Chapter 3796:3-2 | Operations

Rule 3796:3-2-01 | Processor operations and quality assurance.

• Effective: September 8, 2017
• Promulgated Under: 119.03

(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.

Last updated June 12, 2025 at 11:09 AM

Supplemental Information

Authorized By: R.C. 3796.03
Amplifies: R.C. 3796.03
Five Year Review Date: 9/7/2023

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

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

(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-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; and

(viii) Any other cannabinoid determined by the department.

(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.

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: 9/7/2023

Rule 3796:3-2-06 | Laboratory testing.

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

(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-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.

(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-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.

(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.

Last updated June 12, 2025 at 11:09 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: 9/7/2023
Prior Effective Dates: 9/8/2017

Rule 3796:3-2-07 | Processor prohibited activities.

• Effective: September 8, 2017
• Promulgated Under: 119.03

(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.

Last updated June 12, 2025 at 11:09 AM

Supplemental Information

Authorized By: R.C. 3796.03
Amplifies: R.C. 3796.03
Five Year Review Date: 9/7/2023