Current through Bulletin 2024-24, December 15, 2024
(1) Under
Subsection
58-88-205(1), the
operating standards for a licensed dispensing practice shall include the
standards in this section. This section does not apply to dispensing that is
limited or excepted from Title 58, Chapter 88, Part 2, Dispensing Practice,
including dispensing under Subsection
58-88-202(5).
(2) An LDP shall store and maintain drugs and
devices to be dispensed as follows:
(a) by
expiration date, with appropriate labeling and inventory
documentation;
(b) in a sanitary
and controlled environment in accordance with federal and state laws, rules,
and regulations applicable to licensing dispensing practice; and
(c) in a secure, locked area under the
control of the RDP, with access limited to the LDP's RDPs and dispensing
practitioners and the individuals under their supervision.
(3) An LDP shall label dispensed drugs in
accordance with federal and state laws, rules, and regulations applicable to
licensed dispensing practice, and include the following:
(a) facility name, address, and phone
number;
(b) patient's
name;
(c) prescriber's
name;
(d) medication name and
strength;
(e) date
dispensed;
(f) directions for use
and cautionary statements; and
(g)
beyond use date.
(4) LDP
inventory control standards for dispensed drugs shall be in accordance with
federal and state laws, rules, and regulations applicable to licensed
dispensing practice, and include the following:
(a) authorized personnel shall remove
out-of-date legend drugs from the inventory at regular intervals and in
correlation to the beyond use date imprinted on the label;
(b) general requirements for inventory of an
LDP shall include the following:
(i) the RDP
shall be responsible for taking required inventories, but may delegate
performance of an inventory to one or more persons;
(ii) inventory records shall be maintained
for five years and be available for inspection upon request, either in hard
copy or electronic format;
(iii)
inventory records shall be filed separately from all other records;
(iv) inventory records shall be in a written,
typewritten, printed, or electronic form;
(v) an inventory taken by use of a verbal
recording device shall be promptly transcribed;
(vi) an inventory may be taken either as the
opening of the business or the close of business on the inventory
date;
(vii) the individual taking
the inventory and the RDP shall indicate the time the inventory was taken, and
shall sign and date the inventory with the date the inventory was
taken;
(viii) the signature of the
RDP and the date of the inventory shall be documented within 72 hours or three
business days of the completed initial, annual, change of ownership, or closing
inventory; and
(ix) the initial
inventory shall serve as the LDP inventory until the next completed
inventory.
(5)
A dispensing practitioner shall provide counseling to each patient receiving a
dispensed drug or device as follows:
(a)
counseling shall be offered orally in person, unless the patient or patient's
agent is not at the LDP or a specific communication barrier prohibits oral
communication;
(b) counseling may
be provided electronically;
(c) if
a prescription drug or device is delivered to the patient or patient's agent,
the information in Subsection (d) may be delivered with the dispensed
prescription in writing; and
(d)
based upon the professional judgment of the dispensing practitioner, patient
counseling may include the following elements:
(i) name and description of the prescription
drug;
(ii) dosage form, dose, route
of administration and duration of drug therapy;
(iii) intended use of the drug and expected
action;
(iv) special directions and
precautions for preparation, administration and use;
(v) common severe side or adverse effects or
interactions and therapeutic contraindications that may be encountered,
including their avoidance, and the action recommended if they occur;
(vi) techniques for self-monitoring drug
therapy;
(vii) proper
storage;
(viii) prescription refill
information;
(ix) action to be
taken in the event of a missed dose;
(x) comments relevant to the individual's
drug therapy, including any other information specific to the patient or drug;
or
(xi) date after which the
prescription should not be taken or used, or the beyond use date.
(6) Only a dispensing
practitioner may orally provide counseling to a patient or patient's agent and
answer questions concerning a dispensed drug or device.
(7) Operating standards for closing an LDP
shall be as follows:
(a) by the date of
closing, the RDP shall remove the LDP prescription drugs and devices from the
LDP by one or a combination of the following methods:
(i) returning to manufacturer or supplier for
credit or disposal; or
(ii) selling
or giving to one or more persons legally entitled to possess the drug or
device, such as an LDP, underserved population clinic, hospital, or
pharmacy;
(b) within ten
business days of closing, the LDP shall submit a surrender notice to the
Division on a form provided by the Division, which includes the following:
(i) the actual date of closing;
(ii) a surrender of the LDP license;
and
(iii) a statement attesting:
(A) that the LDP has conducted a closing
inventory under Section
R156-88a-205; and
(B) the manner in which the LDP drugs and
devices were transferred or disposed; and
(c) if the LDP is closed suddenly due to
fire, destruction, natural disaster, death, property seizure, eviction,
bankruptcy, or other emergency circumstances, the LDP shall comply with this
subsection in the detail and as promptly as allowed by the
circumstances.
(8)
Unlicensed LDP personnel who are supervised by a dispensing practitioner may
assist in dispensing tasks not requiring professional licensure, such as:
(a) stock ordering and restocking;
(b) cashiering;
(c) billing;
(d) filing;
(e) housekeeping; and
(f) delivering a pre-filled prescription to a
patient.
(9) An LDP that
employs the United States Postal Service, other common carrier, or LDP
personnel to deliver a filled prescription to a patient shall:
(a) use adequate storage or shipping
containers and shipping processes to ensure drug stability and potency and
appropriate storage temperatures throughout delivery, with packaging material
and devices recommended by the manufacturer or the United States Pharmacopeia
Chapter 1079;
(b) use shipping
containers sealed in a manner to detect evidence of opening or
tampering;
(c) have policies and
procedures to ensure accountability, safe delivery, and compliance with
temperature requirements, including the following:
(i) when drugs do not arrive on time or there
is evidence that the integrity of a drug was compromised during shipment;
and
(ii) providing for the
replacement of drugs; and
(d) provide information to the patient
indicating what the patient should do if the integrity of the packaging or drug
was compromised during shipment.
(10) An LDP shall maintain a medication
profile for each patient receiving a dispensed drug or device, as follows:
(a) a patient profile, once established,
shall be maintained by the LDP on a recurring basis for a minimum of one year
from the date of the most recent prescription filled; and
(b) information to be included in the profile
shall be determined by the dispensing practitioner, but shall include at
minimum:
(i) full name of the patient,
address, telephone number, and date of birth or age and gender; and
(ii) patient history where significant,
including known allergies and drug reactions, and a list of prescription drugs
and devices obtained by the patient at the LDP, including:
(A) name of prescription;
(B) strength of prescription drug;
(C) quantity dispensed;
(D) date of filling;
(E) charge for the prescription drug or
device as dispensed to the patient; and
(F) any additional comments relevant to the
patient's drug or device use.
