Or. Admin. Code § 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.
Notes
Stat. Auth.: ORS 689
Stats. Implemented:
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.