Section 144-220-G-D-100 - Use of unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive Is not requiredExcept for quantities that require a written directive under G.40, a licensee may use any unsealed radioactive material, prepared for medical use for uptake, dilution, or excretion 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 from a PET radioactive drug producer licensed under Part C of this rule or equivalent provisions of the NRC Agreement State,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(2) An individual under the supervision, as specified in Part G.27, of the authorized nuclear pharmacist in G.100.B(1) or the physician who is an authorized user in G.100.B(2); andC. 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-D-100