Florida Regulations 64B16-28.900: Definitions – Nuclear Pharmacy
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(1) A “”nuclear pharmacy”” is a pharmacy which provides radiopharmaceutical services.
(2) A “”nuclear pharmacist”” is a pharmacist who has met the training qualifications as described in Fl. Admin. Code R. 64B16-26.303, and has been licensed by the Board of Pharmacy.
(3) A “”radiopharmaceutical service”” shall include, but shall not be limited to, the procurement, storage, preparation, labeling, quality assurance testing, distribution, record keeping and disposal of radiopharmaceuticals.
(4) A “”radiopharmaceutical”” is any substance defined as a drug by 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 salts which contain trace quantities of naturally occurring radionuclides.
(5) “”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.
(6) “”Authentication of product history”” includes, but is not limited to, identifying the purchasing source, the ultimate fate, and intermediate handling of any component of a radiopharmaceutical or other drug.
Rulemaking Authority 465.005 FS. Law Implemented 465.003(14), 465.022(1)(e) FS. History-New 1-7-76, Formerly 21S-3.01, Amended 4-4-88, Formerly 21S-3.001, Amended 7-31-91, 4-15-92, 10-1-92, Formerly 21S-28.900, 61F10-28.900, 59X-28.900, Amended 4-5-05.
(3) A “”radiopharmaceutical service”” shall include, but shall not be limited to, the procurement, storage, preparation, labeling, quality assurance testing, distribution, record keeping and disposal of radiopharmaceuticals.
(4) A “”radiopharmaceutical”” is any substance defined as a drug by 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 salts which contain trace quantities of naturally occurring radionuclides.
(5) “”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.
(6) “”Authentication of product history”” includes, but is not limited to, identifying the purchasing source, the ultimate fate, and intermediate handling of any component of a radiopharmaceutical or other drug.
Rulemaking Authority 465.005 FS. Law Implemented 465.003(14), 465.022(1)(e) FS. History-New 1-7-76, Formerly 21S-3.01, Amended 4-4-88, Formerly 21S-3.001, Amended 7-31-91, 4-15-92, 10-1-92, Formerly 21S-28.900, 61F10-28.900, 59X-28.900, Amended 4-5-05.