Chapter 3796:2-2 | Cultivator Operations

Rule 3796:2-2-01 | Cultivator operations and quality assurance plan.

• Effective: May 6, 2017
• Promulgated Under: 119.03

(A) A cultivator shall establish, maintain, and comply with the policies and procedures contained in the operations plan submitted by the cultivator 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 medical marijuana. 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 cultivation area, with restricted access between the different areas of the facility;

(2) Implement policies and procedures that provide best practices for secure and proper cultivation of medical marijuana, which includes restricted movement between the different production areas by personnel based on access credentials assigned by the facility;

(3) Document the chain for all medical marijuana in the inventory tracking system;

(4) Establish a standard 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 kinds; and

(5) Maintain a facility with adequate lighting, ventilation, temperature, sanitation, equipment and security for the safe and consistent cultivation of medical marijuana.

(B) A cultivator shall submit, as part of the application process, and maintain a quality assurance and quality control plan for the cultivation of medical marijuana in its facility. The purpose of the plan is to ensure a safe, consistent product supply and minimize the deviation in quality of the production batches of medical marijuana.

(1) A cultivator shall submit any proposed changes to its plan to the department sixty days before the effective date of the proposed changes.

(2) The department shall have thirty days to review and approve or reject the proposed changes.

(C) The department, with assistance from the Ohio department of agriculture, shall maintain an approved list of permitted pesticides, fertilizers, and other chemicals. The department shall make this list with the label type, active ingredients, and concentration of the approved pesticides, fertilizers, and other chemicals available electronically. A cultivator that utilizes any approved pesticides, fertilizers, or other chemicals during the cultivation process shall meet the requirements contained in this rule.

(1) The pesticides must be registered with the Ohio department of agriculture and meet either of the following requirements:

(a) Registered with the United States environmental protection agency under section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 - 136y (2012); or

(b) Exempt from registration under 40 C.F.R. 152.25(f) (2015) and the active inert ingredients of the pesticide product are authorized for use on crops or plants intended for human consumption by the United States environmental protection agency.

(2) Any specialty fertilizer, as defined in division (Q) of section 905.31 of the Revised Code, must be registered with the Ohio department of agriculture pursuant to section 905.33 of the Revised Code.

(3) No foliar application of approved pesticides, fertilizers, or other chemicals shall be made after the twenty-first day following the date that a plant is moved into the flowering stage of growth, unless otherwise permitted on the department's approved list.

(4) All individuals applying pesticides, fertilizers, or other chemicals shall adhere to the use requirements of the label and shall employ all applicable personal protective equipment.

(5) The cultivator shall comply with all posting requirements of the standard protection language stated on the label.

(6) A record of all pesticide, fertilizer, or other chemical applications shall be maintained by the cultivator for at least five years and shall be made available to the department upon request. The application record shall include the following information:

(a) Date and time of application;

(b) Stage of cultivation process;

(c) Date when the plants in the application area were moved to the flowering stage, if applicable;

(d) United States environmental protection agency registration number, if applicable;

(e) Analysis of the fertilizer applied;

(f) Application site, which shall be identified by the location legend maintained by the cultivator;

(g) Name of the product being applied;

(h) Amount applied;

(i) Unique plant identifier or other information that identifies which plants received the application;

(j) Size of the application area;

(k) Name of individual making the application; and

(l) Comments or special conditions related to the application.

(7) Disposal of all unused pesticides, fertilizers, and other chemicals shall be performed in compliance with all state and federal laws and regulations, which require compliance with all directions on the product label.

(8) The use of a pesticide, fertilizer, or other chemical by a cultivator that is inconsistent with the product's label or in violation of paragraph (C) of this rule may result in action being taken by the department pursuant to rule 3796:5-6-01 of the Administrative Code.

(D) A cultivator shall maintain a facility in the following manner:

(1) A cultivator shall keep all floors and benches free of debris, dust, and any other potential contaminants, remove dead and unusable plant parts from the marijuana cultivation area, and control rodents and other non-plant related pests.

(2) A cultivator shall use chemicals, cleaning solutions, and other sanitizing agents approved for use around vegetables, fruit, or medicinal plants and shall store them in a manner that protects against contamination.

(3) A cultivator shall keep its equipment in a clean, professional environment and maintain a cleaning and equipment maintenance log at the facility.

(4) The cultivator 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 a regulated water system or a private water supply and shall meet the needs of the cultivator. A private water supply shall be derived from a water source that is capable of providing a safe, potable, and adequate supply of water.

(6) A cultivator shall implement policies and procedures related to receiving, inspecting, transporting, segregating, preparing, packaging, and storing medical marijuana in accordance with adequate sanitation principles.

Supplemental Information

Authorized By: R.C. 3796.03
Amplifies: R.C. 3796.03, R.C. 3796.09
Five Year Review Date: 11/2/2022

Rule 3796:2-2-02 | Cultivator and plant-only processor packaging and labeling.

• Effective: May 2, 2022
• Promulgated Under: 119.03

(A) A cultivator distributing plant material to a processor shall meet the following requirements:

(1) A cultivator shall place plant material in a tamper-evident, light-resistant package approved by the department prior to distributing plant material to a processor. Approved packaging shall maintain the integrity and stability of the plant material.

(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 material was cultivated and harvested;

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

(c) The product identifier;

(d) The registered name of the medical marijuana that was registered with the department;

(e) A unique identification number that will match the medical marijuana with a batch and batch number to facilitate any warnings and recalls the department deems appropriate;

(f) The date of harvest, final testing, and packaging;

(g) The total weight in grams of plant material in each package;

(h) The identification of the independent testing laboratory;

(i) The laboratory analysis, profile and a list of all active ingredients, including the percentage content by weight for the following cannabinoids, at a minimum:

(i) Delta-8-tetraydrocannabinol;

(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; and

(viii) Any other cannabinoid determined by the department.

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

(k) 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 of the State of Ohio."

(B) A cultivator with a plant-only processor license distributing plant material to a dispensary shall meet the following requirements:

(1) A cultivator shall place plant material in a child-proof, tamper-evident, light-resistant package approved by the department prior to distributing plant material to a dispensary. Approved packaging shall maintain the integrity and stability of the plant material.

(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 material was cultivated and harvested;

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

(c) The product identifier;

(d) The registered name of the medical marijuana that was registered with the department;

(e) A unique identification number that will match the medical marijuana with a batch and batch number to facilitate any warnings or recalls the department deems appropriate;

(f) The date of harvest, final testing and packaging;

(g) The total weight in grams of plant material in each package;

(h) The identification of the independent testing laboratory;

(i) The laboratory analysis, profile, and a list of all active ingredients, including the percentage content by weight for the following cannabinoids, at a minimum:

(i) Delta-8-tetraydrocannabinol;

(ii) Delta-8-tetrahydrocannabinolic acid;

(iii) Delta-9-tetrahydrocannabinol;

(iv) Delta-9-tetrahyrdrocannabinolic acid;

(v) Cannabidiol (CBD);

(vi) Cannabidiolic acid (CBDA);

(vii) THC content as defined in rule 3796:1-1-01 of the Administrative Code; and

(viii) Any other cannabinoid determined by the department.

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

(k) 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."

(C) A label may contain the approval or certification logo of a third-party certifier of 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 any of the following:

(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 THC content as defined in rule 3796:1-1-01 of the Administrative Code; or

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

(E) A cultivator 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.

Last updated May 2, 2022 at 9:39 AM

Supplemental Information

Authorized By: ORC 3796.03
Amplifies: ORC 3796.03, ORC 3796.06(D)(1), ORC 3796.06(D)(2), ORC 3796.19(B)(2)
Five Year Review Date: 6/4/2022

Rule 3796:2-2-04 | Cultivator inventory control and storage.

• Effective: May 6, 2017
• Promulgated Under: 119.03

(A) A cultivator shall track and submit into the inventory tracking system any information the department determines necessary for maintaining and tracking medical marijuana. When a plant reaches twelve inches in height or is transplanted from a cloning medium or apparatus into a growth medium or apparatus intended for the vegetative or flowering stages of growth cycle, whichever occurs sooner, the cultivator shall securely attach a tag to the plant or the plant's container that includes, at a minimum, the following information:

(1) The cultivator's name and license number;

(2) The registered name of the strain;

(3) The unique plant identifier; and

(4) General information regarding the plant that is used for traceability.

(B) Prior to commencing business, each cultivator shall do the following:

(1) Conduct an initial comprehensive inventory of all medical marijuana at the cultivator. If the cultivator commences business with no medical marijuana on hand, the cultivator shall record this fact as the initial inventory; and

(2) Establish ongoing inventory controls and procedures for the conduct of inventory reviews and comprehensive inventories of medical marijuana for traceability in the department's inventory tracking system, which shall enable the cultivator to detect any diversion, theft, or loss in a timely manner.

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

(1) The date of the inventory;

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

(a) The total count of plants, whether in the flowering, vegetative, or clone phase of growth and organized by room in which the plants are being grown;

(b) The batch number, weight, and strain name associated with each batch at the cultivator's facility that has been quarantined for testing or ready for sale to a processor or dispensary; and

(c) The total number of plants and every unique plant identifier that have been harvested, but are not yet associated with a batch.

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

(a) The date of sale;

(b) The license number and name of the processor or dispensary to which the medical marijuana was sold; and

(c) The batch number, registered product name and quantity of medical marijuana sold.

(4) The date, quantity, and method of disposal of medical marijuana, if applicable;

(5) A summary of the inventory findings; and

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

(D) On an annual basis and as a condition for renewal of a cultivator license, a type 1 key employee shall conduct a physical, manual inventory of the medical marijuana on hand at the cultivator 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 type 1 key employee 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 rule shall be maintained on the premises and made available to the department at all times.

(F) A cultivator is authorized to store medical marijuana inventory on the premises in a designated, enclosed, locked facility identified in the cultivator'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, a department's designee, law enforcement, or other federal, state, or local government officials from entering any area of a cultivator if necessary to perform their governmental duties.

Supplemental Information

Authorized By: R.C. 3796.03
Amplifies: R.C. 3796.03
Five Year Review Date: 11/2/2022

Rule 3796:2-2-06 | Laboratory testing.

• Effective: May 2, 2022
• Promulgated Under: 119.03

(A) An employee of a licensed testing laboratory shall select a random sample of adequate weight from every batch of medical marijuana cultivated at the facility that is sufficient to perform the required tests, prior to packaging any plant material intended to be sold to a patient or caregiver through a dispensary licensed under Chapter 3796. of the Revised Code. Every sample shall be tested by a licensed testing laboratory in accordance with 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 the following:

(1) Microbial contaminants;

(2) Mycotoxins;

(3) Moisture content;

(4) Foreign matter contamination;

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

(6) Pesticide and fertilizer residue; and

(7) Cannabinoid potency, including, at a minimum, the following:

(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.

(B) An employee of a licensed testing laboratory shall select a random sample of adequate weight from every batch of medical marijuana cultivated at the facility that is sufficient to perform the required tests, prior to packaging any plant material that shall be used in the manufacture of medical marijuana products by a processor licensed under Chapter 3796. of the Revised Code. Every sample shall be tested by a licensed testing laboratory in accordance with 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 the following:

(1) Pesticide and fertilizer residue;

(2) Moisture content;

(3) Foreign matter contamination; and

(4) Cannabinoid potency, including, at a minimum, the following:

(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 licensed testing laboratory shall submit to the cultivator an analysis of every sample of medical marijuana tested by the testing laboratory in accordance with the rules promulgated pursuant to Chapter 3796. of the Revised Code. A cultivator 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.

Last updated May 2, 2022 at 9:40 AM

Supplemental Information

Authorized By: ORC 3796.03
Amplifies: ORC 3796.03, ORC 3796.06(D)(1), ORC 3796.06(D)(2), ORC 3796.19(B)(2)
Five Year Review Date: 11/2/2022

Rule 3796:2-2-07 | Cultivator prohibited activities.

• Effective: May 6, 2017
• Promulgated Under: 119.03

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

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

(C) A cultivator shall not grow a prohibited form of marijuana that is not registered and approved by the state of Ohio board of pharmacy pursuant to section 3796.061 of the Revised Code.

(D) A cultivator 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.

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

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

(G) Pursuant to division (D)(1) of section 3796.06 of the Revised Code, a cultivator shall not sell plant material that exceeds thirty-five per cent THC content as defined in rule 3796:1-1-01 of the Administrative Code.

(H) A licensed cultivator shall not directly or indirectly discriminate in price between different processor or dispensary facilities that are purchasing a like grade, strain, brand, quality, and quantity of medical marijuana. Nothing herein shall prevent price differentials based on differences in the cost of manufacture, sale, or delivery resulting from the differing methods or quantities in which the medical marijuana is sold or delivered.

Supplemental Information

Authorized By: R.C. 3796.03
Amplifies: R.C. 3796.03
Five Year Review Date: 11/2/2022

Rule 3796:2-2-08 | Cultivator records and reporting requirements.

• Effective: May 6, 2017
• Promulgated Under: 119.03

(A) Each cultivator shall keep and maintain upon the licensed premises for a five-year period, unless otherwise stated in this chapter, 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 3796:2-2-03 of the Administrative Code;

(2) Records related to the sale of medical marijuana in accordance with paragraph (C) of rule 3796:2-2-04 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 laboratory and the quality assurance test results;

(5) Security records in accordance with paragraph (B) of rule 3796:2-2-05 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 3796:2-2-04 of the Administrative Code;

(7) Cultivation records, which, at a minimum, shall include the following:

(a) Forms and types of medical marijuana maintained at the cultivator on a daily basis;

(b) Soil amendment, fertilizers, pesticides, or other chemicals applied to the growing medium or plants or used in the process of growing medical marijuana in accordance with paragraph (C) of rule 3796:2-2-01 of the Administrative Code; and

(c) Production records, including planting, harvesting and curing, weighing, and packaging and labeling.

(8) Financial records retained at a location determined by the cultivator 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 cultivator may use an electronic system for storage and retrieval of records required by this rule 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 cultivator that elects to use an electronic system shall use a system that does all of the following:

(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 cultivator;

(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 cultivator 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 cultivator;

(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 cultivator, if applicable; and

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

(D) A cultivator 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.

(3) 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 product name, strain and quantity of medical 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 sale, transportation, or disposal of the medical marijuana; and

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

Supplemental Information

Authorized By: R.C. 3796.03
Amplifies: R.C. 3796.03
Five Year Review Date: 11/2/2022