law pursuant to sections 342.15 to 342.29.
new text end

new text begin (j) Possession of a registry verification or application for enrollment in the program by
a person entitled to possess or apply for enrollment in the registry program does not constitute
probable cause or reasonable suspicion, nor shall it be used to support a search of the person
or property of the person possessing or applying for the registry verification or otherwise
subject the person or property of the person to inspection by any governmental agency.
new text end

new text begin Subd. 3. new text end

new text begin Discrimination prohibited. new text end

new text begin (a) No school or landlord may refuse to enroll or
lease to and may not otherwise penalize a person solely for the person's status as a patient
enrolled in the registry program under sections 342.15 to 342.29 unless failing to do so
would violate federal law or regulations or cause the school or landlord to lose a monetary
or licensing-related benefit under federal law or regulations.
new text end

new text begin (b) For the purposes of medical care, including organ transplants, a registry program
enrollee's use of medical cannabis under sections 342.15 to 342.29 is considered the
equivalent of the authorized use of any other medication used at the discretion of a physician
or advanced practice registered nurse and does not constitute the use of an illicit substance
or otherwise disqualify a patient from needed medical care.
new text end

new text begin (c) Unless a failure to do so would violate federal law or regulations or cause an employer
to lose a monetary or licensing-related benefit under federal law or regulations, an employer
may not discriminate against a person in hiring, termination, or any term or condition of
employment or otherwise penalize a person if the discrimination is based upon either of the
following:
new text end

new text begin (1) the person's status as a patient enrolled in the registry program under sections 342.15
to 342.29; or
new text end

new text begin (2) a patient's positive drug test for cannabis components or metabolites, unless the
patient used, possessed, or was impaired by medical cannabis on the premises of the place
of employment or during the hours of employment.
new text end

new text begin (d) An employee who is required to undergo employer drug testing pursuant to section
181.953 may present verification of enrollment in the patient registry as part of the employee's
explanation under section 181.953, subdivision 6.
new text end

new text begin (e) A person shall not be denied custody of a minor child or visitation rights or parenting
time with a minor child solely based on the person's status as a patient enrolled in the registry
program under sections 342.15 to 342.29. There shall be no presumption of neglect or child
endangerment for conduct allowed under sections 342.15 to 342.29 unless the person's
behavior is such that it creates an unreasonable danger to the safety of the minor as
established by clear and convincing evidence.
new text end

Sec. 22.

new text begin [342.24] VIOLATIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Intentional diversion; criminal penalty. new text end

new text begin In addition to any other
applicable penalty in law, a manufacturer or an agent of a manufacturer who intentionally
transfers medical cannabis to a person other than another registered manufacturer, a patient,
a registered designated caregiver, or, if listed on the registry verification, a parent, legal
guardian, or spouse of a patient is guilty of a felony punishable by imprisonment for not
more than two years or by payment of a fine of not more than $3,000, or both. A person
convicted under this subdivision may not continue to be affiliated with the manufacturer
and is disqualified from further participation under sections 342.15 to 342.29.
new text end

new text begin Subd. 2. new text end

new text begin Intentional diversion outside the state; penalties. new text end

new text begin (a) In addition to any other
applicable penalty in law, the commissioner may levy a fine of $250,000 against a
manufacturer and may immediately initiate proceedings to revoke the manufacturer's
registration using the procedure in section 342.17 if:
new text end

new text begin (1) an officer, director, or controlling person of the manufacturer pleads or is found
guilty under subdivision 1 of intentionally transferring medical cannabis, while the person
was an officer, director, or controlling person of the manufacturer, to a person other than
allowed by law; and
new text end

new text begin (2) in intentionally transferring medical cannabis to a person other than allowed by law,
the officer, director, or controlling person transported or directed the transport of medical
cannabis outside of Minnesota.
new text end

new text begin (b) All fines collected under this subdivision shall be deposited in the state government
special revenue fund.
new text end

new text begin Subd. 3. new text end

new text begin Diversion by patient, registered designated caregiver, parent, legal guardian,
or patient's spouse; criminal penalty. new text end

new text begin In addition to any other applicable penalty in law,
a patient, a registered designated caregiver, or, if listed on the registry verification, a parent,
legal guardian, or spouse of a patient who intentionally sells or otherwise transfers medical
cannabis to a person other than a patient, a designated registered caregiver, or, if listed on
the registry verification, a parent, legal guardian, or spouse of a patient is guilty of a felony
punishable by imprisonment for not more than two years or payment of a fine of not more
than $3,000, or both.
new text end

new text begin Subd. 4. new text end

new text begin False statement; criminal penalty. new text end

new text begin A person who intentionally makes a false
statement to a law enforcement official about any fact or circumstance relating to the medical
use of cannabis to avoid arrest or prosecution is guilty of a misdemeanor punishable by
imprisonment for not more than 90 days or by payment of a fine of not more than $1,000,
or both. The penalty is in addition to any other penalties that may apply for making a false
statement or for the possession, cultivation, or sale of cannabis not protected by sections
342.15 to 342.29. If a person convicted of violating this subdivision is a patient or a registered
designated caregiver, the person is disqualified from further participation under sections
342.15 to 342.29.
new text end

new text begin Subd. 5. new text end

new text begin Submission of false records; criminal penalty. new text end

new text begin A person who knowingly
submits false records or documentation required by the commissioner to register as a
manufacturer of medical cannabis under sections 342.15 to 342.29 is guilty of a felony and
may be sentenced to imprisonment for not more than two years or payment of a fine of not
more than $3,000, or both.
new text end

new text begin Subd. 6. new text end

new text begin Violation by health care practitioner; criminal penalty. new text end

new text begin A health care
practitioner who knowingly refers patients to a manufacturer or to a designated caregiver,
who advertises as a manufacturer, or who issues certifications while holding a financial
interest in a manufacturer is guilty of a misdemeanor and may be sentenced to imprisonment
for not more than 90 days or payment of a fine of not more than $1,000, or both.
new text end

new text begin Subd. 7. new text end

new text begin Other violations; civil penalty. new text end

new text begin If no penalty has been specified, a manufacturer
must be fined up to $1,000 for any violation of sections 342.15 to 342.29 or the regulations
issued pursuant to them. This penalty is in addition to any other applicable penalties in law.
new text end

Sec. 23.

new text begin [342.25] HEALTH CARE FACILITIES.
new text end

new text begin (a) Health care facilities licensed under chapter 144A; hospice providers licensed under
chapter 144A; boarding care homes or supervised living facilities licensed under section
144.50; assisted living facilities; facilities owned, controlled, managed, or under common
control with hospitals licensed under chapter 144; and other health facilities licensed by the
commissioner of health may adopt reasonable restrictions on the use of medical cannabis
by a patient enrolled in the registry program who resides at or is actively receiving treatment
or care at the facility. The restrictions may include a provision that the facility will not store
or maintain the patient's supply of medical cannabis, that the facility is not responsible for
providing the medical cannabis for patients, and that medical cannabis is used only in a
place specified by the facility.
new text end

new text begin (b) Any employee or agent of a facility listed in this section or a person licensed under
chapter 144E is not subject to violations under this chapter for possession of medical cannabis
while carrying out employment duties, including providing or supervising care to a registered
patient, or distribution of medical cannabis to a registered patient who resides at or is actively
receiving treatment or care at the facility with which the employee or agent is affiliated.
Nothing in this section requires the facilities to adopt such restrictions and no facility shall
unreasonably limit a patient's access to or use of medical cannabis to the extent that use is
authorized by the patient under sections 342.15 to 342.29.
new text end

Sec. 24.

new text begin [342.26] FEES; DEPOSIT OF REVENUE.
new text end

new text begin (a) The commissioner shall collect an enrollment fee of $40 from patients enrolled in
the registry program. The fees shall be payable annually and are due on the anniversary
date of the patient's enrollment. The fee amount shall be deposited in the state treasury and
credited to the state government special revenue fund.
new text end

new text begin (b) The commissioner shall collect an application fee of $20,000 from each entity
submitting an application for registration as a medical cannabis manufacturer. Revenue
from the fee shall be deposited in the state treasury and credited to the state government
special revenue fund.
new text end

new text begin (c) The commissioner shall establish and collect an annual fee from a medical cannabis
manufacturer equal to the cost of regulating and inspecting the manufacturer in that year.
Revenue from the fee amount shall be deposited in the state treasury and credited to the
state government special revenue fund.
new text end

new text begin (d) A medical cannabis manufacturer may charge patients enrolled in the registry program
a reasonable fee for costs associated with the operations of the manufacturer. The
manufacturer may establish a sliding scale of patient fees based on a patient's household
income and may accept private donations to reduce patient fees.
new text end

Sec. 25.

new text begin [342.27] IMPACT ASSESSMENT OF MEDICAL CANNABIS
THERAPEUTIC RESEARCH.
new text end

new text begin Subdivision 1. new text end

new text begin Task Force on Medical Cannabis Therapeutic Research. new text end

new text begin (a) A
23-member Task Force on Medical Cannabis Therapeutic Research is created to conduct
an impact assessment of medical cannabis therapeutic research. The task force shall consist
of the following members:
new text end

new text begin (1) two members of the house of representatives, one selected by the speaker of the
house, the other selected by the minority leader;
new text end

new text begin (2) two members of the senate, one selected by the majority leader, the other selected
by the minority leader;
new text end

new text begin (3) four members representing consumers or patients enrolled in the registry program,
including at least two parents of patients under age 18;
new text end

new text begin (4) four members representing health care providers, including one licensed pharmacist;
new text end

new text begin (5) four members representing law enforcement, one from the Minnesota Chiefs of
Police Association, one from the Minnesota Sheriff's Association, one from the Minnesota
Police and Peace Officers Association, and one from the Minnesota County Attorneys
Association;
new text end

new text begin (6) four members representing substance use disorder treatment providers; and
new text end

new text begin (7) the commissioners of health, human services, and public safety.
new text end

new text begin (b) Task force members listed under paragraph (a), clauses (3), (4), (5), and (6), shall
be appointed by the governor under the appointment process in section 15.0597. Members
shall serve on the task force at the pleasure of the appointing authority.
new text end

new text begin (c) There shall be two cochairs of the task force. One cochair shall be selected by the
speaker of the house and the other cochair shall be selected by the majority leader of the
senate. The authority to convene meetings shall alternate between the cochairs.
new text end

new text begin (d) Members of the task force other than those in paragraph (a), clauses (1), (2), and (7),
shall receive expenses as provided in section 15.059, subdivision 6.
new text end

new text begin Subd. 2. new text end

new text begin Administration. new text end

new text begin The commissioner of health shall provide administrative and
technical support to the task force.
new text end

new text begin Subd. 3. new text end

new text begin Impact assessment. new text end

new text begin The task force shall hold hearings to evaluate the impact
of the use of medical cannabis and Minnesota's activities involving medical cannabis,
including but not limited to:
new text end

new text begin (1) program design and implementation;
new text end

new text begin (2) the impact on the health care provider community;
new text end

new text begin (3) patient experiences;
new text end

new text begin (4) the impact on the incidence of substance abuse;
new text end

new text begin (5) access to and quality of medical cannabis and medical cannabis products;
new text end

new text begin (6) the impact on law enforcement and prosecutions;
new text end

new text begin (7) public awareness and perception; and
new text end

new text begin (8) any unintended consequences.
new text end

new text begin Subd. 4. new text end

new text begin No expiration. new text end

new text begin The Task Force on Medical Cannabis Therapeutic Research
does not expire.
new text end

Sec. 26.

new text begin [342.28] FEDERALLY APPROVED CLINICAL TRIALS.
new text end

new text begin The commissioner may prohibit enrollment of a patient in the registry program if the
patient is simultaneously enrolled in a federally approved clinical trial for the treatment of
a qualifying medical condition with medical cannabis. The commissioner shall provide
information to all patients enrolled in the registry program on the existence of federally
approved clinical trials for the treatment of the patient's qualifying medical condition with
medical cannabis as an alternative to enrollment in the patient registry program.
new text end

Sec. 27.

new text begin [342.29] FINANCIAL EXAMINATIONS; PRICING REVIEWS.
new text end

new text begin Subdivision 1. new text end

new text begin Financial records. new text end

new text begin A medical cannabis manufacturer shall maintain
detailed financial records in a manner and format approved by the commissioner and shall
keep all records updated and accessible to the commissioner when requested.
new text end

new text begin Subd. 2. new text end

new text begin Certified annual audit. new text end

new text begin A medical cannabis manufacturer shall submit the
results of an annual certified financial audit to the commissioner no later than May 1 of
each year for the previous calendar year. The annual audit shall be conducted by an
independent certified public accountant and the costs of the audit are the responsibility of
the medical cannabis manufacturer. Results of the audit shall be provided to the medical
cannabis manufacturer and the commissioner. The commissioner may also require another
audit of the medical cannabis manufacturer by a certified public accountant chosen by the
commissioner with the costs of the audit paid by the medical cannabis manufacturer.
new text end

new text begin Subd. 3. new text end

new text begin Power to examine. new text end

new text begin (a) The commissioner or a designee may examine the
business affairs and conditions of any medical cannabis manufacturer, including but not
limited to a review of the financing, budgets, revenues, sales, and pricing.
new text end

new text begin (b) The commissioner shall determine the nature and scope of each examination and in
doing so shall take into account all available relevant factors concerning the financial and
business affairs, practices, and conditions of the examinee. The costs incurred by the
department in conducting an examination shall be paid for by the medical cannabis
manufacturer.
new text end

new text begin (c) When making an examination under this section, the commissioner may retain
attorneys, appraisers, independent economists, independent certified public accountants, or
other professionals and specialists as designees. A certified public accountant retained by
the commissioner may not be the same certified public accountant providing the certified
annual audit in subdivision 2.
new text end

new text begin (d) The commissioner shall make a report of an examination conducted under this section
and provide a copy to the medical cannabis manufacturer. The commissioner shall then post
a copy of the report on the department's website. All working papers, recorded information,
documents, and copies produced by, obtained by, or disclosed to the commissioner or any
other person in the course of an examination made under this section, other than the
information contained in the commissioner's official report, are private data on individuals
or nonpublic data, as defined in section 13.02.
new text end

Sec. 28. new text begin TRANSFER.
new text end

new text begin (a) Any responsibilities to regulate the commercial production and processing of hemp
as provided in Minnesota Statutes, chapter 18K, and the rules adopted under that chapter
are transferred from the Department of Agriculture to the Office of Cannabis Derivatives
in accordance with Minnesota Statutes, section 15.039.
new text end

new text begin (b) Any responsibilities to regulate the medical cannabis program under Minnesota
Statutes, sections 151.22 to 151.37, and the rules adopted under those sections are transferred
from the Department of Health to the Office of Cannabis Derivatives in accordance with
Minnesota Statutes, section 15.039.
new text end

new text begin (c) The commissioner of management and budget shall transfer any amounts in the
general fund and the state government special revenue fund for the medical cannabis program
and any amount in the industrial hemp account under Minnesota Statutes, section 18K.07,
to the hemp account within the state treasury and to the Office of Cannabis Derivatives in
accordance with Minnesota Statutes, section 15.039.
new text end

Sec. 29. new text begin REPEALER.
new text end

new text begin (a) new text end new text begin Minnesota Statutes 2020, sections 18K.01; 18K.02; 18K.03; 18K.04; 18K.05; 18K.06;
18K.07; 18K.08; 18K.09; 151.72, subdivisions 1, 2, 3, 4, and 6; 152.21; 152.22, subdivisions
1, 2, 3, 4, 5, 5a, 5b, 7, 8, 9, 10, 12, 13, and 14; 152.24; 152.25; 152.27, subdivisions 1, 5,
6, and 7; 152.28, subdivisions 2 and 3; 152.29, subdivisions 2, 3a, and 4; 152.30; 152.32;
152.33; 152.34; 152.35; 152.36; and 152.37, new text end new text begin are repealed.
new text end

new text begin (b) new text end new text begin Minnesota Statutes 2021 Supplement, sections 151.72, subdivision 5; 152.22,
subdivisions 5c, 6, and 11; 152.23; 152.26; 152.27, subdivisions 2, 3, and 4; 152.28,
subdivision 1; 152.29, subdivisions 1, 3, 3b, and 3c; and 152.31, new text end new text begin are repealed.
new text end

Sec. 30. new text begin EFFECTIVE DATE.
new text end

new text begin Sections 1 to 29 are effective July 1, 2023.
new text end

APPENDIX

Repealed Minnesota Statutes: 22-07476

18K.01 SHORT TITLE.

This chapter may be referred to as the "Industrial Hemp Development Act."

18K.02 DEFINITIONS.

Subdivision 1.

Scope.

The definitions in this section apply to this chapter.

Subd. 1a.

Applicant.

"Applicant" means an individual who submits an application for a license as required under this chapter. If the applicant is an entity, applicant means the owner or most responsible individual in charge of the entity.

Subd. 1b.

Authorized representative.

"Authorized representative" means any individual authorized by the licensee to make changes to the license and share data on behalf of the licensee.

Subd. 2.

Commissioner.

"Commissioner" means the commissioner of agriculture.

Subd. 2a.

Entity.

"Entity" means a corporation, joint stock company, association, limited partnership, limited liability partnership, limited liability company, irrevocable trust, estate, charitable organization, or other similar organization, including any such organization participating in hemp production as a partner in a general partnership, a participant in a joint venture, or a participant in a similar organization.

Subd. 3.

Industrial hemp.

"Industrial hemp" means the plant Cannabis sativa L. and any part of the plant, whether growing or not, including the plant's seeds, and all the plant's derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis. Industrial hemp is not marijuana as defined in section 152.01, subdivision 9.

Subd. 4.

Marijuana.

"Marijuana" has the meaning given in section 152.01, subdivision 9.

Subd. 5.

Processing.

"Processing" means rendering by refinement hemp plants or hemp plant parts from their natural or original state after harvest. Processing includes but is not limited to decortication, devitalization, chopping, crushing, extraction, and packaging. Processing does not include typical farm operations such as sorting, grading, baling, and harvesting.

Subd. 6.

Processing location.

"Processing location" means any area, building, plant, or facility registered with and approved by the commissioner in which a licensee converts raw hemp into a marketable product.

Subd. 7.

Processor.

"Processor" means a person or business that converts raw hemp into a product.

18K.03 AGRICULTURAL CROP; POSSESSION AUTHORIZED.

Subdivision 1.

Industrial hemp.

Industrial hemp is an agricultural crop in this state. A person may possess, transport, process, sell, or buy industrial hemp that is grown pursuant to this chapter or lawfully grown in another state.

Subd. 2.

Sale to medical cannabis manufacturers.

A licensee under this chapter may sell hemp products derived from industrial hemp grown in this state to medical cannabis manufacturers as authorized under sections 152.22 to 152.37.

18K.04 LICENSING.

Subdivision 1.

Requirement; issuance; presumption.

(a) A person must obtain a license from the commissioner before (1) growing industrial hemp for commercial or research purposes, and (2) before processing industrial hemp for commercial purposes.

(b) To obtain a license under paragraph (a), a person must apply to the commissioner in the form prescribed by the commissioner and must pay the annual registration and inspection fee established by the commissioner in accordance with section 16A.1285, subdivision 2.

(c) For a license to grow industrial hemp for commercial or research purposes, the license application must include the name and address of the applicant and the legal description of the land area or areas where industrial hemp will be grown by the applicant and any other information required under Code of Federal Regulations, title 7, part 990.

(d) For a license to process industrial hemp for commercial purposes, the license application must include the name and address of the applicant, the legal description of the processing location, and any other information required by the commissioner.

(e) A licensee is responsible for compliance with the license requirements irrespective of the acts or omissions of an authorized representative acting on behalf of the licensee.

(f) When an applicant has paid the fee and completed the application process to the satisfaction of the commissioner, the commissioner must issue a license which is valid until December 31 of the year of application.

(g) A person licensed under paragraph (a) to grow industrial hemp is presumed to be growing industrial hemp for commercial or research purposes.

Subd. 2.

Background check; data classification.

The commissioner must require each first-time applicant for a license to submit to a background investigation conducted by the Bureau of Criminal Apprehension as a condition of licensure. As part of the background investigation, the Bureau of Criminal Apprehension must conduct criminal history checks of Minnesota records and is authorized to exchange fingerprints with the United States Department of Justice, Federal Bureau of Investigation for the purpose of a criminal background check of the national files. The cost of the investigation must be paid by the applicant. Criminal history records provided to the commissioner under this section must be treated as private data on individuals, as defined in section 13.02, subdivision 12.

Subd. 3.

Federal requirements.

The applicant must demonstrate to the satisfaction of the commissioner that the applicant has complied with all applicable federal requirements pertaining to the processing, production, distribution, and sale of industrial hemp.

Subd. 4.

Industrial hemp licensing data classification.

(a) In addition to data classified pursuant to section 13.41, the following data collected, created, or maintained by the commissioner under this chapter is classified as private data, as defined in section 13.02, subdivision 12, or nonpublic data, as defined in section 13.02, subdivision 9:

(1) nondesignated addresses provided by licensees and applicants; and

(2) data that identify the specific locations where licensees and applicants grow or process, or will grow or process, industrial hemp, including but not limited to legal descriptions, street addresses, geospatial locations, maps, and property boundaries and dimensions.

(b) The commissioner may disclose data classified as private data or nonpublic data under this subdivision if the commissioner determines that there is a substantive threat to human health or safety or to the environment, or to aid in the law enforcement process.

Subd. 5.

Industrial hemp licensing data security and auditing.

(a) The commissioner must establish written procedures to ensure that only individuals authorized by law may access the private data and nonpublic data identified in subdivision 4. An authorized individual's ability to enter, update, or access data must correspond to the official duties or training level of the individual and to the statutory authorization granting access for that purpose. All queries and responses, including the specific purpose for which data is requested and, if applicable, disclosed, and all actions in which data are entered, updated, accessed, shared, or disseminated, must be recorded in the data audit trail. Data contained in the audit trail are public to the extent the data are not otherwise classified by law.

(b) The commissioner must immediately and permanently revoke the authorization of any individual who willfully entered, updated, accessed, shared, or disseminated data in violation of state or federal law. If an individual willfully gained access to data without authorization by law, the commissioner must forward the matter to the appropriate prosecuting authority for prosecution.

(c) By January 15 of each odd-numbered year, the commissioner must provide a copy of the data audit trail required under paragraph (a) to the commissioner of administration; the chairs and ranking members of the legislative committees and divisions with jurisdiction over agriculture policy and finance, public safety, and data practices; and the Legislative Commission on Data Practices and Personal Data Privacy or its successor commission.

18K.05 ANNUAL REPORT; SALES NOTIFICATION.

(a) Annually, a licensee must file with the commissioner:

(1) documentation demonstrating to the commissioner's satisfaction that the seeds planted by the licensee are of a type and variety that contain no more than three-tenths of one percent delta-9 tetrahydrocannabinol; and

(2) a copy of any contract to grow industrial hemp.

(b) Within 30 days, a licensee must notify the commissioner of each sale or distribution of industrial hemp grown by the licensee including, but not limited to, the name and address of the person receiving the industrial hemp and the amount of industrial hemp sold or distributed.

18K.06 RULEMAKING.

(a) The commissioner shall adopt rules governing the production, testing, processing, and licensing of industrial hemp. Notwithstanding section 14.125, the commissioner's authority to adopt these rules expires June 30, 2022.

(b) Rules adopted under paragraph (a) must include, but not be limited to, provisions governing:

(1) the supervision and inspection of industrial hemp during its growth and harvest;

(2) the testing of industrial hemp to determine delta-9 tetrahydrocannabinol levels;

(3) the use of background check results required under section 18K.04 to approve or deny a license application; and

(4) any other provision or procedure necessary to carry out the purposes of this chapter.

(c) Rules issued under this section must be consistent with federal law regarding the production, distribution, and sale of industrial hemp.

18K.07 FEES.

Fees collected under this chapter must be credited to the industrial hemp account, which is hereby established in the agricultural fund in the state treasury. Interest earned in the account accrues to the account. Funds in the industrial hemp account are annually appropriated to the commissioner to implement and enforce this chapter.

18K.08 DEFENSE FOR POSSESSION OF MARIJUANA.

It is an affirmative defense to a prosecution for the possession of marijuana under chapter 152 if:

(1) the defendant possesses industrial hemp grown pursuant to this chapter; or

(2) the defendant has a valid controlled substance registration from the United States Department of Justice, Drug Enforcement Administration, if required under federal law.

18K.09 PILOT PROGRAM; OTHER RESEARCH AUTHORIZED.

Subdivision 1.

Authorized activity.

The commissioner may grow or cultivate industrial hemp pursuant to a pilot program administered by the commissioner to study the growth, cultivation, or marketing of industrial hemp. The commissioner may: (1) authorize institutions of higher education to grow or cultivate industrial hemp as part of the commissioner's pilot program or as is necessary to perform other agricultural, renewable energy, or academic research; and (2) contract with public or private entities for testing or other activities authorized under this subdivision. Authorized activity under this section may include collecting seed from wild hemp sources.

Subd. 2.

Site registration.

Before growing or cultivating industrial hemp pursuant to this section, each site must be registered with and certified by the commissioner. A person must register each site annually in the form prescribed by the commissioner and must pay the annual registration and certification fee established by the commissioner in accordance with section 16A.1285, subdivision 2.

Subd. 3.

Rulemaking.

The commissioner may adopt rules that govern the pilot program pursuant to this section and Public Law 113-79.

151.72 SALE OF CERTAIN CANNABINOID PRODUCTS.

Subdivision 1.

Definitions.

(a) For the purposes of this section, the following terms have the meanings given.

(b) "Hemp" has the meaning given to "industrial hemp" in section 18K.02, subdivision 3.

(c) "Labeling" means all labels and other written, printed, or graphic matter that are:

(1) affixed to the immediate container in which a product regulated under this section is sold; or

(2) provided, in any manner, with the immediate container, including but not limited to outer containers, wrappers, package inserts, brochures, or pamphlets.

Subd. 2.

Scope.

(a) This section applies to the sale of any product that contains nonintoxicating cannabinoids extracted from hemp other than food that is intended for human or animal consumption by any route of administration.

(b) This section does not apply to any product dispensed by a registered medical cannabis manufacturer pursuant to sections 152.22 to 152.37.

Subd. 3.

Sale of cannabinoids derived from hemp.

Notwithstanding any other section of this chapter, a product containing nonintoxicating cannabinoids may be sold for human or animal consumption if all of the requirements of this section are met.

Subd. 4.

Testing requirements.

(a) A manufacturer of a product regulated under this section must submit representative samples of the product to an independent, accredited laboratory in order to certify that the product complies with the standards adopted by the board. Testing must be consistent with generally accepted industry standards for herbal and botanical substances, and, at a minimum, the testing must confirm that the product:

(1) contains the amount or percentage of cannabinoids that is stated on the label of the product;

(2) does not contain more than trace amounts of any pesticides, fertilizers, or heavy metals; and

(3) does not contain a delta-9 tetrahydrocannabinol concentration that exceeds the concentration permitted for industrial hemp as defined in section 18K.02, subdivision 3.

(b) Upon the request of the board, the manufacturer of the product must provide the board with the results of the testing required in this section.

Subd. 5.

Labeling requirements.

(a) A product regulated under this section must bear a label that contains, at a minimum:

(1) the name, location, contact phone number, and website of the manufacturer of the product;

(2) the name and address of the independent, accredited laboratory used by the manufacturer to test the product; and

(3) an accurate statement of the amount or percentage of cannabinoids found in each unit of the product meant to be consumed; or

(4) instead of the information required in clauses (1) to (3), a scannable bar code or QR code that links to the manufacturer's website.

The label must also include a statement stating that this product does not claim to diagnose, treat, cure, or prevent any disease and has not been evaluated or approved by the United States Food and Drug Administration (FDA) unless the product has been so approved.

(b) The information required to be on the label must be prominently and conspicuously placed and in terms that can be easily read and understood by the consumer.

(c) The label must not contain any claim that the product may be used or is effective for the prevention, treatment, or cure of a disease or that it may be used to alter the structure or function of human or animal bodies, unless the claim has been approved by the FDA.

Subd. 6.

Enforcement.

(a) A product sold under this section shall be considered an adulterated drug if:

(1) it consists, in whole or in part, of any filthy, putrid, or decomposed substance;

(2) it has been produced, prepared, packed, or held under unsanitary conditions where it may have been rendered injurious to health, or where it may have been contaminated with filth;

(3) its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health;

(4) it contains any color additives or excipients that have been found by the FDA to be unsafe for human or animal consumption; or

(5) it contains an amount or percentage of cannabinoids that is different than the amount or percentage stated on the label.

(b) A product sold under this section shall be considered a misbranded drug if the product's labeling is false or misleading in any manner or in violation of the requirements of this section.

(c) The board's authority to issue cease and desist orders under section 151.06; to embargo adulterated and misbranded drugs under section 151.38; and to seek injunctive relief under section 214.11, extends to any violation of this section.

152.21 THC THERAPEUTIC RESEARCH ACT.

Subdivision 1.

Findings and purpose.

The legislature finds that scientific literature indicates promise for delta-9-tetrahydro-cannabinol (THC), the active component of marijuana, in alleviating certain side effects of cancer chemotherapy under strictly controlled medical circumstances.

The legislature also finds that further research and strictly controlled experimentation regarding the therapeutic use of THC is necessary and desirable. The intent of this section is to establish an extensive research program to investigate and report on the therapeutic effects of THC under strictly controlled circumstances in compliance with all federal laws and regulations promulgated by the federal Food and Drug Administration, the National Institute on Drug Abuse and the Drug Enforcement Administration. The intent of the legislature is to allow this research program the greatest possible access to qualified cancer patients residing in Minnesota who meet protocol requirements. The establishment of this research program is not intended in any manner whatsoever to condone or promote the illicit recreational use of marijuana.

Subd. 2.

Definitions.

For purposes of this section, the following terms shall have the meanings given.

(a) "Commissioner" means the commissioner of health.

(b) "Marijuana" means marijuana as defined in section 152.01, subdivision 9, and delta-9-tetrahydro-cannabinol (THC), tetrahydrocannabinols or a chemical derivative of tetrahydrocannabinols, and all species of the genus Cannabis.

(c) "Principal investigator" means the individual responsible for the medical and scientific aspects of the research, development of protocol, and contacting and qualifying the clinical investigators in the state.

(d) "Clinical investigators" means those individuals who conduct the clinical trials.

(e) "Sponsor" means that individual or organization who, acting on behalf of the state, has the total responsibility for the state program.

Subd. 3.

Research grant.

The commissioner of health shall grant funds to the principal investigator selected by the commissioner pursuant to subdivision 4 for the purpose of conducting a research program under a protocol approved by the FDA regarding the therapeutic use of oral THC and other dosage forms, if available, according to the guidelines and requirements of the federal Food and Drug Administration, the Drug Enforcement Administration and the National Institute on Drug Abuse. The commissioner shall ensure that the research principal investigator complies with the requirements of subdivision 5. The commissioner may designate the principal investigator as the sponsor.

Subd. 4.

Principal investigator.

Within three months of April 25, 1980, the commissioner shall, in consultation with a representative chosen by the state Board of Pharmacy and a representative chosen by the state Board of Medical Examiners, select a person or research organization to be the principal investigator of the research program.

Subd. 5.

Duties.

The principal investigator shall:

(1) apply to the Food and Drug Administration for a notice of "Claimed Investigational Exemption for a New Drug (IND)" pursuant to the Federal Food, Drug and Cosmetic Act, United States Code, title 21, section 301, et seq., and shall comply with all applicable laws and regulations of the federal Food and Drug Administration, the Drug Enforcement Administration, and the National Institute on Drug Abuse in establishing the program;

(2) notify every oncologist in the state of the program, explain the purposes and requirements of the program to them, provide on request each of them with a copy of the approved protocol which shall include summaries of current papers in medical journals reporting on research concerning the safety, efficacy and appropriate use of THC in alleviating the nausea and emetic effects of cancer chemotherapy, and provide on request each of them with a bibliography of other articles published in medical journals;

(3) allow each oncologist (clinical investigator) in the state who meets or agrees to meet all applicable federal requirements for investigational new drug research and who so requests to be included in the research program as a clinical investigator to conduct the clinical trials;

(4) provide explanatory information and assistance to each clinical investigator in understanding the nature of therapeutic use of THC within program requirements, including the informed consent document contained in the protocol, informing and counseling patients involved in the program regarding the appropriate use and the effects of therapeutic use of THC;

(5) apply to contract with the National Institute on Drug Abuse for receipt of dosage forms of THC, fully characterized as to contents and delivery to the human system, pursuant to regulations promulgated by the National Institute on Drug Abuse, and the federal Food and Drug Administration. The principal investigator shall ensure delivery of the THC dosages to clinical investigators as needed for participation in the program;

(6) conduct the research program in compliance with federal laws and regulations promulgated by the federal Food and Drug Administration, the Drug Enforcement Administration, the National Institute on Drug Abuse, and the purposes and provisions of this section;

(7) submit periodic reports as determined by the commissioner on the numbers of oncologists and patients involved in the program and the results of the program;

(8) submit reports on intermediate or final research results, as appropriate, to the major scientific journals in the United States; and

(9) otherwise comply with the provisions of this section.

Subd. 6.

Exemption from criminal sanctions.

For the purposes of this section, the following are not violations under this chapter:

(1) use or possession of THC, or both, by a patient in the research program;

(2) possession, prescribing use of, administering, or dispensing THC, or any combination of these actions, by the principal investigator or by any clinical investigator; and

(3) possession or distribution of THC, or both, by a pharmacy registered to handle Schedule I substances which stores THC on behalf of the principal investigator or a clinical investigator.

THC obtained and distributed pursuant to this section is not subject to forfeiture under sections 609.531 to 609.5316.

For the purposes of this section, THC is removed from Schedule I contained in section 152.02, subdivision 2, and inserted in Schedule II contained in section 152.02, subdivision 3.

Subd. 7.

Citation.

This section may be cited as the "THC Therapeutic Research Act."

152.22 DEFINITIONS.

Subdivision 1.

Applicability.

For purposes of sections 152.22 to 152.37, the terms defined in this section have the meanings given them.

Subd. 2.

Commissioner.

"Commissioner" means the commissioner of health.

Subd. 3.

Disqualifying felony offense.

"Disqualifying felony offense" means 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, regardless of the sentence imposed, unless the commissioner determines that the person's conviction was for the medical use of cannabis or assisting with the medical use of cannabis.

Subd. 4.

Health care practitioner.

"Health care practitioner" means a Minnesota licensed doctor of medicine, a Minnesota licensed physician assistant acting within the scope of authorized practice, or a Minnesota licensed advanced practice registered nurse who has the primary responsibility for the care and treatment of the qualifying medical condition of a person diagnosed with a qualifying medical condition.

Subd. 5.

Health records.

"Health records" means health records as defined in section 144.291, subdivision 2, paragraph (c).

Subd. 5a.

Hemp.

"Hemp" has the meaning given to industrial hemp in section 18K.02, subdivision 3.

Subd. 5b.

Hemp grower.

"Hemp grower" means a person licensed by the commissioner of agriculture under chapter 18K to grow hemp for commercial purposes.

Subd. 5c.

Hemp processor.

"Hemp processor" means a person or business licensed by the commissioner of agriculture under chapter 18K to convert raw hemp into a product.

Subd. 6.

Medical cannabis.

(a) "Medical cannabis" means any species of the genus cannabis plant, or any mixture or preparation of them, including whole plant extracts and resins, and is delivered in the form of:

(1) liquid, including, but not limited to, oil;

(2) pill;

(3) vaporized delivery method with use of liquid or oil;

(4) combustion with use of dried raw cannabis; or

(5) any other method approved by the commissioner.

(b) This definition includes any part of the genus cannabis plant prior to being processed into a form allowed under paragraph (a), that is possessed by a person while that person is engaged in employment duties necessary to carry out a requirement under sections 152.22 to 152.37 for a registered manufacturer or a laboratory under contract with a registered manufacturer. This definition also includes any hemp acquired by a manufacturer by a hemp grower as permitted under section 152.29, subdivision 1, paragraph (b).

Subd. 7.

Medical cannabis manufacturer.

"Medical cannabis manufacturer" or "manufacturer" means an entity registered by the commissioner to cultivate, acquire, manufacture, possess, prepare, transfer, transport, supply, or dispense medical cannabis, delivery devices, or related supplies and educational materials.

Subd. 8.

Medical cannabis product.

"Medical cannabis product" means any delivery device or related supplies and educational materials used in the administration of medical cannabis for a patient with a qualifying medical condition enrolled in the registry program.

Subd. 9.

Patient.

"Patient" means a Minnesota resident who has been diagnosed with a qualifying medical condition by a health care practitioner and who has otherwise met any other requirements for patients under sections 152.22 to 152.37 to participate in the registry program under sections 152.22 to 152.37.

Subd. 10.

Patient registry number.

"Patient registry number" means a unique identification number assigned by the commissioner to a patient enrolled in the registry program.

Subd. 11.

Registered designated caregiver.

"Registered designated caregiver" means a person who:

(1) is at least 18 years old;

(2) does not have a conviction for a disqualifying felony offense;

(3) has been approved by the commissioner to assist a patient who requires assistance in administering medical cannabis or obtaining medical cannabis from a distribution facility; and

(4) is authorized by the commissioner to assist the patient with the use of medical cannabis.

Subd. 12.

Registry program.

"Registry program" means the patient registry established in sections 152.22 to 152.37.

Subd. 13.

Registry verification.

"Registry verification" means the verification provided by the commissioner that a patient is enrolled in the registry program and that includes the patient's name, registry number, and, if applicable, the name of the patient's registered designated caregiver or parent, legal guardian, or spouse.

Subd. 14.

Qualifying medical condition.

"Qualifying medical condition" means a diagnosis of any of the following conditions:

(1) cancer, if the underlying condition or treatment produces one or more of the following:

(i) severe or chronic pain;

(ii) nausea or severe vomiting; or

(iii) cachexia or severe wasting;

(2) glaucoma;

(3) human immunodeficiency virus or acquired immune deficiency syndrome;

(4) Tourette's syndrome;

(5) amyotrophic lateral sclerosis;

(6) seizures, including those characteristic of epilepsy;

(7) severe and persistent muscle spasms, including those characteristic of multiple sclerosis;

(8) inflammatory bowel disease, including Crohn's disease;

(9) terminal illness, with a probable life expectancy of under one year, if the illness or its treatment produces one or more of the following:

(i) severe or chronic pain;

(ii) nausea or severe vomiting; or

(iii) cachexia or severe wasting; or

(10) any other medical condition or its treatment approved by the commissioner.

152.23 LIMITATIONS.

(a) Nothing in sections 152.22 to 152.37 permits any person to engage in and does not prevent the imposition of any civil, criminal, or other penalties for:

(1) undertaking any task under the influence of medical cannabis that would constitute negligence or professional malpractice;

(2) possessing or engaging in the use of medical cannabis:

(i) on a school bus or van;

(ii) on the grounds of any preschool or primary or secondary school;

(iii) in any correctional facility; or

(iv) on the grounds of any child care facility or home day care;

(3) vaporizing or combusting medical cannabis pursuant to section 152.22, subdivision 6:

(i) on any form of public transportation;

(ii) where the vapor would be inhaled by a nonpatient minor child or where the smoke would be inhaled by a minor child; or

(iii) in any public place, including any indoor or outdoor area used by or open to the general public or a place of employment as defined under section 144.413, subdivision 1b; and

(4) operating, navigating, or being in actual physical control of any motor vehicle, aircraft, train, or motorboat, or working on transportation property, equipment, or facilities while under the influence of medical cannabis.

(b) Nothing in sections 152.22 to 152.37 require the medical assistance and MinnesotaCare programs to reimburse an enrollee or a provider for costs associated with the medical use of cannabis. Medical assistance and MinnesotaCare shall continue to provide coverage for all services related to treatment of an enrollee's qualifying medical condition if the service is covered under chapter 256B or 256L.

152.24 FEDERALLY APPROVED CLINICAL TRIALS.

The commissioner may prohibit enrollment of a patient in the registry program if the patient is simultaneously enrolled in a federally approved clinical trial for the treatment of a qualifying medical condition with medical cannabis. The commissioner shall provide information to all patients enrolled in the registry program on the existence of federally approved clinical trials for the treatment of the patient's qualifying medical condition with medical cannabis as an alternative to enrollment in the patient registry program.

152.25 COMMISSIONER DUTIES.

Subdivision 1.

Medical cannabis manufacturer registration.

(a) The commissioner shall register two in-state manufacturers for the production of all medical cannabis within the state. A registration agreement between the commissioner and a manufacturer is nontransferable. The commissioner shall register new manufacturers or reregister the existing manufacturers by December 1 every two years, using the factors described in this subdivision. The commissioner shall accept applications after December 1, 2014, if one of the manufacturers registered before December 1, 2014, ceases to be registered as a manufacturer. The commissioner's determination that no manufacturer exists to fulfill the duties under sections 152.22 to 152.37 is subject to judicial review in Ramsey County District Court. Data submitted during the application process are private data on individuals or nonpublic data as defined in section 13.02 until the manufacturer is registered under this section. Data on a manufacturer that is registered are public data, unless the data are trade secret or security information under section 13.37.

(b) As a condition for registration, a manufacturer must agree to:

(1) begin supplying medical cannabis to patients by July 1, 2015; and

(2) comply with all requirements under sections 152.22 to 152.37.

(c) The commissioner shall consider the following factors when determining which manufacturer to register:

(1) the technical expertise of the manufacturer in cultivating medical cannabis and converting the medical cannabis into an acceptable delivery method under section 152.22, subdivision 6;

(2) the qualifications of the manufacturer's employees;

(3) the long-term financial stability of the manufacturer;

(4) the ability to provide appropriate security measures on the premises of the manufacturer;

(5) whether the manufacturer has demonstrated an ability to meet the medical cannabis production needs required by sections 152.22 to 152.37; and

(6) the manufacturer's projection and ongoing assessment of fees on patients with a qualifying medical condition.

(d) If an officer, director, or controlling person of the manufacturer pleads or is found guilty of intentionally diverting medical cannabis to a person other than allowed by law under section 152.33, subdivision 1, the commissioner may decide not to renew the registration of the manufacturer, provided the violation occurred while the person was an officer, director, or controlling person of the manufacturer.

(e) The commissioner shall require each medical cannabis manufacturer to contract with an independent laboratory to test medical cannabis produced by the manufacturer. The commissioner shall approve the laboratory chosen by each manufacturer and require that the laboratory report testing results to the manufacturer in a manner determined by the commissioner.

Subd. 1a.

Revocation or nonrenewal of a medical cannabis manufacturer registration.

If the commissioner intends to revoke or not renew a registration issued under this section, the commissioner must first notify in writing the manufacturer against whom the action is to be taken and provide the manufacturer with an opportunity to request a hearing under the contested case provisions of chapter 14. If the manufacturer does not request a hearing by notifying the commissioner in writing within 20 days after receipt of the notice of proposed action, the commissioner may proceed with the action without a hearing. For revocations, the registration of a manufacturer is considered revoked on the date specified in the commissioner's written notice of revocation.

Subd. 1b.

Temporary suspension proceedings.

The commissioner may institute proceedings to temporarily suspend the registration of a medical cannabis manufacturer for a period of up to 90 days by notifying the manufacturer in writing if any action by an employee, agent, officer, director, or controlling person of the manufacturer:

(1) violates any of the requirements of sections 152.21 to 152.37 or the rules adopted thereunder;

(2) permits, aids, or abets the commission of any violation of state law at the manufacturer's location for cultivation, harvesting, manufacturing, packaging, and processing or at any site for distribution of medical cannabis;

(3) performs any act contrary to the welfare of a registered patient or registered designated caregiver; or

(4) obtains, or attempts to obtain, a registration by fraudulent means or misrepresentation.

Subd. 1c.

Notice to patients.

Upon the revocation or nonrenewal of a manufacturer's registration under subdivision 1a or implementation of an enforcement action under subdivision 1b that may affect the ability of a registered patient, registered designated caregiver, or a registered patient's parent, legal guardian, or spouse to obtain medical cannabis from the manufacturer subject to the enforcement action, the commissioner shall notify in writing each registered patient and the patient's registered designated caregiver or registered patient's parent, legal guardian, or spouse about the outcome of the proceeding and information regarding alternative registered manufacturers. This notice must be provided two or more business days prior to the effective date of the revocation, nonrenewal, or other enforcement action.

Subd. 2.

Range of compounds and dosages; report.

The commissioner shall review and publicly report the existing medical and scientific literature regarding the range of recommended dosages for each qualifying condition and the range of chemical compositions of any plant of the genus cannabis that will likely be medically beneficial for each of the qualifying medical conditions. The commissioner shall make this information available to patients with qualifying medical conditions beginning December 1, 2014, and update the information annually. The commissioner may consult with the independent laboratory under contract with the manufacturer or other experts in reporting the range of recommended dosages for each qualifying medical condition, the range of chemical compositions that will likely be medically beneficial, and any risks of noncannabis drug interactions. The commissioner shall consult with each manufacturer on an annual basis on medical cannabis offered by the manufacturer. The list of medical cannabis offered by a manufacturer shall be published on the Department of Health website.

Subd. 3.

Deadlines.

The commissioner shall adopt rules necessary for the manufacturer to begin distribution of medical cannabis to patients under the registry program by July 1, 2015, and have notice of proposed rules published in the State Register prior to January 1, 2015.

Subd. 4.

Reports.

(a) The commissioner shall provide regular updates to the task force on medical cannabis therapeutic research and to the chairs and ranking minority members of the legislative committees with jurisdiction over health and human services, public safety, judiciary, and civil law regarding: (1) any changes in federal law or regulatory restrictions regarding the use of medical cannabis or hemp; and (2) the market demand and supply in this state for products made from hemp that can be used for medicinal purposes.

(b) The commissioner may submit medical research based on the data collected under sections 152.22 to 152.37 to any federal agency with regulatory or enforcement authority over medical cannabis to demonstrate the effectiveness of medical cannabis for treating a qualifying medical condition.

152.26 RULEMAKING.

(a) The commissioner may adopt rules to implement sections 152.22 to 152.37. Rules for which notice is published in the State Register before January 1, 2015, may be adopted using the process in section 14.389.

(b) The commissioner may adopt or amend rules, using the procedure in section 14.386, paragraph (a), to implement the addition of dried raw cannabis as an allowable form of medical cannabis under section 152.22, subdivision 6, paragraph (a), clause (4). Section 14.386, paragraph (b), does not apply to these rules.

152.27 PATIENT REGISTRY PROGRAM ESTABLISHED.

Subdivision 1.

Patient registry program; establishment.

(a) The commissioner shall establish a patient registry program to evaluate data on patient demographics, effective treatment options, clinical outcomes, and quality-of-life outcomes for the purpose of reporting on the benefits, risks, and outcomes regarding patients with a qualifying medical condition engaged in the therapeutic use of medical cannabis.

(b) The establishment of the registry program shall not be construed or interpreted to condone or promote the illicit recreational use of marijuana.

Subd. 2.

Commissioner duties.

(a) The commissioner shall:

(1) give notice of the program to health care practitioners in the state who are eligible to serve as health care practitioners and explain the purposes and requirements of the program;

(2) allow each health care practitioner who meets or agrees to meet the program's requirements and who requests to participate, to be included in the registry program to collect data for the patient registry;

(3) provide explanatory information and assistance to each health care practitioner in understanding the nature of therapeutic use of medical cannabis within program requirements;

(4) create and provide a certification to be used by a health care practitioner for the practitioner to certify whether a patient has been diagnosed with a qualifying medical condition and include in the certification an option for the practitioner to certify whether the patient, in the health care practitioner's medical opinion, is developmentally or physically disabled and, as a result of that disability, the patient requires assistance in administering medical cannabis or obtaining medical cannabis from a distribution facility;

(5) supervise the participation of the health care practitioner in conducting patient treatment and health records reporting in a manner that ensures stringent security and record-keeping requirements and that prevents the unauthorized release of private data on individuals as defined by section 13.02;

(6) develop safety criteria for patients with a qualifying medical condition as a requirement of the patient's participation in the program, to prevent the patient from undertaking any task under the influence of medical cannabis that would constitute negligence or professional malpractice on the part of the patient; and

(7) conduct research and studies based on data from health records submitted to the registry program and submit reports on intermediate or final research results to the legislature and major scientific journals. The commissioner may contract with a third party to complete the requirements of this clause. Any reports submitted must comply with section 152.28, subdivision 2.

(b) The commissioner may add a delivery method under section 152.22, subdivision 6, or add, remove, or modify a qualifying medical condition under section 152.22, subdivision 14, upon a petition from a member of the public or the task force on medical cannabis therapeutic research or as directed by law. The commissioner shall evaluate all petitions to add a qualifying medical condition or to remove or modify an existing qualifying medical condition submitted by the task force on medical cannabis therapeutic research or as directed by law and may make the addition, removal, or modification if the commissioner determines the addition, removal, or modification is warranted based on the best available evidence and research. If the commissioner wishes to add a delivery method under section 152.22, subdivision 6, or add or remove a qualifying medical condition under section 152.22, subdivision 14, the commissioner must notify the chairs and ranking minority members of the legislative policy committees having jurisdiction over health and public safety of the addition or removal and the reasons for its addition or removal, including any written comments received by the commissioner from the public and any guidance received from the task force on medical cannabis research, by January 15 of the year in which the commissioner wishes to make the change. The change shall be effective on August 1 of that year, unless the legislature by law provides otherwise.

Subd. 3.

Patient application.

(a) The commissioner shall develop a patient application for enrollment into the registry program. The application shall be available to the patient and given to health care practitioners in the state who are eligible to serve as health care practitioners. The application must include:

(1) the name, mailing address, and date of birth of the patient;

(2) the name, mailing address, and telephone number of the patient's health care practitioner;

(3) the name, mailing address, and date of birth of the patient's designated caregiver, if any, or the patient's parent, legal guardian, or spouse if the parent, legal guardian, or spouse will be acting as a caregiver;

(4) a copy of the certification from the patient's health care practitioner that is dated within 90 days prior to submitting the application that certifies that the patient has been diagnosed with a qualifying medical condition; and

(5) all other signed affidavits and enrollment forms required by the commissioner under sections 152.22 to 152.37, including, but not limited to, the disclosure form required under paragraph (c).

(b) The commissioner shall require a patient to resubmit a copy of the certification from the patient's health care practitioner on a yearly basis and shall require that the recertification be dated within 90 days of submission.

(c) The commissioner shall develop a disclosure form and require, as a condition of enrollment, all patients to sign a copy of the disclosure. The disclosure must include:

(1) a statement that, notwithstanding any law to the contrary, the commissioner, or an employee of any state agency, may not be held civilly or criminally liable for any injury, loss of property, personal injury, or death caused by any act or omission while acting within the scope of office or employment under sections 152.22 to 152.37; and

(2) the patient's acknowledgment that enrollment in the patient registry program is conditional on the patient's agreement to meet all of the requirements of sections 152.22 to 152.37.

Subd. 4.

Registered designated caregiver.

(a) The commissioner shall register a designated caregiver for a patient if the patient requires assistance in administering medical cannabis or obtaining medical cannabis from a distribution facility and the caregiver has agreed, in writing, to be the patient's designated caregiver. As a condition of registration as a designated caregiver, the commissioner shall require the person to:

(1) be at least 18 years of age;

(2) agree to only possess the patient's medical cannabis for purposes of assisting the patient; and

(3) agree that if the application is approved, the person will not be a registered designated caregiver for more than six registered patients at one time. Patients who reside in the same residence shall count as one patient.

(b) The commissioner shall conduct a criminal background check on the designated caregiver prior to registration to ensure that the person does not have a conviction for a disqualifying felony offense. Any cost of the background check shall be paid by the person seeking registration as a designated caregiver. A designated caregiver must have the criminal background check renewed every two years.

(c) Nothing in sections 152.22 to 152.37 shall be construed to prevent a person registered as a designated caregiver from also being enrolled in the registry program as a patient and possessing and using medical cannabis as a patient.

Subd. 5.

Parents, legal guardians, and spouses.

A parent, legal guardian, or spouse of a patient may act as the caregiver to the patient without having to register as a designated caregiver. The parent, legal guardian, or spouse shall follow all of the requirements of parents, legal guardians, and spouses listed in sections 152.22 to 152.37. Nothing in sections 152.22 to 152.37 limits any legal authority a parent, legal guardian, or spouse may have for the patient under any other law.

Subd. 6.

Patient enrollment.

(a) After receipt of a patient's application, application fees, and signed disclosure, the commissioner shall enroll the patient in the registry program and issue the patient and patient's registered designated caregiver or parent, legal guardian, or spouse, if applicable, a registry verification. The commissioner shall approve or deny a patient's application for participation in the registry program within 30 days after the commissioner receives the patient's application and application fee. The commissioner may approve applications up to 60 days after the receipt of a patient's application and application fees until January 1, 2016. A patient's enrollment in the registry program shall only be denied if the patient:

(1) does not have certification from a health care practitioner that the patient has been diagnosed with a qualifying medical condition;

(2) has not signed and returned the disclosure form required under subdivision 3, paragraph (c), to the commissioner;

(3) does not provide the information required;

(4) has previously been removed from the registry program for violations of section 152.30 or 152.33; or

(5) provides false information.

(b) The commissioner shall give written notice to a patient of the reason for denying enrollment in the registry program.

(c) Denial of enrollment into the registry program is considered a final decision of the commissioner and is subject to judicial review under the Administrative Procedure Act pursuant to chapter 14.

(d) A patient's enrollment in the registry program may only be revoked upon the death of the patient or if a patient violates a requirement under section 152.30 or 152.33.

(e) The commissioner shall develop a registry verification to provide to the patient, the health care practitioner identified in the patient's application, and to the manufacturer. The registry verification shall include:

(1) the patient's name and date of birth;

(2) the patient registry number assigned to the patient; and

(3) the name and date of birth of the patient's registered designated caregiver, if any, or the name of the patient's parent, legal guardian, or spouse if the parent, legal guardian, or spouse will be acting as a caregiver.

Subd. 7.

Notice requirements.

Patients and registered designated caregivers shall notify the commissioner of any address or name change within 30 days of the change having occurred. A patient or registered designated caregiver is subject to a $100 fine for failure to notify the commissioner of the change.

152.28 HEALTH CARE PRACTITIONER DUTIES.

Subdivision 1.

Health care practitioner duties.

(a) Prior to a patient's enrollment in the registry program, a health care practitioner shall:

(1) determine, in the health care practitioner's medical judgment, whether a patient suffers from a qualifying medical condition, and, if so determined, provide the patient with a certification of that diagnosis;

(2) advise patients, registered designated caregivers, and parents, legal guardians, or spouses who are acting as caregivers of the existence of any nonprofit patient support groups or organizations;

(3) provide explanatory information from the commissioner to patients with qualifying medical conditions, including disclosure to all patients about the experimental nature of therapeutic use of medical cannabis; the possible risks, benefits, and side effects of the proposed treatment; the application and other materials from the commissioner; and provide patients with the Tennessen warning as required by section 13.04, subdivision 2; and

(4) agree to continue treatment of the patient's qualifying medical condition and report medical findings to the commissioner.

(b) Upon notification from the commissioner of the patient's enrollment in the registry program, the health care practitioner shall:

(1) participate in the patient registry reporting system under the guidance and supervision of the commissioner;

(2) report health records of the patient throughout the ongoing treatment of the patient to the commissioner in a manner determined by the commissioner and in accordance with subdivision 2;

(3) determine, on a yearly basis, if the patient continues to suffer from a qualifying medical condition and, if so, issue the patient a new certification of that diagnosis; and

(4) otherwise comply with all requirements developed by the commissioner.

(c) A health care practitioner may conduct a patient assessment to issue a recertification as required under paragraph (b), clause (3), via telehealth, as defined in section 62A.673, subdivision 2.

(d) Nothing in this section requires a health care practitioner to participate in the registry program.

Subd. 2.

Data.

Data collected on patients by a health care practitioner and reported to the patient registry are health records under section 144.291, and are private data on individuals under section 13.02, but may be used or reported in an aggregated, nonidentifiable form as part of a scientific, peer-reviewed publication of research conducted under section 152.25 or in the creation of summary data, as defined in section 13.02, subdivision 19.

Subd. 3.

Advertising restrictions.

(a) A health care practitioner shall not publish or cause to be published any advertisement that:

(1) contains false or misleading statements about medical cannabis or about the medical cannabis registry program;

(2) uses colloquial terms to refer to medical cannabis, such as pot, weed, or grass;

(3) states or implies the health care practitioner is endorsed by the Department of Health or by the medical cannabis registry program;

(4) includes images of cannabis in its plant or leaf form or of cannabis-smoking paraphernalia; or

(5) contains medical symbols that could reasonably be confused with symbols of established medical associations or groups.

(b) A health care practitioner found by the commissioner to have violated this subdivision is prohibited from certifying that patients have a qualifying medical condition for purposes of patient participation in the registry program. The commissioner's decision that a health care practitioner has violated this subdivision is a final decision of the commissioner and is not subject to the contested case procedures in chapter 14.

152.29 MANUFACTURER OF MEDICAL CANNABIS DUTIES.

Subdivision 1.

Manufacturer; requirements.

(a) A manufacturer may operate eight distribution facilities, which may include the manufacturer's single location for cultivation, harvesting, manufacturing, packaging, and processing but is not required to include that location. The commissioner shall designate the geographical service areas to be served by each manufacturer based on geographical need throughout the state to improve patient access. A manufacturer shall not have more than two distribution facilities in each geographical service area assigned to the manufacturer by the commissioner. A manufacturer shall operate only one location where all cultivation, harvesting, manufacturing, packaging, and processing of medical cannabis shall be conducted. This location may be one of the manufacturer's distribution facility sites. The additional distribution facilities may dispense medical cannabis and medical cannabis products but may not contain any medical cannabis in a form other than those forms allowed under section 152.22, subdivision 6, and the manufacturer shall not conduct any cultivation, harvesting, manufacturing, packaging, or processing at the other distribution facility sites. Any distribution facility operated by the manufacturer is subject to all of the requirements applying to the manufacturer under sections 152.22 to 152.37, including, but not limited to, security and distribution requirements.

(b) A manufacturer may acquire hemp grown in this state from a hemp grower, and may acquire hemp products produced by a hemp processor. A manufacturer may manufacture or process hemp and hemp products into an allowable form of medical cannabis under section 152.22, subdivision 6. Hemp and hemp products acquired by a manufacturer under this paragraph are subject to the same quality control program, security and testing requirements, and other requirements that apply to medical cannabis under sections 152.22 to 152.37 and Minnesota Rules, chapter 4770.

(c) A medical cannabis manufacturer shall contract with a laboratory approved by the commissioner, subject to any additional requirements set by the commissioner, for purposes of testing medical cannabis manufactured or hemp or hemp products acquired by the medical cannabis manufacturer as to content, contamination, and consistency to verify the medical cannabis meets the requirements of section 152.22, subdivision 6. The cost of laboratory testing shall be paid by the manufacturer.

(d) The operating documents of a manufacturer must include:

(1) procedures for the oversight of the manufacturer and procedures to ensure accurate record keeping;

(2) procedures for the implementation of appropriate security measures to deter and prevent the theft of medical cannabis and unauthorized entrance into areas containing medical cannabis; and

(3) procedures for the delivery and transportation of hemp between hemp growers and manufacturers and for the delivery and transportation of hemp products between hemp processors and manufacturers.

(e) A manufacturer shall implement security requirements, including requirements for the delivery and transportation of hemp and hemp products, protection of each location by a fully operational security alarm system, facility access controls, perimeter intrusion detection systems, and a personnel identification system.

(f) A manufacturer shall not share office space with, refer patients to a health care practitioner, or have any financial relationship with a health care practitioner.

(g) A manufacturer shall not permit any person to consume medical cannabis on the property of the manufacturer.

(h) A manufacturer is subject to reasonable inspection by the commissioner.

(i) For purposes of sections 152.22 to 152.37, a medical cannabis manufacturer is not subject to the Board of Pharmacy licensure or regulatory requirements under chapter 151.

(j) A medical cannabis manufacturer may not employ any person who is under 21 years of age or who has been convicted of a disqualifying felony offense. An employee of a medical cannabis manufacturer must submit a completed criminal history records check consent form, a full set of classifiable fingerprints, and the required fees for submission to the Bureau of Criminal Apprehension before an employee may begin working with the manufacturer. The bureau must conduct a Minnesota criminal history records check and the superintendent is authorized to exchange the fingerprints with the Federal Bureau of Investigation to obtain the applicant's national criminal history record information. The bureau shall return the results of the Minnesota and federal criminal history records checks to the commissioner.

(k) A manufacturer may not operate in any location, whether for distribution or cultivation, harvesting, manufacturing, packaging, or processing, within 1,000 feet of a public or private school existing before the date of the manufacturer's registration with the commissioner.

(l) A manufacturer shall comply with reasonable restrictions set by the commissioner relating to signage, marketing, display, and advertising of medical cannabis.

(m) Before a manufacturer acquires hemp from a hemp grower or hemp products from a hemp processor, the manufacturer must verify that the hemp grower or hemp processor has a valid license issued by the commissioner of agriculture under chapter 18K.

(n) Until a state-centralized, seed-to-sale system is implemented that can track a specific medical cannabis plant from cultivation through testing and point of sale, the commissioner shall conduct at least one unannounced inspection per year of each manufacturer that includes inspection of:

(1) business operations;

(2) physical locations of the manufacturer's manufacturing facility and distribution facilities;

(3) financial information and inventory documentation, including laboratory testing results; and

(4) physical and electronic security alarm systems.

Subd. 2.

Manufacturer; production.

(a) A manufacturer of medical cannabis shall provide a reliable and ongoing supply of all medical cannabis needed for the registry program through cultivation by the manufacturer and through the purchase of hemp from hemp growers.

(b) All cultivation, harvesting, manufacturing, packaging, and processing of medical cannabis must take place in an enclosed, locked facility at a physical address provided to the commissioner during the registration process.

(c) A manufacturer must process and prepare any medical cannabis plant material or hemp plant material into a form allowable under section 152.22, subdivision 6, prior to distribution of any medical cannabis.

Subd. 3.

Manufacturer; distribution.

(a) A manufacturer shall require that employees licensed as pharmacists pursuant to chapter 151 be the only employees to give final approval for the distribution of medical cannabis to a patient. A manufacturer may transport medical cannabis or medical cannabis products that have been cultivated, harvested, manufactured, packaged, and processed by that manufacturer to another registered manufacturer for the other manufacturer to distribute.

(b) A manufacturer may distribute medical cannabis products, whether or not the products have been manufactured by that manufacturer.

(c) Prior to distribution of any medical cannabis, the manufacturer shall:

(1) verify that the manufacturer has received the registry verification from the commissioner for that individual patient;

(2) verify that the person requesting the distribution of medical cannabis is the patient, the patient's registered designated caregiver, or the patient's parent, legal guardian, or spouse listed in the registry verification using the procedures described in section 152.11, subdivision 2d;

(3) assign a tracking number to any medical cannabis distributed from the manufacturer;

(4) ensure that any employee of the manufacturer licensed as a pharmacist pursuant to chapter 151 has consulted with the patient to determine the proper dosage for the individual patient after reviewing the ranges of chemical compositions of the medical cannabis and the ranges of proper dosages reported by the commissioner. For purposes of this clause, a consultation may be conducted remotely by secure videoconference, telephone, or other remote means, so long as the employee providing the consultation is able to confirm the identity of the patient and the consultation adheres to patient privacy requirements that apply to health care services delivered through telehealth. A pharmacist consultation under this clause is not required when a manufacturer is distributing medical cannabis to a patient according to a patient-specific dosage plan established with that manufacturer and is not modifying the dosage or product being distributed under that plan and the medical cannabis is distributed by a pharmacy technician;

(5) properly package medical cannabis in compliance with the United States Poison Prevention Packing Act regarding child-resistant packaging and exemptions for packaging for elderly patients, and label distributed medical cannabis with a list of all active ingredients and individually identifying information, including:

(i) the patient's name and date of birth;

(ii) the name and date of birth of the patient's registered designated caregiver or, if listed on the registry verification, the name of the patient's parent or legal guardian, if applicable;

(iii) the patient's registry identification number;

(iv) the chemical composition of the medical cannabis; and

(v) the dosage; and

(6) ensure that the medical cannabis distributed contains a maximum of a 90-day supply of the dosage determined for that patient.

(d) A manufacturer shall require any employee of the manufacturer who is transporting medical cannabis or medical cannabis products to a distribution facility or to another registered manufacturer to carry identification showing that the person is an employee of the manufacturer.

(e) A manufacturer shall distribute medical cannabis in dried raw cannabis form only to a patient age 21 or older, or to the registered designated caregiver, parent, legal guardian, or spouse of a patient age 21 or older.

Subd. 3a.

Transportation of medical cannabis; staffing.

(a) A medical cannabis manufacturer may staff a transport motor vehicle with only one employee if the medical cannabis manufacturer is transporting medical cannabis to either a certified laboratory for the purpose of testing or a facility for the purpose of disposal. If the medical cannabis manufacturer is transporting medical cannabis for any other purpose or destination, the transport motor vehicle must be staffed with a minimum of two employees as required by rules adopted by the commissioner.

(b) Notwithstanding paragraph (a), a medical cannabis manufacturer that is only transporting hemp for any purpose may staff the transport motor vehicle with only one employee.

Subd. 3b.

Distribution to recipient in a motor vehicle.

A manufacturer may distribute medical cannabis to a patient, registered designated caregiver, or parent, legal guardian, or spouse of a patient who is at the distribution facility but remains in a motor vehicle, provided:

(1) distribution facility staff receive payment and distribute medical cannabis in a designated zone that is as close as feasible to the front door of the distribution facility;

(2) the manufacturer ensures that the receipt of payment and distribution of medical cannabis are visually recorded by a closed-circuit television surveillance camera at the distribution facility and provides any other necessary security safeguards;

(3) the manufacturer does not store medical cannabis outside a restricted access area at the distribution facility, and distribution facility staff transport medical cannabis from a restricted access area at the distribution facility to the designated zone for distribution only after confirming that the patient, designated caregiver, or parent, guardian, or spouse has arrived in the designated zone;

(4) the payment and distribution of medical cannabis take place only after a pharmacist consultation takes place, if required under subdivision 3, paragraph (c), clause (4);

(5) immediately following distribution of medical cannabis, distribution facility staff enter the transaction in the state medical cannabis registry information technology database; and

(6) immediately following distribution of medical cannabis, distribution facility staff take the payment received into the distribution facility.

Subd. 3c.

Disposal of medical cannabis plant root balls.

Notwithstanding Minnesota Rules, part 4770.1200, subpart 2, item C, a manufacturer is not required to grind root balls of medical cannabis plants or incorporate them with a greater quantity of nonconsumable solid waste before transporting root balls to another location for disposal. For purposes of this subdivision, "root ball" means a compact mass of roots formed by a plant and any attached growing medium.

Subd. 4.

Report.

Each manufacturer shall report to the commissioner on a monthly basis the following information on each individual patient for the month prior to the report:

(1) the amount and dosages of medical cannabis distributed;

(2) the chemical composition of the medical cannabis; and

(3) the tracking number assigned to any medical cannabis distributed.

152.30 PATIENT DUTIES.

(a) A patient shall apply to the commissioner for enrollment in the registry program by submitting an application as required in section 152.27 and an annual registration fee as determined under section 152.35.

(b) As a condition of continued enrollment, patients shall agree to:

(1) continue to receive regularly scheduled treatment for their qualifying medical condition from their health care practitioner; and

(2) report changes in their qualifying medical condition to their health care practitioner.

(c) A patient shall only receive medical cannabis from a registered manufacturer but is not required to receive medical cannabis products from only a registered manufacturer.

152.31 DATA PRACTICES.

(a) Government data in patient files maintained by the commissioner and the health care practitioner, and data submitted to or by a medical cannabis manufacturer, are private data on individuals, as defined in section 13.02, subdivision 12, or nonpublic data, as defined in section 13.02, subdivision 9, but may be used for purposes of complying with chapter 13 and complying with a request from the legislative auditor or the state auditor in the performance of official duties. The provisions of section 13.05, subdivision 11, apply to a registration agreement entered between the commissioner and a medical cannabis manufacturer under section 152.25.

(b) Not public data maintained by the commissioner may not be used for any purpose not provided for in sections 152.22 to 152.37, and may not be combined or linked in any manner with any other list, dataset, or database.

(c) The commissioner may execute data sharing arrangements with the commissioner of agriculture to verify licensing, inspection, and compliance information related to hemp growers and hemp processors under chapter 18K.

152.32 PROTECTIONS FOR REGISTRY PROGRAM PARTICIPATION.

Subdivision 1.

Presumption.

(a) There is a presumption that a patient enrolled in the registry program under sections 152.22 to 152.37 is engaged in the authorized use of medical cannabis.

(b) The presumption may be rebutted by evidence that conduct related to use of medical cannabis was not for the purpose of treating or alleviating the patient's qualifying medical condition or symptoms associated with the patient's qualifying medical condition.

Subd. 2.

Criminal and civil protections.

(a) Subject to section 152.23, the following are not violations under this chapter:

(1) use or possession of medical cannabis or medical cannabis products by a patient enrolled in the registry program, or possession by a registered designated caregiver or the parent, legal guardian, or spouse of a patient if the parent, legal guardian, or spouse is listed on the registry verification;

(2) possession, dosage determination, or sale of medical cannabis or medical cannabis products by a medical cannabis manufacturer, employees of a manufacturer, a laboratory conducting testing on medical cannabis, or employees of the laboratory; and

(3) possession of medical cannabis or medical cannabis products by any person while carrying out the duties required under sections 152.22 to 152.37.

(b) Medical cannabis obtained and distributed pursuant to sections 152.22 to 152.37 and associated property is not subject to forfeiture under sections 609.531 to 609.5316.

(c) The commissioner, the commissioner's staff, the commissioner's agents or contractors, and any health care practitioner are not subject to any civil or disciplinary penalties by the Board of Medical Practice, the Board of Nursing, or by any business, occupational, or professional licensing board or entity, solely for the participation in the registry program under sections 152.22 to 152.37. A pharmacist licensed under chapter 151 is not subject to any civil or disciplinary penalties by the Board of Pharmacy when acting in accordance with the provisions of sections 152.22 to 152.37. Nothing in this section affects a professional licensing board from taking action in response to violations of any other section of law.

(d) Notwithstanding any law to the contrary, the commissioner, the governor of Minnesota, or an employee of any state agency may not be held civilly or criminally liable for any injury, loss of property, personal injury, or death caused by any act or omission while acting within the scope of office or employment under sections 152.22 to 152.37.

(e) Federal, state, and local law enforcement authorities are prohibited from accessing the patient registry under sections 152.22 to 152.37 except when acting pursuant to a valid search warrant.

(f) Notwithstanding any law to the contrary, neither the commissioner nor a public employee may release data or information about an individual contained in any report, document, or registry created under sections 152.22 to 152.37 or any information obtained about a patient participating in the program, except as provided in sections 152.22 to 152.37.

(g) No information contained in a report, document, or registry or obtained from a patient under sections 152.22 to 152.37 may be admitted as evidence in a criminal proceeding unless independently obtained or in connection with a proceeding involving a violation of sections 152.22 to 152.37.

(h) Notwithstanding section 13.09, any person who violates paragraph (e) or (f) is guilty of a gross misdemeanor.

(i) An attorney may not be subject to disciplinary action by the Minnesota Supreme Court or professional responsibility board for providing legal assistance to prospective or registered manufacturers or others related to activity that is no longer subject to criminal penalties under state law pursuant to sections 152.22 to 152.37.

(j) Possession of a registry verification or application for enrollment in the program by a person entitled to possess or apply for enrollment in the registry program does not constitute probable cause or reasonable suspicion, nor shall it be used to support a search of the person or property of the person possessing or applying for the registry verification, or otherwise subject the person or property of the person to inspection by any governmental agency.

Subd. 3.

Discrimination prohibited.

(a) No school or landlord may refuse to enroll or lease to and may not otherwise penalize a person solely for the person's status as a patient enrolled in the registry program under sections 152.22 to 152.37, unless failing to do so would violate federal law or regulations or cause the school or landlord to lose a monetary or licensing-related benefit under federal law or regulations.

(b) For the purposes of medical care, including organ transplants, a registry program enrollee's use of medical cannabis under sections 152.22 to 152.37 is considered the equivalent of the authorized use of any other medication used at the discretion of a physician or advanced practice registered nurse and does not constitute the use of an illicit substance or otherwise disqualify a patient from needed medical care.

(c) Unless a failure to do so would violate federal law or regulations or cause an employer to lose a monetary or licensing-related benefit under federal law or regulations, an employer may not discriminate against a person in hiring, termination, or any term or condition of employment, or otherwise penalize a person, if the discrimination is based upon either of the following:

(1) the person's status as a patient enrolled in the registry program under sections 152.22 to 152.37; or

(2) a patient's positive drug test for cannabis components or metabolites, unless the patient used, possessed, or was impaired by medical cannabis on the premises of the place of employment or during the hours of employment.

(d) An employee who is required to undergo employer drug testing pursuant to section 181.953 may present verification of enrollment in the patient registry as part of the employee's explanation under section 181.953, subdivision 6.

(e) A person shall not be denied custody of a minor child or visitation rights or parenting time with a minor child solely based on the person's status as a patient enrolled in the registry program under sections 152.22 to 152.37. There shall be no presumption of neglect or child endangerment for conduct allowed under sections 152.22 to 152.37, unless the person's behavior is such that it creates an unreasonable danger to the safety of the minor as established by clear and convincing evidence.

152.33 VIOLATIONS.

Subdivision 1.

Intentional diversion; criminal penalty.

In addition to any other applicable penalty in law, a manufacturer or an agent of a manufacturer who intentionally transfers medical cannabis to a person other than another registered manufacturer, a patient, a registered designated caregiver or, if listed on the registry verification, a parent, legal guardian, or spouse of a patient is guilty of a felony punishable by imprisonment for not more than two years or by payment of a fine of not more than $3,000, or both. A person convicted under this subdivision may not continue to be affiliated with the manufacturer and is disqualified from further participation under sections 152.22 to 152.37.

Subd. 1a.

Intentional diversion outside the state; penalties.

(a) In addition to any other applicable penalty in law, the commissioner may levy a fine of $250,000 against a manufacturer and may immediately initiate proceedings to revoke the manufacturer's registration, using the procedure in section 152.25, if:

(1) an officer, director, or controlling person of the manufacturer pleads or is found guilty under subdivision 1 of intentionally transferring medical cannabis, while the person was an officer, director, or controlling person of the manufacturer, to a person other than allowed by law; and

(2) in intentionally transferring medical cannabis to a person other than allowed by law, the officer, director, or controlling person transported or directed the transport of medical cannabis outside of Minnesota.

(b) All fines collected under this subdivision shall be deposited in the state government special revenue fund.

Subd. 2.

Diversion by patient, registered designated caregiver, parent, legal guardian, or patient's spouse; criminal penalty.

In addition to any other applicable penalty in law, a patient, registered designated caregiver or, if listed on the registry verification, a parent, legal guardian, or spouse of a patient who intentionally sells or otherwise transfers medical cannabis to a person other than a patient, designated registered caregiver or, if listed on the registry verification, a parent, legal guardian, or spouse of a patient is guilty of a felony punishable by imprisonment for not more than two years or by payment of a fine of not more than $3,000, or both.

Subd. 3.

False statement; criminal penalty.

A person who intentionally makes a false statement to a law enforcement official about any fact or circumstance relating to the medical use of cannabis to avoid arrest or prosecution is guilty of a misdemeanor punishable by imprisonment for not more than 90 days or by payment of a fine of not more than $1,000, or both. The penalty is in addition to any other penalties that may apply for making a false statement or for the possession, cultivation, or sale of cannabis not protected by sections 152.22 to 152.37. If a person convicted of violating this subdivision is a patient or a registered designated caregiver, the person is disqualified from further participation under sections 152.22 to 152.37.

Subd. 4.

Submission of false records; criminal penalty.

A person who knowingly submits false records or documentation required by the commissioner to register as a manufacturer of medical cannabis under sections 152.22 to 152.37 is guilty of a felony and may be sentenced to imprisonment for not more than two years or by payment of a fine of not more than $3,000, or both.

Subd. 5.

Violation by health care practitioner; criminal penalty.

A health care practitioner who knowingly refers patients to a manufacturer or to a designated caregiver, who advertises as a manufacturer, or who issues certifications while holding a financial interest in a manufacturer is guilty of a misdemeanor and may be sentenced to imprisonment for not more than 90 days or by payment of a fine of not more than $1,000, or both.

Subd. 6.

Other violations; civil penalty.

A manufacturer shall be fined up to $1,000 for any violation of sections 152.22 to 152.37, or the regulations issued pursuant to them, where no penalty has been specified. This penalty is in addition to any other applicable penalties in law.

152.34 HEALTH CARE FACILITIES.

(a) Health care facilities licensed under chapter 144A, hospice providers licensed under chapter 144A, boarding care homes or supervised living facilities licensed under section 144.50, assisted living facilities, facilities owned, controlled, managed, or under common control with hospitals licensed under chapter 144, and other health facilities licensed by the commissioner of health, may adopt reasonable restrictions on the use of medical cannabis by a patient enrolled in the registry program who resides at or is actively receiving treatment or care at the facility. The restrictions may include a provision that the facility will not store or maintain the patient's supply of medical cannabis, that the facility is not responsible for providing the medical cannabis for patients, and that medical cannabis be used only in a place specified by the facility.

(b) Any employee or agent of a facility listed in this section or a person licensed under chapter 144E is not subject to violations under this chapter for possession of medical cannabis while carrying out employment duties, including providing or supervising care to a registered patient, or distribution of medical cannabis to a registered patient who resides at or is actively receiving treatment or care at the facility with which the employee or agent is affiliated. Nothing in this section shall require the facilities to adopt such restrictions and no facility shall unreasonably limit a patient's access to or use of medical cannabis to the extent that use is authorized by the patient under sections 152.22 to 152.37.

152.35 FEES; DEPOSIT OF REVENUE.

(a) The commissioner shall collect an enrollment fee of $200 from patients enrolled under this section. If the patient provides evidence of receiving Social Security disability insurance (SSDI), Supplemental Security Income (SSI), veterans disability, or railroad disability payments, or being enrolled in medical assistance or MinnesotaCare, then the fee shall be $50. For purposes of this section:

(1) a patient is considered to receive SSDI if the patient was receiving SSDI at the time the patient was transitioned to retirement benefits by the United States Social Security Administration; and

(2) veterans disability payments include VA dependency and indemnity compensation.

Unless a patient provides evidence of receiving payments from or participating in one of the programs specifically listed in this paragraph, the commissioner of health must collect the $200 enrollment fee from a patient to enroll the patient in the registry program. The fees shall be payable annually and are due on the anniversary date of the patient's enrollment. The fee amount shall be deposited in the state treasury and credited to the state government special revenue fund.

(b) The commissioner shall collect an application fee of $20,000 from each entity submitting an application for registration as a medical cannabis manufacturer. Revenue from the fee shall be deposited in the state treasury and credited to the state government special revenue fund.

(c) The commissioner shall establish and collect an annual fee from a medical cannabis manufacturer equal to the cost of regulating and inspecting the manufacturer in that year. Revenue from the fee amount shall be deposited in the state treasury and credited to the state government special revenue fund.

(d) A medical cannabis manufacturer may charge patients enrolled in the registry program a reasonable fee for costs associated with the operations of the manufacturer. The manufacturer may establish a sliding scale of patient fees based upon a patient's household income and may accept private donations to reduce patient fees.

152.36 IMPACT ASSESSMENT OF MEDICAL CANNABIS THERAPEUTIC RESEARCH.

Subdivision 1.

Task force on medical cannabis therapeutic research.

(a) A 23-member task force on medical cannabis therapeutic research is created to conduct an impact assessment of medical cannabis therapeutic research. The task force shall consist of the following members:

(1) two members of the house of representatives, one selected by the speaker of the house, the other selected by the minority leader;

(2) two members of the senate, one selected by the majority leader, the other selected by the minority leader;

(3) four members representing consumers or patients enrolled in the registry program, including at least two parents of patients under age 18;

(4) four members representing health care providers, including one licensed pharmacist;

(5) four members representing law enforcement, one from the Minnesota Chiefs of Police Association, one from the Minnesota Sheriff's Association, one from the Minnesota Police and Peace Officers Association, and one from the Minnesota County Attorneys Association;

(6) four members representing substance use disorder treatment providers; and

(7) the commissioners of health, human services, and public safety.

(b) Task force members listed under paragraph (a), clauses (3), (4), (5), and (6), shall be appointed by the governor under the appointment process in section 15.0597. Members shall serve on the task force at the pleasure of the appointing authority. All members must be appointed by July 15, 2014, and the commissioner of health shall convene the first meeting of the task force by August 1, 2014.

(c) There shall be two cochairs of the task force chosen from the members listed under paragraph (a). One cochair shall be selected by the speaker of the house and the other cochair shall be selected by the majority leader of the senate. The authority to convene meetings shall alternate between the cochairs.

(d) Members of the task force other than those in paragraph (a), clauses (1), (2), and (7), shall receive expenses as provided in section 15.059, subdivision 6.

Subd. 1a.

Administration.

The commissioner of health shall provide administrative and technical support to the task force.

Subd. 2.

Impact assessment.

The task force shall hold hearings to evaluate the impact of the use of medical cannabis and hemp and Minnesota's activities involving medical cannabis and hemp, including, but not limited to:

(1) program design and implementation;

(2) the impact on the health care provider community;

(3) patient experiences;

(4) the impact on the incidence of substance abuse;

(5) access to and quality of medical cannabis, hemp, and medical cannabis products;

(6) the impact on law enforcement and prosecutions;

(7) public awareness and perception; and

(8) any unintended consequences.

Subd. 3.

Cost assessment.

By January 15 of each year, beginning January 15, 2015, and ending January 15, 2019, the commissioners of state departments impacted by the medical cannabis therapeutic research study shall report to the cochairs of the task force on the costs incurred by each department on implementing sections 152.22 to 152.37. The reports must compare actual costs to the estimated costs of implementing these sections and must be submitted to the task force on medical cannabis therapeutic research.

Subd. 4.

Reports to the legislature.

(a) The cochairs of the task force shall submit the following reports to the chairs and ranking minority members of the legislative committees and divisions with jurisdiction over health and human services, public safety, judiciary, and civil law:

(1) by February 1, 2015, a report on the design and implementation of the registry program; and every two years thereafter, a complete impact assessment report; and

(2) upon receipt of a cost assessment from a commissioner of a state agency, the completed cost assessment.

(b) The task force may make recommendations to the legislature on whether to add or remove conditions from the list of qualifying medical conditions.

Subd. 5.

No expiration.

The task force on medical cannabis therapeutic research does not expire.

152.37 FINANCIAL EXAMINATIONS; PRICING REVIEWS.

Subdivision 1.

Financial records.

A medical cannabis manufacturer shall maintain detailed financial records in a manner and format approved by the commissioner, and shall keep all records updated and accessible to the commissioner when requested.

Subd. 2.

Certified annual audit.

A medical cannabis manufacturer shall submit the results of an annual certified financial audit to the commissioner no later than May 1 of each year for the calendar year beginning January 2015. The annual audit shall be conducted by an independent certified public accountant and the costs of the audit are the responsibility of the medical cannabis manufacturer. Results of the audit shall be provided to the medical cannabis manufacturer and the commissioner. The commissioner may also require another audit of the medical cannabis manufacturer by a certified public accountant chosen by the commissioner with the costs of the audit paid by the medical cannabis manufacturer.

Subd. 3.

Power to examine.

(a) The commissioner or designee may examine the business affairs and conditions of any medical cannabis manufacturer, including but not limited to a review of the financing, budgets, revenues, sales, and pricing.

(b) An examination may cover the medical cannabis manufacturer's business affairs, practices, and conditions including but not limited to a review of the financing, budgets, revenues, sales, and pricing. The commissioner shall determine the nature and scope of each examination and in doing so shall take into account all available relevant factors concerning the financial and business affairs, practices, and conditions of the examinee. The costs incurred by the department in conducting an examination shall be paid for by the medical cannabis manufacturer.

(c) When making an examination under this section, the commissioner may retain attorneys, appraisers, independent economists, independent certified public accountants, or other professionals and specialists as designees. A certified public accountant retained by the commissioner may not be the same certified public accountant providing the certified annual audit in subdivision 2.

(d) The commissioner shall make a report of an examination conducted under this section and provide a copy to the medical cannabis manufacturer. The commissioner shall then post a copy of the report on the department's website. All working papers, recorded information, documents, and copies produced by, obtained by, or disclosed to the commissioner or any other person in the course of an examination, other than the information contained in any commissioner official report, made under this section are private data on individuals or nonpublic data, as defined in section 13.02.