180 NAC 7-048
180 NAC 7-048. USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED. A 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:
Cite as Neb. Admin. Code tit. 180, ch. 7, § 048
048. USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED. A 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.