reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 3796:2 - Cultivators › Chapter 3796:2-2 - Cultivator Operations › Section 3796:2-2-05 - Cultivator security

Current through all regulations passed and filed through July 1, 2024
(A)
								The department
			 shall determine the appropriate storage and security requirements for all
			 cultivator facilities, and may require additional safeguards to ensure the
			 security of medical marijuana. A cultivator shall comply with the security plan
			 submitted as part of its cultivator provisional license application. At a
			 minimum, the cultivator shall do the following:
(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 to prevent unauthorized
			 entry or access to waste disposal containers, disposal areas or compost areas
			 located outside the facility;
(3)
									Utilize a video
			 surveillance recording system installed by a vendor that is approved by the
			 department and 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 cultivator
			 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.
(b)
										A cultivator shall make available to the department,
			 upon request, a current list of type 1 key employees and contractors who have
			 access to the surveillance rooms. A cultivator shall keep all on-site
			 surveillance rooms locked and shall not use such rooms for any other
			 functions.
(5)
									Keep all approved safes, approved vaults, or any other
			 approved equipment or areas used for cultivating, harvesting, or storing of
			 medical marijuana, securely locked and protected from unauthorized access to
			 medical marijuana;
(6)
									Ensure the outside perimeter of the cultivator is
			 well-lit and in accordance with the cultivator's plan in its license
			 application;
(7)
									Restrict access to any area within a cultivator
			 containing medical marijuana except registered employees and agents or an
			 individual permitted to access the facility under the supervision of a
			 registered employee or agent in accordance with the visitor authorization
			 procedures set forth in this chapter;
(8)
									Limit the use of
			 combination numbers, passwords, or electronic or biometric security systems to
			 registered, 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 registered, authorized
			 employees.
Ohio Administrative Code › Title 3796:2 - Cultivators › Chapter 3796:2-2 - Cultivator Operations › Section 3796:2-2-06 - Laboratory testing

Current through all regulations passed and filed through July 1, 2024
(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.
Ohio Administrative Code › Title 3796:2 - Cultivators › Chapter 3796:2-2 - Cultivator Operations › Section 3796:2-2-07 - Cultivator prohibited activities

Current through all regulations passed and filed through July 1, 2024
(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.
Ohio Administrative Code › Title 3796:2 - Cultivators › Chapter 3796:2-2 - Cultivator Operations › Section 3796:2-2-08 - Cultivator records and reporting requirements

Current through all regulations passed and filed through July 1, 2024
(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.
Ohio Administrative Code › Title 3796:2 - Cultivators › Chapter 3796:2-3 - Cultivator Inspections › Section 3796:2-3-01 - Cultivator inspections

Current through all regulations passed and filed through July 1, 2024
(A)
								The submission of
			 an application that results in the issuance of a provisional license or
			 certificate of operation for a cultivator irrevocably gives the department
			 consent to conduct all inspections necessary to ensure compliance with the
			 cultivator's application, state and local law, Chapter 3796. of the Revised
			 Code, and the rules promulgated in accordance with Chapter 3796. of the Revised
			 Code. The department may conduct the inspection independently, or may work with
			 other departments, state agencies, or local authorities, including the Ohio
			 department of agriculture, the division of industrial compliance, and the
			 division of state fire marshal, to ensure compliance with the cultivator's
			 application, state and local law, Chapter 3796. of the Revised Code, and the
			 rules promulgated in accordance with Chapter 3796. of the Revised
			 Code.
(B)
								An inspector conducting an inspection pursuant to this
			 rule shall be accompanied by a type 1 key employee during the inspection. The
			 inspector may:
(1)
									Review and make copies of all records maintained in
			 accordance with rule
			 3796:2-2-08
			 of the Administrative Code;
(2)
									Enter any area in
			 the facility, with a type 1 key employee's assistance if unaccompanied access
			 to an area could compromise production integrity or interrupt a dark cycle
			 during the flowering stage;
(3)
									Inspect facility
			 vehicles;
(4)
									Review the policies and procedures of the cultivator,
			 including methods of operating;
(5)
									Survey the
			 premises and any off-site facilities;
(6)
									Inspect all
			 equipment, instruments, tools, materials, machinery, or any other resource used
			 to cultivate medical marijuana;
(7)
									Request access to
			 locked areas in the facility;
(8)
									Question
			 registered employees at the location; or
(9)
									Obtain samples
			 for testing of any medical marijuana cultivated at the facility, media used to
			 grow medical marijuana, chemicals and ingredients used in the cultivation
			 process, any labels or containers for medical marijuana, or any raw packaged
			 medical marijuana.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-1 - Generally › Section 3796:3-1-01 - Number of processor provisional licenses

Current through all regulations passed and filed through July 1, 2024
(A)
								Until September
			 8, 2018, the director of the department of commerce or the director's designee
			 may issue up to forty processor provisional licenses, in consideration of the
			 ranking of the applicants in accordance with the criteria listed in section
			 3796.09 of the Revised Code and
			 this chapter.
(B)
								Beginning September 9, 2018, the director or the
			 director's designee, may issue additional processor provisional licenses, if
			 the population of this state, the number of patients seeking to use medical
			 marijuana products, and availability of forms approved by the state of Ohio
			 board of pharmacy in accordance with section
			 3796.06 of the Revised Code
			 support additional licenses, at the discretion of the director.
(C)
								In the event
			 additional provisional licenses are deemed necessary, the department will
			 follow the application procedures outlined in rule
			 3796:3-1-02
			 of the Administrative Code.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-1 - Generally › Section 3796:3-1-04 - Processor provisional license award

Current through all regulations passed and filed through July 1, 2024
(A)
								A provisional
			 license shall be issued to the qualified applicant receiving at least the
			 minimum required score in each category and the highest total score overall as
			 compared to the other applicants.
(B)
								In the event that
			 two or more qualified applicants for a processor provisional license receive
			 the same total score, and awarding a provisional license to all tied applicants
			 would violate paragraph (A) of rule
			 3796:3-1-01
			 of the Administrative Code, the department shall select the applicant that
			 received the highest score in the operations plan category. In the event that
			 the applicants received the same score in the operations plan category, the
			 department shall select the applicant that received the highest score in the
			 security plan category. If a tie score still remains, the tied applicants will
			 be interviewed by an unbiased panel selected by the department.
(C)
								If no qualified
			 applicants are found during the process described in rule
			 3796:3-1-03
			 of the Administrative Code, a provisional licensee fails to fulfill the
			 conditions in the application, or a certificate of operation is revoked, the
			 department may, at the discretion of the director, announce another period to
			 submit applications in accordance with rule
			 3796:3-1-02
			 of the Administrative Code. If the department announces another application
			 period, a qualified applicant that submitted an application during the previous
			 application period, but was not issued a provisional license, may re-submit an
			 application and the application fee under rule
			 3796:5-1-01 of the
			 Administrative Code shall be waived.
(D)
								No person shall
			 hold or be granted more than one processor provisional license or processor
			 certificate of operation at any time. No person shall hold a financial interest
			 in or be an owner, partner, officer, director, shareholder, member, or other
			 person who may significantly influence or control the activities of more than
			 one processor. No corporation, partnership, limited liability partnership,
			 limited liability company, or other entity or subsidiary thereof shall hold a
			 financial interest in or be an owner, principal officer, partner, shareholder,
			 member, or other person who may significantly influence or control the
			 activities of more than one processor.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-1 - Generally › Section 3796:3-1-05 - Processor financial responsibility

Current through all regulations passed and filed through July 1, 2024
(A)
								A provisional
			 licensee shall provide evidence of financial responsibility before a
			 certificate of operation can be issued, which may be payable to the department
			 for any of the following reasons:
(1)
									A processor fails to adhere to the security plan
			 approved by the department or otherwise operates the facility in a manner that
			 allows for or results in theft, loss, or diversion of medical
			 marijuana;
(2)
									A processor engages in activities prohibited under rule
			 3796:3-2-07
			 of the Administrative Code; or
(3)
									A processor has
			 its certification of operation fined, suspended, or revoked, resulting from
			 activities prohibited under rule
			 3796:5-6-02
			 of the Administrative Code.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-1 - Generally › Section 3796:3-1-06 - Processor certificate of operation

Current through all regulations passed and filed through July 1, 2024
(A)
								A provisional
			 licensee is prohibited from operating as a licensed processor and performing
			 any processing or manufacturing activities until a certificate of operation is
			 issued by the department. The information and plan submitted by a provisional
			 licensee shall become mandatory conditions that must be met before a
			 certificate of operation can be awarded.
(B)
								A provisional
			 licensee shall have six months from the date they are notified of selection for
			 a provisional license to obtain a certificate of operation. A certificate of
			 operation shall be issued once all applicable inspections are passed, a
			 certificate of occupancy issued by the building department having jurisdiction
			 for such use is obtained, and the provisional licensee demonstrates that it
			 conforms to the specifications of the application, as well as the requirements
			 imposed by law and rules. If a certificate of operation is issued, the
			 provisional license becomes null and void.
(C)
								The department
			 shall not award a certificate of operation to a provisional licensee if the
			 provisional licensee has not met all of the specifications in the application
			 and passed all applicable inspections under rule
			 3796:3-3-01
			 of the Administrative Code within six months of written or electronic
			 notification of the applicant's selection for a provisional license. If the
			 provisional licensee fails to remedy the deficiencies in accordance with rule
			 3796:3-3-01
			 of the Administrative Code or otherwise satisfy the six-month time period
			 established under paragraph (B) of this rule, the director, at his or her
			 discretion, may extend the time period for the processor to obtain a
			 certificate of operation or take action pursuant to rule
			 3796:5-6-01
			 of the Administrative Code.
(D)
								In addition to
			 entities authorized to purchase medical marijuana pursuant to Chapter 3796. of
			 the Revised Code from a processor possessing a certificate of operation,
			 medical marijuana may be sold to a laboratory licensed under Chapter 4729-13 of
			 the Administrative Code, to possess dangerous drugs and controlled substances
			 for scientific and clinical purposes.
(E)
								The certificate
			 of operation, a copy of the current certificate of occupancy for the facility,
			 and any other certificate, business license, or other authorization required to
			 conduct production activities, shall be posted in a conspicuous place within
			 the facility and made available to the department and all fire code officials
			 upon request.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-1 - Generally › Section 3796:3-1-07 - Uninterrupted supply of medical marijuana

Current through all regulations passed and filed through July 1, 2024
(A)
								A processor shall
			 ensure that a consistent supply of medical marijuana is available to be sold to
			 licensed dispensaries. Evidence of a consistent supply may be shown by:
(1)
									Not more than
			 thirty days elapsing between shipments totaling at least one lot of medical
			 marijuana products, as defined in rule
			 3796:1-1-01 of the
			 Administrative Code, to any licensed dispensaries.; or
(2)
									Maintaining an
			 inventory of at least five hundred grams of medical marijuana extract that is
			 ready for immediate use in the manufacture of marijuana
			 products.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-1 - Generally › Section 3796:3-1-08 - Processor transfer of ownership or location

Current through all regulations passed and filed through July 1, 2024
(A)
								A provisional
			 license granted pursuant to this rule is nontransferable.
(B)
								A certificate of
			 operation shall be issued for the specific processor and location identified on
			 the application, and is valid only for the owner, premises, and name designated
			 on the certificate of operation and the location for which it is issued. A
			 certificate of operation may only be transferred or assigned if the department
			 determines that the proposed ownership or location change complies with Chapter
			 3796. of the Revised Code, the rules promulgated in accordance with Chapter
			 3796. of the Revised Code, and the following:
(1)
									Upon any request
			 for a change in ownership, the processor shall:
(a)
										Notify the
			 department in writing of the proposed ownership change;
(b)
										Facilitate the
			 submission of both an Ohio bureau of criminal identification and investigation
			 criminal records check and a federal bureau of criminal investigation criminal
			 records check pursuant to division (B) of section
			 3796.12 of the Revised
			 Code;
(c)
										Demonstrate to the department that the person acquiring
			 the interest meets the requirements under rules
			 3796:3-1-02
			 and
			 3796:3-1-03
			 of the Administrative Code and the processor will remain in compliance with its
			 application for a processor provisional license, Chapter 3796. of the Revised
			 Code, and the rules promulgated in accordance with Chapter 3796. of the Revised
			 Code, under the proposed ownership structure; and
(d)
										Submit a new
			 application in accordance with rule
			 3796:3-1-02
			 of the Administrative Code if the transfer of ownership would result in a new
			 controlling shareholder or shareholders outside of the current ownership
			 structure approved by the department. For purposes of calculating a controlling
			 interest, the department will consider all transfers of ownership that occur in
			 a given calendar year and calculate such transfers in the
			 aggregate.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-1 - Generally › Section 3796:3-1-09 - Processor certificate of operation renewal

Current through all regulations passed and filed through July 1, 2024
(A)
								Every processor
			 certificate of operation issued by the department under this chapter shall
			 expire annually on the date it was issued. A renewal application for a
			 processor, accompanied by the proper renewal fee established under rule
			 3796:5-1-01 of the
			 Administrative Code, shall be filed with the department at least thirty days
			 prior to the expiration date of the certificate of operation.
(B)
								The department
			 shall grant a renewal application if the application is filed in a timely
			 manner, the processor submits the corresponding renewal fee, the department
			 confirms that nothing warrants the denial of the renewal under rule
			 3796:5-6-01
			 of the Administrative Code, and the processor passes a full inspection, unless
			 a full inspection was passed within three months before the renewal
			 date.
(C)
								If a renewal application is not filed prior to the
			 expiration date of the certificate of operation, the certificate of operation
			 shall be suspended for a maximum of thirty days, at which point it will be
			 deemed expired if the processor has not successfully renewed the certificate of
			 operation under paragraph (B) of this rule. Upon expiration of the certificate
			 of operation, the processor shall not engage in any processing activities in
			 furtherance of the business of manufacturing medical marijuana products. The
			 department shall not renew the certificate of operation and the facility shall
			 permanently cease its operations.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-1 - Generally › Section 3796:3-1-10 - Winding down

Current through all regulations passed and filed through July 1, 2024
(A)
								If a processor
			 decides to voluntarily surrender or not renew its certificate of operation and
			 permanently discontinue business operations, the processor shall provide
			 written notice to the department at least ninety days prior to the effective
			 date of the closure. If the closure is the result of an eviction, the processor
			 shall immediately notify the department of the eviction notice and the
			 effective date of the notice. This notice shall be provided prior to the
			 processor taking any steps to discontinue business operations.
(B)
								A processor that
			 notifies the department of its intent to voluntarily surrender or not renew its
			 certificate of operation under paragraph (A) of this rule shall submit, within
			 sixty days of the effective date, a written plan of closure for approval by the
			 department. This plan shall include, at a minimum:
(1)
									The sale of
			 medical marijuana inventory at market rate;
(2)
									The destruction
			 of medical marijuana on hand at the facility on the effective date of the
			 closure;
(3)
									The sale or removal of equipment and products ancillary
			 to the manufacturing of medical marijuana products;
(4)
									The removal or
			 disposal of any solvents or other chemicals used in the manufacture of medical
			 marijuana products, which shall be carried out in accordance with all
			 applicable local, state, and federal laws;
(5)
									The retention of
			 all records required to be maintained in accordance with the applicable records
			 retention schedules;
(6)
									The steps that will be taken to maintain compliance
			 with Chapter 3796. of the Revised Code, the rules promulgated in accordance
			 with Chapter 3796. of the Revised Code, and any other conditions required by
			 the director until the approved closure date; and
(7)
									The closure and
			 intended use of the premises in which the processor was
			 located.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-2 - Operations › Section 3796:3-2-01 - Processor operations and quality assurance

Current through all regulations passed and filed through July 1, 2024
(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.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-2 - Operations › Section 3796:3-2-03 - Processor waste disposal

Current through all regulations passed and filed through July 1, 2024
(A) A licensed processor shall dispose of
			 undesired, excess, unauthorized, obsolete, adulterated, or deteriorated medical
			 marijuana waste
in
				accordance with the processor's disposal plan under the supervision of a type 1
				 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.
(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.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-2 - Operations › Section 3796:3-2-04 - Processor inventory control and storage

Current through all regulations passed and filed through July 1, 2024
(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.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-2 - Operations › Section 3796:3-2-06 - Laboratory testing

Current through all regulations passed and filed through July 1, 2024
(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.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-2 - Operations › Section 3796:3-2-07 - Processor prohibited activities

Current through all regulations passed and filed through July 1, 2024
(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.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-2 - Operations › Section 3796:3-2-08 - Processor records and reporting requirements

Current through all regulations passed and filed through July 1, 2024
(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.
Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-3 - Enforcement › Section 3796:3-3-01 - Processor enforcement

Current through all regulations passed and filed through July 1, 2024
(A)
								The submission of
			 an application that results in the issuance of a provisional license or
			 certificate of operation for a processor irrevocably gives the department
			 consent to conduct all inspections necessary to ensure compliance with the
			 processor's application, state law, Chapter 3796. of the Revised Code and the
			 rules promulgated in accordance with Chapter 3796. of the Revised Code. The
			 department may conduct the inspection independently, or may work with other
			 departments, state agencies, or local authorities, including the department of
			 agriculture, the division of industrial compliance and the state fire marshal,
			 to ensure compliance with the processor's application, state law, Chapter 3796.
			 of the Revised Code and the rules promulgated in accordance with Chapter 3796.
			 of the Revised Code.
(B)
								An inspector conducting an inspection pursuant to this
			 section rule shall be accompanied by a type 1 key employee during the
			 inspection. The inspector may:
(1)
									Review and make copies of all records maintained in
			 accordance with rule
			 3796:3-2-08
			 of the Administrative Code;
(2)
									Enter any room in
			 the facility;
(3)
									Inspect facility vehicles;
(4)
									Review the
			 policies and procedures of the processor, including methods of
			 operating;
(5)
									Survey the premises and any off-site
			 facilities;
(6)
									Inspect all equipment, instruments, tools, materials,
			 machinery, or any other resource used to process medical marijuana and
			 manufacture medical marijuana products;
(7)
									Request access to
			 locked areas in the facility;
(8)
									Question licensed
			 employees at the location; and
(9)
									Obtain samples
			 for testing of any medical marijuana products processed at the facility,
			 chemicals and ingredients used in processing medical marijuana, any labels or
			 containers for medical marijuana, or any raw packaged medical
			 marijuana.
Ohio Administrative Code › Title 3796:4 - Testing Laboratories › Chapter 3796:4-1 - Generally › Section 3796:4-1-01 - Number of testing laboratory provisional licenses

Current through all regulations passed and filed through July 1, 2024
(A)
								The director of the department of commerce or the
			 director's designee may issue a provisional license to conduct laboratory
			 testing of medical marijuana in accordance with the criteria listed in section
			 3796.09 of the Revised Code to
			 an institution of higher learning that meets all of the following
			 conditions:
(1)
									The institution is public, and is located in the state of
			 Ohio; and
(2)
									The institution has the facilities and resources
			 necessary to conduct testing in accordance with the standards and procedures
			 established in rules adopted by the department under section
			 3796.03 of the Revised
			 Code.
Ohio Administrative Code › Title 3796:4 - Testing Laboratories › Chapter 3796:4-1 - Generally › Section 3796:4-1-04 - Testing laboratory provisional license award

Current through all regulations passed and filed through July 1, 2024
(A)
								A provisional
			 license shall be issued to the qualified applicant receiving at least the
			 minimum required score in each category and the highest total score overall as
			 compared to the other applicants.
(B)
								If no qualified
			 applicants are found during the process described in rule
			 3796:4-1-03
			 of the Administrative Code, a provisional licensee fails to fulfill the
			 conditions in the application, a certificate of operation is revoked, or no
			 license is issued or active for any other reason, the department may, at the
			 discretion of the director, announce another period to submit an application in
			 accordance with rule
			 3796:4-1-02
			 of the Administrative Code.
(C)
								No person shall
			 hold or be granted more than one testing laboratory provisional license or
			 testing laboratory certificate of operation at any time. No person shall hold a
			 financial interest in or be an owner, partner, officer, director, shareholder,
			 member, or other person who may significantly influence or control the
			 activities of more than one testing laboratory. No corporation, partnership,
			 limited liability partnership, limited liability company, or other entity or
			 subsidiary thereof shall hold a financial interest in or be an owner, officer,
			 partner, shareholder, member, or other person who may significantly influence
			 or control the activities of more than one testing laboratory.
Ohio Administrative Code › Title 3796:4 - Testing Laboratories › Chapter 3796:4-1 - Generally › Section 3796:4-1-05 - Testing laboratory financial responsibility

Current through all regulations passed and filed through July 1, 2024
(A)
								A provisional
			 licensee shall provide evidence of financial responsibility before a
			 certificate of operation can be issued, which may be payable to the department
			 for any of the following reasons:
(1)
									A testing laboratory fails to adhere to the security
			 plan approved by the department or otherwise operates the facility in a manner
			 that allows for or results in theft, loss, or diversion of medical
			 marijuana;
(2)
									A testing laboratory engages in activities prohibited
			 under rule
			 3796:4-2-08
			 of the Administrative Code; or
(3)
									A testing
			 laboratory has its certification of operation fined, suspended, or revoked,
			 resulting from activities prohibited under rule
			 3796:5-6-02
			 of the Administrative Code.
Ohio Administrative Code › Title 3796:4 - Testing Laboratories › Chapter 3796:4-1 - Generally › Section 3796:4-1-06 - Testing laboratory certificate of operation

Current through all regulations passed and filed through July 1, 2024
(A)
								A provisional
			 licensee is prohibited from operating as a licensed testing laboratory and
			 performing any analytical testing activities until a certificate of operation
			 is issued by the department. The information and plan submitted by a
			 provisional licensee shall become mandatory conditions that must be met before
			 a certificate of operation can be awarded.
(B)
								A provisional
			 licensee shall have six months from the date they are notified of selection to
			 obtain a certificate of operation. A certificate of operation shall be issued
			 once all applicable inspections are passed and the provisional licensee
			 demonstrates that it conforms to the specifications of the application, as well
			 as the requirements imposed by law and rules. If a certificate of operation is
			 issued, the provisional license becomes null and void.
(C)
								The department
			 shall not award a certificate of operation to a provisional licensee if the
			 provisional licensee has not met all of the specifications in the application
			 and passed all applicable inspections under rule
			 3796:4-3-01
			 of the Administrative Code within six months of written or electronic
			 notification of the applicant's selection. If the provisional licensee fails to
			 remedy the deficiencies in accordance with rule
			 3796:4-3-01
			 of the Administrative Code or otherwise satisfy the six-month time period
			 established under paragraph (B) of this rule, the director, at his or her
			 discretion, may extend the time period for the testing laboratory to obtain a
			 certificate of operation or take action pursuant to rule
			 3796:5-6-01
			 of the Administrative Code.
(D)
								The certificate
			 of operation, along with a copy of the current certificate of occupancy for the
			 facility and any other certificate, business license, or other authorization
			 required to conduct testing activities, shall be posted in a conspicuous place
			 within the facility and made available to the department and all fire code and
			 building officials upon request.
Ohio Administrative Code › Title 3796:4 - Testing Laboratories › Chapter 3796:4-1 - Generally › Section 3796:4-1-07 - Testing laboratory transfer of ownership or location

Current through all regulations passed and filed through July 1, 2024
(A)
								A provisional license issued pursuant to this rule is
			 nontransferable.
(B)
								A certificate of operation shall be issued for the
			 specific testing laboratory and location identified on the application, and is
			 valid only for the owner, premises, and name designated on the certificate of
			 operation, and the location for which it is issued. A certificate of operation
			 may only be transferred or assigned if the department determines that the
			 proposed ownership or location change meets all the requirements of this
			 division and Chapter 3796. of the Revised Code and the following requirements
			 are met:
(1)
									Upon any request for a change in ownership, the testing
			 laboratory shall:
(a)
										Notify the department in writing of the proposed
			 ownership change;
(b)
										Facilitate the submission of both an Ohio bureau of
			 criminal identification and investigation criminal records check and a federal
			 bureau of investigation criminal records check pursuant to division (B) of
			 section 3796.12 of the Revised
			 Code;
(c)
										Demonstrate to the department that the person acquiring
			 the interest meets the requirements under rules
			 3796:4-1-02
			 and
			 3796:4-1-03
			 of the Administrative Code and that the testing laboratory will remain in
			 compliance with its application for a provisional license, Chapter 3796. of the
			 Revised Code, and the rules promulgated in accordance with Chapter 3796. of the
			 Revised Code, under the proposed ownership structure; and
(d)
										Submit a new
			 application in accordance with rule
			 3796:4-1-02
			 of the Administrative Code if the transfer of ownership would result in a new
			 controlling shareholder or shareholders outside of the current ownership
			 structure approved by the department. For purposes of calculating a controlling
			 interest, the department will consider all transfers of ownership that occur in
			 a given calendar year and calculate such transfers in the
			 aggregate.