Section 144-220-G-E-300 - Use of unsealed radioactive material for which a written directive is requiredA licensee may use any unsealed radioactive material identified in G.390.B(1)(b)(vii) prepared for medical use and for which a written directive is required that is:
A. Obtained from a manufacturer or preparer licensed pursuant to Part C or equivalent Nuclear Regulatory Commission or Agreement State requirements; or from a PET radioactive drug producer licensed under Part C of this rule or equivalent provisions of the NRC, Agreement State, orB. Excluding production of PET radionuclides prepared by;(1) An authorized nuclear pharmacist;(2) A physician who is an authorized user and who meets the requirements specified in G.290 or G.390; or(3) An individual under the supervision, as specified in Part G.27, of the authorized nuclear pharmacist in G.300.B(1); or the physician who is an authorized user in G.300.B(2); orC. Obtained from and prepared by 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 Food and Drug Administration; orD. Prepared by the licensee for use in research in accordance with a approved application or an (IND) protocol accepted by the Food and Drug Administration.10-144 C.M.R. ch. 220, § G-E-300