New Jersey Administrative Code
Title 13 - LAW AND PUBLIC SAFETY
Chapter 39 - STATE BOARD OF PHARMACY
Subchapter 12 - NUCLEAR PHARMACIES
Section 13:39-12.1 - Definitions
The following words and terms when used in this subchapter shall have the following meanings, unless the context clearly indicates otherwise.
"Authentication of product history" includes, but is not limited to, identifying the purchase source, the ultimate use or disposition and any intermediate handling of any components of a radiopharmaceutical.
"Authorized practitioner" means a practitioner duly authorized by applicable Federal and State law to possess, use and administer radiopharmaceuticals.
"Designated agent" means an individual under the direct supervision of a practitioner authorized to communicate the practitioner's instructions to the nuclear pharmacy.
"Immediate personal supervision" means that the pharmacist is physically present in the compounding/dispensing area when interns, externs and pharmacy technicians are performing delegated duties, and the pharmacist conducts any necessary in-process checks and the final check in preparation and compounding of medications, including the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, and the finished label.
"Internal test assessment" includes, but is not limited to, conducting those tests necessary to insure the integrity of the test.
"Radiopharmaceutical" means any substance defined as a drug in Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act or in the FDA's Nuclear Pharmacy Guidelines and 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 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.
"Radiopharmaceutical quality assurance" includes, 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.
"Radiopharmaceutical service" includes, but is not limited to, the compounding, dispensing, labeling and delivery of radiopharmaceuticals; the participation in radiopharmaceutical utilization reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance of radiopharmaceutical quality assurance; and the offering of those acts, services, operations or transactions necessary in the conduct, operation, management and control of a nuclear pharmacy.
