Section 335.5010  Use of Unsealed Radioactive Material for Which a Written Directive is Required

A licensee may use any unsealed radioactive material prepared for medical use and for which a written directive is required that is:

a)         Obtained from a person specified in Section 335.30 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements;

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 protocol accepted by FDA; or

d)         Prepared by the licensee for use in research in accordance with an application or a protocol accepted by FDA.

(Source:  Amended at 35 Ill. Reg. 884, effective December 30, 2010)