Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 180 - CONTROL OF RADIATION
Chapter 7 - MEDICAL USE OF RADIOACTIVE MATERIAL
Section 180-7-044 - USE OF UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED

Universal Citation: 180 NE Admin Rules and Regs ch 7 ยง 044

Current through September 17, 2024

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 180 NAC 7-019 that is:

(A) Obtained from:

(i) A manufacturer or preparer licensed according to 180 NAC 3-014.10 or equivalent NRC or Agreement State; or

(ii) A PET radioactive drug producer licensed according to 180 NAC 3-010.11 or equivalent NRC or Agreement State; or

(B) Excluding production of PET radionuclides, prepared by:

(i) An authorized nuclear pharmacist;

(ii) A physician who is an authorized user and who meets the requirements specified in 180 NAC 7-047, or 7-051 and 7-047.03(A)(ii)(7); or

(iii) An individual under the supervision, as specified in 180 NAC 7-018, of the authorized nuclear pharmacist in paragraph 180 NAC 7-044(B)(i) or the physician who is an authorized user in paragraph 180 NAC 7-044(B)(ii); or

(C) Obtained from and prepared by an NRC or Agreement State licensee for use in research according to a Radioactive Drug Research Committee approved protocol or an Investigational New Drug (IND) protocol accepted by the FDA; or

(D) Prepared by the licensee for use in research according to a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by the FDA.

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