Utah Admin. Code R156-17b-614d - Operating Standards - Class B - Nuclear Pharmacy
(1) In accordance with Subsection
58-17b-601(1),
the operating standards for a Class B pharmacy designated as a nuclear pharmacy
are established in this section.
(2) A nuclear pharmacy shall have the
following:
(a) have applied for or possess a
current Utah Radioactive Materials License; and
(b) adequate space and equipment commensurate
with the scope of services required and provided.
(3) Nuclear pharmacies shall only dispense
radiopharmaceuticals that comply with acceptable standards of quality
assurance.
(4) Nuclear pharmacies
shall maintain a library commensurate with the level of radiopharmaceutical
service to be provided.
(5)
(a) A licensed Utah pharmacist shall be
immediately available on the premises at any time when the facility is open or
available to engage in the practice of pharmacy.
(b) In addition to Utah licensure, the
pharmacist shall have classroom and laboratory training and experience as
required by the Utah Radiation Control Rules.
(6) This rule does not prohibit:
(a) a licensed pharmacy intern or technician
from acting under the direct supervision of a pharmacist preceptor who meets
the requirements to supervise a nuclear pharmacy; or
(b) a Utah Radioactive Materials license from
possessing and using radiopharmaceuticals for medical use.
(7) A hospital nuclear medicine department or
an office of a physician-surgeon, osteopathic physician-surgeon, veterinarian,
podiatric physician or dentist that has a current Utah Radioactive Materials
License does not require licensure as a Class B pharmacy.
(8) A nuclear pharmacy preparing sterile
compounds shall follow the USP-NF Chapter 797 Compound for sterile
preparations.
(9) A nuclear
pharmacy preparing medications for a specific person shall be licensed as a
Class B - nuclear pharmacy if located in Utah, and as a Class D pharmacy if
located outside of Utah.
Notes
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