This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and
universities.
| Rule |
Rule 3796:6-3-01 | Dispensary operations generally.
(A) A dispensary awarded a certificate of operation under this division shall: (1) Operate in accordance with the representations made in its application; and (2) Comply with Chapter 3796. of the Revised Code and this division. (B) Only a dispensary with an active certificate of operation from the state board of pharmacy may authorize and engage in medical marijuana dispensary operations. (C) A dispensary shall not dispense marijuana from, obtain marijuana from, or transfer marijuana to, a location outside of the state of Ohio. (D) A dispensary shall not obtain, cultivate, deliver, transfer, transport, sell or dispense marijuana except: (1) It may acquire marijuana from a processor or cultivator holding a plant-only processor designation; (2) It may sell expired plant material to a processor licensed by the department of commerce, if all original tamper-resistant seals from the original cultivator's container remain intact; (3) Dispensary employees may dispense and sell marijuana only to a patient or caregiver, in a dispensary department, in accordance with Chapter 3796. of the Revised Code and this division; and (4) It may initiate a transfer of inventory over the course of discontinuing business pursuant to rule 3796:6-2-14 of the Administrative Code. (E) No person at a dispensary shall provide free medical marijuana samples or engage in compounding as defined under section 4729.01 of the Revised Code. (F) A dispensary shall sell medical marijuana only in the original, sealed containers or packaging as delivered by the processor or cultivator holding a plant-only processor designation. (G) Upon a patient or caregiver's request, a dispensary may provide the patient or caregiver to whom medical marijuana has been dispensed by the dispensary, with a container that is intended to be used for the transport of medical marijuana aliquots. Such a container shall: (1) Meet the requirements in paragraph (A) of rule 3796:8-1-01 of the Administrative Code; (2) Have an affixed label containing: (a) The product name, form, dose, product identifier, product identification number, and quantity for which the container was provided; (b) The date and quantity dispensed, including the net weight measured in ounces and grams or by volume, as appropriate; (c) The name and registry number of the patient and, if applicable, the name of his or her designated caregiver; (d) The name, address and license number of the dispensary; (e) A warning that states: "This product may cause impairment and may be habit-forming;" (f) The statement: "This product may be unlawful outside of the State of Ohio;" (g) If the product is in a form other than plant material, the following must be included: (i) The date on which the product was manufactured and the name and license number of the processor that manufactured the product; (ii) A list of all ingredients and all major food allergens as identified in 21 USC 343; and (iii) A warning that states: "Caution: When eaten or swallowed, the effects and impairment caused by this drug may be delayed." (3) All labels printed for the purposes of this paragraph shall be printed as a duplicate, auditable label in the dispensary's internal inventory control system. (4) A record of all containers provided to a patient or caregiver pursuant to this paragraph shall be kept for at least three years. This record shall include at least the following: (a) The product name, form, dose, product identifier, and quantity for which the container was provided; (b) Positive identification of the employee responsible for providing the container; and (c) Signature of the patient or caregiver who received the container and the date on which the container was received. (H) A dispensary shall place all products sold to the qualifying patient or caregiver in an opaque package that shall not indicate the contents of the package, the originating facility or in any other way cause another person to believe that the package may contain marijuana. (I) A dispensary shall not permit any person to enter the dispensary department unless: (1) Such person is a licensed dispensary employee whose responsibilities necessitate access to the dispensary department; (2) Such person is a registered patient or caregiver whose active registration is verified before entry into the dispensary department. Patients and caregivers shall not be permitted behind the service counter or in other restricted access areas; or (3) Such person's responsibilities otherwise necessitate access to the dispensary department and then only for as long as necessity requires. Persons necessitating access may include authorized agents from the state board of pharmacy and local, state, or federal law enforcement authorities. All others who necessitate access shall be under direct personal supervision while on licensed dispensary premises. (J) All dispensary employees shall at all times while on dispensary premises, wear above the waist, an employee identification card printed by the dispensary at which they are employed. (1) Each employee identification card shall clearly identify the employee to the public and contain, at a minimum, the following features of information: (a) A clear photo of the image of the employee's face measuring two inches by two inches, taken not more than ninety days prior to the issuance to the employee; (b) The date on which the identification card was issued to the employee; (c) The employee's current name; (d) The medical marijuana employee license number; (e) Security features to prevent unauthorized duplication of the employee's identification card; and (f) The name of the dispensary. (2) Identification cards shall expire four years from the date of issuance. The dispensary's designated representative shall be responsible for collecting and destroying all expired cards and cards from employees who are no longer employed by the dispensary. (3) A dispensary employee shall be issued a separate identification card for each dispensary employing that individual, unless the dispensaries employing the individual share common ownership and use identical cards for all dispensaries employing the individual; (4) Dispensaries may only print an employee identification card for an employee that holds an active license issued pursuant to Chapter 3796. of the Revised Code and the rules adopted thereunder. (K) A dispensary shall maintain a list of all third-party vendors. The third-party vendor list shall be provided to the state board of pharmacy upon request. (L) A dispensary designated representative shall review dispensary organization policies and procedures at least once every twelve months from the issue date of the certificate of operation and update as needed or as requested by the state board of pharmacy. The time and date of such reviews shall be documented at the completion of each review. (M) No medical marijuana requiring refrigeration or hot-holding or considered potentially hazardous food shall be possessed or sold by a dispensary.
Last updated July 11, 2022 at 1:26 PM
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Rule 3796:6-3-02 | Dispensary premises generally.
(A) The premises of a dispensary shall be
located within Ohio. (B) Pursuant to section 3796.30 of the
Revised Code, no boundary of a parcel of real estate having situated on it a
proposed dispensary shall be located within five hundred feet of the boundaries
of a parcel of real estate having situated on it a school, church, public
library, public playground, public park, or an opioid treatment program as
defined in rule 3796:6-1-01 of the Administrative Code. (C) The dispensary shall be equipped as to land, buildings,
and equipment to properly carry on the business of a medical marijuana
dispensary. (D) The dispensary certificate of operation shall be
prominently displayed at the location where the licensee is authorized to
operate. (E) The premises and operations of a licensee shall conform
to all relevant fire codes, local zoning and planning
requirements. (F) It is the responsibility of a dispensary's
associated key employees to promptly notify the state board of pharmacy of any
change of the principal place of business. (G) No major renovation or modification shall be undertaken
without notification to and inspection and approval from the state board of
pharmacy and submittal of the required fee. Such renovations include, but are
not limited to: (1) New facilities to be
constructed or used for medical marijuana; and (2) Work or storage areas
to be constructed or used for medical marijuana. (H) All lighting outside and inside of a dispensary
location must be maintained in good working order and wattage sufficient for
clear security and surveillance. (I) A dispensary shall ensure that any building or
equipment used by a dispensary for the storage or sale of medical marijuana is
maintained in a clean and sanitary condition. (J) Each dispensary that sells edible medical marijuana
products shall display a placard that states the following: "Edible
medical marijuana products were produced in a kitchen, not subject to public
health inspections, that may also process common food
allergens." (1) The placard shall be
no smaller than twenty-four inches tall by thirty-six inches wide, with typed
letters no smaller than two inches. (2) The placard shall be
clearly visible and readable by customers and shall be written in
English. (3) The signage shall be
placed in the area where edible medical marijuana products are sold, and may be
translated into additional languages as needed. (K) A dispensary shall display a placard,
meeting the specifications of the placard described in paragraph (J) of this
rule, providing a warning specified by the state board of pharmacy if the board
determines that the warning is necessary to avoid imminent harm to public
health. (L) A dispensary shall have an enclosed
delivery bay or equally secured delivery area where medical marijuana
deliveries will be made pursuant to a standard operating procedure to be
approved by the board. (M) A dispensary shall have a day-storage
area for medical marijuana product with pass-through window(s). (N) A dispensary shall have an approved
vault in conformance with C.F.R. 1301.72(a)(3)(6/30/2021) that is in a location
not visible to the public. (O) A dispensary shall have a
"mantrap" at any ingress/egress from the dispensary
department. (P) A dispensary shall establish, maintain and comply with
written policies and procedures for the safe handling, security, inventory and
distribution of medical marijuana. Such policies and procedures shall include
methods for identifying, recording and reporting diversion, theft or loss, for
correcting errors and inaccuracies in inventories and any other required policy
set forth in Chapter 3796. of the Revised Code and this division. (Q) Notwithstanding any other provision
of this chapter of the administrative code, a dispensary may sell medical
marijuana products to patients and caregivers outside the dispensary building
in accordance with all the following: (1) The purchase of
product, including all monetary transactions, shall take place on the
dispensary's property (i.e., parking lot or sidewalk of
dispensary); (2) Dispensaries shall
not deliver medical marijuana to a patient or caregiver's
home. (3) The patient or
caregiver's card must be verified prior to purchase. (4) Any money collected
shall be taken into the dispensary department after each
transaction. (5) Medical marijuana
products, including those that are awaiting pick-up, shall be maintained in the
dispensary department until the patient arrives. (6) Security shall be
present for outdoor transactions of medical marijuana products. (7) Outdoor transactions
may only occur between the hours of eight am and seven pm EST. (8) A dispensary shall
comply with all other dispensing requirements (labeling, reporting to OARRS,
etc.) for medical marijuana.
Last updated August 2, 2024 at 4:19 PM
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Rule 3796:6-3-04 | Procedures when dispensary is closed.
Effective:
September 8, 2017
(A) During times when a dispensary is closed, it shall be securely locked and equipped with an alarm system approved by the state board of pharmacy. Such alarm shall be activated and operated separately from any other alarm system at the dispensary and shall be able to immediately detect entrance to the dispensary at times when it is closed. (1) Keys and access codes to the alarm system shall be controlled in such a manner so as to prevent access to the dispensary by anyone other than authorized dispensary key employees. (2) Only a dispensary key employee shall have the authority to deactivate the alarm system. (B) During times when a dispensary is closed, it shall have an operating surveillance system in accordance with rule 3796:6-3-16 of the Administrative Code. (1) The surveillance system shall either collect and store video surveillance on a twenty-four-hour basis; or (2) It shall live-stream on a twenty-four-hour basis and be capable of activation when the motion is detected and when the dispensary's security system detects an intrusion. All motion detection delay systems shall carry a filter time of no less than six seconds. (C) A dispensary shall store medical marijuana in an approved safe or approved vault within a restricted access area. (D) A dispensary shall not sell medical marijuana when the dispensary is closed. (E) A designated representative shall notify the state board of pharmacy immediately upon discovery of any unauthorized access at the dispensary.
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Rule 3796:6-3-06 | Receipt of medical marijuana by a dispensary.
(A) Each dispensary shall: (1) Establish a standard operating procedure for all aspects of the receipt, storage, packaging, labeling, handling, tracking and dispensing of products containing medical marijuana and medical marijuana waste. (2) Use the state inventory tracking system, established pursuant to section 3796.07 of the Revised Code, to identify and track all information deemed necessary by the state board of pharmacy as it relates to the dispensary's stock of medical marijuana from the time it is received to the time it is dispensed to a patient or caregiver. All information related to the receipt, dispensing, and destruction of all medical marijuana, that the state board of pharmacy deems necessary, shall be transmitted electronically to the department of commerce through the inventory tracking system. (3) Transmit electronically to the state board of pharmacy the information related to the dispensing of all medical marijuana as set forth in rules 3796:6-3-08 and 3796:6-3-10 of the Administrative Code. (4) Train each dispensary employee in the standard operating procedures related to the receipt, storage, dispensing, and disposal of medical marijuana and retain employee training attendance records. (B) Before accepting a delivery of medical marijuana, a dispensary key employee must inspect and acknowledge that the delivery meets relevant packaging and labeling requirements. The delivery of any medical marijuana failing to adhere to relevant packaging and labeling requirements shall not be accepted by a dispensary and shall be immediately returned to the processor or cultivator holding a plant-only processor designation. (C) A dispensary shall not accept expired, damaged, deteriorated, misbranded, or adulterated medical marijuana. (D) All areas where medical marijuana is delivered shall be secured and monitored with video surveillance. Access shall be limited to necessary licensed processor, cultivator, and dispensary employees. (E) All areas where medical marijuana and devices are stored must be dry, well-lit, well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures and under lighting conditions which will ensure the integrity of medical marijuana prior to its use. (F) Only individuals authorized pursuant to Chapter 3796. of the Revised Code and this division may have unsupervised access to medical marijuana.
Last updated July 11, 2022 at 1:27 PM
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Rule 3796:6-3-07 | Security, control, and storage of medical marijuana at a dispensary.
Effective:
September 8, 2017
(A) Pursuant rule 3796:6-3-05 of the Administrative Code, a designated representative shall provide supervision and control of medical marijuana and medical marijuana products and adequate safeguards to ensure that such items are dispensed in accordance with Chapter 3796. of the Revised Code and this division, by the following procedures: (1) A licensed dispensary key employee shall provide personal supervision of the medical marijuana and medical marijuana products, order forms, all records relating to the dispensing of medical marijuana and medical marijuana products, unless the state board of pharmacy has issued written approval to a dispensary allowing for the storage of records off-site. (2) Whenever personal supervision of medical marijuana and medical marijuana products is not provided by a licensed dispensary key employee, physical or electronic security of such items must be provided according to the following requirements: (a) The dispensary department, restricted access areas and stock of medical marijuana must each be secured by a physical barrier with suitable locks and an electronic barrier to detect entry at a time when licensed dispensary employees are not present. The physical barrier shall be constructed from floor to ceiling to separate the public entry area from the dispensary department. Such a barrier, before being put into use, must be approved by the state board of pharmacy. (b) A restricted access area within the dispensary department must contain all medical marijuana, and if maintained on the licensed premises, all records relating to the dispensing of medical marijuana, and any other items required to be under personal supervision of a licensed dispensary employee. (c) A dispensary maintaining records at a location other than the premises licensed by the state board of pharmacy or via a computerized recordkeeping system shall maintain an executed agreement with the company possessing or storing the records authorizing an agent of the state board of pharmacy access to the records maintained in accordance with this rule within three business days, excluding weekends and holidays. The dispensary is obligated to ensure the board receives the records in the timeframe specified in this rule. (d) No item, product, record, or equipment that must be accessible to anyone other than a licensed dispensary employee may be stored in restricted access areas. (e) No medical marijuana may be sold or otherwise dispensed at any time the dispensary department is closed. (3) Areas designated for the dispensing and storage of medical marijuana shall meet the security requirements in rule 3796:6-3-16 of the Administrative Code. No person may be within the physical confines of the area designated for dispensing or storage of medical marijuana unless under the personal supervision of a licensed dispensary employee. (B) A dispensary shall store inventory on the licensed premises. All inventory stored on the licensed premises must be secured in restricted access areas and tracked in the inventory tracking system. (C) A dispensary shall maintain adequate lighting, ventilation, temperature, humidity control, and equipment. Required equipment includes, but is not limited to, adequate personal protective equipment for employees. (D) Containers storing expired, damaged, deteriorated, misbranded, adulterated or opened medical marijuana shall be separated from other medical marijuana until they are destroyed in accordance with the dispensary's destruction policy. Expired, damaged, deteriorated, misbranded, or adulterated medical marijuana shall not be stored at the licensed dispensary for more than one week. (E) The dispensary shall be maintained in a clean and orderly condition. It shall be free from infestation by insects, rodents, birds, or pests. (F) Medical marijuana shall be stored at appropriate temperatures and under appropriate conditions to help ensure that its identity, strength, quality and purity are not adversely affected.
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Rule 3796:6-3-08 | Dispensing of medical marijuana.
(A) A dispensary is authorized to sell medical marijuana only to: (1) Qualified patients, eighteen years of age and older, and designated caregivers. No one other than employees of a dispensary shall sell medical marijuana to a patient or caregiver; and (2) Laboratories licensed under Chapter 4729-13 of the Administrative Code to possess dangerous drugs and controlled substances for scientific and clinical purposes. (B) A dispensary employee may exercise their judgment to determine whether to dispense medical marijuana to a patient or caregiver if the dispensary employee suspects that dispensing medical marijuana to the patient or caregiver may have negative health or safety consequences for the patient or for the public, or when the patient is exhibiting signs of potential abuse or diversion. Such a determination shall be reported to the state board of pharmacy within twenty-four hours. (C) A dispensary employee shall require the presentation of a registry identification card together with another form of approved state-issued photographic identification belonging to a qualifying patient or caregiver, prior to selling medical marijuana to such qualifying patient or caregiver. (D) Except as provided in paragraph (B) of this rule, a dispensary employee shall dispense in accordance with fill periods specified in rule 3796:7-2-04 of the Administrative Code. No caregiver shall receive more than the aggregate amount of medical marijuana authorized for each of the caregiver's patients. (E) Each dispensary internal inventory system shall be compatible with and capable of integrating with the state inventory tracking system. (F) Each dispensary shall use a scanner approved by the state board of pharmacy to retrieve patient registry data by scanning patient or caregiver registry identification cards and government issued photographic identification. (G) A dispensary shall not dispense expired, damaged, deteriorated, misbranded, adulterated, or opened medical marijuana. (H) When dispensing or selling medical marijuana all dispensaries shall comply with division (B) of section 3796.20 of the Revised Code including: (1) Dispense or sell only upon a showing of a current, valid patient or caregiver registry identification card; and current and valid state photo identification or other identification approved by the board. Medical marijuana may not be dispensed to a patient or caregiver who does not possess a registry identification card issued by the state board of pharmacy, unless the dispensation is in accordance with a reciprocal agreement established pursuant to section 3796.16 of the Revised Code. (2) A dispensary employee shall verify: (a) The validity of the patient or caregiver's registration by scanning the patient or caregiver's state-issued identification, such as a driver's license or other identification approved by the board. The identification number on the item presented by the patient or caregiver must be identical to the identification number included in the patient's or caregiver's registry record; (b) Possession of a patient or caregiver registry card with the holder's name and identification card number identical to the identification provided pursuant to subdivision (2)(a) of paragraph (H) of this rule; (c) The patient or caregiver has not exceeded the purchase limits established in rule 3796:7-2-04 of the Administrative Code or that the amount of medical marijuana that the patient or caregiver is requesting would not cause the patient to exceed the purchase limits established in rule 3796:7-2-04 of the Administrative Code. (3) A dispensary employee shall confirm that each recommendation is complete. A complete recommendation contains the following: (a) Patient full name; (b) Patient residential address; (c) Patient telephone number; (d) Patient date of birth; (e) Patient qualifying condition; (f) State-issued identification number (such as driver's license number) or other identification approved by the board; (g) Patient registration number issued by the state board of pharmacy; (h) Recommending physician's full name (first name and last name); (i) Recommending physician's drug enforcement administration identification number; (j) Recommending physician's medical license number issued by the state medical board; (k) Recommending physician's certificate to recommend identification issued by the state medical board; (l) Date recommendation was issued by the recommending physician; (m) Recommending physician's business address, telephone number, and email address; (n) Indication whether the recommendation is new or a refill; (o) Number of the refill being dispensed; and (p) Date order written, which shall be the date the written recommendation was issued. (4) Update the patient record in the dispensary's internal inventory system with the following information: (a) Dispensary certificate of operation number, which shall be populated by a number provided by the board; (b) Dispensary name; (c) Dispensary address; (d) Dispensary telephone number; (e) Date order filled, which shall be the date medical marijuana is dispensed; (f) Order number, which shall be the serial number assigned to each medical marijuana product dispensed to a patient; (g) Quantity; (h) Days' supply; (i) Product identifier, which shall be assigned by the state board of pharmacy; (j) Payment code for either cash or third-party provider; and (k) Drug name, which shall be the brand name of the medical marijuana. (I) A dispensary may sell medical marijuana to patients and caregivers only in a direct, face-to-face exchange without the assistance of any electronic or mechanical device (such as a vending machine or other automated dispensing unit). A dispensary must sell medical marijuana in whole day increments. (J) A dispensary shall dispense medical marijuana in a manner consistent with any instructions for use as determined by the recommending physician. (K) A dispensary must include the name of the dispensary on the packaging of any medical marijuana or medical marijuana product it sells. Each package sold must be placed in an unmarked, opaque bag before leaving the dispensary. (L) All recommendations must be serially numbered when dispensed. (1) There must be a complete accounting of all numbers used in the serial numbering system. (2) All recommendations which are not refillable, either because of the dispensing of all refills or the length of time since issuance, shall be assigned a new serial number upon an authorization for additional dispensing by a recommending physician. (M) A dispensary shall maintain a record of each sale, purchase and return of medical marijuana in the inventory tracking system established pursuant to section 3796.07 of the Revised Code. (N) An order purporting to be a recommendation issued not in the usual course of professional treatment or in legitimate and authorized research is not a recommendation within the meaning and scope of Chapter 3796. of the Revised Code and the person who knowingly dispenses such a purported recommendation, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. A dispensary employee is not required to dispense a recommendation of doubtful, questionable, or suspicious origin. (O) No medical marijuana shall be sold, dispensed, or distributed to a patient or caregiver via a delivery service or any other manner outside of a dispensary, except that a caregiver may deliver medical marijuana to the caregiver's registered patient.
Last updated July 11, 2022 at 1:28 PM
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Rule 3796:6-3-09 | Labeling requirements for medical marijuana sold at a dispensary and accompanying materials.
Effective:
September 8, 2017
(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.
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Rule 3796:6-3-11 | Duty to report.
(A) A person licensed under this chapter is responsible to monitor for suspicious recommendations, unusual usage, or questionable disposition of medical marijuana. (B) Each person licensed under this chapter shall notify the following upon discovery of the theft or loss of any medical marijuana or medical marijuana device, including medical marijuana in transit that was either shipped from or to the dispensary: (1) The state board of pharmacy, by telephone immediately upon discovery of the theft or loss; (2) Law enforcement authorities with jurisdiction over the location where the theft or loss occurred pursuant to section 2921.22 of the Revised Code. (C) Medical marijuana thefts or unexplained losses must be reported to the state board of pharmacy in writing irrespective of whether the medical marijuana is recovered and/or the responsible parties are identified and action taken against them. Written reports must be provided to the state board of pharmacy within forty-eight hours following the discovery of such theft or loss. (1) The written report must include: (a) The name, address, and license number of the dispensary; (b) The amount and type of medical marijuana lost or stolen; (c) The circumstances surrounding the loss or theft; (d) The date the loss or theft was discovered; (e) The person who discovered the loss or theft; (f) The person responsible for the loss or theft if known; and (g) Any other information that the reporter believes might be helpful in establishing the cause of the loss or theft. (2) An exemption may be obtained upon sufficient cause if written notification cannot be completed within five calendar days. (3) A request for waiver of the five calendar day limit must be requested in writing prior to the passing of the fifth business day. (D) Each person licensed under this chapter, immediately upon discovery of any fraudulent or otherwise unlawful recommendation, shall notify the state board of pharmacy and law enforcement authorities. Upon receiving such notice, the state board of pharmacy shall notify the state medical board of all suspected fraudulent recommendations. (E) Each dispensary, through its designated representative, who knows or should know that a prohibited facility or an opioid treatment program as defined in rule 4729:5-21-01 of the Administrative Code, has been established within five hundred feet of the dispensary shall notify the state board of pharmacy, for purposes of assessing the adequacy of existing security measures. (F) A person licensed under this chapter who has knowledge, from direct observation or objective evidence, of violations described in paragraph (G) of this rule shall report such conduct to the state board of pharmacy, in a manner specified by the board, within ten days of learning or witnessing the alleged violations. (G) The following shall be reported to the board: (1) Except as provided in paragraph (G)(1)(a) of this rule, conduct indicating a dispensary employee is addicted to or is suspected to be abusing alcohol, drugs or other chemical substances or impaired physically or mentally to such a degree as to render the individual unfit to carry out their professional duties. (a) A dispensary employee shall not be required to report in accordance with this rule if the dispensary employee becomes aware of any condition described in paragraph (G)(1) of this rule as a result of either: (i) The employee's treatment of the individual for the condition; or (ii) The employee having access to the individual's protected health information. (2) Violations, attempts to violate, or aiding and abetting in the violation of any of the provisions of Chapter 3796. of the Revised Code, or any rule adopted by the board under that chapter, by an individual or entity licensed or registered under chapter 3796:6 and chapter 3796:7 of the Revised Code. (3) Conduct by a dispensary employee that constitutes unprofessional conduct or dishonesty as defined in this rule. (H) (1) Pursuant to section 4729.23 of the Revised Code, the identity of the person licensed under this chapter making a report in accordance with this rule shall remain confidential. (2) Notwithstanding the confidentiality provided in accordance with paragraph (H)(1) of this rule, a dispensary employee may be required to testify in a disciplinary proceeding as to the conduct or violations listed in paragraph (G) of this rule without disclosing the person licensed under this chapter was the reporting individual. (I) A dispensary employee shall notify the board of any of the following: (1) Any criminal conviction within ten days after the date of conviction, except for minor traffic violations such as parking violations, speeding tickets and violations such as failure to obey a red light, failure to use a turn signal or expired registration. (2) The employee is convicted of, pled guilty to, is subject to a judicial finding of eligibility for intervention in lieu of conviction in this state under section 2951.041 of the Revised Code or the equivalent thereof in another jurisdiction within ten days after the individual is deemed eligible. (3) The employee is granted entry into a diversion program, deferred prosecution program, or the equivalent thereof within ten days after the individual is granted entry into a program. (4) Any arrest for a felony within ten days after the arrest. (J) A dispensary employee shall notify the board of any disciplinary licensing or registration action taken by another state against the licensee within ten days of the notice action. This includes, but is not limited to, a disciplinary action that is stayed pending appeal. (K) Reporting required in accordance with this rule shall be made in writing, either by mail or using the board's online complaint form (available on the board's web site: www.pharmacy.ohio.gov). (L) "Unprofessional conduct" means conduct that is detrimental to the best interests of the public, including conduct that endangers the health, safety or welfare of a patient or client. Such conduct shall include, but not be limited to, the following acts: coercion, intimidation, harassment, sexual harassment, improper use of private health information, threats, degradation of character, indecent or obscene conduct, and theft. (M) "Dishonesty" means any action by a licensee or applicant to include, but is not limited to, making any statement that deceives, misrepresents or misleads, or be a party to or an accessory to any fraudulent or deceitful practice or transaction in the dispensation of medical marijuana or in the operation or conduct of a dispensary.
Last updated July 11, 2022 at 1:28 PM
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Rule 3796:6-3-12 | Dispensing error reporting.
(A) A dispensary shall display a sign concerning the reporting of dispensing errors in a conspicuous location visible to qualifying patients and caregivers. The sign shall: (1) Measure a minimum of eight inches in height and ten inches in width and the lettering shall be in a size and style that allows such sign to be read without difficulty; (2) Read: "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." (B) A dispensary designated representative shall implement and comply with a quality assurance program that describes, in writing, policies and procedures to detect, identify and prevent dispensing errors. A dispensary shall: (1) Provide to the state board of pharmacy a written copy of such quality assurance program; (2) Distribute it to all dispensary employees; and (3) Make it readily available on the premises of the dispensary. (C) A dispensary's quality assurance program shall include: (1) Directions for communicating the details of a dispensing error to the physician who recommended a qualifying patient, the patient, the patient's caregiver where appropriate, or appropriate family member if the patient is deceased or is unable to fully comprehend communication. Such communication shall describe methods of correcting the dispensing error or reducing the negative impact of the error on the qualifying patient; and (2) A process to document and assess dispensing errors to determine the cause of the error and the appropriate response. (D) A dispensary shall use the findings of its quality assurance program to develop dispensary systems and workflow processes designed to prevent dispensing errors. (E) A dispensary designated representative shall inform dispensary employees of changes to dispensary policy, procedure, systems, or processes made as a result of recommendations generated by the quality assurance program.
Last updated July 11, 2022 at 1:28 PM
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Rule 3796:6-3-13 | Review of dispensing errors.
(A) A dispensary designated representative shall notify all dispensary employees that the discovery or reporting of a dispensing error shall be relayed immediately to a dispensary designated representative. (B) The dispensary designated representative shall report an error in dispensing to the state board of pharmacy, in a manner determined by the board, within forty-eight hours of learning of such error. (C) A dispensary designated representative shall ensure that a quality assurance review for each dispensing error is completed and that such review is commenced as soon as is reasonably possible, but no later than two business days from the date the dispensing error is discovered. (D) A dispensary shall create a record of every quality assurance review. This record must contain, but is not limited to, the following: (1) The date or dates of the quality assurance review; (2) The pertinent data and other information relating to the dispensing error reviewed; (3) Documentation of contact with the qualifying patient, caregiver where applicable, and the recommending physician; (4) The findings and determinations generated by the quality assurance review; and (5) Recommended changes to dispensary policy, procedure, systems or processes if any.
Last updated July 11, 2022 at 1:29 PM
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Rule 3796:6-3-15 | Dispensary patient and caregiver educational materials.
(A) Each dispensary shall develop and maintain a policy regarding patient and caregiver education and support. (B) A patient and caregiver education and support policy shall include: (1) Information regarding the signs and symptoms of substance abuse, including tolerance, dependency, and withdrawal; (2) Whether possession of medical marijuana is illegal under federal law; (3) Information about possible side effects and contraindications for medical marijuana including possible impairment with use and operation of a motor vehicle or heavy machinery, when caring for children, or of job performance; (4) Guidelines for contacting the recommending physician if side effects or contraindications occur; (5) A warning that smoking of medical marijuana is not permitted per Ohio law; (6) Information on drug-to-drug interactions, including interactions with alcohol, prescription drugs, non-prescription drugs, and supplements; and (7) Offer any other appropriate patient education or support materials. (C) A dispensary shall make available information to patients and caregivers regarding the possession and use of marijuana. All such information shall be submitted to the state board of pharmacy for approval prior to being provided to qualifying patients and caregivers and shall include: (1) Limitations on the right to possess and use marijuana pursuant to Chapter 3796. of the Revised Code; (2) Safe techniques for the proper use of medical marijuana and medical marijuana paraphernalia; (3) Prohibition against and dangers associated with medical marijuana extractions; (4) Alternative methods and forms of consumption or inhalation by which one can use medical marijuana; (5) Instruction for patients and caregivers with medical marijuana-related inquiries or reports of adverse reactions to the toll-free telephone line established by the state board of pharmacy in accordance with section 3796.17 of the Revised Code; (6) Signs and symptoms of substance abuse; and (7) Opportunities to participate in substance abuse programs. (D) No dispensary shall include in its education policy, instruction for patients or caregivers to cut or otherwise partition medical marijuana patches as appropriate preparation for transdermal administration. (E) A dispensary shall make publicly available the price of all medical marijuana products offered by the dispensary to prospective qualifying patients and caregivers. Such disclosure may include posting information on the dispensary internet website. (F) A dispensary shall post a sign directing patients and caregivers with medical marijuana-related inquiries or reports of adverse reactions to the toll-free telephone line established by the state board of pharmacy in accordance with section 3796.17 of the Revised Code. Such sign shall be clearly visible and unobstructed.
Last updated July 11, 2022 at 1:29 PM
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Rule 3796:6-3-17 | Record keeping requirements.
Effective:
September 5, 2022
(A) Dispensary records may be maintained
either manually and/or electronically and shall be available for inspection by
the state board of pharmacy in a readily retrievable manner 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 state board of pharmacy'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 be available
for inspection by the state board of pharmacy and include, but is not limited
to: (1) Background checks for
employees conducted by the dispensary, if applicable; (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
(not including video camera recordings); (8) Attendance
logs; (9) Employee training
records; (10) Quality assurance
review logs; (11) Records relating to the purchase or return, dispensing,
distribution, destruction, and sale of medical marijuana; and (12) All other records required under
Chapter 3796. of the Revised Code and this division. (F) All records listed in paragraph (E)
of this rule shall be maintained for at least three years under appropriate
supervision to ensure confidentiality and be made readily available for release
in accordance with rule 3796:6-3-18 of the Administrative Code.
Last updated September 6, 2022 at 8:33 AM
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Rule 3796:6-3-18 | Release of records related to patient transactions maintained by dispensaries.
Dispensaries shall ensure the confidentiality of all records related to patient transactions, the contents of which may only be released to the following: (A) The patient or that patient's designated caregiver; (B) The certified physician who issued the recommendation to the patient; (C) Certified or licensed health care personnel who are responsible for the care of the patient; (D) The state board of pharmacy; (E) Any person that the dispensary is legally required to release the information to, including upon issuance of a valid subpoena, court order, or other similar document only in a criminal matter or an equivalent juvenile matter; (F) 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; (G) 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; (H) Any person, other than those listed in paragraphs (A) through (G) 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 or legal guardian. (1) Any consent must be signed by the patient or caregiver and dated. (2) Any consent for disclosure is valid until rescinded by the patient or caregiver. (3) 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.
Last updated July 11, 2022 at 1:30 PM
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Rule 3796:6-3-19 | Employee training requirements.
(A) A dispensary designated representative shall establish and oversee a dispensary employee training program. (B) Each dispensary shall maintain evidence of all training provided for every dispensary employee in its files. Such records are subject to inspection and audit by the state board of pharmacy. Acceptable forms of evidence are: (1) Transcripts; (2) Certificates of completion; or (3) Other form of documentation which includes: (a) The participant's name; (b) Course title; (c) Course content; (d) Date(s) of training; (e) Provider's name(s); and (f) Signature of the course instructor. (C) All dispensary employees shall receive foundational training regarding the dispensing of medical marijuana before dispensing any medical marijuana. All dispensary employees with access to confidential patient information and/or the patient registry shall receive foundational training pursuant to subsection (5) even if not dispensing medical marijuana.Training received in accordance with this paragraph does not qualify as continuing education described in paragraphs (D) and (E) of this rule. Mandatory training for dispensary employees before the employee may begin dispensing medical marijuana includes: (1) Relevant training on the drug database established pursuant to section 4729.75 of the Revised Code; (2) Relevant training on the inventory tracking system established pursuant to section 3796.07 of the Revised Code; (3) Responsible use training, which shall include specific instruction on: (a) Use of the toll-free telephone line established pursuant to section 3796.17 of the Revised Code; and (b) Learning to recognize signs of medicine abuse or adverse events in the medical use of marijuana by a patient. (4) The proper use of security measures and controls that have been adopted by the dispensary for the prevention of diversion, theft or loss of medical marijuana; (5) Confidentiality requirements of a dispensary; (6) Instruction on the different forms, methods of administration, and strains of medical marijuana; (7) Instruction on qualifying conditions for medical marijuana patients; (8) Authorized uses of medical marijuana in the treatment of qualifying conditions; (9) Instruction regarding regulatory inspection preparedness and law enforcement interaction; (10) Awareness of the legal requirements for maintaining status as a licensed dispensary employee, including but not limited to the duty to report information to the board; and (11) Other topics as specified by the state board of pharmacy. (D) Dispensary employees who dispense medical marijuana shall receive a minimum of sixteen hours of continuing education, on topics described in paragraph (E) of this rule, for each two-year licensing period. Continuing education hours shall not be carried over from one licensing period to another. A dispensary employee who is licensed within six months of a dispensary employee biennial renewal cycle shall be exempt from continuing education requirements. (E) The designated representative shall be responsible for ensuring that each dispensary key and support employee who dispenses medical marijuanareceives continuing education on the following subjects during each biennial licensing period: (1) Guidelines for providing information to patients and caregivers related to the risks associated with medical marijuana, including possible drug interactions; (2) Guidelines for providing support to patients related to the patients' symptoms; (3) Recognizing signs and symptoms of substance abuse; (4) Guidelines for refusing to provide medical marijuana to an individual who appears to be impaired or abusing medical marijuana; (5) The safe handling of medical marijuana, including an overview of common industry hazards, current health and safety standards, and dispensary best practices; (6) Legal updates training pertaining to the Ohio medical marijuana control program; and (7) Other topics as specified by the state board of pharmacy. (F) Before any training in paragraphs (C) and (E) of this rule may be provided to dispensary employees for credit, a designated representative shall submit, in a manner determined by the board, all of the following items to the state board of pharmacy and obtain approval: (1) Names and qualifications of the persons responsible for training content; (2) The agenda with a detailed time schedule; (3) A set of training materials; and (4) Any other items requested by the state board of pharmacy. (G) Before training may be provided to dispensary employees for credit under paragraphs (C)(3)(b), (C)(7), and (E)(1) to (E)(4) of this rule, a designated representative shall submit, in a manner determined by the board, all of the following to the state board of pharmacy: (1) A signed attestation by the person responsible for training content that the person or persons responsible for the content of the educational materials is a pharmacist licensed under Chapter 4729. of the Revised Code, or any of the following professionals authorized to prescribe under division (I) of section 4729.01 of the Revised Code: (a) A clinical nurse specialist or certified nurse practitioner; (b) A physician; or (c) A physician assistant; (2) The professional license number of the person or persons identified in paragraph (G)(1) of this rule; and (3) That the person or persons approve of the content. (H) All training materials submitted for approval under paragraph (F) of this rule shall be submitted a minimum of sixty days prior to the date of presentation of the intended training. Any representation that the training has been approved for dispensary employee credit is prohibited until such approval is received by the designated representative who submitted the application for approval. (I) Training approved for credit by the state board of pharmacy pursuant to paragraphs (F) and (G) of this rule, shall be valid for dispensary employee continuing education credit for remainder of the two-year licensing period in which the continuing education credit will be offered. Training material is valid for two years from the date of approval. Approved training shall be available to any licensed dispensary employee. (J) Before or at the time of training, each participant shall be provided with course materials in the form of written, electronic, or other format that are of such quality and quantity to indicate that adequate time has been devoted to their preparation and that they will be of value to participants. Any presentation materials, electronic or otherwise, shall be subject to the same criteria as other materials. (K) Training credit shall not be awarded for breaks or opening or closing remarks. Only time of actual instruction shall count toward a credit hour. Partial hours shall be rounded to the nearest one-quarter of an hour and should be expressed in decimals. (L) The state board of pharmacy, upon receipt of evidence that any approved training program or training provider is not conforming to the requirements developed pursuant to this rule, may revoke or otherwise limit the scope of the board's prior approval. (M) An attendee at an out-of-state training may seek post-program approval if such approval is sought within sixty days after the program is presented. An application for out-of-state training shall be made on a completed form, developed in accordance with section 3796.04 of the Revised Code. (N) A designated representative shall, in cooperation with the individual or individuals described in paragraph (O) of this rule, provide oversight for the development and dissemination of: (1) Educational materials for patients and caregivers in accordance with paragraphs (C)(6) and (C)(7) of rule 3796:6-3-15 of the Administrative Code; (2) A system for a patient or caregiver to document the patient's symptoms related to a qualifying condition that includes: (a) A logbook, maintained by the patient and/or caregiver, in which the patient or the caregiver may track the use and effects of medical marijuana; (b) A rating scale for symptoms associated with a qualifying condition; (c) Guidelines for the patient's self-assessment, or if applicable, assessment of the patient by the caregiver; and (d) Guidelines for reporting usage and symptoms to the recommending physician and any other treating physicians. (3) Policies and procedures for refusing to provide medical marijuana to an individual who appears to be impaired or abusing medical marijuana. (O) A designated representative shall maintain all of the following records regarding the educational materials outlined in paragraph (N) of this rule: (1) A signed attestation by the person or persons responsible for content described in paragraph (N) of this rule is a pharmacist licensed under Chapter 4729. of the Revised Code, or any of the following professionals authorized to prescribe under division (I) of section 4729.01 of the Revised Code: (a) A clinical nurse specialist or certified nurse practitioner; (b) A physician; or (c) A physician assistant; (2) The professional license number of the person or persons identified in paragraph (O)(1) of this rule; and (3) That the person or persons approve of the content.
Last updated July 11, 2022 at 1:30 PM
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Rule 3796:6-3-20 | Medical marijuana dispensary internal inventory control system.
Effective:
January 2, 2023
(A) A dispensary designated
representative shall have primary oversight of the dispensary's medical
marijuana inventory control system. The inventory control system shall be
real-time, web-based, backed-up at least daily and accessible by the state
board of pharmacy immediately upon request. (B) A dispensary's inventory
control system shall allow for tracking so that the oldest stock of medical
marijuana is distributed first. A dispensary may deviate from this requirement,
if such deviation is temporary and appropriate. (C) A dispensary shall establish and
implement an inventory control system for its medical marijuana that documents
an exact accounting of: (1) Each transaction and
each day's beginning inventory, acquisitions, sales, disposal and ending
inventory. (2) Acquisitions of
medical marijuana from a licensed processor or cultivator holding a plant-only
processor designation, including: (a) A description of the products including the quantity, strain,
variety and batch number of each product received; (b) For each product, the finished form, number of units or
volume of each finished form in each container, the number of commercial
containers of each finished form; (c) The name and license number of each of the processors and
cultivators providing the medical marijuana; (d) The name and license number of the licensed processor and
cultivator agents delivering the medical marijuana; (e) The name and license number of the licensed dispensary
employee receiving the medical marijuana; (f) The date of acquisition; and (g) Any other information deemed appropriate by the state board
of pharmacy. (3) Records of the sale
or dispensing of medical marijuana and denials of such sales, which shall
contain: (a) A description of the products including the quantity, strain,
variety and batch number of each product dispensed; (b) The name and license number of the licensed dispensary
employee selling, dispensing, or denying the sale or dispensing of the medical
marijuana; (c) The date of dispensing; and (d) The name and registration number of the patient and, if
applicable, the caregiver. (4) The disposal of
medical marijuana, including: (a) A description of the products, including quantity, strain,
variety, batch number and cause for the medical marijuana being
destroyed; (b) The name and license number of the dispensary employee
destroying the medical marijuana or medical marijuana product; (c) The name and license number of the dispensary key employee
verifying the destruction of the medical marijuana or medical marijuana
product; (d) The method of disposal and the name, address and telephone
number of the disposal company; and (e) The date of disposal. (D) The designated representative shall
conduct and document an audit of the dispensary's daily inventory
according to generally accepted accounting principles at least once
weekly. (1) If the audit
identifies a reduction in the amount of medical marijuana in the
dispensary's inventory not due to documented causes, the dispensary shall
determine where the loss occurred and immediately take and document corrective
action. The dispensary shall immediately inform the state board of pharmacy of
the loss by telephone and provide written notice of the loss and the corrective
action taken within two business days after first discovery. (2) If the reduction in
the amount of medical marijuana in the inventory is due to criminal activity or
suspected criminal activity, the dispensary shall immediately make a report
identifying the circumstances surrounding reduction to the state board of
pharmacy and law enforcement with jurisdiction where the suspected criminal
acts occurred. (3) If the audit
identifies an increase in the amount of medical marijuana in the
dispensary's inventory not due to documented causes, the dispensary shall
determine where the increase occurred and take and document corrective
action. (4) At the conclusion of
every fiscal year, each medical marijuana dispensary or the common owner of
multiple dispensaries within the state, shall cause an audit to be prepared and
certified by a licensed independent auditor or an independent certified public
accountant. The audit may be part of a consolidated audit for all dispensaries
owned by an ultimate owner of multiple dispensaries in the state, but must
specify where relevant information pertaining to Ohio dispensaries is located
within the consolidated audit. The audit must be certified as accurate based on
the information provided and conducted under generally accepted auditing
standards (GAAS). Each dispensary, or their common owner, shall also provide a
certified statement which includes an annual income statement, balance sheet,
and cash flow statement, prepared under generally accepted accounting practices
(GAAP). The audit and certified statement signed by the chief financial
officer, auditor, or accountant shall be submitted to the board within one
hundred twenty days of the end of the fiscal year. (E) A dispensary shall: (1) Maintain the
documentation required of this rule in a secure, locked location for three
years from the date on the document. 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; (2) Provide any
documentation required to be maintained in this rule to the state board of
pharmacy for review upon request; and (3) If maintaining a bank
account, retain for a period of three years a record of each deposit or
withdrawal from the account. (F) A dispensary shall not accept returns
of medical marijuana, unless the return is pursuant to a program offered under
paragraph (D) of rule 3796:6-3-14 of the Administrative Code, a recall, or the
consequence of an error in dispensing. If medical marijuana is abandoned at the
dispensary, it shall be accounted for and destroyed. All returned or abandoned
medical marijuana shall be destroyed in compliance with rule 3796:6-3-14 of the
Administrative Code. A dispensary shall notify the state board of pharmacy in
writing of any returned or abandoned medical marijuana. (G) All records of each day's
beginning inventory, acquisitions, sales, disposal and ending inventory shall
be kept for a period of three years at the place where the medical marijuana
and medical marijuana products are located. Any dispensary intending to
maintain such records at a location other than this place must first send a
written request to the state board of pharmacy. The request shall contain the
dispensary name and license number 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
state board of pharmacy's approval shall be maintained with the other
records of medical marijuana. Any such alternate location shall be secured and
accessible only to authorized dispensary employees.
Last updated January 3, 2023 at 9:57 AM
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Rule 3796:6-3-21 | Recall procedures.
(A) A dispensary shall establish policies and procedures to conduct mandatory and voluntary recalls of medical marijuana. The procedure shall be adequate to deal with recalls due to any action initiated at the request of the department of commerce or the state board of pharmacy and any voluntary action by the dispensary to remove defective or potentially defective medical marijuana from the market or any action undertaken to promote public health and safety by replacing existing medical marijuana with improved products or packaging. (B) A dispensary's policy must establish a plan for communicating a recall of medical marijuana. The communication plan shall include: (1) A mechanism to contact all customers who have, or likely have, obtained the product from the dispensary. The communication must include information on the process for return of the recalled product; (2) A mechanism to contact the processor or cultivator that manufactured the recalled product; (3) Communication with the state board of pharmacy, the department of commerce, and the state medical board within twenty-four hours; and (4) Outreach via media, as necessary and appropriate. (C) In the event of a product recall, a patient and/or caregiver may return the recalled product to the dispensary where the product was purchased. The dispensary must accept the return of unused recalled product from the patient and/or caregiver. (D) Any recalled medical marijuana or medical marijuana product returned to the dispensary because of the recall must be destroyed by: (1) The dispensary in a manner consistent with rule 3796:6-3-14 of the Administrative Code; or (2) Returning the recalled medical marijuana to the licensed cultivator or processor that manufactured the recalled medical marijuana to be destroyed in a manner approved by the department of commerce.
Last updated July 11, 2022 at 1:30 PM
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Rule 3796:6-3-22 | Prohibitions.
Effective:
September 5, 2022
(A) No dispensary employee may share
office space with, compensate, receive compensation from, or refer patients to
a physician holding a certificate to recommend issued by the state medical
board under section 4731.30 of the Revised Code. (B) A dispensary shall not allow a
physician holding a certificate to recommend issued by the state medical board
under section 4731.30 of the Revised Code to conduct a physical examination of
a patient or any follow up care for purposes of diagnosing or treating a
qualifying medical condition at the dispensary. (C) No dispensary shall be open or in
operation, and no person shall be in the dispensary department, unless a
designated representative is actively employed by the dispensary and available
for consultation by any dispensary employee. At all other times, the dispensary
shall be closed and properly secured, in accordance with standard operating
security procedures and in compliance with this division. (D) No dispensary shall be left
unattended by dispensary employees during hours of operation. (E) No dispensary shall sell anything
other than authorized medical marijuana, medical marijuana products, medical
marijuana devices, and advertising materials authorized pursuant to rule
3796:6-3-24 of the Administrative Code. (F) No dispensary shall offer discounts
unless the discount is offered in accordance with a written discount policy
and: (1) The discount is offered to all patients registered as
indigent or veteran under agency 3796 of the Administrative Code;
or (2) The discount is offered equally to all patients or
caregivers registered under agency 3796 of the Administrative Code;
or (3) The discount is offered to all patients registered
under agency 3796 of the Administrative Code also licensed as an employee for a
medical marijuana entity under agency 3796 of the Administrative Code
and: (a) The employee presents
their employee identification card in addition to the identification required
under paragraph (C) of rule 3796:6-3-08 of the Administrative Code;
and (b) The discount does not
exceed the discount offered in accordance with paragraph (F)(1) of this
rule. (G) No medical marijuana or medical
marijuana products shall be consumed on the premises of a
dispensary. (H) No food or beverages shall be
offered, furnished, or consumed on the premises of a dispensary, except that
complimentary non-alcoholic beverages may be available for patients and
caregivers who are at the dispensary. Licensed dispensary employees shall be
authorized to consume food and non-alcoholic beverages in designated employee
break areas. No medical marijuana shall be accessed, stored, possessed, or
administered in designated employee break areas. (I) A dispensary shall not produce or
manufacture medical marijuana or medical marijuana products without being
licensed pursuant to this division by the department of commerce. (J) No medical marijuana shall be sold, dispensed, or
distributed to a patient or caregiver via a delivery service or any other
manner outside of a dispensary, except that a caregiver may deliver medical
marijuana to the caregiver's registered patient. (K) A dispensary shall not operate if its surveillance
equipment is inoperable. If the surveillance equipment is partially inoperable,
that matter should be immediately reported to the state board of pharmacy to
determine whether the dispensary may continue to operate in any
fashion. (L) A dispensary shall not allow intoxicating liquor or
beer as defined in section 4301.01 of the Revised Code onto its licensed
premises. (M) No dispensary shall change a written discount policy
described in this rule unless the board is notified in writing at least ten
calendar days prior to the effective date of the change. (N) Dispensary employees who have an active patient or
caregiver registration shall not receive rebates or discounts on medical
marijuana products offered by a cultivator, processor, or third-party
entity.
Last updated September 6, 2022 at 8:33 AM
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Rule 3796:6-3-23 | Dispensary access.
Effective:
September 5, 2022
(A) Except as provided under this
division, no person, except a registered patient or caregiver, dispensary
employee, or a cultivator or processor employee delivering medical marijuana,
shall be granted access to a dispensary. One individual may also accompany a
registered patient or caregiver into the dispensary; however, that individual
must remain in the waiting area. (B) Notwithstanding paragraph (A) of
this rule, the following may be granted access to a dispensary: (1) Third party service personnel, such
as technicians, utility workers, and employee representatives, , provided that
such visitors are entered in the visitor log, are identified on the third party
vendor list maintained in compliance with paragraph (E)(6)(b) of rule
3796:6-3-17 of the Administrative Code, and are accompanied at all times by a
dispensary employee. Such visitors may only enter non-restricted areas, and may
not have access to areas containing medical marijuana without continuous
supervision by a dispensary employee; (2) Local, state or federal law
enforcement, emergency service personnel, or government officials in the
performance of their civil or administrative governmental duties; (3) Upon written request
on a form approved by the state board of pharmacy and approval by the board,
physicians who hold a certificate to recommend issued by the state medical
board; and (4) Upon written request
on a form approved by the state board of pharmacy and approval by the board,
any other person demonstrating a legitimate need to be granted access to the
dispensary. (C) A dispensary employee shall escort
and supervise such visitors at all times the visitor or visitors are on the
dispensary premises. (D) Visitors shall obtain and display a
visitor identification badge at all times that the visitor is on dispensary
premises and shall return the visitor identification badge to a dispensary
employee upon exiting the dispensary. To obtain a visitor identification badge,
the individual must present a valid, government issued identification
containing a photograph. (E) All visitors shall log in and out.
The dispensary shall maintain the visitor log, which shall include the date,
time, and purpose of the visit. Visitor logs shall be available to the state
board of pharmacy upon request. (F) Except as otherwise provided in this
rule, visitors shall only enter non-restricted access areas. Access to
restricted access areas or any room containing medical marijuana is
prohibited. (G) Visitors shall not enter the
dispensary during hours of operation or when patients or caregivers are present
unless approved by the board. (H) No photographs or recordings in any
form shall be made of restricted dispensary areas. (I) No photographs or recordings that
identify patients or caregivers shall be made absent a consent form signed by
the identified patient or caregiver. (J) A written request described in this
rule requires reasonable advance notice, as determined by the
board.
Last updated September 6, 2022 at 8:33 AM
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Rule 3796:6-3-24 | Advertising, marketing, and signage.
Effective:
September 8, 2017
(A) For purposes of this rule "advertisement" means any written or verbal statement, illustration, or depiction created to induce sales through a combination of letters, pictures, objects, lighting effects, illustrations, or other similar means. An "advertisement" includes brochures, promotional material and other marketing materials. An advertisement that renders medical marijuana or medical marijuana products attractive to children is prohibited. (B) The state of Ohio has a compelling interest in ensuring that any advertisement or marketing campaigns related to or involving medical marijuana does not encourage, promote, or otherwise create any impression that marijuana is legal or acceptable to use in a manner except as specifically authorized under Chapter 3796. of the Revised Code, or the rules promulgated in accordance with Chapter 3796. of the Revised Code, or that recreational marijuana use has any potential health or therapeutic benefits, or that recreational marijuana use or possession is somehow legal. (C) A dispensary shall not use a name, logo, sign or advertisement unless the name, logo, sign or advertisement has been submitted to the state board of pharmacy and the applicable advertising approval fee has been paid. Materials submitted to the board shall include, but are not limited to: (1) A brief description of the format, medium and length of the distribution; (2) Verification that an actual patient is not being used on the advertisement; (3) Verification that an official translation of a foreign language advertisement is accurate; (4) Annotated references to support statements related to effectiveness of treatment; and (5) A final copy of the advertisement, including a video where applicable, in a format acceptable to the board. (D) Until September 8, 2019, the state board of pharmacy shall have fifteen business days to review materials submitted under paragraph (C) of this rule. Beginning September 9, 2019, the board shall have ten business days to review materials submitted under paragraph (C) of this rule. (1) After the state board of pharmacy reviews the proposed advertisement, the board may: (a) Require a specific disclosure be made in the advertisement in a clear and conspicuous manner if the advertisement would be false or misleading without such a disclosure; (b) Make recommendations with respect to changes that are necessary to protect the public health, safety, and welfare; or (c) Prohibit the use of the advertisement. (2) If the state board of pharmacy does not complete one of the actions permitted under paragraph (D)(1) of this rule within the applicable review period, the submitted materials may be used in accordance with this division. Failure by the board to act within the applicable review period, however, does not constitute a waiver of its authority to undertake any of the actions permitted by this rule and the rules promulgated pursuant to Chapter 3796. of the Revised Code, if it is subsequently determined that the submitted material violates any provision of this Chapter 3796. of the Revised Code or this division. (E) No dispensary shall place or maintain, or cause to be placed or maintained, an advertisement of medical marijuana or medical marijuana products, including paraphernalia, in any form or through any medium: (1) Within five hundred feet of the perimeter of a prohibited facility, a community addiction services provider as defined under section 5119.01 of the Revised Code, a game arcade admission to which is not restricted to persons aged twenty-one years or older, or any other location where the placement of the advertisement targets or is attractive to children, as determined by the state board of pharmacy; (2) On a billboard; (3) On a radio or television broadcast; (a) A radio or television broadcast includes a system for transmitting sound alone or visual images and sound; and (b) Includes broadcast, cable, on-demand, satellite, or internet programming; (4) On any handheld or other portable sign; (5) With respect to public places, on a handbill, leaflet, or flyer directly handed, deposited, fastened, thrown, scattered, cast, or otherwise distributed to any person; (6) Left upon any private property without the consent of the property owners; (7) On or in a public transit vehicle or public transit shelter; or (8) On or in a publicly-owned or operated property. (F) An advertisement for a dispensary, regardless of the medium, shall not: (1) Include any image bearing a resemblance to a cartoon character, fictional character whose target audience is children or youth, or pop culture icon; (2) Market, distribute, offer, sell, license or cause to be marketed, distributed, offered sold or licensed, any apparel or other merchandise related to the sale of marijuana, to an individual under eighteen years of age. (3) Contain any statement, design, representation, picture or illustration that is: (a) False or misleading; (b) A departure from the medical marijuana registered name, including, marijuana leaves, slang terms, and similar references; (c) Disparaging to a competitor's products; (d) Obscene or indecent; or (e) Related to the safety or efficacy of marijuana, unless supported by substantial evidence or substantial clinical data. (4) Suggest or otherwise indicate that the product or entity in the advertisement has been approved or endorsed by the department of commerce, the state board of pharmacy, the state of Ohio or any person or entity associated with the state of Ohio; or (5) Encourage the use of medical marijuana for a condition other than a qualifying medical condition. (G) A dispensary may develop a website or otherwise establish a web presence advertising the name, business address, contact information, and services provided by a dispensary. A dispensary operating a website shall require age affirmation of at least eighteen years of age by the user before access to the website is granted. A dispensary that establishes any type of web presences shall not: (1) Allow for direct engagement between consumers or user-generated content or reviews; (2) Provide a medium for website users to transmit website content to individuals under the age of eighteen; (3) Display or otherwise post content that has not been submitted to the state board of pharmacy pursuant to paragraph (C) of this rule; (4) Facilitate sales transactions to any patient, caregiver, or medical marijuana entity; (5) Target a consumer audience under the age of eighteen; or (6) Maintain a web presence in violation of Chapter 3796. of the Revised Code or this division; (H) A dispensary shall not: (1) Display external signage larger than sixteen inches in height by eighteen inches in width that is not attached to the entity's permanent structure; (2) Illuminate a sign advertising medical marijuana at any time; (3) Sell or otherwise distribute clothing, apparel, or wearable accessories, unless such sale or distribution is to an employee for purposes of identification while working for the licensed entity; (4) Advertise medical marijuana brand names or use graphics related to medical marijuana on the exterior of the building in which the dispensary is operating; and (5) Display medical marijuana or paraphernalia that is visible from the exterior of the dispensary. (I) I. No dispensary shall license or otherwise expressly authorize any third party to use or advertise in a manner prohibited by this division. (J) J. This rule, as it pertains to advertisements, does not apply to a noncommercial message.
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