Use of Unsealed Radioactive Material for Imaging and Localization Studies for Which a Written Directive is Not Required

Section 335.4010  Use of Unsealed Radioactive Material for Imaging and Localization Studies for Which a Written Directive is Not Required Except for quantities that require a written directive under subsection 335.1110(a), a licensee may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is: a)         Obtained from a person specified in Section 335.30 of this Part, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or b)         Excluding production of PET radionuclides, prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in Section 335.9040 or a combination of Section 335.9050 and subsection 335.9040(c)(1)(B)(vii) or an individual under the supervision of either as specified in Section 335.1050; or c)         Obtained from and prepared by an Agency, U.S. Nuclear Regulatory Commission or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an application or protocol accepted by the FDA; or d)         Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an application or a protocol accepted by the FDA.