Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 180 - CONTROL OF RADIATION
Chapter 7 - MEDICAL USE OF RADIOACTIVE MATERIAL
Section 180-7-041 - USE OF UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, AND EXCRETION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED

Universal Citation: 180 NE Admin Rules and Regs ch 7 ยง 041

Current through September 17, 2024

A licensee may use any unsealed radioactive material, in quantities that do not require a written directive, prepared for medical use involving measurements of uptake, dilution, or excretion that is:

(A) RING RADIOACTIVE MATERIA Obtained from:

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

(ii) A PET radioactive drug producer licensed under 180 NAC 3-010.11 or equivalent NRC or Agreement State requirements; 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 180 NAC 7-041(B(i) or the physician who is authorized user in 180 NAC 7-041(Bii).

(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.

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

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