Except as provided in He-P 4035.71, the licensee shall require the authorized user of unsealed byproduct material listed in He-P 4035.35 to be a physician who:

1. (a) Is certified by a medical specialty board, as posted in the NRC’s Medical Uses Licensee Toolkit, whose certification process has been recognized by DHHS/RHS, an agreement state, or the NRC, and who meets the requirements in He-P 4035.65(b)(2)b. and He-P 4035.65(c). The medical specialty board shall require all candidates for certification to:

   1. (1) Successfully complete residency training, as 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 Council on Postdoctoral Training of the American Osteopathic Association, in a radiation therapy, nuclear medicine training program, or a related medical specialty. The residency training shall include 700 hours of training and experience as described in He-P 4035.65(b)(1) through He-P 4035.65(b)(2)a.5.; and
   2. (2) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality assurance and clinical use of unsealed byproduct material for which a written directive is required; or

2. (b) Has the following credentials:

   1. (1) Completion of 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 classroom and laboratory training shall include:

      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. (2) Clinical work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.65 or He-P 4035.71, including experience in administering dosages in the same dosage category or categories, as in He-P 4035.65(b)(2)b., or the equivalent requirements of an agreement state, or the NRC. The work experience shall involve and include:

      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; and

      6. f. Administering dosages involving minimally 3 cases in the same dosage category or categories of radioactive drugs to patients or human subjects from the 3 categories listed below in f.1., f.2., and f.3. Radioactive drugs containing radionuclides in categories not included in this paragraph shall be regulated under He-P 4035.29. The 3 categories listed are as follows:

         1. 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. 2. Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131. Experience with at least 3 cases in Category b.2. also satisfies the requirement in Category b.1.; and
         3. 3. Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or a photon energy less than 150 keV, for which a written directive is required; and

3. (c) Has obtained a written attestation from a preceptor authorized user or from a residency program director that the individual has satisfactorily completed the requirements in He-P 4035.65(b)(1) and (b)(2) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under He-P 4035.35 for which the individual is requesting authorized user status. The written attestation shall be obtained from either:

   1. (1) A preceptor authorized user who meets the requirements in He-P 4035.65 or He-P 4035.71, or the equivalent requirements of an agreement state, or the NRC and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or

   2. (2) A residency program director:

      1. a. Whose residency training program were 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 Council on Postdoctoral Training of the American Osteopathic Association and included training and experience specified in He-P 4035.65(b)(1) and (b)(2).;
      2. b. Who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in He-P 4035.65 or He-P 4035.71, or the equivalent requirements of an agreement state, or the NRC;
      3. c. Has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; and
      4. d. Who concurs with the attestation provided by the residency program director.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07 New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22; ss by #13817-A, eff 12-5-23