Section 180-7-041 - USE OF UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, AND EXCRETION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIREDA 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.180 Neb. Admin. Code, ch. 7, § 041
Amended effective 11/3/2020Amended effective 6/14/2023