OAR 855-042-0010: Definitions

(1) A “Nuclear Pharmacy” is a pharmacy providing radiopharmaceutical services. (2) “Nuclear Pharmacist” means a licensed pharmacist who has met the requirements of these rules regarding training, education, and experience, and has received a letter of notification from the board indicating the board recognizes the pharmacist, based on evidence submitted, as qualified to provide radiopharmaceutical services. (3) “Radiopharmaceutical Services” shall mean, but shall not be limited to, the compounding, dispensing, labeling and delivery or radiopharmaceuticals; the participation in radiopharmaceutical selection and radiopharmaceutical utilization reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance of radiopharmaceutical quality assurance; 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. (4) A “Radiopharmaceutical” is any substance defined as a drug in Section 201(g)(1) of the federal Food, Drug and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any such drug which is intended to be made radioactive. This definition includes nonradioactive reagent kits and nuclide generators which are intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. (5) “Radiopharmaceutical Quality Assurance” means, but is not limited to, the performance of appropriate chemical, biological and physical tests on radiopharmaceuticals 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. (6) “Internal Test Assessment” means, but is not limited to, conducting those tests of quality assurance necessary to insure the integrity of the test. (7) “Authentication of Product History” means, but is not limited to, identifying the purchasing source, the ultimate fate, and intermediate handling of any component of a radiopharmaceutical. (8) “Authorized Practitioner” means a practitioner duly authorized by law to possess, use, and administer radiopharmaceuticals.