Link to an amendment published at 83 FR 33107, July 16, 2018.

Except as provided in § 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.300 to be a physician who -

1. (a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraphs (b)(1)(ii)(G) and (b)(2) of this section. (Specialty boards whose certification processes have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To be recognized, a specialty board shall require all candidates for certification to:

   1. (1) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include 700 hours of training and experience as described in paragraphs (b)(1)(i) through (b)(1)(ii)(E) of this section. Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Committee on Post-Graduate Training of the American Osteopathic Association; and
   2. (2) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed byproduct material for which a written directive is required; or

2. (b)

   1. (1) Has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material requiring a written directive. The training and experience must include -

      1. (i) Classroom and laboratory training in the following areas -

         1. (A) Radiation physics and instrumentation;
         2. (B) Radiation protection;
         3. (C) Mathematics pertaining to the use and measurement of radioactivity;
         4. (D) Chemistry of byproduct material for medical use; and
         5. (E) Radiation biology; and

      2. (ii) Work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.390, or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in § 35.390(b), must also have experience in administering dosages in the same dosage category or categories (i.e., § 35.390(b)(1)(ii)(G)) as the individual requesting authorized user status. The work experience must involve -

         1. (A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
         2. (B) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;
         3. (C) Calculating, measuring, and safely preparing patient or human research subject dosages;
         4. (D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
         5. (E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;
         6. (F) [Reserved]

         7. (G) Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each of the following categories for which the individual is requesting authorized user status -

            (1) Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131, for which a written directive is required;

            (2) Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 ² ;

            (3) Parenteral administration of any beta emitter, or a photon-emitting radionuclide with a photon energy less than 150 keV, for which a written directive is required; and/or

            (4) Parenteral administration of any other radionuclide, for which a written directive is required; and

   2. (2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (a)(1) and (b)(1)(ii)(G) or (b)(1) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under § 35.300. The written attestation must be signed by a preceptor authorized user who meets the requirements in §§ 35.57, 35.390, or equivalent Agreement State requirements. The preceptor authorized user, who meets the requirements in § 35.390(b) must have experience in administering dosages in the same dosage category or categories (i.e., § 35.390(b)(1)(ii)(G)) as the individual requesting authorized user status.

² Experience with at least 3 cases in Category (G)(2) also satisfies the requirement in Category (G)(1).

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 75389, Dec. 31, 2003; 70 FR 16364, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006; 74 FR 33905, July 14, 2009]