Authority and Purpose

247 CMR 13.00 is promulgated under the authority granted the Board byM.G.L. c. 112, § 39B to register an establishment for transacting business as a nuclear pharmacy as defined in M.G.L. c. 94C. Thepurposeof247 CMR 13.00 is to establish minimum professional standards for the operation of a nuclear pharmacy in order to safeguard the public health and welfare. 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 radiopharmaceutical or component thereof. Authorized practitioner means a practitioner who is legally authorized to receive and administer radiopharmaceutical drugs. Compoundingofradiopharmaceuticals 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 practitionerfora patientwho is being treated by the that practitioner. Such compounding of radiopharmaceuticals 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 andconductingquality assurance tests of radiochemicals which are to be used as radiopharmaceuticals. 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 radiopharmaceutical 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, onthe basis of the evidence submitted, he or she has been found qualified to deal with radiopharmaceutical 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. Radiopharmaceuticalqualityassurance means the performance of appropriate chemical, biological and physicaltests onpotentialradiopharmaceuticals, and the interpretation of the resulting data todetermine the suitability of the radiopharmaceutical for use in humans or animals. The termincludes 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 controlofradio-pharmaceutical services within a nuclear pharmacy.