§ 35.930 - Training for therapeutic use of unsealed byproduct material.

Except as provided in § 35.57, the licensee shall require the authorized user of radiopharmaceuticals in § 35.300 to be a physician who—

(a) Is certified by—

(1) The American Board of Nuclear Medicine;

(2) The American Board of Radiology in radiology, therapeutic radiology, or radiation oncology;

(3) The Royal College of Physicians and Surgeons of Canada in nuclear medicine; or

(4) The American Osteopathic Board of Radiology after 1984; or

(b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as follows—

(1) 80 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; and

(iv) Radiation biology; and

(2) Supervised clinical experience under the supervision of an authorized user at a medical institution that includes—

(i) Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and

(ii) Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals.