UNSEALED RADIOACTIVE MATERIAL; WRITTEN DIRECTIVE REQUIRED

A 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; or D. prepared by the licensee for use in research according to an investigational new drug protocol accepted by the Food and Drug Administration.