Ohio Seed-to-Sale Traceability Info
You can find more information on Ohio’s Medical Marijuana Program here.
(A) A cultivator distributing plant material to a processor shall meet the following requirements:
(1) A cultivator shall place plant material in a tamper-evident, light-resistant package approved by the department prior to distributing plant material to a processor. Approved packaging shall maintain the integrity and stability of the plant material.
(2) A label shall be affixed to every package and state in legible English:
(a) The name and license number of the cultivator where the packaged material was cultivated and harvested;
(b) The name and license number of the processor facility receiving the shipment;
(c) The product identifier;
(d) The registered name of the medical marijuana that was registered with the department;
(e) A unique identification number that will match the medical marijuana with a batch and batch number to facilitate any warnings and recalls the department deems appropriate;
(f) The date of harvest, final testing, and packaging;
(g) The total weight in grams of plant material in each package;
(h) The identification of the independent testing laboratory;
(i) The laboratory analysis, profile and a list of all active ingredients, including the percentage content by weight for the following cannabinoids, at a minimum:
(i) Delta-9-tetrahydrocannabinol (THC);
(ii) Delta-9-tetrahydrocannabinolic acid (THCA);
(iii) Cannabidiol (CBD); and
(iv) Cannabidiolic acid (CBDA);
(j) The expiration date, which shall not exceed one calendar year from the date of harvest; and
(k) A statement with the following language: “This product is for medical use and not for resale or transfer to another person. This product may cause impairment and may be habit-forming. This product may be unlawful outside of the State of Ohio.”
(B) A cultivator with a plant-only processor license distributing plant material to a dispensary shall meet the following requirements:
(1) A cultivator shall place plant material in a child-proof, tamper-evident, light-resistant package approved by the department prior to distributing plant material to a dispensary. Approved packaging shall maintain the integrity and stability of the plant material.
(2) A label shall be affixed to every package and state in legible English:
(a) The name and license number of the cultivator where the packaged material was cultivated and harvested;
(b) The name and license number of the dispensary receiving the shipment;
(c) The product identifier;
(d) The registered name of the medical marijuana that was registered with the department;
(e) A unique identification number that will match the medical marijuana with a batch and batch number to facilitate any warnings or recalls the department deems appropriate;
(f) The date of harvest, final testing and packaging;
(g) The total weight in grams of plant material in each package;
(h) The identification of the independent testing laboratory;
(i) The laboratory analysis, profile, and a list of all active ingredients, including the percentage content by weight for the following cannabinoids, at a minimum:
(i) Delta-9-tetrahydrocannabinol (THC);
(ii) Delta-9-tetrahyrdrocannabinolic acid (THCA);
(iii) Cannabidiol (CBD); and
(iv) Cannabidiolic acid (CBDA);
(j) The expiration date, which shall not exceed one calendar year from the date of harvest; and
(k) A statement with the following language: “This product is for medical use and not for resale or transfer to another person. This product may cause impairment and may be habit-forming. This product may be unlawful outside the State of Ohio.”
(C) A label may contain the approval or certification logo of a third-party certifier of cultivation practices if:
(1) The third-party certifier does not have a direct or indirect financial interest in any medical marijuana entity licensed in the state of Ohio; and
(2) The certification protocols used by the third-party certifier have been reviewed and approved by the department.
(D) A label shall not contain any of the following:
(1) Any false or misleading statement or design;
(2) Depictions of the product, cartoons, or images that are not registered with the department, which includes any insignia related to a governmental entity;
(3) Any sum totals of cannabinoids or terpenes, except THC content as defined in rule 3796:1-1-01 of the Administrative Code; or
(4) Any information that would violate paragraph (F) of rule 3796:5-7-01 of the Administrative Code.
(E) A cultivator may provide a dispensary free samples of plant material sold at the dispensary. A free sample shall be packaged in a sample jar protected by a plastic or metal mesh screen to allow patients and caregivers to smell the plant material before purchase. A sample jar may not contain more than three grams of a particular strain of plant material. The sample jar and the plant material within may not be sold to a patient or caregiver and shall be destroyed by the dispensary after use by the dispensary. The dispensary shall document the destruction of every free sample in accordance with the rules established pursuant to Chapter 3796. of the Revised Code.
(F) It is prohibited for anyone to knowingly or intentionally alter, obliterate, or otherwise destroy any container or label attached to an approved container. In the event a container or label is altered, obliterated, or otherwise destroyed, the department may act in accordance with rule 3796:5-6-01 of the Administrative Code.
Effective: 5/6/2017
Five Year Review (FYR) Dates: 05/06/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03
(A) A cultivator shall track and submit into the inventory tracking system any information the department determines necessary for maintaining and tracking medical marijuana. When a plant reaches twelve inches in height or is transplanted from a cloning medium or apparatus into a growth medium or apparatus intended for the vegetative or flowering stages of growth cycle, whichever occurs sooner, the cultivator shall securely attach a tag to the plant or the plant’s container that includes, at a minimum, the following information:
(1) The cultivator’s name and license number;
(2) The registered name of the strain;
(3) The unique plant identifier; and
(4) General information regarding the plant that is used for traceability.
(B) Prior to commencing business, each cultivator shall do the following:
(1) Conduct an initial comprehensive inventory of all medical marijuana at the cultivator. If the cultivator commences business with no medical marijuana on hand, the cultivator shall record this fact as the initial inventory; and
(2) Establish ongoing inventory controls and procedures for the conduct of inventory reviews and comprehensive inventories of medical marijuana for traceability in the department’s inventory tracking system, which shall enable the cultivator to detect any diversion, theft, or loss in a timely manner.
(C) Upon commencing business, each cultivator shall prepare a weekly inventory of medical marijuana at the facility, which shall include, at a minimum, the following:
(1) The date of the inventory;
(2) The amount of medical marijuana on hand, which shall include the following:
(a) The total count of plants, whether in the flowering, vegetative, or clone phase of growth and organized by room in which the plants are being grown;
(b) The batch number, weight, and strain name associated with each batch at the cultivator’s facility that has been quarantined for testing or ready for sale to a processor or dispensary; and
(c) The total number of plants and every unique plant identifier that have been harvested, but are not yet associated with a batch.
(3) The amount of medical marijuana sold since previous weekly inventory, which shall include the following:
(a) The date of sale;
(b) The license number and name of the processor or dispensary to which the medical marijuana was sold; and
(c) The batch number, registered product name and quantity of medical marijuana sold.
(4) The date, quantity, and method of disposal of medical marijuana, if applicable;
(5) A summary of the inventory findings; and
(6) The name, signature, and title of the employees who conducted the inventory and oversaw the inventory.
(D) On an annual basis and as a condition for renewal of a cultivator license, a type 1 key employee shall conduct a physical, manual inventory of the medical marijuana on hand at the cultivator and compare the findings to an annual inventory report generated using the inventory tracking system. If any discrepancies are discovered outside of loss standard to the industry due to moisture loss and handling, the type 1 key employee shall report such findings to the department in accordance with rule 3796:5-4-01of the Administrative Code.
(E) All inventories, procedures and other documents required by this rule shall be maintained on the premises and made available to the department at all times.
(F) A cultivator is authorized to store medical marijuana inventory on the premises in a designated, enclosed, locked facility identified in the cultivator’s plans and specifications submitted to the department and accessible only by authorized individuals. Notwithstanding the requirements of this chapter, nothing shall prohibit members of the department, a department’s designee, law enforcement, or other federal, state, or local government officials from entering any area of a cultivator if necessary to perform their governmental duties.
Effective: 5/6/2017
Five Year Review (FYR) Dates: 05/06/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03
(A) Each cultivator shall keep and maintain upon the licensed premises for a five-year period, unless otherwise stated in this chapter, true, complete, legible and current books and records. All required records must be made available for inspection if requested by the department. The following records shall be maintained:
(1) Records relating to the disposal of medical marijuana, medical marijuana products, and waste in accordance with paragraph (E) of this rule and rule 3796:2-2-03 of the Administrative Code;
(2) Records related to the sale of medical marijuana in accordance with paragraph (C) of rule 3796:2-2-04 of the Administrative Code;
(3) Transportation records in accordance with rule 3796:5-3-01 of the Administrative Code;
(4) Records of all samples sent to an independent testing laboratory and the quality assurance test results;
(5) Security records in accordance with paragraph (B) of rule 3796:2-2-05 of the Administrative Code;
(6) Inventory tracking records and inventory records maintained in the inventory tracking system, as well as records maintained by the facility outside the inventory tracking system, in accordance with rule 3796:2-2-04 of the Administrative Code;
(7) Cultivation records, which, at a minimum, shall include the following:
(a) Forms and types of medical marijuana maintained at the cultivator on a daily basis;
(b) Soil amendment, fertilizers, pesticides, or other chemicals applied to the growing medium or plants or used in the process of growing medical marijuana in accordance with paragraph (C) of rule 3796:2-2-01 of the Administrative Code; and
(c) Production records, including planting, harvesting and curing, weighing, and packaging and labeling.
(8) Financial records retained at a location determined by the cultivator in accordance with paragraph (C) of this rule;
(9) Employee records in accordance with paragraph (D) of this rule; and
(10) Records of any theft, loss, or other unaccountability of any medical marijuana as described in rule 3796:5-4-01 of the Administrative Code.
(B) A cultivator may use an electronic system for storage and retrieval of records required by this rule or other records relating to medical marijuana. Any loss of electronically-maintained records shall not be considered a mitigating factor for violations of this rule. A cultivator that elects to use an electronic system shall use a system that does all of the following:
(1) Guarantees the confidentiality of the information stored in the system;
(2) Is capable of providing safeguards against erasures and unauthorized changes in data after the information has been entered and verified by the cultivator;
(3) Is capable of placing a litigation hold or enforcing a records retention hold for purposes of conducting an investigation or pursuant to ongoing litigation; and
(4) Is capable of being reconstructed in the event of a computer malfunction or accident resulting in the destruction of the data bank.
(C) A cultivator shall maintain financial records, which shall include the following:
(1) Records that clearly reflect all financial transactions and the financial condition of the business, including contracts for services performed or received that relate to the cultivator;
(2) Purchase invoices, bills of lading, manifests, sales records, copies of bills of sale, and any supporting documents, including the items and/or services purchased, from whom the items were purchased, and the date of purchase;
(3) Bank statements and canceled checks for all accounts relating to the cultivator, if applicable; and
(4) Accounting and tax records related to the cultivator and all investors in the facility.
(D) A cultivator shall maintain employee records, which shall include the following:
(1) All records relating to the hiring of employees, including applications, documentation of verification of references, and any other related materials;
(2) An employee log that includes the following information for every current and former employee:
(a) Employee name, address, phone number and emergency contact information;
(b) Registration number and access credential designation;
(c) Date of hire and date of separation from employment, if applicable, and the reason for the separation;
(d) All training, education, and disciplinary records; and
(e) Salary and wages paid to each employee, and any executive compensation, bonus, benefit, or item of value paid to any individual affiliated with any medical marijuana entity, including members of a non-profit corporation, if any.
(3) Visitor logs maintained in accordance with rule 3796:5-2-01 of the Administrative Code.
(E) Medical marijuana production and disposal records may be stored at the facility and shall include all of the following:
(1) The registered product name, strain and quantity of medical marijuana involved;
(2) The date of production or removal from production;
(3) The reason for removal from production, if applicable;
(4) A record of all medical marijuana sold, transported, or otherwise disposed of;
(5) The date and time sale, transportation, or disposal of the medical marijuana; and
(6) If the medical marijuana is destroyed, the cultivator shall maintain records in accordance with paragraph (D) of rule 3796:2-2-03 of the Administrative Code.
Effective: 5/6/2017
Five Year Review (FYR) Dates: 05/06/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03
(A) A processor distributing medical marijuana to a dispensary shall meet the following requirements:
(1) A processor shall place medical marijuana in a child-proof, tamper-evident, light-resistant package approved by the department prior to distribution to a dispensary. Approved packaging shall maintain the integrity and stability of the medical marijuana, and shall comply with the rules promulgated by the state of Ohio board of pharmacy pursuant to Chapter 3796. of the Revised Code.
(2) A label shall be affixed to every package and state in legible English:
(a) The name and license number of the cultivator where the packaged plant material was cultivated or the name and license number of the processor where the medical marijuana products were manufactured;
(b) The name and license number of the dispensary facility receiving the shipment;
(c) The product identifier;
(d) The registered name of the medical marijuana plant material strain that was registered with the department or the registered name, form, and dose of the medical marijuana product that was registered with the department;
(e) A unique batch or lot number as defined in paragraph (A) of rule 3796:1-1-01 of the Administrative Code that will match the medical marijuana or medical marijuana products with a batch or lot, in order to facilitate any warnings or recalls the department deems appropriate;
(f) The dates of manufacture, final testing, and packaging;
(g) The total weight in grams of medical marijuana or medical marijuana products in each package;
(h) The name and license number of the independent testing laboratory that performed the required tests on the batch or lot from which the medical marijuana or medical marijuana products in the package were taken;
(i) The laboratory analysis and cannabinoid profile, including the percentage content by weight or total milligrams and milligrams per unit for:
(i) Delta-9-tetrahydrocannabinol (THC);
(ii) Delta-9-tetrahydrocannabinolic acid (THCA);
(iii) cannabidiol (CBD); and
(iv) cannabidiolic acid (CBDA).
(j) The expiration date, which shall not exceed one calendar year from the date of manufacture;
(k) If the product is edible, the following additional information:
(i) A list of all ingredients and subingredients, providing that all ingredients comply with the standards of identity under rule 901:3-1-12 of the Administrative Code;
(ii) A list of all major food allergens as identified in 21 USC 343; and
(iii) A statement with the following language: “Caution: When eaten or swallowed, the effects and impairment caused by this drug may be delayed.”
(l) If a marijuana extract was used in the manufacture of the product, a disclosure of the type of extraction process and any solvent, gas, or other chemical used in the extraction process or any other compound added to the extract; and
(m) A statement with the following language: “This product is for medical use and not for resale or transfer to another person. This product may cause impairment and may be habit-forming. This product may be unlawful outside the State of Ohio.”
(n) If the product was manufactured using plant material that was acquired from a dispensary pursuant to paragraph (B) of rule 3796:3-2-01 of the Administrative Code, a statement with the following language: “This product was manufactured using medical marijuana that exceeded the expiration date defined in OAC 3796:1-1-01.”
(o) The intended method of administration of the medical marijuana product.
(B) A processor that elects to or is required to determine portions for an edible medical marijuana product under rules promulgated by the state of Ohio board of pharmacy pursuant to Chapter 3796. of the Revised Code shall apply a universal symbol that denotes that the product contains medical marijuana as an ingredient, as determined by the department, to each portion of the medical marijuana product, in accordance with the following:
(1) If the medical marijuana product is presented as separate single portions, the processor shall apply the universal symbol to each single portion;
(2) If the medical marijuana product is presented as a single unit comprised of more than one portion, the processor shall make clearly visible lines of demarcation between portions and apply the universal symbol to each portion; and
(3) The size of the universal symbol marking shall be determined by the size of the portion instead of the overall product size, and shall not be less than one-fourth inch by one- fourth inch.
(C) The label may contain the approval or certification logo of a third-party certifier of manufacturing or cultivation practices if:
(1) The third-party certifier does not have a direct or indirect financial interest in any medical marijuana entity licensed in the state of Ohio; and
(2) The certification protocols used by the third-party certifier have been reviewed and approved by the department.
(D) A label shall not contain:
(1) Any false or misleading statement or design;
(2) Depictions of the product, cartoons, or images that are not registered with the department, which includes any insignia related to a governmental entity;
(3) Any sum totals of cannabinoids or terpenes, except as defined in paragraph (A)(49) of rule 3796:1-1-01 of the Administrative Code; or
(4) Any information that would violate paragraph (E) of rule 3796:5-7-01 of the Administrative Code.
(E) A processor may provide a dispensary free samples of plant material sold at the dispensary. A free sample shall be packaged in a sample jar protected by a plastic or metal mesh screen to allow patients and caregivers to smell the plant material before purchase. A sample jar may not contain more than three grams of a particular strain of plant material. The sample jar and the plant material within may not be sold to a patient or caregiver and shall be destroyed by the dispensary after use by the dispensary. The dispensary shall document the destruction of every free sample in accordance with the rules established pursuant to Chapter 3796. of the Revised Code.
(F) It is prohibited for anyone to knowingly or intentionally alter, obliterate, or otherwise destroy any container or label attached to an approved container. In the event a container or label is altered, obliterated, or otherwise destroyed, the department may act in accordance with rule 3796:5-6-01 of the Administrative Code.
Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03
(A) Each processor shall keep and maintain upon the licensed premises for a five-year period, unless otherwise stated in these rules, true, complete, legible, and current books and records. All required records must be made available for inspection if requested by the department. The following records shall be maintained:
(1) Records relating to the disposal of medical marijuana, medical marijuana products, and waste in accordance with paragraph (E) of this rule and rule 3796:3-2-03 of the Administrative Code;
(2) Records related to the sale of medical marijuana in accordance with paragraph (D) of rule 3796:3-2-04 of the Administrative Code;
(3) Transportation records in accordance with rule 3796:5-3-01 of the Administrative Code;
(4) Records of all samples sent to an independent testing lab and the quality assurance test results;
(5) Security records in accordance with paragraph (B) of rule 3796:3-2-05 of the Administrative Code;
(6) Inventory tracking records and inventory records maintained in the inventory tracking system, as well as records maintained by the facility outside the inventory tracking system, in accordance with rule 3796:3-2-04 of the Administrative Code;
(7) Processing records, which at a minimum shall include:
(a) The form and types of medical marijuana maintained at the facility on a daily basis;
(b) Production records, including extraction, refining, manufacturing, packaging, and labeling;
(8) Financial records in accordance with paragraph (C) of this rule;
(9) Employee records in accordance with paragraph (D) of this rule; and
(10) Records of any theft, loss, or other unaccountability of any medical marijuana as described in rule 3796:5-4-01 of the Administrative Code.
(B) A processor may use an electronic system for the storage and retrieval of records required by this chapter or other records relating to medical marijuana. Any loss of electronically-maintained records shall not be considered a mitigating factor for violations of this rule. A processor shall use a system that:
(1) Guarantees the confidentiality of the information stored in the system;
(2) Is capable of providing safeguards against erasures and unauthorized changes in data after the information has been entered and verified by the processor;
(3) Is capable of placing a litigation hold or enforcing a records retention hold for purposes of conducting an investigation or pursuant to ongoing litigation; and
(4) Is capable of being reconstructed in the event of a computer malfunction or accident resulting in the destruction of the data bank.
(C) A processor shall maintain financial records, which shall include the following:
(1) Records that clearly reflect all financial transactions and the financial condition of the business, including contracts for services performed or received that relate to the processor;
(2) Purchase invoices, bills of lading, manifests, sales records, copies of bills of sale, and any supporting documents, including the items and/or services purchased, from whom the items were purchased, and the date of purchase;
(3) Bank statements and canceled checks for all accounts relating to the processor, if applicable; and
(4) Accounting and tax records related to the processor and all investors in the facility.
(D) A processor shall maintain employee records, which shall include the following:
(1) All records relating to the hiring of employees, including applications, documentation of verification of references, and any other related materials;
(2) An employee log that includes the following information for every current and former employee:
(a) Employee name, address, phone number, and emergency contact information;
(b) Registration number and access credential designation;
(c) Date of hire and date of separation from employment, if applicable, and the reason for the separation;
(d) All training, education, and disciplinary records; and
(e) Salary and wages paid to each employee, and any executive compensation, bonus, benefit, or item of value paid to any individual affiliated with any medical marijuana entity, including members of a non-profit corporation, if any, and
(3) Documentation that each employee has been successfully trained in accordance with the operations plan submitted as part of the processor application and in compliance with paragraph (B)(3)(f) of rule 3796:3-1-02 of the Administrative Code.
(4) Visitor logs maintained in accordance with rule 3796:5-2-01 of the Administrative Code.
(E) Medical marijuana production and disposal records may be stored at the facility and shall include all of the following:
(1) The registered strain or product name, form, and quantity of marijuana involved;
(2) The date of production or removal from production;
(3) The reason for removal from production, if applicable;
(4) A record of all medical marijuana sold, transported, or otherwise disposed of;
(5) The date and time of selling, transporting, or disposing of the medical marijuana; and
(6) If the medical marijuana is destroyed, the processor shall maintain records in accordance with paragraph (D) of rule 3796:3-2-03 of the Administrative Code.
Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03
(A) A dispensary shall ensure that the following information is clearly provided on the outside of each container or package containing medical marijuana, prior to sale:
(1) The business or trade name and the license number of the cultivator that cultivated the marijuana;
(2) The product identifier;
(3) The date and quantity dispensed, including the net weight measured in ounces and grams or by volume, as appropriate;
(4) The name and registry number of the patient and, if applicable, the name of his or her designated caregiver;
(5) The name, address and license number of the dispensary;
(6) The cannabinoid profile and concentration levels and terpenoid profile as determined by the testing laboratory;
(7) A warning that states: “This product may cause impairment and may be habit-forming;”
(8) The statement: “This product may be unlawful outside of the State of Ohio;”
(9) The date on which the marijuana was harvested;
(10) If the product is in a form other than plant material, the following must be included:
(a) The date on which the product was manufactured and the name and license number of the processor that manufactured the product;
(b) A list of all ingredients and all major food allergens as identified in 21 USC 343;
(c) A warning that states: “Caution: When eaten or swallowed, the effects and impairment caused by this drug may be delayed;” and
(d) If a marijuana extract was added to the product, a disclosure of the type of extraction process and any solvent, gas or other chemical used in the extraction process or any other compound added to the extract.
(B) The requirements set forth under paragraph (A) of this rule may be partially satisfied if required information is included on the cultivator or processor-created package. A dispensary shall include on its affixed label, any required information that is also included on the cultivator or processor-created package if that information is obscured, in whole or in part, by the affixed label.
(C) A dispensary must provide with all medical marijuana dispensed, accompanying material that discloses any pesticide applied to the marijuana plants and growing medium during production and process and that contains the following warnings:
(1) “Warning: This product may cause impairment and may be habit-forming. Smoking medical marijuana is not permitted in the State of Ohio.”
(2) “There may be health risks associated with consumption of this product.”
(3) “Should not be used by women who are pregnant or breastfeeding.”
(4) “For use only by the person named on the label of the dispensed product. Keep out of reach of children.”
(5) “Marijuana can impair concentration, coordination and judgment. Do not operate a vehicle or machinery under the influence of this drug.”
(6) The toll-free telephone line established by the state board of pharmacy in accordance with section 3796.17 of the Revised Code
(7) The text used on all accompanying material must be printed in at least twelve-point font and may not be in italics.
(D) A dispensary shall include the following printed statement on the receipt or in the bag or other similar packaging in which dispensed medical marijuana is transferred from the dispensary to a patient or caregiver: “If you have a concern that an error may have occurred in the dispensing of your medical marijuana, you may contact the State of Ohio Board of Pharmacy, using the contact information found at medicalmarijuana.ohio.gov.” Such language shall be in a size and font that is easily readable by patients.
Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: 3796.04
Rule Amplifies: 3796.04 , 3796.17, 3769.20
(A) A dispensary shall transmit electronically to the state board of pharmacy, in a format suitable to the board, the information set forth below within five minutes of the dispensing of any and all medical marijuana:
(1) State license number, which shall be populated by a number provided by the board;
(2) Dispensary name;
(3) Dispensary address;
(4) Dispensary telephone number;
(5) Patient full name;
(6) Patient registry identification number;
(7) Patient residential address;
(8) Patient telephone number;
(9) Patient date of birth;
(10) Patient gender;
(11) Recommending physician’s full name (first name and last name);
(12) Drug enforcement administration physician identification number;
(13) Date recommendation was issued by the recommending physician;
(14) Indication whether the recommendation is new or a refill;
(15) Number of the refill being dispensed;
(16) Date order filled, which shall be the date medical marijuana is dispensed;
(17) Order number, which shall be the serial number assigned to each medical marijuana product dispensed to a patient;
(18) Quantity;
(19) Days’ supply;
(20) Product identifier, which shall be assigned by the board;
(21) Date order written, which shall be the date the written recommendation was issued;
(22) Payment code for either cash or third-party provider; and
(23) Drug name, which shall be the brand name of the medical marijuana.
(B) If a dispensary has no drug dispensing information required to be submitted to the board of pharmacy over any twenty-four-hour period, it must submit a “zero report.”
(C) The dispensing report or the “zero report” shall be consecutive and inclusive from the last date and time that information was submitted and shall be reported no later than thirty-six hours after the last time reported on a previous report.
(D) Any dispensary whose normal business hours are not seven days per week shall electronically indicate its normal business hours to the board and a “zero report” will be automatically submitted on the dispensary’s behalf on non-business days.
(E) If a dispensary ceases to possess medical marijuana for dispensing, the designated representative shall notify the board of pharmacy electronically or in writing. The board shall be notified if the dispensary resumes dispensing.
(F) All dispensing information required to be submitted to the board of pharmacy pursuant to paragraph (A) of this rule, must be transmitted in the format specified by the American society for automation in pharmacy (“ASAP”), for prescription monitoring systems.
(G) If a dispensary cannot electronically transmit the required information pursuant to paragraph (A) of this rule, they must immediately contact the board of pharmacy to determine a mutually acceptable method of reporting. The dispensary must document in writing to the board of pharmacy the reasons for their inability to submit the required information.
(H) A dispensary shall transmit the information required pursuant to this section in such a manner as to ensure the confidentiality of the information in compliance with all federal and state laws, including the federal Health Insurance Portability and Accountability Act of 1996, Public Law 104-191.
(I) All medical marijuana dispensing information submitted to the drug database pursuant to this rule must be reported in an accurate and timely manner.
(J) If the omission of dispensing information is discovered, the corrected information must be submitted to the board of pharmacy during the next reporting period after the discovery.
(K) If the omission of data or erroneous data is the result of a computer programming error, the dispensary must notify the board of pharmacy immediately by telephone and submit written documentation. The documentation shall fully describe the error and propose a date for submitting the corrected dispensing information. The board will review the written documentation to assure compliance with paragraph (A) of this rule.
(L) Except as noted in paragraph (E) of this rule, all data must be submitted or corrected electronically unless prior permission for an alternate method is approved by the board of pharmacy.
Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: 3796.04
Rule Amplifies: 3796.04 , 3796.20, 4729.771, 4729.80, 4729.84
(A) Dispensary records may be maintained electronically and be available for inspection by the state board of pharmacy upon request. The dispensary shall develop recordkeeping policies and procedures consistent with this division.
(B) Any dispensary that uses an electronic system for the storage and retrieval of patient information or other medical marijuana records, shall use a system that:
(1) Guarantees the confidentiality of the information contained within;
(2) Can be accessed by the state board of pharmacy in accordance with this division;
(3) Can provide safeguards against erasures and unauthorized changes in data after the information has been entered and verified by the dispensary;
(4) Contains a true audit trail that indicates and dates any edits or deletions to a patient record; and
(5) Is capable of being reconstructed or retrieved within three business days, in the event of a computer malfunction or accident resulting in the destruction of the database.
(C) Each dispensary shall keep a record of all medical marijuana received, dispensed, sold, destroyed, or used. The acts of dispensing and destroying of a controlled substance must be documented with the positive identification of the responsible individual. These records may be kept electronically if the method is approved by the state board of pharmacy and the records are backed-up each business day.
(D) Any dispensary intending to maintain records at a location other than the licensed dispensary premises must first send a written request to the state board of pharmacy. The request shall contain the dispensary name and license number of the requestor and the name and address of the alternate location. The state board of pharmacy will send written notification to the dispensary documenting the approval or denial of the request. A copy of the board’s approval shall be maintained with the medical marijuana records located on the licensed dispensary premises. Any alternate location shall be secured and accessible only to authorized dispensary employees.
(E) Documentation maintained and organized by a dispensary in the normal course of business must include, but is not limited to:
(1) Background checks for employees
(2) Operating procedures;
(3) Inventory records;
(4) Audit records;
(5) Staffing plan;
(6) Business records that include:
(a) Assets and liabilities;
(b) Third party vendor list;
(c) Monetary transactions;
(d) Written or electronic accounts that shall include bank statements, journals, ledgers, and supporting documents, agreements, checks, invoices and vouchers; and
(e) Any other financial accounts reasonably related to dispensary operations.
(7) Surveillance records;
(8) Attendance logs;
(9) Employee training records;
(10) Quality assurance review logs;
(11) All other records required under Chapter 3796. of the Revised Code and this division.
(F) All records relating to the purchase or return, dispensing, distribution, destruction, and sale of medical marijuana shall be maintained under appropriate supervision and control to restrict unauthorized access.
Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: 3796.04
Rule Amplifies: 3796.04 , 3796.20
(A) Pursuant to division (B) of section 3796.08 of the Revised Code and division (C) of section 4729.80 of the Revised Code, patient-specific dispensary transactions are confidential and not a public record. A person having custody of, or access to, such records shall not divulge the contents thereof, or provide a copy thereof, to anyone except:
(1) The patient for whom the recommendation or medical marijuana order was issued or that patient’s designated caregiver;
(2) The certified physician who issued the recommendation;
(3) Certified and or licensed health care personnel who are responsible for the care of the patient;
(4) A member, inspector, agent, or other investigator of the state board of pharmacy or any federal, state, county, or municipal officer whose duty is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific investigation involving a designated person or drug;
(5) A government agent charged with the responsibility of providing medical care for the patient upon a written request by an authorized representative of the agency requesting such information;
(6) If applicable, an agent of a medical insurance company who provides insurance coverage for medical marijuana upon authorization and proof of insurance by the patient or proof by the insurance company for those medications requested;
(7) An agent who contracts with the dispensary as a “business associate” in accordance with the regulations promulgated by the secretary of the United States department of health and human services pursuant to the federal standards for the privacy of individually identifiable health information;
(8) Any person, other than those listed in paragraphs (A)(1) to (A)(7) of this rule, only when the patient has given consent for such disclosure in writing, except where a patient is unable to deliver written consent, in which case, written consent must be provided by the patient’s caregiver.
(a) Any consent must be signed by the patient or caregiver and dated;
(b) Any consent for disclosure is valid until rescinded by the patient or caregiver.
(c) In an emergency, a dispensary may disclose the recommendation information when it is deemed to be in the best interest of the patient. A dispensary employee making an oral disclosure in an emergency must prepare a written statement showing the patient’s name, the date and time the disclosure was made, and the nature of the emergency, and the names of the individuals by whom and to whom the information was disclosed.
(B) Patient-specific information related to the dispensing of medical marijuana which may be required as evidence of a violation of Chapter 3796. of the Revised Code or of this division shall be released to a member, inspector, agent, or investigator of the state board of pharmacy, state medical board or any state, county, or municipal officer whose duty is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific investigation involving a designated person or drug upon his request. Such person shall furnish a receipt to the person having legal custody of the records. If the record is a recommendation, the receipt shall list the following information:
(1) Recommendation identification number;
(2) The name of the patient;
(3) The quantity of the medical marijuana or medical marijuana product dispensed;
(4) Name of the recommending physician; and
(5) Date, name and address of the agency, and signature of the person removing the records.
(C) All patient-specific information related to the dispensing of medical marijuana, including consents, written statements of emergency disclosures, and written requests pursuant to paragraph (A)(8) of this rule, shall be kept on file at the dispensary for a period of three years in a readily retrievable manner.
Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: 3796.04
Rule Amplifies: 3796.04 , 3796.08, 4729.80
