Current through Bulletin 2024-24, December 15, 2024
In accordance with Subsection
58-17b-601(1),
the following operating standards apply to Class A and Class B pharmacies, and
may be supplemented or amended by additional standards in this rule applicable
to specific types of Class A and B pharmacies.
(1) The general operating standards include:
(a) A facility shall be well lighted, well
ventilated, clean and sanitary.
(b)
A facility that transfers a drug from a manufacturer's or distributor's
original container to another container shall have a sink with hot and cold
culinary water separate and apart from restroom facilities. This sink
requirement does not apply to clean rooms where sterile products are prepared.
Clean rooms may not have sinks or floor drains.
(c) Required equipment shall be clean and in
good operating condition.
(d) A
facility shall be equipped to store prescription drugs and durable medical
equipment:
(i) in an orderly manner that
permits clear identification, separation, and easy retrieval of products;
and
(ii) in an environment
necessary to maintain the integrity of the product inventory.
(e) A facility shall be equipped
to permit practice within the standards and ethics of the profession as
dictated by the usual and ordinary scope of practice conducted within that
facility.
(f) A facility shall be
stocked with the quality and quantity of product necessary for the facility to
meet its scope of practice in a manner consistent with the public
safety.
(g) A facility that
dispenses controlled substances shall be equipped with a security system that:
(i) permits detection of entry at all times
when the facility is closed; and
(ii) provides notice of unauthorized entry to
an individual.
(h) A
pharmacy department shall:
(i) be equipped
with a lock where drugs are stored; and
(ii) be securely locked when the pharmacy
department is closed.
(i) A facility shall have a counseling area
to allow for confidential patient counseling, if applicable.
(2)
(a) Prescription labels for compounded
sterile and non-sterile medications, when dispensed to the patient or patient's
agent, shall include:
(i) the minimum
information required under Section
58-17b-602;
(ii) generic name;
(iii) quantity or concentration of each
active ingredient; and
(iv)
labeling for sterile preparation for parenteral use shall include:
(A) the name of the diluent;
(B) assigned compounding record or lot
number; and
(C) the phrase
"compounded preparation."
(b) The requirements described in Subsections
(2)(a)(i) and (2)(a)(iv) shall not apply to a label on the container of a drug
that a health care provider administers to a patient at:
(i) a pharmaceutical administration facility;
or
(ii) a hospital licensed under
Title 26, Chapter 21, Health Care Facility Licensing and Inspection
Act.
(3) The
temperature of the pharmacy shall be maintained within a range compatible with
the proper storage of drugs. If a refrigerator or freezer is necessary to
properly store drugs at the pharmacy, the pharmacy shall keep a daily written
or electronic log of the temperature of the refrigerator or freezer on days of
operation. The pharmacy shall retain each log entry for at least three
years.
(4) A facility shall have
current editions of the following reference publications in print or electronic
format, that are readily available to and retrievable by facility personnel:
(a) Title 58, Chapter 1, Division of
Occupational and Professional Licensing Act;
(b) Rule R156-1, General Rule of the Division
of Occupational and Professional Licensing;
(c) Title 58, Chapter 17b, Pharmacy Practice
Act;
(d) Rule R156-17b, Utah
Pharmacy Practice Act Rule;
(e)
Title 58, Chapter 37, Utah Controlled Substances Act;
(f) Rule R156-37, Utah Controlled Substances
Act Rule;
(g) Title 58, Chapter
37f, Controlled Substance Database Act;
(h) R156-37f, Controlled Substance Database
Act Rule;
(i) 21 CFR 1300 et seq.
(2021) or equivalent such as the USP DI Drug Reference Guides;
(j) current FDA-Approved Drug Products;
and
(k) any other general drug
references necessary to permit practice, as dictated by the usual and ordinary
scope of practice conducted within that facility.
(5)
(a) A
facility shall maintain a current list of licensed employees involved in the
practice of pharmacy at the facility, that includes:
(i) individual licensee names;
(ii) license classifications;
(iii) license numbers; and
(iv) license expiration dates.
(b) The list shall be readily
retrievable for inspection by the Division, and may be maintained in paper or
electronic form.
(6) A
pharmacy may not dispense a prescription drug or device to a patient unless a
pharmacist or DMP is physically present and immediately available in the
facility, or, for a remote dispensing pharmacy, physically present and
immediately available in the facility or supervising through a telepharmacy
system.
(7) Only a licensed Utah
pharmacist, DMP, or authorized personnel shall have access to the pharmacy when
the pharmacy is closed.
(8) The
facility or parent company shall maintain a record for at least five years of
the initials or identification codes that identify each dispensing pharmacist
or DMP by name. The initials or identification code shall be unique to ensure
that each pharmacist or DMP can be identified; therefore identical initials or
identification codes may not be used.
(9) The pharmacy facility shall maintain:
(a) copy 3 of DEA order form 222 that has
been properly dated, initialed, and filed;
(b) copies of each unaccepted or defective
order form; and
(c) any attached
statements or other documents.
(10) If applicable, a hard copy of a power of
attorney authorizing a pharmacist, DMP, or DMP designee to sign DEA order form
222 shall be available to the Division upon request.
(11) A pharmacist, DMP, or other responsible
individual shall verify that controlled substances are listed on the suppliers'
invoices and were actually received, by clearly recording their initials and
the actual date of receipt of the controlled substances.
(12) The facility shall maintain a record of
suppliers' credit memos for controlled substances.
(13) A copy of the inventories required under
Section
R156-17b-605 shall be made available to the Division when requested.
(14) The facility shall maintain hard copy
reports of surrender or destruction of controlled substances and legend drugs
submitted to appropriate state or federal agencies.
(15) If the pharmacy does not store drugs in
a locked cabinet and has a drop or false ceiling, the pharmacy's perimeter
walls shall extend to the hard deck, or the pharmacy shall take other measures
to prevent unauthorized entry into the pharmacy.
