Iowa Administrative Code
Agency 641 - Public Health Department
Chapter 154 - Medical Cannabidiol Program
Rule 641-154.50 - Content Testing
Universal Citation: IA Admin Code 641-154.50
Current through Register Vol. 47, No. 6, September 18, 2024
(1) Cannabinoids.
a. For each
unique lot of medical cannabidiol, and if asked to do so by a requester for
other medical cannabis goods, a laboratory shall, at minimum, test for and
report measurements for the following cannabinoid analytes:
(1) THC;
(2) THCA;
(3) CBD; and
(4) CBDA.
b. A laboratory shall report that the primary
sample passed or failed THC and CBD potency testing according to guidance in
the Laboratory Acceptance and Criteria Document described in subrule
154.47(1).
c. For each cannabinoid
analyte test, a laboratory shall issue a certificate of analysis that contains
the following:
(1) Concentrations of
cannabinoid analytes in mg/ml for liquids and mg/g for solids, or other
measures approved by the department.
(2) Whether the primary sample passed or
failed the test in accordance with paragraph
154.50(1)"b."
d. The laboratory may test for and provide
test results for additional cannabinoid analytes if asked to do so by a
requester.
(2) Contaminants testing.
a. For
each unique lot of medical cannabidiol, unless otherwise referenced in the
laboratory testing requirements and acceptance criteria document described in
subrule 154.47(1), a laboratory shall conduct contaminants testing for the
following analytes:
(1) Residual solvents and
processing chemicals.
(2)
Pesticides.
(3) Microbiological
impurities.
(4) Heavy
metals.
b. The
laboratory may test and provide test results for additional contaminants if
asked to do so by a requestor.
c.
The department shall provide a list of contaminants for which primary samples
are to be tested with corresponding action levels on the department's website
(hhs.iowa.gov).
d. For each
contaminant for which a laboratory tests, the laboratory shall report that the
primary sample passed the testing if the concentration of contaminant is at or
below the action level approved by the department.
e. For each contaminant for which a
laboratory tests, the laboratory shall report that the primary sample failed
the testing if the concentration of contaminants is above the action level
approved by the department.
f. If a
laboratory is using gas chromatography-mass spectrometry instrumentation to
analyze primary samples for contaminants and the laboratory determines that a
primary sample contains contaminants or chemical analytes that are not included
in the department-approved list of required tests, the laboratory shall attempt
to achieve tentative identification and semiquantitative results of the
contaminant analytes.
g. The
laboratory may test for and provide test results for additional contaminants or
processing chemicals if asked to do so by a requester.
h. For each primary sample tested, a
laboratory shall issue a certificate of analysis that contains the following:
(1) The name and concentration of each
contaminant for which the primary sample was tested.
1. The concentrations shall be listed in
parts per million (ppm) or other units as determined by the
department.
2. The laboratory shall
report a result of "detected but not quantified" for any contaminant that falls
below the LOQ, has a signal-to-noise ratio of greater than 3:1, and meets
identification criteria.
(2) Whether the primary sample passed or
failed the test in accordance with paragraphs 154.50(2)"c" and
"d."
(3) The
names and amounts of any additional contaminants identified by the
laboratory.
i. If the
primary sample fails testing for residual solvents and processing chemicals,
the lot fails laboratory testing.
j. When a laboratory identifies additional
contaminants in a primary sample, the laboratory shall:
(1) Notify the department of the additional
contaminants and the amounts detected, if applicable.
(2) Refrain from issuing a final certificate
of analysis until given approval to do so by the department.
Disclaimer: These regulations may not be the most recent version. Iowa 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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