Title 26, Chapter 4, Section 171
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
(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
(8) "Radiopharmaceutical" means radioactive drugs and chemical
products used for diagnostic and therapeutic purposes and includes
the terms radioactive pharmaceuticals, radioisotopes, and
(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.