Current through Bulletin 2024-23, December 1, 2024
Section R66-5-3 - General Operating Standards(1) In addition to general operating standards established in Title 4, Chapter 41a, Cannabis Production Establishments and Pharmacies, medical cannabis pharmacies shall comply with the operating standards established in this rule. Medical cannabis pharmacies shall:(a) be well lit, well ventilated, clean, and sanitary;(b) maintain a current list of employees working at the medical cannabis pharmacy that: (i) includes employee name, department registration license classification and license number, registration expiration date, and work schedule; and(ii) be readily retrievable for inspection by the department and may be maintained in paper or electronic form;(c) have a counseling area to allow for confidential patient counseling; and(d) have current and retrievable editions of the following reference publications, in print or electronic format, readily available and retrievable to medical cannabis pharmacy personnel: (i) Title 4, Chapter 41a, Cannabis Production Establishments and Pharmacies;(ii) Title 26B, Chapter 4, Part 2, Cannabinoid Research and Medical Cannabis; and(iii) applicable administrative rules.(2) A medical cannabis pharmacy may not distribute medical cannabis products or medical cannabis devices to a medical cannabis cardholder unless an employee who is a PMP is physically present and immediately available in the medical cannabis pharmacy.(3) A medical cannabis pharmacy location shall be open for a cardholder to buy a medical cannabis product and medical devices for a minimum of 35 hours a week, except as authorized by the department.(4) A medical cannabis pharmacy that closes during normal hours of operation shall implement procedures to notify cardholders when the medical cannabis pharmacy will resume normal hours of operation. Procedures may include telephone system messages and conspicuously posted signs.(5)(a) Deliveries from a cannabis processing facility or another medical cannabis pharmacy shall be carried out under the direct supervision of a PMP or pharmacy agent.(b) A PMP or pharmacy agent shall be present to accept the delivery.(c) Upon delivery, the medical cannabis product or medical cannabis devices shall immediately be placed in a limited access area of the medical cannabis pharmacy.(6) A medical cannabis pharmacy shall protect confidential cardholder data and information stored in the Electronic Verification System to ensure that access to and use of the data and information is limited to those individuals and purposes authorized under Title 26B, Chapter 4, Part 2, Cannabinoid Research and Medical Cannabis and this rule.(7) A medical cannabis pharmacy may not dispense expired, damaged, deteriorated, misbranded, adulterated, or opened medical cannabis products or medical cannabis devices.(8)(a) A medical cannabis pharmacy license may not be assigned or transferred but a licensee may make changes to its ownership or company structure.(b) Any changes to a pharmacy's ownership or company structure shall be reported to the department no later than ten calendar days before the change is to take place.(c) When making a change to its ownership, a licensee may not:(i) make an ownership change by an interest of 2% or more without notification of the department at least 10 days before the date of the change; and(ii) make an ownership change by an interest of 50% or more without applying to the department and receiving department approval and payment of the fee authorized under Subsection 4-41a-1001(3)(c) that the department sets in accordance with Section 63J-1-504.(9) When applying to the department for approval of an ownership change of more than 50%, the medical cannabis pharmacy shall submit to the department: (a) a complete application form;(b) payment of an application fee that covers the cost of the application review;(c) a description of how the medical cannabis pharmacy maintains its compliance with the minimum standards for licensure and operation of the medical cannabis pharmacy; and(d) the results of any formal investigation or adverse action taken against the new owners or individuals with financial or management control who make up the new owners, during the past seven years by any licensing jurisdiction, government agency, law enforcement agency, or court.(10) A medical cannabis pharmacy shall provide a copy of a certificate of analysis for a medical cannabis product to a medical cannabis cardholder or a recommending medical provider if:(a) it is requested in writing; and(b) the requestor signs a non-disclosure agreement upon request by the medical cannabis pharmacy.(11) A medical cannabis pharmacy may be in the same building as a medical clinic that offers medical cannabis evaluations under the following conditions: (a) the building owner may not be the medical cannabis pharmacy or an owner, director, board member, employee, or agent of the medical cannabis pharmacy; and(b) the two businesses cannot share an outdoor entrance unless the entrance leads to a common area shared by multiple tenants of the building where the two businesses have separate facility entrances to facility reception areas separated by walls and locked doors.Adopted by Utah State Bulletin Number 2024-10, effective 5/13/2024Amended by Utah State Bulletin Number 2024-15, effective 7/25/2024