§35.200. Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required. — Inbound Citations

(b) An application for a license for medical use of byproduct material as described in §§ 35.100, 35.200, 35.300, 35.400, 35.500, 35.600, and 35.1000 must be made by—

(1) Filing an original NRC Form 313, “Application for Material License,” that includes the facility diagram, equipment, and training and experience qualifications of the Radiation Safety Officer, Associate Radiation Safety Officer(s), authorized user(s), authorized medical physicist(s), ophthalmic physicist(s), and authorized nuclear pharmacist(s); and

(2) Submitting procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable.

(e) Before it receives byproduct material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;

(5) The licensee has added to or changed the areas of use identified in the application or on the license where byproduct material is used in accordance with either § 35.100 or § 35.200 if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area; or

(2) Is currently identified as an Associate Radiation Safety Officer for the types of use of byproduct material for which the individual has been assigned duties and tasks by the Radiation Safety Officer on—

(i) A specific medical use license issued by the Commission or an Agreement State; or

(ii) Authorized medical physicist means an individual who—

Except as provided in § 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.200 to be a physician who—

(b) The regulations in 10 CFR part 35 that are not issued under subsections 161b, 161i, or 161o for the purposes of Section 223 are as follows: §§ 35.1, 35.2, 35.7, 35.8, 35.12, 35.15, 35.18, 35.19, 35.65, 35.100, 35.200, 35.300, 35.4001, and 35.4002.

(i) For uses authorized under § 35.100 or § 35.200, or oral administration of sodium iodide I-131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology by the American Board of Radiology; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or American Osteopathic Board of Nuclear Medicine in nuclear medicine;

(b) Is an authorized user for uses listed in § 35.200 or equivalent Agreement State requirements; or