Minnesota Administrative Rules
Agency 144 - Health Department
Chapter 4770 - MEDICAL CANNABIS
Part 4770.2100 - MEDICAL CANNABIS LABORATORY APPROVAL; INSPECTION AND COMPLIANCE
Universal Citation: MN Rules 4770.2100
Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1. Laboratory inspection and reports.
A. The commissioner may inspect a lab without
prior notice at any time during normal business hours to verify compliance with
parts 4770.1900 to 4770.2200. The commissioner may inspect:
(1) approved laboratories; and
(2) laboratories requesting
approval.
B. If the
commissioner has sufficient cause to believe that a laboratory's proficiency,
execution, or validation of analytical methodologies are deficient, the
commissioner may require and a laboratory must obtain third-party validation
and ongoing monitoring of the laboratory . The laboratory must pay for all
costs associated with the commissioner-ordered third-party
validation.
C. An approved
laboratory must provide reports to the commissioner regarding chemical
compositions, microbial compositions, dosages, and noncannabis drug
interactions under Minnesota Statutes, section
152.25, as
requested by the commissioner.
D.
An approved laboratory must provide reports to the medical cannabis
manufacturer on forms provided by the commissioner.
Subp. 2. Laboratory approval requirements.
A. An approved laboratory
may not misrepresent its approval on any document or marketing
material.
B. A laboratory must make
its current approval documentation and corresponding scope of approval
available upon the request of:
(1) a
client;
(2) the commissioner;
or
(3) a regulatory
agency.
Subp. 3. Rescinding approval.
A. The commissioner may rescind an approved
cannabis laboratory's approval if the commissioner determines the laboratory
has failed to:
(1) submit accurate
application materials to the commissioner under part 4770.2000;
(2) comply with application requirements
under part 4770.2000;
(3) comply
with all applicable laws, rules, standards, policies, and procedures;
(4) allow the commissioner or designee to
perform physical inspection of facilities;
(5) submit copies of inspection and
corrective reports issued by the approved ISO/IEC 17025 accreditation body, as
requested by the commissioner;
(6)
provide the medical cannabis manufacturer with timely reports; or
(7) provide the medical cannabis manufacturer
with reports compliant with the commissioner's designated test report
format.
B. A laboratory
must return its approval letter to the commissioner immediately if the
commissioner rescinds the laboratory's approval.
C. The commissioner's decision to rescind
approval of an approved medical cannabis laboratory is a final agency
decision.
Disclaimer: These regulations may not be the most recent version. Minnesota may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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