Utah Administrative Code
Topic - Commerce
Title R156 - Professional Licensing
Rule R156-17b - Pharmacy Practice Act Rule
Section R156-17b-614g - Operating Standards - Class A or Class B Pharmacy - Remote Dispensing Pharmacy
Universal Citation: UT Admin Code R 156-17b-614g
Current through Bulletin 2024-18, September 15, 2024
(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.
Disclaimer: These regulations may not be the most recent version. Utah may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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