SF 1723

as introduced - 90th Legislature (2017 - 2018) Posted on 03/03/2017 09:25am

A bill for an act
relating to health; modifying provisions in the Medical Cannabis Therapeutic
Research Act; amending Minnesota Statutes 2016, sections 144.99, subdivision
1; 152.25, subdivision 1, by adding a subdivision; 152.29, subdivisions 1, 3;
proposing coding for new law in Minnesota Statutes, chapter 152; repealing
Minnesota Statutes 2016, section 152.33, subdivision 6.

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

Section 1.

Minnesota Statutes 2016, section 144.99, subdivision 1, is amended to read:

Subdivision 1.

Remedies available.

The provisions of chapters 103I and 157 and sections
115.71 to 115.77; 144.12, subdivision 1, paragraphs (1), (2), (5), (6), (10), (12), (13), (14),
and (15); 144.1201 to 144.1204; 144.121; 144.1222; 144.35; 144.381 to 144.385; 144.411
to 144.417; 144.495; 144.71 to 144.74; 144.9501 to 144.9512; 144.97 to 144.98; 144.992;
new text begin 152.22 to 152.37; new text end 326.70 to 326.785; 327.10 to 327.131; and 327.14 to 327.28 and all rules,
orders, stipulation agreements, settlements, compliance agreements, licenses, registrations,
certificates, and permits adopted or issued by the department or under any other law now
in force or later enacted for the preservation of public health may, in addition to provisions
in other statutes, be enforced under this section.

Sec. 2.

Minnesota Statutes 2016, section 152.25, subdivision 1, is amended to read:

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 deleted text begin by December 1, 2014, unless the commissioner obtains an adequate supply of
federally sourced medical cannabis by August 1, 2014 deleted text end . The commissioner shall register
new manufacturers or reregister the existing manufacturers by December 1 every two years,
using the factors described in paragraph (c). deleted text begin The commissioner shall continue to accept
applications after December 1, 2014, if two manufacturers that meet the qualifications set
forth in this subdivision do not apply before December 1, 2014. deleted text end 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
new text begin medical cannabis manufacturer new text end application process are private data on individuals or
nonpublic data as defined in section 13.02 until the deleted text begin manufacturer is registered under this
section. Data on a manufacturer that is registered are deleted text end new text begin commissioner makes a final decision
regarding registration. The application of a registered manufacturer and its contents become new text end
public data, unless the data are trade secret or security information under section 13.37. new text begin The
application of a nonselected applicant and its contents shall remain private data on individuals
or nonpublic data as defined in section 13.02.
new text end

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

(1) begin supplying medical cannabis to patients deleted text begin by July 1, 2015 deleted text end new text begin by a date specified by
the commissioner in the commissioner's decision regarding registration of the new
manufacturer new text end ; and

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

(c) The commissioner deleted text begin shall deleted text end new text begin may new text end consider the following factors when determining deleted text begin which
manufacturer to register deleted text end new text begin whether to register a new manufacturer, approve or deny a
reregistration application from a current registered manufacturer, or revoke the registration
of a current registered manufacturer new text end :

(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; deleted text begin and
deleted text end

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

new text begin (7) the manufacturer's history of past violations, including their number, willfulness,
gravity, and any economic benefit derived by the manufacturer related to documented
violations new text end .

(d) new text begin Registrations issued under this section are nontransferable without prior written
consent of the commissioner.
new text end

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

new text begin (f) When necessary to investigate an imminent threat to the health or safety of patients
or the public, employees of a laboratory approved by the commissioner to test medical
cannabis may, at the request of the commissioner, collect samples and transport cannabis
plant material, cannabis extracts, medical cannabis, and excipients and diluents used in
producing medical cannabis from a manufacturer's production facility to the testing
laboratory. The transport motor vehicle must be staffed with a minimum of two employees
of the laboratory.
new text end

Sec. 3.

Minnesota Statutes 2016, section 152.25, is amended by adding a subdivision to
read:

new text begin Subd. 1a. new text end

new text begin Medical cannabis manufacturer revocation, nonrenewal, or denial of
consent to transfer. new text end

new text begin (a) If the commissioner intends to revoke, not renew, or deny consent
to transfer 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. The registration of a manufacturer is considered revoked
either on the date the manufacturer's current registration expires or as of the effective date
as stated on the commissioner's written notice of revocation.
new text end

new text begin (b) Upon the revocation of a manufacturer's registration, the commissioner shall notify
in writing each patient and the patient's registered designated caregiver or registered parent
or legal guardian two or more business days prior to the revocation's effective date, about
the outcome of the proceeding and information regarding alternative registered manufacturers.
new text end

Sec. 4.

Minnesota Statutes 2016, section 152.29, subdivision 1, is amended to read:

Subdivision 1.

Manufacturer; requirements.

(a) A manufacturer shall operate four
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. deleted text begin A manufacturer is required to begin distribution of medical cannabis from at least
one distribution facility by July 1, 2015. All distribution facilities must be operational and
begin distribution of medical cannabis by July 1, 2016. deleted text end new text begin If the commissioner is registering
a new manufacturer under section 152.25, the commissioner shall specify the date by which
the new manufacturer is required to begin distribution of medical cannabis from at least
one distribution facility, and the date by which all distribution facilities must be operational
and distributing medical cannabis. new text end The distribution facilities shall be located based on
geographical need throughout the state to improve patient access. A manufacturer shall
disclose the proposed locations for the distribution facilities to the commissioner during the
registration process. A manufacturer shall operate only one location where all cultivation,
harvesting, manufacturing, packaging, and processing shall be conducted. Any 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 an additional distribution facility
site. 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 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 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. new text begin If, based on test results, the commissioner
determines the presence of contaminating substances in any medical cannabis product in
sufficient quantities to present a likely threat to patient health or safety, the manufacturer,
upon order of the commissioner, shall destroy all quantities of the contaminated medical
cannabis product so identified and provide the commissioner proof of the product's
destruction. new text end The cost of laboratory testing shall be paid by the manufacturer.

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

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

(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.

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

(e) 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.

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

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

(h) 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.

(i) 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.

(j) 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.

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

new text begin (l) A manufacturer must use a seed-to-sale tracking system that will create and maintain
records relating to cannabis and medical cannabis inventory at every stage of the medical
cannabis life cycle, from plant stage through cultivation, extraction, final processing,
transportation, distribution, and sale.
new text end

new text begin (m) A manufacturer must notify the commissioner of any assignment or transfer of an
ownership interest in the manufacturer of five percent or more. The transferee 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 prior to any
transfer or assignment. 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 transferee's national criminal history records information. The
bureau shall return the results of the Minnesota and federal criminal history records checks
to the commissioner.
new text end

Sec. 5.

Minnesota Statutes 2016, 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.

(b) A manufacturer may dispense medical cannabis products, whether or not the products
have been manufactured by the manufacturer, but is not required to dispense medical cannabis
products.

(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 or legal guardian 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 using a videoconference, so long as the employee
providing the consultation is able to confirm the identity of the patient, the consultation
occurs while the patient is at a distribution facility, and the consultation adheres to patient
privacy requirements that apply to health care services delivered through telemedicine;

(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 new text begin recommended for that patient new text end ; and

(6) ensure that the medical cannabis distributed contains a maximum of a 30-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 to carry identification
showing that the person is an employee of the manufacturer.

Sec. 6.

new text begin [152.291] TEMPORARY SUSPENSION OF A MEDICAL CANNABIS
MANUFACTURER.
new text end

new text begin Subdivision 1. new text end

new text begin Suspension proceedings. new text end

new text begin The commissioner of health 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 officer,
director, or controlling person of the manufacturer:
new text end

new text begin (1) violates any of the requirements of sections 152.21 to 152.37 or the rules adopted
thereunder;
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 any act contrary to the welfare of a 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. 2. new text end

new text begin Notice to patients. new text end

new text begin Within five working days after proceedings are initiated
by the commissioner to suspend a manufacturer's registration, the commissioner shall notify
each patient and the patient's registered designated caregiver or registered parent or legal
guardian about the proceedings and potential patient impacts.
new text end

new text begin Subd. 3. new text end

new text begin Notice and hearing. new text end

new text begin No manufacturer registration may be suspended without
a hearing held as a contested case under chapter 14. The hearing must commence within
60 days after the proceedings are initiated.
new text end

new text begin Subd. 4. new text end

new text begin Expedited suspension. new text end

new text begin When the commissioner determines the operations or
medical cannabis of a registered manufacturer presents an imminent threat to the health or
safety of patients or the public, the commissioner may immediately suspend the registration
of a medical cannabis manufacturer by bringing an action in the district court in Ramsey
or Hennepin County or in the district in which a manufacturer is located to enjoin employees
of the manufacturer from illegally engaging in activities regulated by sections 152.21 to
152.37. A temporary restraining order may be granted by the court in the proceeding if
continued activity by the manufacturer would create an imminent risk of harm to patients.
new text end

Sec. 7. new text begin REPEALER.
new text end

new text begin Minnesota Statutes 2016, section 152.33, subdivision 6, new text end new text begin is repealed.
new text end

APPENDIX

Repealed Minnesota Statutes: 17-3868

152.33 VIOLATIONS.

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.