Ohio Admin. Code 3796:3-2-01 - Processor operations and quality assurance
(A)
A processor shall
establish, maintain, and comply with the policies and procedures contained in
the operations plan submitted by the processor as part of the application that
was approved by the department. The operations plan shall include policies and
procedures for the production, storage, inventory, and transportation of plant
material, medical marijuana extract, and medical marijuana products. At a
minimum, a facility's operations plan shall accomplish the following:
(1)
Designate areas
in the facility that are compartmentalized based on function, such as the
marijuana extraction area, with restricted access between the different areas
based on access credentials assigned by the facility;
(2)
Implement
policies and procedures that provide best practices for safe, secure, and
proper processing of medical marijuana, which includes restricted movement
between the different production areas by personnel;
(3)
Establish
training and safety policies and procedures to ensure that any person involved
in processing medical marijuana:
(a)
Has been fully trained in the safe operation and
maintenance of any and all equipment that will be used for processing medical
marijuana, with supporting documentation of the training;
(b)
Has been fully
trained in the safe use, handling, and storage of any and all chemicals that
will be used for processing medical marijuana, in accordance with OSHA
protocols, with supporting documentation of the training;
(c)
Has been fully
trained in the safe and sanitary execution of any applicable post-extraction
refining protocols;
(d)
Has been fully trained in the safe and sanitary
execution of any applicable manufacturing processes, including any applicable
food safety standards under Chapter 901:3-1 of the Administrative
Code;
(e)
Has direct access to applicable material safety data
sheets and labels;
(f)
Has been fully trained regarding compliance with
Chapter 3796. of the Revised Code and the rules promulgated in accordance with
Chapter 3796. of the Revised Code.
(4)
Document the
chain for all medical marijuana in the inventory tracking
system;
(5)
Establish sanitary operating procedures for the
facility to be maintained in a clean and orderly condition, which includes free
from infestation by rodents, insects, birds, and other animals of any kind;
and
(6)
Maintain a facility with adequate lighting,
ventilation, temperature, sanitation, equipment, and security for the
processing of medical marijuana.
(B)
A processor shall
acquire plant material from a cultivator or dispensary licensed under Chapter
3796. of the Revised Code. Plant material may only be acquired from a
dispensary under the following conditions:
(1)
The plant
material has reached or exceeded the expiration date listed on the
label;
(2)
The plant material shall be processed into medical
marijuana extract for use in the manufacture of medical marijuana
products;
(3)
The plant material acquired from the dispensary shall
not be combined with other batches of plant material during
processing;
(4)
The medical marijuana products manufactured using the
plant material shall not be identified as or associated with the brand,
cultivator, or processor that originally packaged and sold the plant material
to the dispensary; and
(5)
The medical marijuana products manufactured using the
plant material shall be subject to laboratory testing pursuant to rule
3796:3-2-06 of
the Administrative Code.
(C)
A processor may
only use the methods, equipment, solvents, and gases set forth in this
paragraph in the manufacture of medical marijuana products.
(1)
A processor may
use hydrocarbon solvent-based extraction methods in a spark-free and properly
ventilated environment, isolated from any open flame or ignition source, and
may use the following solvents, at a minimum of ninety-nine per cent purity, in
a professional grade, closed-loop extraction system designed to recover the
solvents:
(a)
Propane;
(b)
N-butane;
(c)
Isobutane;
(d)
Heptane;
or
(e)
Other solvents exhibiting minimal potential toxicity to
humans with the approval of the department.
(2)
A processor may
use carbon dioxide-based extraction methods using food grade carbon dioxide at
a minimum of ninety-nine per cent purity in a professional grade, closed-loop
system in which each vessel is rated to a minimum pressure to accommodate the
specific extraction protocol, including supercritical, liquid, and
subcritical.
(3)
A processor may use ethanol at a minimum of ninety-nine
per cent purity to produce extracts for use in the manufacture of medical
marijuana products.
(4)
A processor may use food grade glycerin and propylene
glycol in the manufacture of medical marijuana products.
(5)
A processor may
use non-solvent extraction methods involving the mechanical separation of
cannabinoids from plant material to produce medical marijuana extracts for use
in the manufacture of medical marijuana products.
(6)
A processor may
use non-marijuana ingredients in the manufacture of medical marijuana products
that meet the following conditions:
(a)
The non-marijuana ingredients must be obtained from
licensed and regulated sources that comply with the requirements of federal and
state laws and regulations;
(b)
The non-marijuana
ingredients are nontoxic and safe for human consumption; and
(c)
The non-marijuana
ingredients were not prepared or stored in a private residence.
(7)
A
processor shall comply with all applicable OSHA regulations as well as comply
with and pass inspection for any applicable fire, safety, and building codes
pertaining to the use and storage of the equipment and solvents used in the
manufacture of medical marijuana products.
(D)
A processor using
hydrocarbon solvent-based or carbon dioxide extraction methods shall designate
at least one individual to train and supervise employees in the use of
extraction equipment and associated solvents who has earned, at minimum, a
Bachelor's Degree in engineering or physical sciences from an accredited
university, or who has at least three years of experience in the operation of
the equipment being used in the facility or similar equipment.
(E)
A processor shall
submit, as part of the application process, and maintain an operations plan and
quality control plan for the processing of medical marijuana in its facility.
The purpose of these plans is to ensure a safe, consistent product supply and
minimize the deviation in quality of the production lots of medical marijuana
products
(1)
A
processor shall submit to the department any proposed changes to its plans
approved as part of its application submitted under rule
3796:3-1-02
of the Administrative Code.
(2)
The department
shall review and approve or reject the proposed changes before the proposed
changes can be made.
(F)
A processor shall
maintain a facility in the following manner:
(1)
A processor shall
keep all floors and benches free of debris, dust, and any other potential
contaminants, and shall control rodents and other pests.
(2)
A processor shall
use chemicals, cleaning solutions, and other sanitizing agents approved for use
around vegetables, fruit, medicinal plants, or food contact surfaces, and shall
store them in a manner that protects against contamination.
(3)
A processor shall
keep its equipment in a clean environment and maintain a cleaning and equipment
maintenance log at the facility.
(4)
The processor
shall have its scales, balances, or other weight and/or mass measuring devices
routinely calibrated using "National Institute of Standards and Technology"
(NIST)-traceable reference weights, at least once each calendar year, by an
independent third party approved by the department.
(5)
The water supply
shall be derived from a source that is compliant with rule
901:3-1-05
of the Administrative Code.
(6)
A processor shall
implement policies and procedures related to receiving, inspecting,
transporting, segregating, preparing, packaging, and storing plant material,
medical marijuana extract, and medical marijuana products in accordance with
adequate sanitation principles.
Notes
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03
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