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 rule 4729-16-01 of the Administrative 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, 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, the employee identification card issued by the state board of pharmacy. The card shall clearly identify the employee to the public and contain, at a minimum:

(1) An image of the employee;

(2) The date on which the license expires;

(3) The employee's current name; and

(4) The name of the dispensary.

(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 shall establish, maintain and comply with written policies and procedures as submitted in an operations and management practices plan, approved by the state board of pharmacy, 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.

(M) 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.

(N) No medical marijuana requiring refrigeration or hot-holding or considered potentially hazardous food shall be possessed or sold by a dispensary.

Cite as Ohio Admin. Code 3796:6-3-01

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