Section 180-7-048 - USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIREDA licensee may use any unsealed radioactive material identified in 180 NAC 7-051(B)(i)(2)(f) prepared for medical use and for which a written directive is required that is:
(A) Obtained from: (i) A manufacturer or preparer licensed in 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, a physician who is an authorized user and who meets the requirements specified in 180 NAC 7-047 or 7-051;(ii) An individual under the supervision of either as specified in 180 NAC 7-018; or(iii) An individual under the supervision, as specified in 180 NAC 7-018, of the authorized nuclear pharmacist in 7-048(B)(i) or the physician who is authorized in 7-048(B)(ii); or(C) Obtained from and prepared by the Department, NRC or Agreement State licensee according to a Radioactive Drug Research Committee's approval protocol or an Investigational New Drug protocol accepted by the FDA for use in research; or(D) Prepared by the licensee for use in research according to an approved application or an Investigational New Drug protocol accepted by the FDA for use in research.180 Neb. Admin. Code, ch. 7, § 048
Amended effective 11/3/2020Amended effective 6/14/2023