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 Section 335.1110(a) of this Part, 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, Agreement State or Licensing State requirements; or

b)         Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in Section 335.9040, or Sections 335.9050 and 335.9040(c)(1)(B)(vii)of this Part, or an individual under the supervision of either, as specified in Section 335.1050 of this Part; or

c)         Obtained from and prepared by an Agency, U.S. Nuclear Regulatory Commission, Agreement State or Licensing 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.

(Source:  Amended at 32 Ill. Reg. 9247, effective June 13, 2008)