Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
Unless 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.
O.C.G.A. §§
									26-4-27,  26-4-28,  26-4-110,  26-4-130,  26-4-171, 26-5-178.