Utah Administrative Code
Topic - Commerce
Title R156 - Professional Licensing
Rule R156-17b - Pharmacy Practice Act Rule
Section R156-17b-603 - Operating Standards - Consulting Pharmacist, Pharmacist-In-Charge, Remote Dispensing Pharmacist-in-Charge, or Dispensing-Medical-Practitioner-In-Charge
Universal Citation: UT Admin Code R 156-17b-603
Current through Bulletin 2024-18, September 15, 2024
(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.
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