Utah Administrative Code (Current through November 1, 2019) |
R156. Commerce, Occupational and Professional Licensing |
R156-17b. Pharmacy Practice Act Rule |
R156-17b-603. Operating Standards - Pharmacist-In-Charge or Dispensing-Medical-Practitioner-In-Charge
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(1) The PIC or DMPIC shall have the responsibility to oversee the operation of the pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy and the distribution of drugs, durable medical equipment and medical supplies. The PIC or DMPIC shall be personally in full and actual charge of the pharmacy.
(2) In accordance with Subsections 58-17b-103(1) and 58-17b-601(1), a unique email address shall be established by the PIC, DMPIC, or responsible party for the pharmacy to be used for self-audits or pharmacy alerts initiated by the Division. The PIC, 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 PIC or DMPIC shall include:
(a) assuring 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) assuring 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) assuring 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) assuring 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 all materials, including drugs, chemicals and biologicals;
(j) maintenance of records of all transactions of the pharmacy necessary to maintain accurate control over and accountability for all pharmaceutical materials required by applicable state and federal laws and regulations;
(k) establishment and maintenance of effective controls against theft or diversion of prescription drugs and records for such drugs;
(l) if records are kept on a data processing system, the maintenance of records stored in that system shall be in compliance with pharmacy requirements;
(m) legal operation of the pharmacy including meeting all inspection and other requirements of all 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) assuring that all relevant information is submitted to the Controlled Substance Database in the appropriate format and in a timely manner;
(q) assuring that all pharmacy personnel have the appropriate licensure;
(r) assuring that no pharmacy operates with a ratio of pharmacist or DMP to other pharmacy personnel circumstances that result in, or reasonably would be expected to result in, an unreasonable risk of harm to public health, safety, and welfare;
(s) assuring that the PIC or DMPIC assigned to the pharmacy is recorded with the Division and that the Division is notified of a change in PIC or DMPIC within 30 days of the change; and
(t) assuring, with regard to the unique email address used for self-audits and pharmacy alerts, that:
(i) the pharmacy uses a single email address; and
(ii) the pharmacy notifies the Division, on the form prescribed, of any change in the email address within seven calendar days of the change.