UNSEALED RADIOACTIVE MATERIAL; UPTAKE, DILUTION, AND EXCRETION STUDIES; WRITTEN DIRECTIVE NOT REQUIRED

Except for quantities that require a written directive under part 4731.4408 or 4731.4409 , a licensee may use any unsealed radioactive material prepared for medical use for uptake, dilution, or excretion studies 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: (1) an authorized nuclear pharmacist; (2) a physician who is an authorized user and who meets the requirements of part 4731.4436 or parts 4731.4436 , subpart 1, item C, subitem (1), unit (b), subunit vii, and 4731.4443 ; or (3) an individual under the supervision, according to part 4731.4407 , of the authorized nuclear pharmacist in subitem (1) or the physician who is an authorized user in subitem (2); C. obtained from and prepared for a commissioner, NRC, or agreement state licensee for use in research according to a radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by the Food and Drug Administration; or D. prepared by the licensee for use in research according to a radioactive drug research committee-approved application or an investigational new drug protocol accepted by the Food and Drug Administration.