Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
Quality control program.
A medical cannabis manufacturer must develop and implement a
written quality assurance program that assesses the chemical and
microbiological composition of medical cannabis. Assessment includes a profile
of the active ingredients, including shelf life, and the presence of inactive
ingredients and contaminants. A medical cannabis manufacturer must use these
testing results to determine appropriate storage conditions and expiration
dates.
Subp. 2.
Sampling protocols.
A medical cannabis manufacturer must develop and follow
written procedures for sampling medical cannabis that require the manufacturer
to:
A. conduct sample collection in a
manner that provides analytically sound and representative samples;
B. document every sampling event and provide
this documentation to the commissioner upon request;
C. describe all sampling and testing plans in
written procedures that include the sampling method and the number of units per
batch to be tested;
D. ensure that
random samples from each batch are:
(1) taken
in an amount necessary to conduct the applicable test;
(2) labeled with the batch unique identifier;
and
(3) submitted for testing;
and
E. retain the
results from the random samples for at least five years.
Subp. 3.
Sampling; testing
levels.
A medical cannabis manufacturer must:
A. develop acceptance criteria for all
potential contaminants based on the levels of metals, microbes, or other
contaminants that the manufacturer uses in cultivating and producing medical
cannabis. The testing levels are subject to approval by the
commissioner;
B. conduct sampling
and testing using acceptance criteria that are protective of patient health.
The sampling and testing results must ensure that batches of medical cannabis
meet allowable health risk limits for contaminants;
C. reject a medical cannabis batch that fails
to meet established standards, specifications, and any other relevant
quality-control criteria;
D.
develop and follow a written procedure for responding to results indicating
contamination. The procedure must include destroying contaminated medical
cannabis and determining the source of contamination; and
E. retain documentation of test results,
assessment, and destruction of medical cannabis for at least five
years.
Subp. 4.
Quality assurance program; stability testing.
A. The quality assurance program must include
procedures for performing stability testing of each product type produced to
determine product shelf life that addresses:
(1) sample size and test intervals based on
statistical criteria for each attribute examined to ensure valid stability
estimates;
(2) storage conditions
for samples retained for testing; and
(3) reliable and specific test
methods.
B. Stability
studies must include:
(1) medical cannabis
testing at appropriate intervals;
(2) medical cannabis testing in the same
container-closure system in which the drug product is marketed; and
(3) testing medical cannabis for
reconstitution at the time of dispensing, as directed in the labeling, and
after the samples are reconstituted.
C. If shelf-life studies have not been
completed before July 1, 2015, a medical cannabis manufacturer may assign a
tentative expiration date, based on any available stability information. The
manufacturer must concurrently conduct stability studies to determine the
actual product expiration date.
D.
After the manufacturer verifies the tentative expiration date, or determines
the appropriate expiration date, the medical cannabis manufacturer must include
that expiration date on each batch of medical cannabis.
E. Stability testing must be repeated if the
manufacturing process or the product's chemical composition is
changed.
Subp. 5.
Reserve samples.
A. A medical
cannabis manufacturer must retain a uniquely labeled reserve sample that
represents each batch of medical cannabis and store it under conditions
consistent with product labeling. The reserve sample must be stored in the same
immediate container-closure system in which the medical cannabis is marketed,
or in one that has similar characteristics. The reserve sample must consist of
at least twice the quantity necessary to perform all the required
tests.
B. A medical cannabis
manufacturer must retain the reserve for at least one year following the
batch's expiration date.
Subp.
6.
Retesting.
If the commissioner deems that public health may be at risk,
the commissioner may require the manufacturer to retest any sample of plant
material or medical cannabis.
