Section Ph 405.02 - Definitions(a) "Authentication of product history" means identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical or other drug.(b) "Nuclear pharmacy" means a pharmacy which provides radiopharmaceutical services.(c) "Practice of nuclear pharmacy" means a patient-oriented service that embodies the scientific knowledge and professional judgment required to improve and promote health through the assurance of the safe and efficacious use of radiopharmaceuticals and other drugs.(d) "Quality assurance procedures" means all activities necessary to guarantee the integrity of the process used to provide radiopharmaceutical services, including authentication of product history and maintenance of all records as required by the department of health and human services, bureau of radiological health.(e) "Quality control testing" means the performance of chemical, biological and physical tests on compounded radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals.(f) "Radiopharmaceutical" means any drug which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. The term includes any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term also includes any biological product which is labeled with a radionuclide or intended solely to be labeled with a radionuclide.(g) "Radiopharmaceutical service" means the procurement, storage, handling, compounding, preparation, labeling, quality control testing, dispensing, distribution, transfer, record keeping and disposal of radiochemicals, radiopharmaceuticals and ancillary drugs.N.H. Admin. Code § Ph 405.02
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05
Amended by Volume XXXV Number 18, Filed May 7, 2015 , Proposed by #10812, Effective 4/18/2015, Expires 4/18/2025.