Rule 480-25-.06 - Nuclear Pharmacy General Requirements(1) In addition to complying with these Rules and Regulations, nuclear pharmacies shall comply with the Rules and Regulations of the Board and with all applicable Federal and State laws and regulations pertaining to nonradioactive drugs and pharmaceuticals.(2) The pharmacist in charge at a nuclear pharmacy shall be a licensed nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals shall be under the direct supervision of a licensed nuclear pharmacist. All acts of compounding and dispensing of 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.(3) Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with acceptable professional standards of radiopharmaceutical quality assurance.(4) Radiopharmaceuticals are to be dispensed only upon prescription drug order by a practitioner who is authorized by the Department to possess, use, and administer radioactive materials.(5) A nuclear pharmacist may transfer to authorized persons radioactive materials not intended for drug use, in accordance with the Department Rules and Regulations for Radioactive Materials. A nuclear pharmacy may also furnish radioactive materials for use to practitioners, for individual patient use in accordance with subsection (4) of this regulation.(6) The amount of radioactivity dispensed in each individual preparation shall be determined by the nuclear pharmacist through radiometric methods immediately prior to dispensing.(7) Nuclear pharmacies may redistribute Federal Food and Drug Administration approved radiopharmaceuticals if the pharmacy does not possess 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.Ga. Comp. R. & Regs. R. 480-25-.06
O.C.G.A. Secs. 16-13-71, 26-4-110, 26-4-130, 26-4-138, 26-4-174, 26-4-178.
Original Rule entitled "Nuclear Pharmacy General Requirements" adopted. F. Mar. 9, 1984; eff. Mar. 29, 1984.Repealed: New Rule of same title adopted. F. June 13, 2002; eff. July 3, 2002.