Part 4731.4440 - UNSEALED RADIOACTIVE MATERIAL; WRITTEN DIRECTIVE REQUIREDA licensee may use any unsealed radioactive material identified in part 4731.4443, subpart 1, item B, subitem (1), unit (b), subunit vi, prepared for medical use and for which a written directive is required that is:
A. obtained from a manufacturer or preparer licensed under part 4731.3395 or equivalent requirements of the NRC or an agreement state or a PET radioactive drug producer licensed according to part 4731.3065, subpart 7, or equivalent requirements of the NRC or an agreement state;B. excluding production of PET radionuclides, prepared by an authorized nuclear pharmacist, a physician who is an authorized user and meets the requirements under part 4731.4436 or 4731.4443, or an individual under the supervision of either, as specified under part 4731.4407;C. obtained from and prepared by a commissioner, NRC, or agreement state licensee for use in research according to an investigational new drug protocol accepted by the Food and Drug Administration; orD. prepared by the licensee for use in research according to an investigational new drug protocol accepted by the Food and Drug Administration.Minn. R. agency 144, ch. 4731, MEDICAL USE OF RADIOACTIVE MATERIAL, pt. 4731.4440
Statutory Authority: MS s 144.1202; 144.1203