Section 144-220-G-D-200 - Use of unsealed radioactive material for imaging and localization studies for which a written directive is not requiredExcept for quantities that require a written directive under G.40, a licensee may use for any unsealed radioactive material prepared for medical use for imaging and localization studies that is:
A. Obtained from a manufacturer or preparer licensed pursuant to Part C or equivalent Nuclear Regulatory Commission or Agreement State requirements, or a PET radioactive drug producer licensed under Part C of this rule or equivalent provisions of the NRC, Agreement State, or B. 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 and G.290.C(1)(b)(vii); or(3) An individual under the supervision, as specified in G.27, of the authorized nuclear pharmacist in G.200.B(1) or the physician who is an authorized user in G.200.B(2);C. Obtained from and prepared by an Agency, Nuclear Regulatory Commission, or 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-D-200