Rule 480-25-.01 - DefinitionsUnless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereinafter respectively ascribed to them:
(a) "Authentication of product history" means, but is not limited to, identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical.(b) "Board" means the State Board of Pharmacy.(c) "Compounding of radiopharmaceuticals" means the addition of a radioactive substance to nonradioactive substances or the use of a radioactive substance in preparation for single or multidose dispensation upon the prescription order of a physician who is licensed to use radioactive materials. Compounding of radiopharmaceuticals may include: loading and eluting of radionuclide generators; using manufactured reagents; preparing reagent kits; a liquoting reagents; formulation and quality assurance testing of radiochemicals for use as radiopharmaceuticals, and radiolabeling of compounds or products, including biological products, for use as radiopharmaceuticals.(d) "Department" means the Department of Natural Resources.(e) "Governing Body" or "Management" means the board of directors, trustees, partnership, corporation, association, person or group of persons who maintain and control the operation of the nuclear pharmacy, and who are legally responsible for its operation.(f) "Internal Test Assessment" means, but is not limited to conducting those tests of a quality assurance necessary to ensure the integrity of the test.(g) "Licensed Nuclear Pharmacist" means an authorization granted by the Board to a pharmacist to practice as a nuclear pharmacist.(h) "Manufacturing of radiopharmaceuticals" means the preparation, derivation, or production of a product to which a radioactive substance is or will be added to provide a radiopharmaceutical for sale, resale, redistribution, or reconstitution.(i) "Nuclear pharmacist" means a pharmacist who compounds and dispenses radiopharmaceuticals in the course of his/her pharmacy practice.(j) "Nuclear Pharmacy" means a pharmacy providing radiopharmaceutical services.(k) "Nuclear Pharmacy Permit" means an authorization granted by the Board to the governing body of a facility to operate a nuclear pharmacy.(l) "Pharmacist" means an individual who is currently licensed to practice pharmacy under the provisions of O.C.G.A. Title 26, Chapter 4, Article 3.(m) "Pharmacy Intern" means an individual who is currently licensed to practice as a pharmacy intern under the provisions of O.C.G.A. Title 26, Chapter 4, Article 3.(n) "Physician" means an individual who is currently licensed to practice medicine under the provisions of O.C.G.A. Title 43, Chapter 34.(o) "Radiopharmaceutical" means radioactive drugs and chemical products used for diagnostic and therapeutic purposes and includes the terms radioactive pharmaceuticals, radioisotopes, and radioactive tracers.(p) "Radiopharmaceutical quality assurance" means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on radiopharmaceuticals and their component materials and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.(q) "Radiopharmaceutical service" means, but is not limited to, the compounding, dispensing, labeling, and delivering of radiopharmaceuticals; the participation in radiopharmaceutical selection and radiopharmaceutical utilization review; the maintenance of radiopharmaceutical quality assurance; and the responsibility for advising, where necessary or where regulated, of therapeutic values, hazards, and use of radiopharmaceuticals; and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of a nuclear pharmacy.(r) "Unit dose transport container" (a/k/a "lead pig") means a lead lined container designed to transport doses of radiopharmaceutical agents and prevent the emission of radiation or radioactive materials during the process. The terms "unit dose transport container" and "lead pig" may be used interchangeably.Ga. Comp. R. & Regs. R. 480-25-.01
O.C.G.A. §§ 26-4-27, 26-4-28, 26-4-110, 26-4-130, 26-4-171, 26-5-178.
Original Rule entitled "Dangerous Drugs Identified" adopted as ER. 480-25-0.6-.01 F. June 17, 1980; eff. June 12, 1980, the date of adoption.Amended: ER. 480-25-0.7-.01 of same title adopted. F. Sept. 25, 1980; eff. Sept. 22, 1980, the date of adoption.Amended: Permanent Rule of same title adopted. F. Dec. 30, 1980; eff. Jan. 19, 1981.Repealed: New Rule entitled "Definitions" adopted. F. Mar. 9, 1984; eff. Mar. 29, 1984.Repealed: New Rule of same title adopted. F. June 13, 2002; eff. July 3, 2002.Amended: F. Apr. 20, 2015; eff. May 10, 2015.