Pursuant to section 3796.15 of the Revised Code, the state board of pharmacy shall regulate activities and enforce compliance with activities as they relate to the dispensing of medical marijuana and medical marijuana products to registered patients and designated caregivers. The state board of pharmacy shall investigate all activities related to Chapters 2925., 3715., 3719., and 3796. of the Revised Code as they relate to dispensing operations.
Chapter 3796:6-4 | Enforcement
Rule 3796:6-4-02 | Compliance and inspection of medical marijuana dispensaries.
(A) Dispensaries are subject to random and unannounced dispensary inspections and medical marijuana testing by the state board of pharmacy.
(B) The state board of pharmacy and its authorized representatives may:
(1) Enter any place, including a vehicle, in which medical marijuana is held, stored, dispensed, sold, produced, delivered, transported, manufactured, or disposed of;
(2) Inspect in a reasonable manner, the place and all pertinent equipment, containers, and labeling and all things including records, files, financial data, sales data, shipping data, pricing data, personnel data, research, papers, processes, controls, and facility, and inventory of any stock of medical marijuana; and
(3) Obtain any medical marijuana or medical marijuana product, any labels or containers for medical marijuana, or paraphernalia.
(C) The state board of pharmacy may investigate an applicant, application, a dispensary with under a provisional license, a licensed dispensary, principle officer, dispensary employee, third party vendor or any other party associated with a dispensary for an alleged violation of Chapter 3796. of the Revised Code or this division or to determine qualifications to be granted a license by the state board of pharmacy.
(D) The state board of pharmacy may require an applicant, a dispensary under a provisional license, or a licensed dispensary to produce documents, records or any other material pertinent to the investigation of an application or alleged violation of Chapter 3796. of the Revised Code or this division. Failure to provide the required material may be grounds for denial or discipline.
(E) Every person charged with preparation, obtaining or keeping records, logs, reports or other documents in connection with Chapter 3796. of the Revised Code or this division, and every person in charge, or having custody of those documents shall, upon request by the state board of pharmacy, make the documents immediately available for inspection and copying by the state board of pharmacy, the state board of pharmacys authorized representative or others authorized by law to review the documents.
(F) All information collected by the state board of pharmacy in the course of an examination, inspection or investigation of a licensee or applicant, including, but not limited to, any complaint against a license filed with the state board of pharmacy and information collected to investigate a complaint, shall be maintained for the use of the state board of pharmacy and shall not be disclosed except as authorized by state or federal law.
Rule 3796:6-4-03 | Grounds for discipline.
(A) The state board of pharmacy, after notice and hearing in accordance with Chapter 119. of the Revised Code, may revoke, suspend, limit, place on probation, or refuse to grant or renew a dispensary provisional license, certificate of operation, or a dispensary employee license, or may impose a monetary penalty or forfeiture if the board finds that the licensee:
(1) Has violated any state or federal law or rule, regardless of jurisdiction in which acts were committed, 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. Acts in accordance to Chapter 3796. of the Revised Code and this division that constitute a violation of federal law shall not be considered as grounds for discipline;
(2) Has committed a crime of moral turpitude, as defined in section 4776.10 of the Revised Code;
(3) Demonstrates an absence of good moral character and habits;
(4) Guilty of dishonesty or unprofessional conduct over the course of his or her dispensary duties;
(5) Is addicted to or abusing alcohol or drugs or impaired physically or mentally to such a degree as to render the employee unfit to operate or work in a dispensary;
(6) Has been convicted of a misdemeanor or felony related to, or committed in, any function related to the operation of a dispensary;
(7) Violated, conspired to violate, attempted to violate, or aided and abetted the violation of any of the provisions of Chapter 2925., 3715., 3719., 3796., or 4729. of the Revised Code, or of any rule adopted by the board under those provisions;
(8) Divided or agreed to divide remuneration made in the course of the cultivation, processing, dispensing, purchase or sale of medical marijuana with any licensed health professional certified to recommend medical marijuana;
(9) Knowingly lent the employees name to an illegal operator of a medical marijuana cultivating, processing, or dispensing facility or having professional connection with an illegal medical marijuana entity;
(10) Allowed a physician with a certificate to recommend medical marijuana to obtain an ownership or investment interest in or a compensation arrangement with a licensed dispensary;
(11) Allowed a recommending physician to conduct a physical examination or follow up care on dispensary premises;
(12) Allowed medical marijuana to be consumed on licensed dispensary premises or consumed medical marijuana on licensed dispensary premises;
(13) Committed fraud, misrepresentation, or deception in furnishing information to the state board of pharmacy, including in applying for or securing a license, registration, or renewal issued under Chapter 3715., 3719., 3796., or 4729. of the Revised Code;
(14) Failed to comply with an order of the board or a settlement agreement;
(15) Engaged in a pattern of conduct that demonstrates incompetence;
(16) Failed to respond to a written request for information by the state board of pharmacy within thirty days, unless otherwise provided in the written request from the state board of pharmacy;
(17) Was arrested and/or convicted of a disqualifying offense;
(18) Has a causal connection to a finding by the state board of pharmacy of a substantial discrepancy in a state board of pharmacy audit of medical marijuana;
(19) Has a causal connection to a finding by the state board of pharmacy of a substantial discrepancy in a state board of pharmacy audit of capital or funds;
(20) Has an inability to operate using reasonable judgment, skill or safety due to physical or mental illness or other impairment or disability, including without limitation, deterioration through the aging process or loss of motor skills or mental incompetence;
(21) Has engaged in or permitted the fraudulent use of a dispensary employee identification card;
(22) Tampered with, falsified, altered, modified, or duplicated a dispensary employee identification card;
(23) Failed to report to the state board of pharmacy, within five calendar days of becoming aware, that an employee identification card has been lost, stolen, or destroyed;
(24) Failed to report to the state board of pharmacy, within five calendar days, any arrest, charge, or conviction for a disqualifying offense;
(25) Failed to report to the state board of pharmacy, within five calendar days, any adverse action taken against the employee by any licensing jurisdiction in any state or any territory of the United States or any foreign jurisdiction, any governmental agency, any law enforcement agency or any court;
(26) Failed to notify the state board of pharmacy of a change of address;
(27) Disclosed customer names, personal information or protected health information in violation of any state or federal law;
(28) Dispensed medical marijuana to any person other than a qualified patient or designated caregiver, or when otherwise prohibited under this division;
(29) Is an entity that operated as a dispensary before obtaining a certificate of operation from the state board of pharmacy;
(30) Is an associated key or key employee who failed to report to the state board of pharmacy when he or she knew or should have known that a dispensary employee was using medical marijuana when the employee does not have a qualifying patient registration;
(31) Is subject to any fact or condition which, if it had existed at the time of the original application for the license, would have warranted the denial of the license;
(32) Selling, distributing, transferring in any manner, or giving medical marijuana or medical marijuana products to any unauthorized persons;
(33) Permitted a person without a valid dispensary employee license to be employed by a dispensary;
(34) Failed to assign a designated representative as required under this division;
(35) Failed to hire sufficient personnel or maintained employment of employees who were unqualified in training or experience to properly operate a dispensary;
(36) Engaged in any pattern of activity that causes harm to the community;
(37) Dispensed or allowed to be dispensed, medical marijuana with improper labeling or medical marijuana that did not meet the labeling requirements of this division;
(38) Failed to provide appropriate education to a patient or caregiver in compliance with rule 3796:6-3-15 of the Administrative Code;
(39) Knowingly provided inaccurate or inappropriate education to a patient or caregiver;
(40) Has ever been denied a license to prescribe, dispense, administer, supply, or sell a controlled substance by the appropriate issuing body of any state or jurisdiction, based, in whole or in part, on the inappropriate prescribing dispensing, administering, supplying or selling a controlled substance or other dangerous drug other than medical marijuana dispensed;
(41) Has held a license issued by the drug enforcement administration or a state licensing agency in any jurisdiction, under which the person may prescribe, dispense, administer, supply or sell a controlled substance, that has ever been restricted, based, in whole or in part, on the prescriber's inappropriate prescribing, dispensing, personally furnishing, diverting, administering, supplying, or selling a controlled substance or other dangerous drug;
(42) Has been subject to disciplinary action by any licensing entity that was based, in whole or in part, on the prescribers inappropriate prescribing, dispensing, diverting, administering, personally furnishing, diverting, supplying or selling a controlled substance or other dangerous drug;
(43) Canceled a bond and the licensee failed to file a new bond with the state board of pharmacy in the required amount on or before the effective date of cancellation;
(44) Placed or maintained, or caused to be placed or maintained, an unauthorized advertisement of medical marijuana or medical marijuana products; and
(45) Failed to prevent diversion, theft, or loss of medical marijuana or to notify the state board of pharmacy thereof;
(46) Engaged in any other conduct for which the board may impose discipline as set forth in rules adopted under Chapter 3796. of the Revised Code or this division.
(B) A dispensary is responsible to the state or local governmental entity for all expenses incurred by the state or local governmental entity in the following:
(1) Cleaning up, mitigating or remedying any environmental damage caused by the dispensary; and
(2) Administrative costs for investigation and prosecution.
(C) When considering disciplinary action against a dispensary employee, the state board of pharmacy shall consider compliance with rule 3796:6-3-20 of the Administrative Code as a mitigating factor.
Rule 3796:6-4-04 | Revocation, suspension and termination of a medical marijuana dispensary certificate of operation or employee license.
(A) The state board of pharmacy, after notice and hearing in accordance with Chapter 119. of the Revised Code, may impose any one or more of the following sanctions on a dispensary or a dispensary employee if the board finds evidence of any of the conduct set forth in rule 3796:6-4-03 of the Administrative Code:
(1) Revoke, suspend, restrict, limit, or refuse to grant or renew a license, including a dispensary certificate of operation;
(2) Reprimand or place the license holder on probation;
(3) Impose a monetary penalty, not to exceed fifty thousand dollars for each finding, or forfeiture.
(B) Any licensee whose license is revoked, suspended, or refused, shall return his or her identification card to the offices of the state board of pharmacy within ten business days of receipt of notice of such action.
(C) If, the board has reasonable cause to believe that a dispensary employee is physically or mentally impaired, the board may require the employee to submit to a physical or mental examination, or both.
Rule 3796:6-4-05 | Suspension of a dispensary employee license without a hearing.
(A) Pursuant to division (B)(3) of section 3796.14 of the Revised Code, the state board of pharmacy may suspend a dispensary employee license by using a telephone conference call to review the allegations and take a vote under the following circumstances:
(1) Upon a finding that a dispensary employee is abusing or becomes addicted to the use of controlled substances the dispensary employees license shall be suspended by the board until the person offers satisfactory proof to the state board of pharmacy that the person no longer is addicted to the use of controlled substances;
(2) If the board determines that there is clear and convincing evidence that continuation of the dispensary employees practice or method of dispensing, using or furnishing medical marijuana presents a danger of immediate and serious harm to oneself or to others, the state board of pharmacy shall suspend the persons license without a hearing;
(3) On receiving notification that a dispensary employee has been convicted of or pleaded guilty to a disqualifying offense, the state board of pharmacy shall suspend the persons license without a hearing;
(4) On receiving notification that a dispensary employee pleaded guilty to, was found guilty by a jury or court of, or was convicted of a felony drug abuse offense; a finding by a court of the dispensary employees eligibility for intervention in lieu of conviction; a dispensary employees plea of guilty to, or a finding by a jury or court of the employees guilt of, or the employees conviction of an offense in another jurisdiction that is substantially the same as a felony drug abuse offense; or a finding by a court of the employees eligibility for treatment or intervention in lieu of conviction in another jurisdiction, the state board of pharmacy immediately shall suspend the license of that person.
(B) The board shall follow the procedure for suspension without a prior hearing in section 119.07 of the Revised Code. The suspension shall remain in effect, unless removed by the board, until the boards final adjudication order becomes effective, except that if the board does not issue its final adjudication order within ninety days after the hearing the suspension shall be void ninety-one days after the hearing.
Rule 3796:6-4-06 | Suspension of a dispensary provisional license or certificate of operation without a hearing.
Pursuant to division (B)(3) of section 3796.14 of the Revised Code, if the state board of pharmacy determines that there is clear and convincing evidence that the method used by a dispensary to possess or dispense medical marijuana presents a danger of immediate and serious harm to others, the board may suspend the dispensarys license without a hearing. Upon the suspension of a dispensary certificate of operation, all medical marijuana shall be placed under seal in accordance with division (C) of section 3796.15 of the Revised Code. The board shall follow the procedure for suspension without a prior hearing in section 119.07 of the Revised Code. The suspension shall remain in effect, unless removed by the board until the boards final adjudication order becomes effective, except that if the board does not issue its final judgment order within ninety days after the hearing, the suspension shall be void on the ninety-first day after the hearing.
Rule 3796:6-4-07 | Failure to properly store medical marijuana.
(A) Any dispensary that does not store medical marijuana in compliance with this division, or that stores medical marijuana at a location other than that for which the dispensary license was issued, may have its license suspended or revoked. In such a case, all medical marijuana under the dispensarys control will be subject to being placed under seal by the state board of pharmacy in compliance with division (C) of section 3796.15 of the Revised Code.
(B) The state board of pharmacy may retrieve samples of dispensary inventory and submit such samples to a testing laboratory for appropriate testing upon reasonable suspicion that expired, damaged, deteriorated, misbranded or adulterated medical marijuana:
(1) Is being or has been dispensed to patients or caregivers; or
(2) Is intermingled with a dispensarys medical marijuana inventory until they are destroyed in accordance with the dispensarys destruction policy. Expired, damaged, deteriorated, misbranded or adulterated medical marijuana shall not be stored at the licensed dispensary for more than one week.
Rule 3796:6-4-08 | Restoration of license from discipline.
At any time after the successful completion of a term of probation or suspension of a license, the state board of pharmacy may reinstate the license to active status, if all conditions precedent are demonstrated and are determined by the board to be met.
Rule 3796:6-4-09 | Interagency cooperation.
Whenever the state board of pharmacy revokes or suspends a medical marijuana dispensary license, it shall notify the department of commerce, the medical board, local police departments and county sheriffs office whose jurisdiction includes the licensees dispensing location.
Rule 3796:6-4-10 | Variances.
(A) The state board of pharmacy may grant variances from this division in cases in which:
(1) The applicable provision is not statutorily mandated;
(2) Granting the variance will not be contrary to public interest;
(3) No party will be injured by the granting of the variance; and
(4) The rule from which the variance is granted would, in the particular case, be unreasonable or unnecessarily burdensome.
(B) An approval for a variance may be revocable, may be granted for a limited period or may be granted subject to the conditions as the state board of pharmacy may prescribe.