SF 1179

1st Engrossment - 92nd Legislature (2021 - 2022) Posted on 11/09/2021 01:29pm

A bill for an act
relating to health; modifying operation of the medical cannabis program; allowing
combustion of dried raw cannabis by patients age 21 or older; adding opiate
addiction as a qualifying medical condition for participation in the medical cannabis
registry program; modifying the process for adding or modifying a delivery method
or qualifying medical condition; amending Minnesota Statutes 2020, sections
152.22, subdivisions 6, 14, by adding a subdivision; 152.27, subdivision 2; 152.29,
subdivisions 1, 3, by adding subdivisions; 152.31.

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

Section 1.

Minnesota Statutes 2020, section 152.22, is amended by adding a subdivision
to read:

new text begin Subd. 5c. new text end

new text begin Hemp processor. new text end

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

Sec. 2.

Minnesota Statutes 2020, section 152.22, subdivision 6, is amended to read:

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 deleted text begin but which does not require the
use of dried leaves or plant form; or deleted text end new text begin ;
new text end

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

deleted text begin (4) deleted text end new text begin (5) new text end any other method deleted text begin , excluding smoking, deleted text end 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).

Sec. 3.

Minnesota Statutes 2020, section 152.22, subdivision 14, is amended to read:

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) deleted text begin any other medical condition or its treatment approved by the commissioner deleted text end new text begin opiate
addiction new text end .

Sec. 4.

Minnesota Statutes 2020, section 152.27, subdivision 2, is amended to read:

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) new text begin Effective August 1, 2021, new text end the commissioner may deleted text begin add a deleted text end new text begin recommend to the legislature
an addition or modification to the new text end delivery deleted text begin method deleted text end new text begin methods new text end under section 152.22, subdivision
6, or deleted text begin add or modify a deleted text end new text begin an addition or modification to the new text end qualifying medical deleted text begin condition deleted text end new text begin
conditions new text end under section 152.22, subdivision 14, deleted text begin upon deleted text end new text begin based on new text end 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 new text begin submitted new text end to add a qualifying medical
condition or modify an existing qualifying medical condition deleted text begin submitted by the task force
on medical cannabis therapeutic research deleted text end or as directed by law and deleted text begin shall make deleted text end new text begin may
recommend to the legislature new text end the addition or modification if the commissioner determines
the addition or modification is warranted based on the best available evidence and research.
If the commissioner deleted text begin wishes to add deleted text end new text begin recommends the addition or modification of new text end a delivery
method under section 152.22, subdivision 6, or 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 deleted text begin addition deleted text end new text begin recommendation new text end and the reasons for deleted text begin its addition deleted text end new text begin the recommendation new text end ,
including any written comments received by the commissioner from the public and any
guidance received from the task force on medical cannabis research deleted text begin , by January 15 of the
year in which the commissioner wishes to make the change deleted text end . The new text begin recommended new text end change shall
deleted text begin be deleted text end new text begin not become new text end effective deleted text begin on August 1 of that year, unless the legislature by law provides
otherwise deleted text end new text begin unless the change is enacted into law new text end . new text begin Any addition or modification of a delivery
method or qualifying medical condition made by the commissioner that is in effect on
January 1, 2021, shall remain in effect unless removed or modified by law, and any addition
or modification that the commissioner has proposed to make and has notified the legislature
of the proposed change by January 1, 2021, shall become effective on August 1, 2021,
unless otherwise provided by law.
new text end

Sec. 5.

Minnesota Statutes 2020, section 152.29, subdivision 1, is amended to read:

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 new text begin , and may
acquire hemp products produced by a hemp processor new text end . A manufacturer may manufacture
or process hemp new text begin and hemp products new text end into an allowable form of medical cannabis under
section 152.22, subdivision 6. Hemp new text begin and hemp products new text end acquired by a manufacturer under
this paragraph deleted text begin is deleted text end new text begin are new text end 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 new text begin or hemp products new text end 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 new text begin and for the delivery and transportation of hemp products between hemp
processors and manufacturers new text end .

(e) A manufacturer shall implement security requirements, including requirements for
the delivery and transportation of hemp new text begin and hemp products new text end , 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 new text begin or hemp products from
a hemp processor new text end , the manufacturer must verify that the hemp grower new text begin or hemp processor
new text end 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.

Sec. 6.

Minnesota Statutes 2020, section 152.29, subdivision 3, is amended to read:

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 deleted text begin using a deleted text end new text begin by secure new text end videoconference new text begin , telephone, or
other remote means new text end , so long as the employee providing the consultation is able to confirm
the identity of the patient deleted text begin , the consultation occurs while the patient is at a distribution facility, deleted text end
and the consultation adheres to patient privacy requirements that apply to health care services
delivered through telemedicine new text begin . 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 new text end ;

(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.

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

Sec. 7.

Minnesota Statutes 2020, section 152.29, is amended by adding a subdivision to
read:

new text begin Subd. 3b. 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, provided:
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 feasible 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

Sec. 8.

Minnesota Statutes 2020, section 152.29, is amended by adding a subdivision to
read:

new text begin Subd. 3c. 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

Sec. 9.

Minnesota Statutes 2020, section 152.31, is amended to read:

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 new text begin and hemp processors new text end under chapter 18K.