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Title 10: Energy
CHAPTER I: NUCLEAR REGULATORY COMMISSION
PART 35: MEDICAL USE OF BYPRODUCT MATERIAL
Subpart J: Training and Experience Requirements
35.910 - Training for uptake, dilution, and excretion studies.
Except as provided in ? 35.57, the licensee shall require the authorized user of a radiopharmaceutical in ? 35.100(a) to be a physician who?
(a) Is certified in?
(1) Nuclear medicine by the American Board of Nuclear Medicine;
(2) Diagnostic radiology by the American Board of Radiology;
(3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology;
(4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
(5) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or
(b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, and supervised clinical experience as follows?
(1) 40 hours of classroom and laboratory training that includes?
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity;
(iv) Radiation biology; and
(v) Radiopharmaceutical chemistry; and
(2) 20 hours of supervised clinical experience under the supervision of an authorized user and that includes?
(i) Examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications;
(ii) Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;
(iii) Administering dosages to patients or human research subjects and using syringe radiation shields;
(iv) Collaborating with the authorized user in the interpretation of radioisotope test results; and
(v) Patient or human research subject follow up; or
(c) Has successfully completed a 6-month training program in nuclear medicine as part of a training program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section.
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