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HF 1413

as introduced - 92nd Legislature (2021 - 2022) Posted on 03/25/2021 07:37pm

KEY: stricken = removed, old language.
underscored = added, new language.
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A bill for an act
relating to health; modifying operation of the medical cannabis Next program; amending
Minnesota Statutes 2020, sections 152.22, by adding a subdivision; 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 152.29, 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 Previous cannabis Next shall be conducted. This location may be one of the
manufacturer's distribution facility sites. The additional distribution facilities may dispense
medical Previous cannabis Next and medical Previous cannabis Next products but may not contain any medical Previous cannabis Next
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 growernew text begin, and may
acquire hemp products produced by a hemp processor
new text end. A manufacturer may manufacture
or process hemp new text beginand hemp products new text endinto an allowable form of medical Previous cannabis Next under
section 152.22, subdivision 6. Hemp new text beginand hemp products new text endacquired by a manufacturer under
this paragraph deleted text beginisdeleted text endnew text begin arenew text end subject to the same quality control program, security and testing
requirements, and other requirements that apply to medical Previous cannabis Next under sections 152.22
to 152.37 and Minnesota Rules, chapter 4770.

(c) A medical Previous cannabis Next manufacturer shall contract with a laboratory approved by the
commissioner, subject to any additional requirements set by the commissioner, for purposes
of testing medical Previous cannabis Next manufactured or hemp new text beginor hemp products new text endacquired by the medical
Previous cannabis Next manufacturer as to content, contamination, and consistency to verify the medical
Previous cannabis Next 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 Previous cannabis Next and unauthorized entrance into areas containing medical
Previous cannabis Next ; and

(3) procedures for the delivery and transportation of hemp between hemp growers and
manufacturersnew 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 hempnew text begin and hemp productsnew 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 Previous cannabis Next 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 Previous cannabis Next manufacturer is not
subject to the Board of Pharmacy licensure or regulatory requirements under chapter 151.

(j) A medical Previous cannabis Next 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 Previous cannabis Next 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 Previous cannabis Next .

(m) Before a manufacturer acquires hemp from a hemp growernew text begin or hemp products from
a hemp processor
new text end, the manufacturer must verify that the hemp grower new text beginor 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 Previous cannabis Next 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. 3.

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 Previous cannabis Next to a patient. A manufacturer may transport medical
Previous cannabis Next or medical Previous cannabis Next 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 Previous cannabis Next products, whether or not the products
have been manufactured by that manufacturer.

(c) Prior to distribution of any medical Previous cannabis Next , 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 Previous cannabis Next 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 Previous cannabis Next 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 Previous cannabis Next and
the ranges of proper dosages reported by the commissioner. For purposes of this clause, a
consultation may be conducted remotely deleted text beginusing adeleted text endnew text begin by securenew text end videoconferencenew 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 patientdeleted 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 telemedicinenew text begin. A pharmacist consultation under this clause is not required
when a manufacturer is distributing medical Previous cannabis Next 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 Previous cannabis Next 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 Previous cannabis Next 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 Previous cannabis Next ; and

(v) the dosage; and

(6) ensure that the medical Previous cannabis Next 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 Previous cannabis Next or medical Previous cannabis Next products to a distribution facility or to another
registered manufacturer to carry identification showing that the person is an employee of
the manufacturer.

Sec. 4.

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 Previous cannabis Next 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 Previous cannabis Next 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
Previous cannabis Next 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 Previous cannabis Next outside a restricted access area at
the distribution facility, and distribution facility staff transport medical Previous cannabis Next 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 Previous cannabis Next 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 Previous cannabis Next , distribution facility staff
enter the transaction in the state medical Previous cannabis Next registry information technology database;
and
new text end

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

Sec. 5.

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 Previous cannabis Next 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 Previous cannabis Next 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. 6.

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 Previous cannabis Next 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 Previous 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 beginand hemp processors new text endunder chapter 18K.