§ 26-4-171 - Definitions - Georgia Statutes

O.C.G.A. 26-4-171 (2010)
26-4-171. Definitions

As used in this article, the term:

(1) "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.

(2) "Board" means the State Board of Pharmacy.

(3) "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 reagent kits to prepare radiopharmaceuticals; preparing reagent kits; aliquoting 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.

(4) "Department" means the Department of Natural Resources.

(5) "Internal test assessment" means, but is not limited to, conducting those tests of quality assurance necessary to ensure the integrity of the test.

(6) "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.

(7) "Nuclear pharmacy" means a pharmacy providing radiopharmaceutical service.

(8) "Radiopharmaceutical" means radioactive drugs and chemical products used for diagnostic and therapeutic purposes and includes the terms radioactive pharmaceuticals, radioisotopes, and radioactive tracers.

(9) "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.

(10) "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.