1. (a) Except as provided in He‑P 4035.71, the licensee shall require the authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries), to be a physician who:

   1. (1) Is certified by a medical specialty board whose certification process includes all the requirements in He-P 4035.66(b)(1), (b)(2), and whose certification process has been recognized by DHHS/RHS, an agreement state, or the NRC. The names of board certifications that have been recognized by DHHS/RHS, an agreement state, or the NRC which has the name of the board certifications as currently listed on the NRC’s Medical Uses Licensee Toolkit web page; or
   2. (2) Is an authorized user under He-P 4035.65 for uses listed in He-P 4035.65(b)(2)b.1., He-P 4035.65(b)(2)b.2., He-P 4035.66(c) or (d), equivalent requirements of an agreement state, or the NRC;

2. (b) Except as provided in He-P 4035.71, a physician who does not meet the requirement of He-P 4035.66(a) above shall have successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The classroom and laboratory training shall include the following:

   1. (1) Courses on:

      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, He-P 4035.66(a) through (d), He-P 4035.65(b)(2)b.1. or (b)(2)b.2, He-P 4035.71, or the equivalent requirements of an agreement state, or the NRC. The clinical work experience shall 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 patients or human research subject dosages;
      4. d. Using administrative controls to prevent a medical event involving the use of byproduct material;
      5. e. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
      6. f. Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

   3. (3) Have obtained a written attestation from either a preceptor authorized user or a residency program director that the physician has satisfactorily completed the requirements in He-P 4035.66(b)(1) and (b)(2), and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerel (33 millicuries) of sodium iodide I-133 for medical uses authorized under He-P 4035.35. The written attestation shall be obtained from either:

      1. a. A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(a)-(d), He-P 4035.71, or the equivalent requirements of an agreement state, or the NRC; and has experience in administering dosages as specified in He-P 4035.65(b)(2)b.1. or b.2.; or

      2. b. A residency program director:

         1. 1. Whose residency training program has been 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 shall include and experience specified in He-P 4035.66(b)(1) and (2); and
         2. 2. 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, He-P 4035.66(a)- (d), He-P 4035.71, or the equivalent requirements of an agreement state, or the NRC, has experience in administering dosages as specified in He-P 4035.65(b)(2)b.1., or b.2., and concurs with the attestation provided by the residency program director.

3. (c) Except as provided in He‑P 4035.71, the licensee shall require the authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries), to be a physician who:

   1. (1) Is certified by a medical specialty board, as posted on the NRC’s Medical Uses Licensee Toolkit, whose certification process includes all of the requirements in He-P 4035.66(d)(1) and (2), and whose certification has been recognized by DHHS/RHS, or an agreement state, or the NRC; or
   2. (2) Is an authorized user under He-P 4035.65 for uses listed in He-P 4035.65(b)(2)b.2., or the equivalent requirements of an agreement state, or the NRC.

4. (d) Except as provided in He‑P 4035.71, the licensee shall require the authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries), to be a physician who:

   1. (1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive, Including the following:

      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;

   2. (2) Has clinical work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.65(b) and (c), He-P 4035.65(b)(2)b.2., He-P 4035.66(c) and (d), He-P 4035.71, or the equivalent requirements of an agreement state, or the NRC, with work experience including:

      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 byproduct material;
      5. e. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
      6. f. Administering dosages to patients or human research subjects, that include at least 3 cases involving the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

   3. (3) Has obtained written attestation from either a preceptor authorized user or a residency program director that the individual has satisfactorily completed the requirements in He-P 4035.66(d)(1) and (d)(2), and is able to independently fulfill the radiation safety-related duties as an authorized user for medical uses authorized under He-P 4035.35. The attestation shall be obtained from either:

      1. a. A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(d), and (e), He-P 4035.71, the equivalent requirements of an agreement state, or the NRC, and has experience in administering dosages as specified in He-P 4035.65(b)(2)b.2.; or

      2. b. A residency program director:

         1. 1. Whose residency training program 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 all experience specified in He-P 4035.66(d)(1) and (2);
         2. 2. 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, He-P 4035.66(c) and (d), He-P 4035.71, or the equivalent requirements of an agreement state, or the NRC;
         3. 3. Has experience in administering dosages as specified in He-P 4035.65(b)(2)b.2.; and
         4. 4. Concurs with the attestation provided by the residency program director.

5. (e) Except as provided in He-P 4035.71, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who:

   1. (1) Is an authorized user under He-P 4035.65 for uses listed in He-P 4035.65(b)(2)b.3. the equivalent requirements of an agreement state, or the NRC; or
   2. (2) Is an authorized user under He-P 4035.59 or He-P 4035.69, or the equivalent requirements of an agreement state, or NRC and meets the requirements in He-P 4035.66(e)(4) through (e)(6).

6. (f) Except as provided in He-P 4035.71, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who:

   1. (1) Is certified by a medical specialty board whose certification process has been recognized by DHHS/RHS, under He-P 4035.59 or He-P 4035.69, or the equivalent requirements of an agreement state or the NRC, and who meets the requirements in He-P 4035.66(e)(4) through (e)(6);

   2. (2) Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations listed in He-P 4035.65(b)(2)b.3. including:

      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;

   3. (3) Has clinical work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(e), He-P 4035.71, to include experience in administering dosages in the same category or categories, or the equivalent requirements of an agreement state, or the NRC, in the parenteral administration listed in He-P 4035.65(b)(2)b.3. The work experience shall 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; and
      6. f. Administering dosages to patients or human research subjects that include a minimum of 3 cases involving the parenteral administration as specified in He-P 4035.65(b)(2)b.3.; and

   4. (4) Has obtained written attestation from either a preceptor authorized user or a residency program director that the individual has satisfactorily completed the requirements in He-P 4035.66(e)(4) and (e)(5) and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The written attestation shall be obtained from either:

      1. a. A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(e), He-P 4035.71, the equivalent requirements of an agreement state, or the NRC. A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(e), the equivalent requirements of an agreement state, or the NRC shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or
      2. b. A residency program director, whose residency training program has been 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 4035.66(e)(4) and (5), 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, He-P 4035.66(e), He-P 4035.71, the equivalent requirements of an agreement state, or the NRC, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and 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; amd by #12054, eff 11-19-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22, ss by #13817-A, eff 12-5-23