Section 144-220-G-C-63 - Determination of dosages of unsealed radioactive material for medical useA. A licensee shall determine and record the activity of each dosage within 30 minutes before medical use.B. For a unit dosage, this determination must be made by:(1) Direct measurement of radioactivity; or(2) A decay correction, based on the activity or activity concentration determined by: (a) A manufacturer or preparer licensed under Part C or equivalent Nuclear Regulatory Commission, or Agreement State requirements;(b) An Agency, Nuclear Regulatory Commission, or an Agreement State licensee for use in research in accordance with a approved protocol or an (IND) protocol accepted by the FDA; or(c) A PET radioactive drug producer licensed under Part C of this rule or equivalent provisions of the NRC, or an Agreement State.C. For other than unit dosages, this determination must be made by -(1) Direct measurement of radioactivity;(2) Combination of measurement of radioactivity and mathematical calculations; or(3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by a manufacturer or preparer licensed under Part C or equivalent Nuclear Regulatory Commission, or Agreement State requirements, or a PET radioactive drug producer licensed under Part C or equivalent provisions of the NRC or an Agreement State.D. Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.E. A licensee shall retain a record of the dosage determination required by this section in accordance with G.2063.10-144 C.M.R. ch. 220, § G-C-63