Except as provided in Sec. 35.57, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who--
(a) Is an authorized user under Sec. 35.390 for uses listed in Sec. Sec. 35.390(b)(1)(ii)(G)(3) or 35.390(b)(1)(ii)(G)(4), or equivalent Agreement State requirements; or
(b) Is an authorized user under Sec. Sec. 35.490, 35.690, or equivalent Agreement State requirements and who meets the requirements in paragraph (d) of this section; or
(c) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State under Sec. Sec. 35.490 or 35.690, and who meets the requirements in paragraph (d) of this section.
(d)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. The training must include--
(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. The training must include--
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity;
(iv) Chemistry of byproduct material for medical use; and
(v) Radiation biology; and
(2) Has work experience, under the supervision of an authorized user who meets the requirements in Sec. Sec. 35.57, 35.390, 35.396, or equivalent Agreement State requirements, in the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. A supervising authorized user who meets the requirements in Sec. 35.390 must have experience in administering dosages as specified in Sec. Sec. 35.390(b)(1)(ii)(G)(3) and/or 35.390(b)(1)(ii)(G)(4). The work experience must involve--
(i) Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys;
(ii) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;
(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;
(iv) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
(v) Using procedures to contain spilled byproduct material safely, and using proper decontamination procedures; and
(vi) Administering dosages to patients or human research subjects, that include at least 3 cases involving the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV and/or at least 3 cases involving the parenteral administration of any other radionuclide, for which a written directive is required; and
(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (b) or (c) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The written attestation must be signed by a preceptor authorized user who meets the requirements in Sec. Sec. 35.57, 35.390, 35.396, or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirements in Sec. 35.390, must have experience in administering dosages as specified in Sec. Sec. 35.390(b)(1)(ii)(G)(3) and/or 35.390(b)(1)(ii)(G)(4). [70 FR 16365, Mar. 30, 2005, as amended at 71 FR 15010, Mar. 27, 2006; 74 FR 33906, July 14, 2009]