Section R156-17b-614g - Operating Standards - Class A or Class B Pharmacy - Remote Dispensing Pharmacy(1) In accordance with Subsections 58-17b-102(58), 58-17b-601(1), 58-17b-612(1)(b), and 58-1-301(3), the operating standards for a remote dispensing pharmacy are established in this section.(2) A remote dispensing pharmacy shall:(a) be a Class A or Class B pharmacy;(b) have a Class A or Class B pharmacy serve as its supervising pharmacy to oversee its operations; and(c) be located in an area of need as defined in Subsection R156-17b-102(4).(3) A remote dispensing pharmacy may not perform compounding.(4)(a) The supervising pharmacy's PIC shall serve as the remote dispensing pharmacy's RDPIC, who is responsible for any remote dispensing pharmacy operations.(b) An RDPIC may not serve as the RDPIC for more than one remote dispensing pharmacy, unless approved by the Division in collaboration with the Board.(5)(a) At any time that a remote dispensing pharmacy is open and available to serve patients, its pharmacy technicians shall be physically or electronically supervised by a pharmacist from the supervising pharmacy, under Subsection 58-17b-102(70).(b) In accordance with Subsections 58-17b-612(1)(b) and (d) a pharmacist may oversee the operation of up to two remote dispensing pharmacies simultaneously.(c) Unless a pharmacist is physically present, a remote dispensing pharmacy shall be staffed by no more than two licensed pharmacy technicians.(d) Each pharmacy technician staffing a remote dispensing pharmacy shall have at least 500 hours of pharmacy technician experience.(e)(i) Adequate supervision by a pharmacist of a remote dispensing pharmacy shall include maintaining uninterrupted visual supervision and auditory communication with the site, and full supervisory control of the automated system, if applicable.(ii) A supervising pharmacist may not delegate supervision to any other person.(6) The supervising pharmacy shall maintain a surveillance system and telepharmacy system that provides for effective video and audio communication between supervising pharmacy personnel and remote dispensing pharmacy personnel and patients, that includes the following features: (a) provides an adequate number of views of the entire site;(b) facilitates adequate pharmacist supervision;(c) allows the appropriate exchanges of visual, verbal, and written communication for patient counseling and other matters involved in the lawful transaction or dispensing of drugs;(d) confirms that the drug selected to fill the prescription is the same as indicated on the prescription label and prescription; and(e) is secure and HIPAA compliant as defined in R156-17b-102(64).(7)(a) Each component of the telepharmacy system shall be in good working order.(b) If a component of the system is malfunctioning, the remote dispensing pharmacy shall immediately close to the public and remain closed until system corrections or repairs are completed, unless a pharmacist is present onsite.(8)(a) The supervising pharmacy shall develop and include in both the supervising pharmacy's and the remote dispensing pharmacy's policies and procedures a plan for continuation of pharmaceutical services by the remote dispensing pharmacy in case of an emergency interruption.(b)(i) The plan shall address the timely arrival at the remote dispensing pharmacy of necessary personnel, and the delivery to the remote dispensing pharmacy of necessary supplies, within a reasonable period of time following the identification of an emergency need. (ii) A pharmacist shall be available onsite at the remote dispensing pharmacy as soon as possible after an emergency, and shall notify the Division in writing if the time exceeds 24 hours.(c) The plan may provide for alternate methods of continuation of the services of the remote dispensing pharmacy, including personal delivery of patient prescription medications from an alternate pharmacy location or on-site pharmacist staffing at the remote dispensing pharmacy.(9)(a)(i) The remote dispensing pharmacy's security system shall track entries into the remote dispensing pharmacy.(ii) The RDPIC shall periodically review the record of entries.(b) A remote dispensing pharmacy shall display a sign easily visible to the public that informs patients of the following: (i) that the pharmacy is a remote dispensing pharmacy;(ii) the location of the supervising pharmacy; and(iii) that at the patient's request a pharmacist will counsel the patient using audio and video communication systems.(10)(a)(i) The supervising pharmacy shall maintain records of the orders entered into its information system, including orders entered from the remote dispensing pharmacy.(ii) Electronic records shall be available to and accessible from both the remote dispensing pharmacy and the supervising pharmacy.(iii) The original records of the controlled substance prescriptions dispensed from the remote dispensing pharmacy shall be maintained at the remote dispensing pharmacy.(b) The remote dispensing pharmacy shall retain a recording of surveillance, excluding patient communications, for at least 45 days.(c)(i) The RDPIC shall oversee documented monthly inspections of the remote dispensing pharmacy.(ii) Documentation of the inspections shall be kept for five years, and shall include: (A) maintenance and reconciliation of any controlled substance;(B) a perpetual inventory of Schedule II controlled substances;(C) temperature logs of the refrigerator and freezer that hold medications; and(D) the RDPIC's periodic review of the record of entries into the remote dispensing pharmacy.Utah Admin. Code R156-17b-614g
Adopted by Utah State Bulletin Number 2019-24, effective 11/25/2019Amended by Utah State Bulletin Number 2020-22, effective 11/10/2020Amended by Utah State Bulletin Number 2021-07, effective 3/11/2021