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4770.1900 MEDICAL CANNABIS LABORATORY APPROVAL.

Subpart 1.

Commissioner's authority.

The commissioner must approve any medical cannabis laboratory that tests medical cannabis for a registered medical cannabis manufacturer under Minnesota Statutes, section 152.25, subdivision 1, paragraph (d). A medical cannabis laboratory may seek approval to use specific procedures to test the allowable product types and analytes according to parts 4770.1900 to 4770.2400, which specify the commissioner's requirements authorized by Minnesota Statutes, section 152.29, subdivision 1, paragraph (b).

Subp. 2.

Eligibility.

The commissioner may only approve a medical cannabis laboratory that tests under a contract with a medical cannabis manufacturer that can demonstrate its eligibility under this subpart. The laboratory must:

A.

operate using proper laboratory equipment under a quality assurance system and test product types for analytes listed in the commissioner's list in subpart 3;

B.

test medical cannabis delivered in the product types specified in subpart 4;

C.

test accurately for the following elements:

(1)

content, by testing for analytes for a cannabinoid profile;

(2)

contamination, by testing for analytes for:

(a)

metals;

(b)

pesticide residues and plant growth regulators;

(c)

microbiological contaminants and mycotoxins; and

(d)

residual solvents; and

(3)

consistency of medical cannabis by testing for stability.

Subp. 3.

Commissioner list of approved cannabis labs.

A.

The commissioner must publish a list of approved cannabis laboratories in the State Register and on the department's medical cannabis program website at least annually.

B.

The commissioner must provide the following information for each approved laboratory:

(1)

its scope of approval;

(2)

name, telephone number, and e-mail address of primary laboratory contact; and

(3)

physical and mailing address of laboratory.

Subp. 4.

Commissioner's approved medical cannabis product types.

The commissioner's approved product types include:

A.

liquid, including in oil form;

B.

pill;

C.

vaporized delivery method using liquid or oil, but not dried leaves or plant form; and

D.

any other method, excluding smoking, approved by the commissioner.

Subp. 5.

Commissioner's analyte list.

A.

The commissioner must maintain a list of analytes that laboratories must be able to test for. The analyte categories include:

(1)

cannabinoid profile;

(2)

metals;

(3)

pesticide residues and plant growth regulators;

(4)

microbiological contaminants and mycotoxins; and

(5)

residual solvents.

B.

The commissioner must publish the analyte list in the State Register and on the department's medical cannabis program website.

C.

The commissioner must review the analyte list and publish a notice of any analyte updates in the State Register and on the department's medical cannabis program website at least every six months.

Statutory Authority:

MS s 14.389; 152.25; 152.26

History:

39 SR 1080

Published Electronically:

September 7, 2018