Title 26, Chapter 4, Section 174
( 26-4-174)
(a) A permit to operate a nuclear pharmacy shall only be issued in
accordance with Article 6 of this chapter with the added designation
that the pharmacist in charge be a nuclear pharmacist. All
personnel performing tasks in the preparation and distribution of
radiopharmaceuticals shall be under the supervision of a licensed
nuclear pharmacist. All acts of compounding and dispensing
radiopharmaceuticals shall be performed by the nuclear pharmacist or
by a pharmacist or pharmacy intern under the direct supervision and
control of a nuclear pharmacist. A nuclear pharmacist shall be
responsible for all operations of the nuclear pharmacy and shall be
in personal attendance at all times when the acts of compounding and
dispensing are performed and the pharmacy is open for business. (b) Nuclear pharmacies shall have adequate space, commensurate with
the scope of services provided and, as required by rules and
regulations promulgated by the board pursuant to implementation of
this article, shall meet minimal space requirements established for
all pharmacies in the state. The nuclear pharmacy area shall be
separate from the pharmacy areas for nonradiopharmaceuticals and
shall be secured from unauthorized personnel. (c) Nuclear pharmacies shall only dispense radiopharmaceuticals
which comply with acceptable professional standards of
radiopharmaceutical quality assurance. (d) Nuclear pharmacies shall maintain records of acquisition and
disposition of all radiopharmaceuticals in accordance with
requirements of the board and the department. (e) Nuclear pharmacies shall comply with all applicable laws and
regulations of federal and state agencies, including those laws and
regulations governing nonradioactive drugs and pharmaceuticals. (f) Radiopharmaceuticals are to be dispensed only upon prescription
order by a physician who is authorized by the department to possess,
use, and administer radioactive materials. (g) A nuclear pharmacist may transfer to authorized persons
radioactive materials not intended for drug use, in accordance with
department regulations for radioactive materials. A nuclear
pharmacy may also furnish radioactive materials for use to
physicians, for individual patient use in accordance with subsection
(f) of this Code section. (h) In addition to any labeling requirements required by rules and
regulations of the board for nonradiopharmaceuticals, the immediate
outer container of a radiopharmaceutical to be dispensed shall also
be labeled as required in rules and regulations of the board and of
the department. (i) The amount of radioactivity dispensed in each individual
preparation shall be determined by the nuclear pharmacist through
radiometric methods immediately prior to dispensing. (j) Nuclear pharmacies may redistribute federal Food and Drug
Administration approved radiopharmaceuticals if the pharmacy does
not process the radiopharmaceuticals in any manner or violate the
product packaging. Such redistribution may only be made to another
nuclear pharmacy or other authorized person or institution. |