Use of Unsealed Byproduct Material for Imaging and Localization Studies for Which a Written

Directive Is Not Required A licensee may use, for imaging and localization studies, any radioactive material prepared for medical use, in quantities that do not require a written directive as described in 105 CMR 120.521 that is: (A) Obtained from: (1) A manufacturer or preparer licensed pursuant to 105 CMR 120.128(J) or equivalent regulations of another Agreement State, or the Nuclear Regulatory Commission; (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 120.547(B)(1) or the physician who is an authorized user in 105 CMR 120.547(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. (E) Provided the conditions of 105 CMR 120.542 are met, a licensee may use radioactive aerosols or gases if specific application is made to and approved by the Agency.