SF 3895

as introduced - 91st Legislature (2019 - 2020) Posted on 05/27/2020 02:45pm

A bill for an act
relating to health; requiring the commissioner of health to conduct an annual
inspection of medical cannabis Next manufacturers; modifying who is eligible for the
reduced enrollment fee; amending Minnesota Statutes 2018, section 152.35;
Minnesota Statutes 2019 Supplement, section 152.29, subdivision 1.

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

Section 1.

Minnesota Statutes 2019 Supplement, section 152.29, subdivision 1, is amended
to read:

Subdivision 1.

Manufacturer; requirements.

(a) A manufacturer shall 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 grower. A
manufacturer may manufacture or process hemp into an allowable form of medical Previous cannabis Next
under section 152.22, subdivision 6. Hemp acquired by a manufacturer under this paragraph
is 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 acquired 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
manufacturers.

(e) A manufacturer shall implement security requirements, including requirements for
the delivery and transportation of hemp, 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 grower, the manufacturer must
verify that the hemp grower has a valid license issued by the commissioner of agriculture
under chapter 18K.

new text begin (n) Until a state-centralized, seed-to-sale system is implemented that can track a specific
medical Previous cannabis Next product from cultivation through testing and point of sale, the commissioner
shall conduct an annual unannounced inspection 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

Sec. 2.

Minnesota Statutes 2018, section 152.35, is amended to read:

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 deleted text begin attests to deleted text end new text begin provides evidence of new text end receiving Social Security
disability new text begin insurance (SSDI) new text end , Supplemental Security deleted text begin Insurance deleted text end new text begin Income (SSI), veterans
disability, or railroad disability new text end payments, or being enrolled in medical assistance or
MinnesotaCare, then the fee shall be $50. new text begin For the purposes of this section, a patient is
considered receiving SSDI if they were receiving SSDI at the time they were transitioned
to retirement benefits by the United States Social Security Administration. For purposes of
this section, veterans disability payments include VA dependency and indemnity
compensation. new text end 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 Previous cannabis Next 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 Previous cannabis Next
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 Previous 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.