Ga. Comp. R. & Regs. R. 480-25-.01 - Definitions
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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.