Current through all regulations passed and filed through September 16, 2024
(A) A testing laboratory shall analyze a
sample of at least one half of one percent of the net weight of the batch from
each batch of dried, cured plant material intended to be sold to a dispensary
licensed by the state of Ohio board of pharmacy for, at minimum:
(1) Moisture content;
(2) Water activity;
(3) Cannabinoid potency including, 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.
(4) Foreign matter contamination;
(5) Microbial contamination;
(6) Mycotoxin contamination;
(7) Heavy metal contamination including, at a
minimum, arsenic, cadmium, lead, and mercury; and
(8) Pesticide and fertilizer
residue.
(B) A testing
laboratory shall analyze a sample of at least one half of one percent of the
net weight of the batch from each batch of plant material intended to be sold
to a processor licensed by the department for use in the manufacture of medical
marijuana products for, at minimum:
(1)
Pesticide and fertilizer residue; and
(2) Cannabinoid potency for, at a 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.
(C) A testing laboratory shall analyze a
sample of one unit of the same size, weight, and volume intended to be packaged
and sold to a licensed dispensary from each lot of medical marijuana products
prior to sale to a dispensary licensed by the state of Ohio board of pharmacy
for, at minimum:
(1) Cannabinoid potency
including, 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.
(2) Foreign matter contamination;
(3) Microbial contamination;
(4) Mycotoxin contamination, if a medical
marijuana extract was used in the manufacture of the product that was not
previously tested for mycotoxin contamination by a licensed testing
laboratory;
(5) Heavy metal
contamination including, at a minimum, arsenic, cadmium, lead, and mercury, if
a medical marijuana extract was used in the manufacture of the product that was
not previously tested for heavy metal contamination by a licensed testing
laboratory;
(6) Pesticide and
fertilizer residue, if a medical marijuana extract was used in the manufacture
of the product that was not previously tested for pesticide or fertilizer
residue contamination by a licensed testing laboratory; and
(7) Residual solvents, if a hydrocarbon-based
medical marijuana extract was used in the manufacture of the product that was
not previously tested for residual solvent contamination by a licensed testing
laboratory.
(D) A
testing laboratory may perform analysis on marijuana-derived ingredients used
in the manufacture of medical marijuana products, including but not limited to
medical marijuana extract. When performing analysis on medical
marijuana-derived ingredients, the following sample sizes and required tests
shall apply:
(1) A sample of at least one half
of one percent of the net weight of the batch from a batch of medical marijuana
extract derived from a system utilizing hydrocarbon solvents for, at minimum:
(a) Pesticide and fertilizer residue;
and
(b) Cannabinoid potency
including, at minimum:
(i)
Delta-8-tetrahydrocannabinol;
(ii)
Delta-8-tetrahydrocannabinolic acid;
(iii)
Delta-9-tetrahydrocannabinol;
(iv)
Delta-9-tetrahydrocannabinolic acid;
(v)
Cannabidiol
(CBD);
(vi)
Cannabidiolic
acid (CBDA);
(vii)
THC content as defined by rule 3796:1-1-01 of the
Administrative Code;
(viii)
Cannabinol (CBN); and
(ix)
Any other
cannabinoid determined by the department.
(c) Mycotoxin contamination;
(d) Heavy metal contamination including, at a
minimum, arsenic, cadmium, lead, and mercury; and
(e) Residual solvents.
(2) A sample of at least one half of one
percent of the net weight of the batch from a batch of medical marijuana
extract derived from a system utilizing carbon dioxide for, at minimum:
(a) Pesticide and fertilizer residue;
and
(b) Cannabinoid potency for, at
a minimum:
(i)
Delta-8-tetrahydrocannabinol;
(ii)
Delta-8-tetrahydrocannabinolic acid;
(iii)
Delta-9-tetrahydrocannabinol;
(iv)
Delta-9-tetrahydrocannabinolic acid;
(v)
Cannabidiol
(CBD);
(vi)
Cannabidiolic
acid (CBDA);
(vii)
THC content as defined in rule 3796:1-1-01 of the
Administrative Code;
(viii)
Cannabinol (CBN); and
(ix)
Any other
cannabinoid determined by the department.
(c) Mycotoxin contamination; and
(d) Heavy metal contamination including, at a
minimum, arsenic, cadmium, lead, and mercury.
(3) A sample of at least one half of one per
cent of the net weight of the batch from a batch of medical marijuana extract
derived from a method that does not involve the use of a hydrocarbon or carbon
dioxide as a solvent for, at a minimum:
(a)
Cannabinoid potency including, at minimum:
(i)
Delta-8-tetrahydrocannabinol;
(ii)
Delta-8-tetrahydrocannabinolic acid;
(iii)
Delta-9-tetrahydrocannabinol;
(iv)
Delta-9-tetrahydrocannabinol;
(v)
Cannabidiol
(CBD);
(vi)
Cannabidiolic
acid (CBDA);
(vii)
THC content as defined by rule 3796:1-1-01 of the
Administrative Code;
(viii)
Cannabinol (CBN); and
(ix)
Any other
cannabinoid determined by the department.
(b) Foreign matter contamination;
(c) Microbial contamination;
(d) Mycotoxin contamination;
(e) Heavy metal contamination including, at a
minimum, arsenic, cadmium, lead, and mercury; and
(f) Pesticide and fertilizer
residue.
(E)
A testing laboratory may request additional sample material in excess of the
amounts listed in this rule if necessary for completion of the required quality
assurance tests.
(F) For the
purposes of microbial contamination analysis, a sample provided to a testing
laboratory shall be deemed to have passed if it satisfies the standards set
forth in Table 9 of the "Cannabis Inflorescence: Standards of Identity,
Analysis, and Quality Control" (2014) monograph.
(1) If a batch of plant material is not
deemed to have passed testing for microbial contamination, that batch may be
designated for extraction by hydrocarbonbased or carbon dioxide-based
methods
(2) Medical marijuana
extract derived from a batch of plant material not deemed to have passed
testing for microbial contamination must be tested for microbial contamination
prior to use in the manufacture of medical marijuana products.
(G) For the purposes of mycotoxin
contamination analysis, a sample provided to a testing laboratory pursuant to
this rule shall be deemed to have passed if:
(1) The total of the detected amounts, if
any, of aflatoxin B1, aflatoxin B2, aflatoxin G1, and aflatoxin G2 is less than
twenty micrograms per kilogram; and
(2) The detected amount, if any, of
ochratoxin A is less than twenty micrograms per kilogram.
(H) For the purposes of heavy metal
contamination analysis, a sample provided to a testing laboratory shall be
deemed to have passed if:
(1) The detected
amount of arsenic, if any, is less than 0.14 micrograms per kilogram.
(2) The detected amount of cadmium, if any,
is less than 0.09 micrograms per kilogram.
(3) The detected amount of lead, if any, is
less than 0.29 micrograms per kilogram.
(4) The detected amount of mercury, if any,
is less than 0.29 micrograms per kilogram.
(I) For the purposes of pesticide residue
analysis, a sample shall be deemed to have passed if it satisfies the most
stringent acceptable standard for an approved pesticide chemical residue in a
food item as set forth in Subpart C of 40 C.F.R. Part 180, as effective on
September 8, 2017. A sample shall automatically be deemed to have failed if
residue is detected from any pesticide not on the approved pesticide list
maintained by the department, regardless of the detected level of
residue.
(J) Except as provided in
paragraph (G)(1) of this rule, if a sample is deemed to have failed tests for
any contaminants listed in this rule, the cultivator or processor that provided
the sample must immediately destroy the corresponding batch of plant material
or extract or lot of medical marijuana products and document the destruction in
the inventory tracking system.
