Section 120.544 - Use of Unsealed Radioactive Material for Uptake, Dilution, or Excretion Studies for Which a Written Directive Is Not RequiredA licensee may use any unsealed radioactive material, in quantities that do not require a written directive, for a diagnostic use involving measurements of uptake, dilution, or excretion:
(A)(1) Obtained from a manufacturer or preparer licensed pursuant to 105 CMR 120 128(J) or equivalent regulations of another Agreement State, or the Nuclear Regulatory Commission; or(2) A PET radioactive drug producer licensed under 105 CMR 120.100 or equivalent regulations of the Nuclear Regulatory Commission or equivalent Agreement State requirements; or(B) Excluding production PET radionuclides, prepared by:(1) an authorized nuclear pharmacist;(2) A physician who is an authorized user and who meets the requirements specified in 105 CMR 120.551, or 120.556 and 120.551(C)(1)(b)7.; or(3) An individual under the supervision, as specified in 105 CMR 120.519, of the authorized nuclear pharmacist in 105 CMR 120.544(B)(1) or the physician who is an authorized user in 105 CMR 120.544(B)(2); or(C) Obtained from and prepared by an Agency, Nuclear Regulatory Commission, Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or(D) Prepared by the licensee in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA for use in research.Amended by Mass Register Issue 1480, eff. 10/14/2022.