Section R156-17b-603 - Operating Standards - Consulting Pharmacist, Pharmacist-In-Charge, Remote Dispensing Pharmacist-in-Charge, or Dispensing-Medical-Practitioner-In-Charge(1) The consulting pharmacist, PIC, RDPIC, or DMPIC shall have the responsibility to oversee the operation of the pharmacy in conformance with laws and rules pertinent to the practice of pharmacy and the distribution of drugs, durable medical equipment, and medical supplies. The consulting pharmacist, PIC, RDPIC, or DMPIC shall be personally in full and actual charge of the pharmacy.(2)(a) In accordance with Subsections 58-17b-103(1) and 58-17b-601(1), a unique email address shall be established by the consulting pharmacist, PIC, RDPIC, DMPIC, or responsible party for the pharmacy to be used for self-audits or pharmacy alerts initiated by the Division.(b) The consulting pharmacist, PIC, RDPIC, DMPIC, or responsible party shall notify the Division of the pharmacy's email address in the initial application for licensure.(3) The duties of the consulting pharmacist, PIC, RDPIC, or DMPIC shall include: (a) ensuring that a pharmacist, pharmacy intern, DMP, or DMP designee dispenses drugs or devices, including: (i) packaging, preparation, compounding and labeling; and(ii) ensuring that drugs are dispensed safely and accurately as prescribed;(b) ensuring that pharmacy personnel deliver drugs to the patient or the patient's agent, including ensuring that drugs are delivered safely and accurately as prescribed;(c) ensuring that a pharmacist, pharmacy intern, or DMP communicates to the patient or the patient's agent, at their request, information concerning any prescription drugs dispensed to the patient by the pharmacist, pharmacy intern, or DMP;(d) ensuring that a reasonable effort is made to obtain, record and maintain patient medication records;(e) education and training of pharmacy personnel;(f) establishment of policies for procurement of prescription drugs and devices and other products dispensed from the pharmacy;(g) disposal and distribution of drugs from the pharmacy;(h) bulk compounding of drugs;(i) storage of materials, including drugs, chemicals and biologicals;(j) maintenance of records of transactions of the pharmacy necessary to maintain accurate control over and accountability for pharmaceutical materials required by state and federal laws and regulations;(k) establishment and maintenance of effective controls against theft or diversion of prescription drugs and records for the prescription drugs;(l) if records are kept on a data processing system, the maintenance of records stored in that system in compliance with pharmacy requirements;(m) legal operation of the pharmacy including meeting inspection and other requirements of state and federal laws, rules and regulations governing the practice of pharmacy;(n) implementation of an ongoing quality assurance program that monitors performance of the automated pharmacy system, which is evidenced by written policies and procedures developed for pharmaceutical care;(o) if permitted to use an automated pharmacy system for dispensing purposes: (i) ensuring that the system is in good working order and accurately dispenses the correct strength, dosage form and quantity of the drug prescribed while maintaining appropriate record keeping and security safeguards; and(ii) implementation of an ongoing quality assurance program that monitors performance of the automated pharmacy system, which is evidenced by written policies and procedures developed for pharmaceutical care;(p) ensuring that relevant information is submitted to the Controlled Substance Database in the appropriate format and in a timely manner;(q) ensuring that pharmacy personnel have the appropriate licensure;(r) ensuring that no pharmacy operates with a ratio of pharmacist or DMP to other pharmacy personnel in circumstances that result in, or reasonably would be expected to result in, an unreasonable risk of harm to public health, safety, and welfare;(s) ensuring that the consulting pharmacist, PIC, RDPIC, or DMPIC assigned to the pharmacy is recorded with the Division on a form provided by the Division, and that the Division is notified of a change in consulting pharmacist, PIC, RDPIC, or DMPIC within 30 days of the change;(t) ensuring, with regard to the unique email address used for self-audits and pharmacy alerts, that the pharmacy:(i) uses a single email address; and(ii) notifies the Division, on the form prescribed, of a change in the email address within seven calendar days of the change;(u) under Subsection 58-17b-103(1), conducting a pharmacy self-audit on a form provided by the Division, in accordance with the following timeframes: (i) within 30 days of a change of consulting pharmacist, PIC, DMPIC or RDPIC;(ii) within 30 days of the opening of a new facility; and(iii) at least 90 days before the end of each renewal cycle; and(iv) maintaining each pharmacy self-audit form for two years from the date of the self-audit.Utah Admin. Code R156-17b-603
Amended by Utah State Bulletin Number 2015-6, effective 2/24/2015Amended by Utah State Bulletin Number 2019-24, effective 11/25/2019Amended by Utah State Bulletin Number 2022-03, effective 1/27/2022Amended by Utah State Bulletin Number 2023-02, effective 1/5/2023