Current through all regulations passed and filed through September 16, 2024
(A) A testing laboratory performing analysis
on medical marijuana shall input the results of analysis into the inventory
tracking system. The department may require a testing laboratory to submit, in
portable document format (.pdf), an electronic copy of the results of analysis
of any batches and lots tested to an email address specified and maintained by
the department.
(B) A testing
laboratory performing analysis on medical marijuana shall create a unique
certificate of analysis for each batch or lot tested, which shall include, at
minimum:
(1) The name and license number of
the testing laboratory where the analysis was performed;
(2) The name and license number of the
cultivator or processor from whom the sample was received;
(3) The registered name of the medical
marijuana strain or medical marijuana product that was registered with the
department;
(4) A unique batch or
lot number as defined in rule
3796:1-1-01 of the
Administrative Code that will match the sample of medical marijuana or medical
marijuana products with a batch or lot, in order to facilitate any warnings or
recalls the department deems appropriate;
(5) The date or dates on which each test was
performed;
(6) A grid or table
listing all tests performed, and indicating "pass" or "fail" for each, as
defined in rule
3796:4-2-04
of the Administrative Code.
(7) The
cannabinoid profile of the sample, including the percentage content by weight
for, at minimum:
(a)
Delta-8-tetrahydrocannabinol;
(b)
Delta-8-tetrahydrocannabinolic acid;
(c)
Delta-9-tetrahydrocannabinol ;
(d)
Delta-9-tetrahydrocannabinolic acid ;
(e) Cannabidiol
(CBD);
(f) Cannabidiolic acid
(CBDA);
(g)
THC content as
defined in rule 3796:1-1-01 of the Administrative Code;
(h)
Cannabinol (CBN); and
(i)
Any other
cannabinoid determined by the department.
(8) Moisture content;
(9) Water activity;
(10) Results of analysis for foreign matter
contamination;
(11) Quantitative
results of analysis for microbial contamination;
(12) Quantitative results of analysis for
heavy metal contamination;
(13)
Quantitative results of analysis for pesticide and fertilizer
residue;
(14) Quantitative results
of analysis for mycotoxins;
(15)
Quantitative results of analysis for residual solvents; and
(16) The signature of the laboratory manager
or scientific director certifying the analysis.
(C) The certificate of analysis may contain
the following:
(1) Results of quantitative
analysis of additional cannabinoids for which the laboratory is able to obtain
a standard for comparison;
(2)
Results of quantitative analysis of terpenes for which the laboratory is able
to obtain a standard for comparison;
(D) A certificate of analysis shall not
contain any sum totals of cannabinoids or terpenes, except THC content as
defined in paragraph rule
3796:1-1-01 of the
Administrative Code.
