Code of Massachusetts Regulations
247 CMR - BOARD OF REGISTRATION IN PHARMACY
Title 247 CMR 13.00 - Registration Requirements And Minimal Professional Standards For Nuclear Pharmacies
Section 13.02 - Definitions
Authentication of product history means the identification of the purchasing source, or of any intermediate handler, or of the ultimate fate of any radio pharmaceutical or component thereof.
Authorized practitioner means a practitioner who is legally authorized to receive and administer radio pharmaceutical drugs.
Compounding of radio pharmaceuticals means the addition of a radioactive substance, or the use of a radioactive substance in preparation of a single-dose or multiple-dose medication, pursuant to the prescription of an authorized practitioner for a patient who is being treated by the that practitioner. Such compounding of radio pharmaceuticals includes, but is not limited to, loading and eluting of radionuclide generators, using manufactured reagent kits to prepare radio-pharmaceuticals, preparing reagent kits, aliquoting reagents, and formulating and conducting quality assurance tests of radiochemicals which are to be used as radio pharmaceuticals.
Internal test assessment means such testing or quality assurance which is necessary to insure the integrity of a particular test.
Nuclear pharmacy means a facility under the direction or supervision of a registered pharmacist which is registered by the Board to dispense radio pharmaceutical drugs pursuant to M.G.L. c. 112, § 39 and 247 CMR 13.00.
NRC means the Nuclear Regulatory Commission.
Qualified nuclear pharmacist means, for the purposes of 247 CMR 13.00, a pharmacist who is registered as a pharmacist by the Board pursuant to the provisions of M.G.L. c. 112, § 24, who is employed in a nuclear pharmacy, and who has submitted evidence satisfactory to the Board that he or she meets the requirements of 247 CMR 13.00 in regard to education, training and experience, and who has received from the Board an official letter stating that, on the basis of the evidence submitted, he or she has been found qualified to deal with radio pharmaceutical drugs and to handle radiopharmaceutical services.
Radioactive biological product means a biological product which is labeled with a radionuclide or intended to be labeled solely with a radionuclide.
Radiolabeling means the process of adding a radioisotope to a suitable nonradioactive substance.
Radiopharmaceutical means a radioactive drug or other radioactive pharmaceutical products.
Radiopharmaceutical drug means any substance defined as a drug in section 201(g)(1) of 21 USCA § 321 et seq. (Federal Food, Drug and Cosmetic Act) which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons, and 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.
Radiopharmaceutical quality assurance means the performance of appropriate chemical, biological and physicaltests on potential radio pharmaceuticals, and the interpretation of the resulting data to determine the suitability of the radiopharmaceutical for use in humans or animals. The term includes internal test assessment, authentication of product history, and the maintenance of proper records.
Radiopharmaceutical service means the counting, dispensing, labeling, and delivery of radiopharmaceuticals; participating in radiopharmaceutical selection and radiopharmaceutical utilization reviews; properly and safely storing and distributing radiopharmaceuticals; maintaining radiopharmaceutical quality assurance; advising on therapeutic values, hazards, and use of radiopharmaceuticals; and offering or performing those acts, services, operations or transactions necessary in the conduct, operation, management and control of radio-pharmaceutical services within a nuclear pharmacy.
