§ 26-4-174 - Nuclear pharmacy operators permit; separate entity; quality; maintain records; compliance of laws; authorized dispensing; transfer; labeling; redistribution - Georgia Statutes

O.C.G.A. 26-4-174 (2010)
26-4-174. Nuclear pharmacy operators permit; separate entity; quality; maintain records; compliance of laws; authorized dispensing; transfer; labeling; redistribution

(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.