Ohio Adm.Code 3796:4 | Ohio Administrative Code 3796:4 — Medical Marijuana Control Program | Testing Laboratories

Chapter 3796:4-1 Generally

Ohio Adm.Code 3796:4-1-01 Number of testing laboratory provisional licenses.

(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.

(B) Beginning on the date that occurs one year after the date on which the department begins accepting applications for licensure under section 3796.09 of the Revised Code, the director or the director's designee may issue a provisional license or certificate of operation to conduct laboratory testing of medical marijuana to a laboratory that is not part of an institution of higher learning as specified in paragraph (A) of this rule, in accordance with the criteria listed in section 3796.09 of the Revised Code and this division.

(C) In the event additional provisional licenses are deemed necessary, as determined by the director or the director's designee based on the volume of medical marijuana being produced and consumed by patients in the state of Ohio, the department will follow the license application procedures outlined in rule 3796:4-1-02 of the Administrative Code.

History

Effective: September 8, 2017
Promulgated Under: 119.03

Ohio Adm.Code 3796:4-1-03 Testing laboratory application review.

(A) The department, an independent contractor selected by the department, or a combination of the two shall review the submitted applications as described in this chapter and the application instructions. In order to receive consideration under paragraph (B) of this rule, an applicant shall:

(1) Demonstrate sufficient liquid capital pursuant to rule 0 of the Administrative Code and an ability to meet the financial responsibility requirements under rule 3796:4-1-05 of the Administrative Code;

(2) Certify in writing at the time of application that an owner or prospective owner, officer or prospective officer, board member or prospective board member, administrator or prospective administrator, employee or prospective employee, agent or other person has not been:

(a) Convicted of a disqualifying offense, as defined in rule 3796:1-1-01 of the Administrative Code; or

(b) Issued a certificate to recommend or applied for certification under section 4731.30 of the Revised Code;

(3) Verify that the proposed facility is not located within five hundred feet from a prohibited facility, which shall be measured in accordance with rule 3796:5-5-01 of the Administrative Code;

(4) Certify that the local jurisdiction where the facility is proposed has not passed a moratorium or taken other action that would prohibit the applicant from operating as a medical marijuana testing laboratory;

(5) Certify that an owner or prospective owner, officer or prospective officer, board member or prospective board member, administrator or prospective administrator, employee or prospective employee, agent, or other person who may significantly influence or control the activities of the testing laboratory does not have a direct or indirect financial interest in, or serve as an owner, officer, board member, administrator, employee, agent, or other person who may significantly influence or control the activities of any of the following:

(a) A cultivator, processor, or dispensary licensed under Chapter 3796. of the Revised Code;

(b) An applicant for a cultivator, processor, or dispensary license;

(6) Provide documentation sufficient to establish that the applicant is in compliance with the applicable tax laws of this state and any jurisdiction where the applicant operates and conducts business;

(7) Submit an application with the applicable fee under rule 3796:5-1-01 of the Administrative Code during the established application submission period established under paragraph (A) of rule 3796:4-1-02 of the Administrative Code. The application shall be submitted in accordance with the application instructions and forms issued by the department. The department may remove an application from consideration for any of the following:

(a) Failure or refusal to submit information required under rule 3796:4-1-02 of the Administrative Code or requested by the department during the application submission or review process;

(b) Inclusion of information in the application that misleads the department, misrepresents a material fact, or fails to disclose a material fact to the department;

(c) Submission of an application that is in violation of the application instructions issued by the department, or includes forms issued by the department that have been altered.

(B) The applicants shall be evaluated using an impartial and numerical process taking into account the criteria identified in rule 3796:4-1-02 of the Administrative Code, as developed by the department, an independent contractor selected by the department, or a combination of the two. The applicants will be evaluated based on the following criteria, at a minimum:

(1) A business plan, which, at a minimum, shall include:

(a) A proposed business model demonstrating a likelihood of success, a sufficient business ability and experience on the part of the applicant;

(b) An organizational chart of the company, including name, address, and date of birth of each principal officer and board member of the testing laboratory, provided that all those individuals shall be at least twenty-one years of age;

(c) Experience with the analytical testing of medical marijuana or other agricultural, horticultural, or pharmaceutical products, which includes information on licenses held by any person affiliated with the applicants, regardless if said license is active or expired. If expired, applicant shall provide the grounds behind the expiration. The information provided on business licenses shall include the type of license, the licensing agency, the date the license was obtained, and a summary of any negative actions taken against each license.

(d) Evidence that the applicant owns the property on which the proposed testing laboratory will be located, has executed a lease for the property that does not contain any use restrictions that would otherwise prevent the testing laboratory from operating pursuant to Chapter 3796. of the Revised Code and the rules promulgated in accordance with Chapter 3796. of the Revised Code, or has secured the ability to purchase or lease the property that does not contain any use restrictions that would otherwise prevent the testing laboratory from operating pursuant to Chapter 3796. of the Revised Code and the rules promulgated in accordance with Chapter 3796. of the Revised Code;

(e) Documentation that the applicant is currently in compliance, or will be in compliance prior to the issuance of a certificate of operation, with any local ordinances, rules or regulations adopted by the locality in which the applicant's property is located, which are in effect at the time of the application. Such documentation may include, but is not limited to, local building department approval demonstrating compliance with rules adopted by the board of building standards pursuant to Chapters 3781. and 3791. of the Revised Code to construct the proposed facility, local approval to operate as a medical marijuana cultivation facility, and evidence that the applicant's proposed location is in compliance with local ordinances, rules or regulations adopted by the locality in which the applicant's property is located, which are in effect at the time of the application.

(2) An operations plan, which shall include but not be limited to:

(a) Laboratory analysis techniques, including specific instrumentation and protocols necessary to perform the tests required by this division;

(b) The implementation of standards and methods for conducting testing laboratory analysis of medical marijuana and medical marijuana products that will allow the applicant to obtain accreditation to the ISO/IEC 17025 "General Requirements for the Competence of Testing and Calibration Laboratories" standard within two years of issuance of a provisional license;

(d) Facility specifications, designating the areas in the facility where analytical testing will occur, and evidencing that the applicant will comply with the requirements of Chapter 3796. of the Revised Code and will operate in accordance with the rules promulgated pursuant to Chapter 3796. of the Revised Code;

(e) Facility staffing and employment matters, which shall include, but not be limited to;

(i) Employee training standards for the safe operation and maintenance of any and all instrumentation that will be used in the testing of medical marijuana;

(ii) Employee training standards for the safe use, handling, storage, and disposal of any and all chemicals that will be used in the testing of medical marijuana, in accordance with OSHA protocols; and

(iii) Employee compliance with Chapter 3796. of the Revised Code and the rules promulgated in accordance with Chapter 3796. of the Revised Code;

(f) Compliance with the inventory tracking system implemented by the department; and

(g) Policies and procedures for the destruction and disposal of medical marijuana waste and other wastes that ensure medical marijuana waste is rendered unusable.

(3) A security plan, which shall include but not be limited to:

(a) Policies and procedures to ensure a secure, safe facility to prevent theft, loss, or diversion and protect facility personnel;

(b) Physical equipment used to monitor the facility and meet the security requirements under Chapter 3796. of the Revised Code and the rules promulgated in accordance with Chapter 3796. of the Revised Code;

(d) A plot plan of the laboratory facility drawn to a reasonable scale that designates the different areas of operation, with the mandatory access restrictions; and

(e) Transportation policies and procedures, which includes the transportation of medical marijuana from a cultivator or processor licensed by the department to the proposed testing laboratory in the state of Ohio, in accordance with rule 3796:4-2-10 of the Administrative Code.

(4) A financial plan, which, at a minimum, shall include:

(a) The identity and ownership interest of every person, association, partnership, other entity, or corporation having a financial interest, direct or indirect, in the testing laboratory with respect to which licensure is sought;

(b) A cost breakdown of the applicant's anticipated costs in building the facility and implementing the policies and procedures submitted as part of the application and the source of funding for the associated costs;

(c) Documentation acceptable to the department that the individual or entity filing the application has secured at least two hundred fifty thousand dollars in liquid assets for a testing laboratory provisional license are unencumbered and can be converted within thirty days after a request to liquidate such assets;

(i) Documentation acceptable to the department includes a signed statement from an Ohio licensed certified public accountant attesting to proof of the required amount of liquid assets under the control of an owner or the entity applying, if such a statement is available at the time of application.

(ii) The documentation must be dated within thirty calendar days before the date the application was submitted.

(d) Information verifying that the applicant will be able to conform to the financial responsibility requirements under rule 3796:4-1-05 of the Administrative Code; and

(e) A record of tax payments in the form of tax summary pages for individuals and businesses at the state and federal level in this state and in all jurisdictions in which an applicant has operated as a business and for every person with a financial interest of one percent or greater in the applicant for the five years before the filing of the application, unless the department determines that documentation should be submitted for all individuals and entities.

(5) Any other information that the department deems necessary to evaluate and determine the applicant's suitability to operate as a medical marijuana testing laboratory.

(C) In addition to the criteria established in paragraph (B) of this rule, the department may also consider the following when awarding a provisional license:

(1) Principal place of business;

(a) The applicant must provide documentation establishing that its principal place of business is headquartered in Ohio. The applicant may also provide the names, addresses, and verification of any persons associated with the applicant that have established residency in Ohio.

(b) The applicant may also provide a plan for generating Ohio-based jobs and economic development.

(2) Employment practices, in which the applicant must demonstrate a plan of action to inform, hire, and educate minorities, women, veterans, disabled persons, and Ohio residents;

(3) Verification of economically disadvantaged groups; and

(a) The applicant must demonstrate the following:

(i) It is owned and controlled by a United States citizen who is a resident of this state and is a member of one of the economically disadvantaged groups set forth in division (C) of section 3796.09 of the Revised Code. As used in this rule, "owned and controlled" means that at least fifty-one per cent of the business, including corporate stock if a corporation, is owned by persons who belong to one or more of the groups set forth in this rule, and that those owners have control over the management and day-to-day operations of the business and an interest in the capital, assets, and profits and losses of the business proportionate to their percentage of ownership; or

(ii) It is owned and controlled as a woman-owned business by a United States citizen who is a resident of this state. For purpose of the paragraph, "owned and controlled" has the same ownership and control requirements as listed in paragraph (C)(3)(a)(i) of this rule.

(4) Research plan, in which the applicant must provide the department with a detailed proposal to conduct or facilitate a scientific study or studies related to the medicinal use of marijuana. Such a proposal shall address any applicable regulatory restrictions and compliance therewith.

(D) The department may request additional information as part of the application review process from an applicant that otherwise meets all of the requirements under paragraph (A) of this rule. The applicant shall have thirty calendar days from the date the applicant receives the department's request to provide the information. If the applicant fails to provide the requested information within thirty calendar days, it will result in an abandoned application. An abandoned application shall not receive further consideration.

(E) An applicant forfeits all fees associated with an abandoned application. The department shall not be required to act on an abandoned application and the application may be destroyed by the department. An abandoned application will not prevent an applicant from applying for a provisional license in the future if the department issues additional provisional licenses pursuant to rule 3796:4-1-01 of the Administrative Code.

Last updated June 12, 2025 at 11:08 AM

History

Effective: September 8, 2017
Promulgated Under: 119.03

Ohio Adm.Code 3796:4-2-10

(A) Prior to transporting any medical marijuana samples, regardless of form, a testing laboratory licensed by the department shall maintain a transportation log, in writing, that contains the following information:

(1) The name and address of the medical marijuana entity from which the sample is taken;

(2) The name and registration number of the registered testing laboratory employee transporting the medical marijuana samples;

(3) The license plate number and vehicle type that will transport the samples;

(4) The time of departure and estimated time of arrival;

(5) The specific travel route, which includes street names and distances; and

(6) The total weight of the samples collected, a description of each sample, and the total number of samples being transported.

(B) The testing laboratory transporting medical marijuana under paragraph (A) of this rule shall enter the information required in the inventory tracking system in accordance with section 3796.07 of the Revised Code and the rules promulgated in accordance with Chapter 3796. of the Revised Code. The transportation log shall be made available to law enforcement agencies upon request. A testing laboratory shall maintain all transportation logs in accordance with the record keeping requirements established under the rules promulgated in accordance with Chapter 3796. of the Revised Code, and make them available at the request of the department.

(C) The vehicle transporting the medical marijuana samples or any product containing medical marijuana shall meet the following requirements:

(1) Be insured as required by law;

(2) Store the medical marijuana samples in a locked, safe, and secure storage compartment that is part of the motor vehicle, or in a locked storage container that has a separate key or combination pad;

(3) Ensure that any medical marijuana samples are not visible from the outside of the vehicle;

(4) Be staffed by a testing laboratory employee registered with the department;

(5) Have access to a secure form of communication with personnel at the testing laboratory and the ability to contact law enforcement through the 911 emergency system at all times that the vehicle contains medical marijuana samples, unless notification is impractical under the circumstances; and

(6) Not contain any marks, logos, brands, or other illustrations on the exterior of the vehicle, other than those affixed to the vehicle by the vehicle manufacturer or dealership.

(D) Any vehicle transporting medical marijuana samples shall travel directly from the facility from which the samples were collected to the testing laboratory, and shall not make any stops in between except to other medical marijuana entities listed on the transportation log for the purpose of collecting samples, to refuel the vehicle, or to notify the medical marijuana entities, the department and law enforcement in the event of an emergency. In the event of an emergency, the employees will report the emergency immediately to law enforcement through the 911 emergency system and to the medical marijuana entities, which will immediately notify the department, unless the notification is impractical under the circumstances.

(E) A registered testing laboratory employee transporting medical marijuana samples shall do the following:

(1) Display his or her department issued employee identification card at all times when transporting medical marijuana samples and shall produce it for the department or department's authorized representative or law enforcement official upon request;

(2) Ensure sample pick up times vary and routes are randomized;

(3) Report any vehicle accident that occurs during the transportation to the management staff of the testing laboratory within two hours after the accident occurs;

(4) Report any loss or theft of medical marijuana that occurs during the transportation of medical marijuana in accordance with rule 3796:5-4-01 of the Administrative Code; and

(5) Carry a copy of the transportation log completed pursuant to paragraph (A) of this rule for the duration of the trip.

Last updated July 21, 2026 at 12:33 PM

History

Effective: September 8, 2017
Promulgated Under: 119.03

Ohio Adm.Code 3796:4-1-04 Testing laboratory provisional license award.

(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.

Last updated June 12, 2025 at 11:08 AM

History

Effective: September 8, 2017
Promulgated Under: 119.03

Chapter 3796:4-2 Operations

Ohio Adm.Code 3796:4-2-01 Testing laboratory operations.

(A) A testing laboratory shall establish, maintain, and comply with the policies and procedures contained in the operations plan submitted by the testing laboratory as part of the application that was approved by the department. The operations plan shall include policies and procedures for the analysis, storage, sample inventory tracking, 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, including any areas to which access is restricted, and including areas that segregate samples awaiting analysis from those samples being analyzed or prepared for analysis, to prevent cross-contamination;

(2) Implement policies and procedures that provide best practices for safe, secure, and proper testing of medical marijuana;

(3) Establish training and safety policies and procedures to ensure that any person involved in analytical testing of medical marijuana:

(a) Has been fully trained in the safe operation and maintenance of any and all instrumentation that will be used in the testing of 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 in the testing of medical marijuana, in accordance with OSHA protocols, with supporting documentation of the training;

(d) 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 of custody for all medical marijuana in the inventory tracking system;

(5) 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 kind; and

(6) Maintain a facility with adequate lighting, ventilation, temperature, sanitation, equipment, and security for the testing of medical marijuana, including the following:

(a) A testing laboratory shall keep all floors and benches free of debris, dust, and any other potential contaminants;

(b) A testing laboratory shall use chemicals, cleaning solutions, and other sanitizing agents generally accepted for laboratory use, and shall store them in a manner that protects against contamination;

(c) A testing laboratory shall keep its equipment in a clean, professional environment and maintain a cleaning and equipment maintenance log at the facility, including preventive and routine maintenance plans and corresponding records, whether the preventive or routine maintenance is performed by laboratory staff or by service contract with third-parties or the original equipment manufacturer;

(d) A testing laboratory 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; and

(e) A testing laboratory shall standardize all analytical test instrumentation using reference materials traceable to reference material producers accredited to ISO/IEC 17034 "General Requirements for the Competence of Reference Material Producers" or the national metrology institute (NMI), where available.

(B) A testing laboratory shall employ a scientific director who will be responsible for supervision of all laboratory staff and for ensuring that the laboratory achieves and maintains quality standards of practice. The scientific director shall meet the following qualifications, at minimum:

(1) A doctorate degree in chemical, environmental, or biological sciences from an accredited college or university and two years of post-degree laboratory experience; or

(2) A master's degree in chemical, environmental, or biological sciences from an accredited college or university and four years of post-degree laboratory experience.

(1) Methods established in accordance with "Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control" (2014) monograph published by the "American Herbal Pharmacopoeia"; or

(2) Alternative methods that have been reviewed and approved by the department. If the proposed methods are approved, the department may require the testing laboratory to have the methods validated by an independent third party, at the expense of the testing laboratory, prior to the testing laboratory using the proposed methods to conduct testing services.

(D) A testing laboratory shall track and submit into the inventory tracking system any information the department determines necessary for tracking medical marijuana, including, but not limited to, transportation of samples, sample inventory, and results of analysis.

History

Effective: September 8, 2017
Promulgated Under: 119.03

Ohio Adm.Code 3796:4-2-02 Testing laboratory proficiency testing and certification.

(A) Within two calendar years of the date of issuance of a provisional license by the department, a testing laboratory shall become accredited to the ISO/IEC 17025 "General Requirements for the Competence of Testing and Calibration Laboratories" standard by a non-profit accreditation body that is signatory to the "International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA)" and which operates in accordance with ISO/IEC 17011 "General Requirements for accreditation Bodies Accrediting Conformity Assessment Bodies," and shall consent to have all inspections and reports pertaining to certification and accreditation made available to the department.

(1) If the director believes that a testing laboratory has failed to meet the requirements of paragraph (A) of this rule, the director may issue a notice of noncompliance to a licensed testing laboratory. The notice shall include the factual basis for the director's belief, including any appropriate supporting documentation.

(2) Upon a notice issued pursuant to paragraph (B) of this rule, a testing laboratory may respond with any evidence sufficient to prove that the testing laboratory has met, and continues to meet, the standards established by paragraph (A) of this rule.

(3) If a testing laboratory fails to respond to a notice issued, or the director determines the evidence provided is insufficient to establish that the conditions in paragraph (A) of this rule have been met, the director shall move to fine, suspend, or revoke the testing laboratory certificate of operation pursuant to rule 3796:5-6-01 of the Administrative Code.

(4) At any time prior to the issuance of a notice of noncompliance under this rule, a testing laboratory may petition the director to toll computation of the time frames provided in paragraph (A) of this rule. Such a petition shall provide the following:

(a) An explanation of the facts and circumstances that will not allow the testing laboratory to become certified and accredited as required in paragraph (A) of this rule; and

(b) A plan for how and when the testing laboratory will be able to meet the requirement of paragraph (A) of this rule, with specific attention to how such a plan will allow the testing laboratory to meet the standards established in paragraph (A).

(5) Upon receipt of a petition under paragraph (E) of this rule, the director may stay the requirement of paragraph (A) of this rule for a testing laboratory. A director's order staying the requirement of paragraph (A) of this rule shall state the date upon which the stay is lifted using information provided by the testing laboratory in accordance with paragraph (E)(2) of this rule.

(B) The department may require a testing laboratory to participate in third party proficiency testing programs administered by organizations accredited to ISO/IEC 17043 "Conformity Assessment - General Requirements for Proficiency Testing," if such programs are available.

Last updated July 21, 2026 at 12:33 PM

History

Effective: September 8, 2017
Promulgated Under: 119.03

Ohio Adm.Code 3796:4-2-03 Testing laboratory sample procurement.

(A) A testing laboratory shall collect samples of harvested plant material for analysis from a cultivator. Samples must be taken from each segregated, homogenized batch of harvested marijuana, as defined in rule 3796:1-1-01 of the Administrative Code, in such a manner as to ensure that a random sample is selected.

(B) A testing laboratory shall collect samples of medical marijuana products for analysis from a processor. Samples must be taken from each lot of medical marijuana products, as defined in rule 3796:1-1-01 of the Administrative Code, in such a manner as to ensure that a random sample is selected.

(C) A testing laboratory may collect samples of marijuana-derived ingredients, including but not limited to extracts, intended for use in the manufacture of medical marijuana products, if analysis is requested by a processor. Samples must be taken from each batch of marijuana-derived ingredients in such a manner as to ensure that a random sample is selected. Tests performed on medical marijuana extract may satisfy the requirements set forth in paragraph (C) of rule 3796:4-2-04 of the Administrative Code for the following analyses:

(1) Mycotoxin contamination;

(2) Heavy metal contamination;

(3) Pesticide and fertilizer residue contamination; or

(4) Residual solvent contamination.

(D) A testing laboratory may collect samples of plant material at any phase of cultivation for the purposes of assisting cultivators in research and development regarding new strains of medical marijuana or cultivation techniques, if analysis is requested by a cultivator. Tests performed pursuant to this paragraph must be reported to the department in accordance with rule 3796:4-2-05 of the Administrative Code, and the resulting certificate of analysis must be clearly marked with the phrase "For research and development only. Not for sale."

(E) A testing laboratory shall transport all samples in accordance with rule 3796:4-2-10 of the Administrative Code.

Last updated July 21, 2026 at 12:33 PM

History

Effective: September 8, 2017
Promulgated Under: 119.03

Ohio Adm.Code 3796:4-2-04

(A) A testing laboratory shall analyze a sample of at least one half of one percent of the net weight of the batch from each batch of dried, cured plant material intended to be sold to a dispensary licensed by the state of Ohio board of pharmacy for, at minimum:

(1) Moisture content;

(2) Water activity;

(3) Cannabinoid potency including, at minimum:

(a) Delta-8- tetrahydrocannabinol;

(b) Delta-8- tetrahydrocannabinolic acid;

(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.

(4) Foreign matter contamination;

(5) Microbial contamination;

(6) Mycotoxin contamination;

(7) Heavy metal contamination including, at a minimum, arsenic, cadmium, lead, and mercury; and

(8) Pesticide and fertilizer residue.

(B) A testing laboratory shall analyze a sample of at least one half of one percent of the net weight of the batch from each batch of plant material intended to be sold to a processor licensed by the department for use in the manufacture of medical marijuana products for, at minimum:

(1) Pesticide and fertilizer residue; and

(2) Cannabinoid potency for, at a minimum:

(a) Delta-8-tetrahydrocannabinol;

(b) Delta-8-tetrahydrocannabinolic acid;

(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 testing laboratory shall analyze a sample of one unit of the same size, weight, and volume intended to be packaged and sold to a licensed dispensary from each lot of medical marijuana products prior to sale to a dispensary licensed by the state of Ohio board of pharmacy for, at minimum:

(1) Cannabinoid potency including, at minimum:

(a) Delta-8-tetrahydrocannabinol;

(b) Delta-8-tetrahydrocannabinolic acid;

(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.

(2) Foreign matter contamination;

(3) Microbial contamination;

(4) Mycotoxin contamination, if a medical marijuana extract was used in the manufacture of the product that was not previously tested for mycotoxin contamination by a licensed testing laboratory;

(5) Heavy metal contamination including, at a minimum, arsenic, cadmium, lead, and mercury, if a medical marijuana extract was used in the manufacture of the product that was not previously tested for heavy metal contamination by a licensed testing laboratory;

(6) Pesticide and fertilizer residue, if a medical marijuana extract was used in the manufacture of the product that was not previously tested for pesticide or fertilizer residue contamination by a licensed testing laboratory; and

(7) Residual solvents, if a hydrocarbon-based medical marijuana extract was used in the manufacture of the product that was not previously tested for residual solvent contamination by a licensed testing laboratory.

(D) A testing laboratory may perform analysis on marijuana-derived ingredients used in the manufacture of medical marijuana products, including but not limited to medical marijuana extract. When performing analysis on medical marijuana-derived ingredients, the following sample sizes and required tests shall apply:

(1) A sample of at least one half of one percent of the net weight of the batch from a batch of medical marijuana extract derived from a system utilizing hydrocarbon solvents for, at minimum:

(a) Pesticide and fertilizer residue; and

(b) Cannabinoid potency including, at minimum:

(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 by rule 3796:1-1-01 of the Administrative Code;

(viii) Cannabinol (CBN); and

(ix) Any other cannabinoid determined by the department.

(d) Heavy metal contamination including, at a minimum, arsenic, cadmium, lead, and mercury; and

(e) Residual solvents.

(2) A sample of at least one half of one percent of the net weight of the batch from a batch of medical marijuana extract derived from a system utilizing carbon dioxide for, at minimum:

(a) Pesticide and fertilizer residue; and

(b) Cannabinoid potency for, at a minimum:

(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;

(viii) Cannabinol (CBN); and

(ix) Any other cannabinoid determined by the department.

(d) Heavy metal contamination including, at a minimum, arsenic, cadmium, lead, and mercury.

(3) A sample of at least one half of one per cent of the net weight of the batch from a batch of medical marijuana extract derived from a method that does not involve the use of a hydrocarbon or carbon dioxide as a solvent for, at a minimum:

(a) Cannabinoid potency including, at minimum:

(i) Delta-8-tetrahydrocannabinol;

(ii) Delta-8-tetrahydrocannabinolic acid;

(iii) Delta-9-tetrahydrocannabinol;

(iv) Delta-9-tetrahydrocannabinol;

(v) Cannabidiol (CBD);

(vi) Cannabidiolic acid (CBDA);

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

(viii) Cannabinol (CBN); and

(ix) Any other cannabinoid determined by the department.

(b) Foreign matter contamination;

(d) Mycotoxin contamination;

(e) Heavy metal contamination including, at a minimum, arsenic, cadmium, lead, and mercury; and

(f) Pesticide and fertilizer residue.

(E) A testing laboratory may request additional sample material in excess of the amounts listed in this rule if necessary for completion of the required quality assurance tests.

(F) For the purposes of microbial contamination analysis, a sample provided to a testing laboratory shall be deemed to have passed if it satisfies the standards set forth in Table 9 of the "Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control" (2014) monograph.

(1) If a batch of plant material is not deemed to have passed testing for microbial contamination, that batch may be designated for extraction by hydrocarbon-based or carbon dioxide-based methods

(2) Medical marijuana extract derived from a batch of plant material not deemed to have passed testing for microbial contamination must be tested for microbial contamination prior to use in the manufacture of medical marijuana products.

(G) For the purposes of mycotoxin contamination analysis, a sample provided to a testing laboratory pursuant to this rule shall be deemed to have passed if:

(1) The total of the detected amounts, if any, of aflatoxin B1, aflatoxin B2, aflatoxin G1, and aflatoxin G2 is less than twenty micrograms per kilogram; and

(2) The detected amount, if any, of ochratoxin A is less than twenty micrograms per kilogram.

(H) For the purposes of heavy metal contamination analysis, a sample provided to a testing laboratory shall be deemed to have passed if:

(1) The detected amount of arsenic, if any, is less than 0.14 micrograms per kilogram.

(2) The detected amount of cadmium, if any, is less than 0.09 micrograms per kilogram.

(3) The detected amount of lead, if any, is less than 0.29 micrograms per kilogram.

(4) The detected amount of mercury, if any, is less than 0.29 micrograms per kilogram.

(I) For the purposes of pesticide residue analysis, a sample shall be deemed to have passed if it satisfies the most stringent acceptable standard for an approved pesticide chemical residue in a food item as set forth in Subpart C of 40 C.F.R. Part 180, as effective on September 8, 2017. A sample shall automatically be deemed to have failed if residue is detected from any pesticide not on the approved pesticide list maintained by the department, regardless of the detected level of residue.

(J) Except as provided in paragraph (G)(1) of this rule, if a sample is deemed to have failed tests for any contaminants listed in this rule, the cultivator or processor that provided the sample must immediately destroy the corresponding batch of plant material or extract or lot of medical marijuana products and document the destruction in the inventory tracking system.

Last updated July 21, 2026 at 12:33 PM

History

Effective: May 2, 2022
Promulgated Under: 119.03

Ohio Adm.Code 3796:4-2-05

(A) A testing laboratory performing analysis on medical marijuana shall input the results of analysis into the inventory tracking system. The department may require a testing laboratory to submit, in portable document format (.pdf), an electronic copy of the results of analysis of any batches and lots tested to an email address specified and maintained by the department.

(B) A testing laboratory performing analysis on medical marijuana shall create a unique certificate of analysis for each batch or lot tested, which shall include, at minimum:

(1) The name and license number of the testing laboratory where the analysis was performed;

(2) The name and license number of the cultivator or processor from whom the sample was received;

(3) The registered name of the medical marijuana strain or medical marijuana product that was registered with the department;

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

(5) The date or dates on which each test was performed;

(6) A grid or table listing all tests performed, and indicating "pass" or "fail" for each, as defined in rule 3796:4-2-04 of the Administrative Code.

(7) The cannabinoid profile of the sample, including the percentage content by weight for, at minimum:

(a) Delta-8-tetrahydrocannabinol;

(b) Delta-8-tetrahydrocannabinolic acid;

(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.

(8) Moisture content;

(9) Water activity;

(10) Results of analysis for foreign matter contamination;

(11) Quantitative results of analysis for microbial contamination;

(12) Quantitative results of analysis for heavy metal contamination;

(13) Quantitative results of analysis for pesticide and fertilizer residue;

(14) Quantitative results of analysis for mycotoxins;

(15) Quantitative results of analysis for residual solvents; and

(16) The signature of the laboratory manager or scientific director certifying the analysis.

(1) Results of quantitative analysis of additional cannabinoids for which the laboratory is able to obtain a standard for comparison;

(2) Results of quantitative analysis of terpenes for which the laboratory is able to obtain a standard for comparison;

(D) A certificate of analysis shall not contain any sum totals of cannabinoids or terpenes, except THC content as defined in paragraph rule 3796:1-1-01 of the Administrative Code.

Last updated July 21, 2026 at 12:33 PM

History

Effective: May 2, 2022
Promulgated Under: 119.03