Current through Register Vol. 47, No. 6, September 18, 2024
(1)
Quality
control program. A manufacturer shall develop and implement a written
quality assurance program that assesses the chemical and microbiological
composition of medical cannabidiol. Assessment includes a profile of the active
ingredients, including stability studies, and the presence of inactive
ingredients and contaminants. A manufacturer shall use these testing results to
determine appropriate storage conditions and product expiration
dates.
(2)
Sampling
protocols. A manufacturer shall develop and follow written procedures
for sampling medical cannabidiol 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 department upon request;
c. Describe all sampling and testing plans in
written procedures that include the sampling method and the number of units per
lot to be tested;
d. Ensure that
random samples from each lot are:
(1) Taken in
an amount necessary to conduct the applicable test;
(2) Labeled with the lot number;
and
(3) Submitted for
testing;
e. Retain the
results from the random samples for at least five years; and
f. Notify the department at least two
business days prior to sample collection and allow the department or its
designees to be present to observe the sampling procedures when the samples are
to be sent to a laboratory for testing.
(3)
Sampling and testing. A
manufacturer shall:
a. Work with the
department and laboratory personnel to develop acceptance criteria for
contaminants, including but not limited to cannabinoid content, metals,
microbiological impurities, solvents, or other contaminants that the
manufacturer uses in cultivating and producing medical cannabidiol;
b. Conduct sampling and testing of plant
material and medical cannabidiol lots using acceptance criteria that are
protective of patient health. Sampling method results shall be approved by the
department and laboratory personnel and shall ensure that lots of medical
cannabidiol are homogenous and representative of the process or package
lot;
c. Reject and destroy medical
cannabidiol from a lot that fails to meet established standards, and any other
relevant quality control criteria, when remixing and retesting are not
warranted;
d. Develop and follow a
written procedure for responding to results failing to meet established
standards, and any other relevant quality control criteria, including:
(1) Criteria for when remixing and retesting
are warranted;
(2) Instructions for
destroying contaminated or substandard medical cannabidiol when remixing and
retesting are not warranted; and
(3) Instructions for determining the source
of contamination;
e.
Retain documentation of test results, assessment, and destruction of medical
cannabidiol for at least five years.
(4)
Stability testing.
a. The quality assurance program shall
include procedures for performing stability testing of each product type
produced to determine product expiration dates. The procedures shall describe:
(1) Sample size and test intervals based on
departmental guidance pursuant to subrule 154.47(1);
(2) Storage conditions for samples retained
for testing; and
(3) Reliable and
specific test methods.
b. Stability studies shall include:
(1) Medical cannabidiol testing at
appropriate intervals; and
(2)
Medical cannabidiol testing in the same container-closure system in which the
medical cannabidiol is marketed and dispensed.
c. If product-expiration-date studies have
not been completed, a manufacturer shall assign a tentative product expiration
date, not to exceed one year, based on any available stability
information.
d. If a manufacturer
determines a product expiration date beyond one year, a manufacturer shall
submit justification to the department, and receive approval, prior to labeling
a product with an expiration date beyond one year.
(5)
Reserve samples.
a. A manufacturer shall retain a uniquely
labeled reserve sample that represents each lot of medical cannabidiol and
store the reserve sample under conditions consistent with product labeling. The
reserve sample shall be stored in the same immediate container-closure system
in which the medical cannabidiol is marketed or in one that has similar
characteristics. The reserve sample shall consist of at least twice the
quantity necessary to perform all the required tests.
b. A manufacturer shall retain the reserve
for at least one year from the date of manufacture.
c. After one year from the date of
manufacture, reserve samples shall be destroyed.
(6)
Retesting. If the
department deems that public health may be at risk, the department may require
the manufacturer to retest any sample of medical cannabidiol.
(7)
Disposal of substandard
product. A manufacturer shall dispose of all medical cannabidiol when
samples fail to meet established standards, and other relevant quality control
criteria.
(8)
Recall
procedures. Each manufacturer shall establish a procedure for
recalling product from the market that has a reasonable probability of causing
an unexpected or harmful response in a patient population, despite appropriate
use, that outweighs the potential benefit of the medical cannabidiol. This
procedure shall include:
a. Factors that make
a recall necessary;
b.
Manufacturer's personnel who are responsible for overseeing the recall;
and
c. How to notify affected
parties of a recall.
