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 of this Part, or equivalent U.S. Nuclear Regulatory Commission, Agreement State or Licensing State requirements;

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 335.9050 of this Part, or an individual under the supervision of either as specified in Section 335.1050 of this Part;

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 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 30 Ill. Reg. 9029, effective April 28, 2006)