Chapter 3796:3-2 Operations

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.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:3-2-02 Processor packaging and labeling.

(A) A processor distributing medical marijuana to a dispensary shall meet the following requirements:

(1) A processor shall place medical marijuana in a child-proof, tamper-evident, light-resistant package approved by the department prior to distribution to a dispensary. Approved packaging shall maintain the integrity and stability of the medical marijuana, and shall comply with the rules promulgated by the state of Ohio board of pharmacy pursuant to Chapter 3796. of the Revised Code.

(2) A label shall be affixed to every package and state in legible English:

(a) The name and license number of the cultivator where the packaged plant material was cultivated or the name and license number of the processor where the medical marijuana products were manufactured;

(b) The name and license number of the dispensary facility receiving the shipment;

(c) The product identifier;

(d) The registered name of the medical marijuana plant material strain that was registered with the department or the registered name, form, and dose of the medical marijuana product that was registered with the department;

(e) A unique batch or lot number as defined in paragraph (A) of rule 3796:1-1-01 of the Administrative Code that will match the medical marijuana or medical marijuana products with a batch or lot, in order to facilitate any warnings or recalls the department deems appropriate;

(f) The dates of manufacture, final testing, and packaging;

(g) The total weight in grams of medical marijuana or medical marijuana products in each package;

(h) The name and license number of the independent testing laboratory that performed the required tests on the batch or lot from which the medical marijuana or medical marijuana products in the package were taken;

(i) The laboratory analysis and cannabinoid profile, including the percentage content by weight or total milligrams and milligrams per unit for:

(i) Delta-9-tetrahydrocannabinol (THC);

(ii) Delta-9-tetrahydrocannabinolic acid (THCA);

(iii) cannabidiol (CBD); and

(iv) cannabidiolic acid (CBDA).

(j) The expiration date, which shall not exceed one calendar year from the date of manufacture;

(k) If the product is edible, the following additional information:

(i) A list of all ingredients and subingredients, providing that all ingredients comply with the standards of identity under rule 901:3-1-12 of the Administrative Code;

(ii) A list of all major food allergens as identified in 21 USC 343; and

(iii) A statement with the following language: "Caution: When eaten or swallowed, the effects and impairment caused by this drug may be delayed."

(l) If a marijuana extract was used in the manufacture of the product, a disclosure of the type of extraction process and any solvent, gas, or other chemical used in the extraction process or any other compound added to the extract; and

(m) A statement with the following language: "This product is for medical use and not for resale or transfer to another person. This product may cause impairment and may be habit-forming. This product may be unlawful outside the State of Ohio."

(n) If the product was manufactured using plant material that was acquired from a dispensary pursuant to paragraph (B) of rule 3796:3-2-01 of the Administrative Code, a statement with the following language: "This product was manufactured using medical marijuana that exceeded the expiration date defined in OAC 3796:1-1-01."

(o) The intended method of administration of the medical marijuana product.

(B) A processor that elects to or is required to determine portions for an edible medical marijuana product under rules promulgated by the state of Ohio board of pharmacy pursuant to Chapter 3796. of the Revised Code shall apply a universal symbol that denotes that the product contains medical marijuana as an ingredient, as determined by the department, to each portion of the medical marijuana product, in accordance with the following:

(1) If the medical marijuana product is presented as separate single portions, the processor shall apply the universal symbol to each single portion;

(2) If the medical marijuana product is presented as a single unit comprised of more than one portion, the processor shall make clearly visible lines of demarcation between portions and apply the universal symbol to each portion; and

(3) The size of the universal symbol marking shall be determined by the size of the portion instead of the overall product size, and shall not be less than one-fourth inch by one- fourth inch.

(C) The label may contain the approval or certification logo of a third-party certifier of manufacturing or cultivation practices if:

(1) The third-party certifier does not have a direct or indirect financial interest in any medical marijuana entity licensed in the state of Ohio; and

(2) The certification protocols used by the third-party certifier have been reviewed and approved by the department.

(D) A label shall not contain:

(1) Any false or misleading statement or design;

(2) Depictions of the product, cartoons, or images that are not registered with the department, which includes any insignia related to a governmental entity;

(3) Any sum totals of cannabinoids or terpenes, except as defined in paragraph (A)(49) of rule 3796:1-1-01 of the Administrative Code; or

(4) Any information that would violate paragraph (E) of rule 3796:5-7-01 of the Administrative Code.

(E) A processor may provide a dispensary free samples of plant material sold at the dispensary. A free sample shall be packaged in a sample jar protected by a plastic or metal mesh screen to allow patients and caregivers to smell the plant material before purchase. A sample jar may not contain more than three grams of a particular strain of plant material. The sample jar and the plant material within may not be sold to a patient or caregiver and shall be destroyed by the dispensary after use by the dispensary. The dispensary shall document the destruction of every free sample in accordance with the rules established pursuant to Chapter 3796. of the Revised Code.

(F) It is prohibited for anyone to knowingly or intentionally alter, obliterate, or otherwise destroy any container or label attached to an approved container. In the event a container or label is altered, obliterated, or otherwise destroyed, the department may act in accordance with rule 3796:5-6-01 of the Administrative Code.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:3-2-03 Processor waste disposal.

(A) A licensed processor shall dispose of undesired, excess, unauthorized, obsolete, adulterated, or deteriorated medical marijuana waste in the following manner:

(1) By disposal executed in accordance with the processor's disposal plan under the supervision of a type 1 key employee, as defined in paragraph (H) of rule 3796:5-2-01 of the Administrative Code, and in such a manner as to render the medical marijuana waste unusable; or

(2) By surrender without compensation of such medical marijuana to the director or the director's designee, at the director's discretion.

(B) The disposal procedures established by the processor and submitted as part of the application process shall be sufficient to render the medical marijuana waste unusable. Medical marijuana waste that is rendered unusable shall be discarded into a locked dumpster or other approved, locked container for removal from the facility by a waste removal company selected by the processor. Medical marijuana waste shall be rendered unusable by grinding and incorporating the medical marijuana waste with one or more of the non-consumable, solid wastes listed below, such that the resulting mixture is at least fifty-one per cent non-marijuana waste:

(1) Paper waste;

(2) Cardboard waste;

(3) Food waste;

(4) Yard waste;

(5) Soil or other growth media;

(6) Other wastes approved by the department.

(C) The disposal of medical marijuana or medical marijuana products shall be performed by a type 1 key employee in the designated destruction area identified in the processor's plans and specifications submitted to the department. The disposal shall be performed under video surveillance from the time the destruction begins to when it is placed in a locked dumpster or other approved, locked container and removed from the facility.

(D) The type 1 key employee overseeing the disposal of medical marijuana shall maintain and make available in accordance with this chapter a separate record of every disposal indicating:

(1) The date and time of disposal;

(2) The manner of disposal;

(3) The volume and weight of approved solid waste used to render the medical marijuana waste unusable;

(4) The reasoning for and description of the disposal;

(5) The signature of the type 1 employee overseeing the disposal of the medical marijuana;

(6) The batch number or numbers, volume, and weight of any medical marijuana extract or plant material being disposed of; and

(7) The lot number, registered product name, volume, weight, and unit count of any medical marijuana products being disposed of.

(E) The disposal of other waste from the processor that does not include medical marijuana, including hazardous waste and liquid waste, shall be performed in a manner consistent with federal and state law.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:3-2-04 Processor inventory control and storage.

(A) A processor shall track and submit into the inventory tracking system any information the department determines necessary for maintaining and tracking medical marijuana extract and medical marijuana products.

(1) Upon completion of each iteration of an approved extraction process, the processor shall securely attach a label to the container of medical marijuana extract that includes, at a minimum, the following information:

(a) The processor's name and license number;

(b) The batch numbers of any batches of plant material used in the extraction;

(c) The registered strain names of any plant material used during the extraction;

(d) The batch number assigned to the batch of medical marijuana extract;

(e) The date of extraction; and

(f) The net weight and volume of medical marijuana extract.

(2) Upon completion of each iteration of an approved manufacturing process, the processor shall securely attach a label to the container of medical marijuana products that includes, at a minimum, the following information:

(a) The processor's name and license number;

(b) The registered product name;

(c) The batch numbers of any batches of medical marijuana extract used in the manufacturing process;

(d) The date of manufacture; and

(e) The net weight and unit count of medical marijuana products prepared or packaged for sale to a licensed dispensary.

(B) Prior to commencing business, each processor shall establish ongoing inventory controls and procedures for the conduct of inventory reviews and comprehensive inventories of medical marijuana, medical marijuana extract, and medical marijuana products for traceability in the department's inventory tracking system, which shall enable the processor to detect any diversion, theft, or loss in a timely manner.

(C) Upon commencing business, each processor shall prepare a weekly inventory of medical marijuana at the facility, which shall include, at a minimum:

(1) The date of the inventory;

(2) The amount of medical marijuana on hand, which shall include:

(a) The net weight of plant material;

(b) The net weight and volume of medical marijuana extract;

(c) The net weight and unit count of medical marijuana products prepared or packaged for sale to a dispensary;

(d) The results from a testing laboratory indicating the amounts of delta-9-tetreahydrocannabinol and cannabidiol, if available; and

(e) The registered strain or product names and batch or lot numbers of plant material, medical marijuana extract, and medical marijuana products.

(3) The amount of medical marijuana and medical marijuana products sold since previous weekly inventory, which shall include:

(a) The date of sale;

(b) The name of the dispensary to which the medical marijuana and medical marijuana products were sold;

(c) The lot number, strain or product name, and quantity sold.

(4) The date, quantity, and method of disposal of any plant material, medical marijuana extract, and medical marijuana products, if applicable;

(5) A summary of the inventory findings; and

(6) The name, signature and title of the type 1 or type 2 employees who conducted the inventory and oversaw the inventory.

(D) On an annual basis and as a condition for renewal of a processor license, a processor shall conduct a physical, manual inventory of plant material, medical marijuana extract, and medical marijuana products on hand at the processor and compare the findings to an annual inventory report generated using the inventory tracking system. If any discrepancies are discovered outside of loss standard to the industry due to moisture loss and handling, the processor shall report such findings to the department in accordance with rule 3796:5-4-01 of the Administrative Code.

(E) All inventories, procedures, and other documents required by this chapter shall be maintained on the premises and made available to the department at all times.

(F) A processor is authorized to store plant material, medical marijuana extract, and medical marijuana product inventory on the premises in a designated, enclosed, locked area identified in the processor's plans and specifications submitted to the department and accessible only by authorized individuals. Notwithstanding the requirements of this chapter nothing shall prohibit members of the department, the department's designee, law enforcement, or other federal, state, or local government officials from entering any area of a processor facility if necessary to perform their governmental duties.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:3-2-05 Processor security.

(A) The department shall determine the appropriate storage and security requirements for all processor facilities, and may require additional safeguards to ensure the security of medical marijuana. A processor shall comply with the security plan submitted as part of its processor provisional license application. At a minimum, the processor shall:

(1) Install an adequate security alarm system around the perimeter of the facility to prevent and detect diversion, theft, or loss of medical marijuana, utilizing commercial grade equipment;

(2) Maintain or construct fencing and gates that surround the facility to prevent unauthorized entry to the facility or unauthorized access to waste disposal containers located outside the facility;

(3) Utilize a video surveillance recording system installed by a vendor that is approved by the department and that meets the standards required by the department to prevent and detect diversion, theft, or loss of medical marijuana;

(4) Maintain all security system equipment and video surveillance systems in a secure location so as to prevent theft, loss, destruction, or alterations:

(a) A processor shall limit access to surveillance areas to type 1 key employees that are essential to surveillance operations, law enforcement agencies, security system service employees, the department, and others when approved by the department; and

(b) A processor shall make available to the department, upon request, a current list of type 1 key employees and contractors who have access to the surveillance room. A processor shall keep all on-site surveillance rooms locked and shall not use such rooms for any other functions.

(5) Keep all approved safes, vaults, or any other approved equipment or areas used for processing or storing of plant material, medical marijuana extract, and medical marijuana products securely locked and protected from unauthorized access;

(6) Ensure the outside perimeter of the facility is well-lit and in accordance with the processor's plan in its license application;

(7) Restrict access to any area within the facility containing plant material, medical marijuana extract, or medical marijuana products to all persons except licensed employees and agents or an individual permitted to access the facility under the supervision of a licensed employee or agent in accordance with the visitor authorization procedures set forth in rule 3796:5-2-01 of the Administrative Code;

(8) Limit the use of combination numbers, passwords, or electronic or biometric security systems to licensed, authorized employees, and prevent the sharing of any employee-specific access credentials; and

(9) Not allow keys to be left in the locks and not store or place keys or badges in a location accessible to persons other than licensed, authorized employees.

(B) The processor shall install a security alarm system and a video surveillance recording system under paragraph (A) of this rule. A security alarm system and video surveillance recording system shall, at a minimum, contain the following:

(1) A system designed to detect motion and identify unauthorized access to the facility;

(2) Video cameras that capture the entire facility, including direct placement near the entrances, exits, and parking areas to capture a clear and certain identification of any person entering or exiting the facility, which shall be appropriate for the normal lighting conditions of the area under surveillance;

(3) Video cameras shall be directed at all approved safes, approved vaults, marijuana sales areas, and any other area where plant material, medical marijuana extract, or medical marijuana products are being processed, stored, or handled;

(4) The video surveillance recording system shall comply with the following minimum capabilities:

(a) Provide a direct feed and login capabilities to the department to allow for real-time access and monitoring of the facility via the live video surveillance recording system.

(b) A display monitor with a minimum screen size of twelve inches shall be connected to the electronic recording security system at all times.

(c) Installed in a manner that will prevent cameras from being readily obstructed, tampered with, or disabled.

(d) The ability to immediately produce a clear color still photo that is a minimum of ninety-six hundred dpi from any camera image, live or recorded.

(e) A date and time stamp embedded on all recordings. The date and time shall be synchronized and set correctly and shall not significantly obscure the picture.

(f) Cameras installed outdoors and in low-light interior areas shall be day/night cameras with a minimum resolution of six hundred lines per inch (analog) or D1 (IP) and a minimum light factor requirement of 0.7 LUX. The installation of additional lighting may be required to increase picture clarity and brightness. Cameras shall be calibrated and focused to maximize the quality of the recorded image.

(g) Allow for the exporting of still images in an industry standard image format, including .jpg, .bmp and .gif. Exported video shall have the ability to be archived in a proprietary format that ensures authentication of the video and guarantees that no alteration of the recorded image has taken place. Exported video shall also have the ability to be saved in an industry standard file format that can be played on a standard computer operating system. All recordings shall be erased or destroyed prior to disposal.

(h) Security recordings shall provide an image resolution of at least D1, and the image frame rate shall be at least three frames per second during alarm or motion based recording.

(i) Repair or replace any failed component of the video surveillance recording system within twenty-four hours, unless notice is provided to the department and an extension is approved.

(5) Twenty-four hour live feed with motion-activated recording capabilities from all video cameras, which the processor facility shall make available for immediate viewing by the department upon request and shall retain the recordings for at least forty-five days. If a processor is aware of a pending criminal, civil or administrative investigation or legal proceeding for which a recording may contain relevant information, the processor shall retain an unaltered copy of the recording until the investigation or proceeding is closed or the entity conducting the investigation or proceeding notifies the processor that it is not necessary to retain the recording;

(6) Silent alarm, which can be utilized in the event of a holdup or other instances of duress, which notifies law enforcement;

(7) Panic alarm, which for purposes of this subsection means an audible security alarm system signal generated by the manual activation of a device intended to signal a life threatening or emergency situation requiring a law enforcement response;

(8) Automatic voice dialer, which for purposes of this subsection means any electrical, electronic, mechanical, or other device capable of being programmed to send a prerecorded voice message, when activated, over a telephone line, radio or other communication system, to a law enforcement, public safety or emergency services agency requesting dispatch;

(9) A failure notification system that provides an audible, text or visual notification of any failure in the surveillance system. The failure notification system shall provide an alert to the processor facility within five minutes of the failure, either by telephone, email, or text message; and

(10) The ability to comply with the security requirements of this rule for a period of at least forty-eight hours during a power outage.

(C) In addition to the requirements listed in paragraph (B) of this rule, each processor shall have a back-up alarm system approved by the department that shall detect unauthorized entry during times when no employees are present at the facility and that shall be provided by a company supplying commercial grade equipment, which shall not be the same company supplying the primary security system.

(D) A processor shall keep all security equipment in good-working order and the systems shall be inspected and all devices tested on an annual basis.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:3-2-06 Laboratory testing.

(A) Prior to the sale of any medical marijuana product to a dispensary licensed under Chapter 3796. of the Revised Code, an employee of a licensed testing laboratory shall select a random sample from every lot of medical marijuana products at the facility that is of sufficient quantity to perform the required tests. Every sample shall be tested by a licensed testing laboratory in accordance with the testing standards established for testing laboratories in the rules promulgated pursuant to Chapter 3796. of the Revised Code. At a minimum, a testing laboratory shall test every sample for:

(1) Microbial contaminants;

(2) Cannabinoid potency including, at minimum:

(a) Delta-9-tetrahydrocannabinolic acid (THCA);

(b) Delta-9-tetrahydrocannabinol (THC);

(c) Cannabidiolic acid (CBDA); and

(d) Cannabidiol (CBD).

(3) If the medical marijuana extract used in the manufacture of the product was not previously tested by a licensed testing laboratory for the following contaminants, the product sample shall also be analyzed for:

(a) Mycotoxins;

(b) Heavy metals, including, at a minimum, arsenic, cadmium, lead, and mercury;

(c) Pesticide and fertilizer residue; and

(d) Residual solvents, if a solvent other than carbon dioxide was used in the extraction process.

(B) Prior to the sale of any medical marijuana product to a dispensary licensed under Chapter 3796. of the Revised Code that was manufactured using plant material acquired from a dispensary pursuant to paragraph (B) of rule 3796:3-2-01 of the Administrative Code, an employee of a licensed testing laboratory shall select a random sample from every lot of medical marijuana products at the facility that is of sufficient quantity to perform the required tests. Every sample shall be tested by a licensed testing laboratory in accordance with the testing standards established for testing laboratories in the rules promulgated pursuant to Chapter 3796. of the Revised Code. At a minimum, a testing laboratory shall test every sample for:

(1) Microbial contaminants;

(2) Cannabinoid potency including, at minimum:

(a) Delta-9-tetrahydrocannabinolic acid (THCA);

(b) Delta-9-tetrahydrocannabinol (THC);

(c) Cannabidiolic acid (CBDA); and

(d) Cannabidiol (CBD).

(3) Mycotoxins;

(4) Heavy metals, including, at a minimum, arsenic, cadmium, lead, and mercury;

(5) Pesticide and fertilizer residue; and

(6) Residual solvents, if a solvent other than carbon dioxide was used in the extraction process.

(C) Prior to the sale of any plant material to a dispensary licensed under Chapter 3796. of the Revised Code, a processor shall verify that the required laboratory tests have been performed on each batch of plant material pursuant to paragraph (A) of rule 3796:2-2-06 of the Administrative Code.

(D) A licensed testing laboratory shall submit to the processor a certificate of analysis of every sample of medical marijuana tested by the laboratory in accordance with the rules promulgated pursuant to Chapter 3796. of the Revised Code. A processor shall not sell or otherwise distribute medical marijuana unless the medical marijuana meets the standards set forth by the department and the package or label contains the analysis from a licensed testing laboratory.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:3-2-07 Processor prohibited activities.

(A) A licensed processor shall not sell medical marijuana in any form to a patient or caregiver.

(B) A licensed processor shall not permit the consumption of medical marijuana in any form on the premises.

(C) A licensed processor shall not process or manufacture a form of marijuana that is not permitted by section 3796.06 of the Revised Code or approved by the state of Ohio board of pharmacy pursuant to division (A)(6) of section 3796.06 of the Revised Code.

(D) Pursuant to division (D)(1) of section 3796.06 of the Revised Code, a processor shall not manufacture medical marijuana products that exceed seventy per cent THC content as defined in paragraph (A)(49) of rule 3796:1-1-01 of the Administrative Code.

(E) A licensed processor shall not amend or otherwise change its approved operations plan, quality assurance plan, or manufacturing techniques, unless written approval is obtained from the department.

(F) A licensed processor shall not produce or maintain medical marijuana in excess of the quantity required for normal, efficient operation based on patient population and consumption reported in the inventory tracking system.

(G) A licensed processor shall not directly or indirectly discriminate in price between different dispensary facilities that are purchasing a like, grade, strain, brand, and quality of medical marijuana, provided nothing herein shall prevent differentials which only make due allowance for differences in the cost of manufacture, sale, or delivery resulting from the differing methods or quantities in which such medical marijuana or medical marijuana products are sold or delivered to such dispensary facilities.

(H) A licensed processor shall not change the use or occupancy of the facility unless the department is notified of and provides prior written approval of such changes.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:3-2-08 Processor records and reporting requirements.

(A) Each processor shall keep and maintain upon the licensed premises for a five-year period, unless otherwise stated in these rules, true, complete, legible, and current books and records. All required records must be made available for inspection if requested by the department. The following records shall be maintained:

(1) Records relating to the disposal of medical marijuana, medical marijuana products, and waste in accordance with paragraph (E) of this rule and rule 3796:3-2-03 of the Administrative Code;

(2) Records related to the sale of medical marijuana in accordance with paragraph (D) of rule 3796:3-2-04 of the Administrative Code;

(3) Transportation records in accordance with rule 3796:5-3-01 of the Administrative Code;

(4) Records of all samples sent to an independent testing lab and the quality assurance test results;

(5) Security records in accordance with paragraph (B) of rule 3796:3-2-05 of the Administrative Code;

(6) Inventory tracking records and inventory records maintained in the inventory tracking system, as well as records maintained by the facility outside the inventory tracking system, in accordance with rule 3796:3-2-04 of the Administrative Code;

(7) Processing records, which at a minimum shall include:

(a) The form and types of medical marijuana maintained at the facility on a daily basis;

(b) Production records, including extraction, refining, manufacturing, packaging, and labeling;

(8) Financial records in accordance with paragraph (C) of this rule;

(9) Employee records in accordance with paragraph (D) of this rule; and

(10) Records of any theft, loss, or other unaccountability of any medical marijuana as described in rule 3796:5-4-01 of the Administrative Code.

(B) A processor may use an electronic system for the storage and retrieval of records required by this chapter or other records relating to medical marijuana. Any loss of electronically-maintained records shall not be considered a mitigating factor for violations of this rule. A processor shall use a system that:

(1) Guarantees the confidentiality of the information stored in the system;

(2) Is capable of providing safeguards against erasures and unauthorized changes in data after the information has been entered and verified by the processor;

(3) Is capable of placing a litigation hold or enforcing a records retention hold for purposes of conducting an investigation or pursuant to ongoing litigation; and

(4) Is capable of being reconstructed in the event of a computer malfunction or accident resulting in the destruction of the data bank.

(C) A processor shall maintain financial records, which shall include the following:

(1) Records that clearly reflect all financial transactions and the financial condition of the business, including contracts for services performed or received that relate to the processor;

(2) Purchase invoices, bills of lading, manifests, sales records, copies of bills of sale, and any supporting documents, including the items and/or services purchased, from whom the items were purchased, and the date of purchase;

(3) Bank statements and canceled checks for all accounts relating to the processor, if applicable; and

(4) Accounting and tax records related to the processor and all investors in the facility.

(D) A processor shall maintain employee records, which shall include the following:

(1) All records relating to the hiring of employees, including applications, documentation of verification of references, and any other related materials;

(2) An employee log that includes the following information for every current and former employee:

(a) Employee name, address, phone number, and emergency contact information;

(b) Registration number and access credential designation;

(c) Date of hire and date of separation from employment, if applicable, and the reason for the separation;

(d) All training, education, and disciplinary records; and

(e) Salary and wages paid to each employee, and any executive compensation, bonus, benefit, or item of value paid to any individual affiliated with any medical marijuana entity, including members of a non-profit corporation, if any, and

(3) Documentation that each employee has been successfully trained in accordance with the operations plan submitted as part of the processor application and in compliance with paragraph (B)(3)(f) of rule 3796:3-1-02 of the Administrative Code.

(4) Visitor logs maintained in accordance with rule 3796:5-2-01 of the Administrative Code.

(E) Medical marijuana production and disposal records may be stored at the facility and shall include all of the following:

(1) The registered strain or product name, form, and quantity of marijuana involved;

(2) The date of production or removal from production;

(3) The reason for removal from production, if applicable;

(4) A record of all medical marijuana sold, transported, or otherwise disposed of;

(5) The date and time of selling, transporting, or disposing of the medical marijuana; and

(6) If the medical marijuana is destroyed, the processor shall maintain records in accordance with paragraph (D) of rule 3796:3-2-03 of the Administrative Code.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03