| (D) pass an examination in nuclear pharmacy administered
by diplomates of the specialty board, that assesses knowledge and
competency in procurement, compounding, quality assurance, dispensing,
distribution, health and safety, radiation safety, provision of information
and consultation, monitoring patient outcomes, research and development;
or
(2) has completed a 700 hour structured educational
program including both:
(A) 200 hours of classroom and laboratory training
in the following areas:
(i) radiation physics and instrumentation;
(ii) radiation protection;
(iii) mathematics pertaining to the use and measurement
of radioactivity;
(iv) chemistry of radioactive material for medical
use; and
(v) radiation biology; and
(B) supervised practical experience in a nuclear pharmacy
involving the following:
(i) shipping, receiving, and performing related radiation
surveys;
(ii) using and performing checks for proper operation
of instruments used to determine the activity of dosages, survey meters,
and, if appropriate, instruments used to measure alpha- or beta-emitting
radionuclides;
(iii) calculating, assaying, and safely preparing dosages
for patients or human research subjects;
(iv) using administrative controls to avoid medical
events in the administration of radioactive material; and
(v) using procedures to prevent or minimize radioactive
contamination and using proper decontamination procedures; and
(C) has obtained written attestation, signed by a preceptor
authorized nuclear pharmacist, that the individual has satisfactorily
completed the requirements in paragraph (1)(A), (B) and (C) or (2)(A)
and (B) of this subsection or this paragraph and has achieved a level
of competency sufficient to function independently as an authorized
nuclear pharmacist.
(l) Training for experienced RSO, teletherapy or medical
physicist, authorized medical physicist, authorized user, nuclear
pharmacist, and authorized nuclear pharmacist.
(1) An individual identified as an RSO, a teletherapy
or medical physicist, or a nuclear pharmacist on one of the following
before October 24, 2002, need not comply with the training requirements
of subsections (h), (j), or (k) of this section, respectively:
(A) an agency, NRC, or agreement state license;
(B) a permit issued by an agency, NRC, or agreement
state licensee with broad scope authorization;
(C) an NRC master material license permit; or
(D) an NRC master material license permit with broad
scope authorization.
(2) An individual identified as an RSO, an authorized
medical physicist, or an authorized nuclear pharmacist on one of the
following between October 24, 2002, and April 29, 2005, need not comply
with the training requirements of subsections (h), (j) and (k) of
this section, respectively:
(A) an agency, NRC, or agreement state license;
(B) a permit issued by the agency, the NRC, or an agreement
state with broad scope authorization;
(C) an NRC master material license permit; or
(D) an NRC master material license permit with broad
scope authorization.
(3) An individual identified as a physician, dentist,
podiatrist or veterinarian authorized for the medical or veterinary
use of radioactive material and who performs only those medical or
veterinary uses for which they were authorized on one of the following
before the effective date of this rule need not comply with the training
requirements of subsections (gg) - (ttt) of this section:
(A) an agency, NRC, or agreement state license;
(B) a permit issued by the agency, the NRC, or an agreement
state licensee with broad scope authorization;
(C) an NRC master material license permit; or
(D) an NRC master material license permit with broad
scope authorization.
(4) Individuals who need not comply with training requirements
in this subsection may serve as preceptors for, and supervisors of,
applicants seeking authorization on an agency license for the same
uses for which these individuals are authorized.
(m) Recentness of training. The training and experience
specified in subsections (h), (j) - (m), and (gg) - (ttt) of this
section for medical and veterinary use shall have been obtained within
the seven years preceding the date of application or the individual
shall have had related continuing education and experience since the
required training and experience was completed.
(n) Licenses for medical and veterinarian uses of radioactive
material without broad scope authorization. In addition to the requirements
of subsection (f) of this section, a license for medical and veterinarian
use of radioactive material as described in the applicable subsections
(ff), (hh), (kk), (rr), (bbb) and (ddd) of this section will be issued
if the agency approves the following documentation submitted by the
applicant:
(1) that the physician(s) or veterinarian(s) designated
on the application as the authorized user(s) is qualified in accordance
with subsections (gg), (jj), (nn) - (qq), (zz), (aaa), (ccc) and (ttt)
of this section, as applicable;
(2) that the radiation detection and measuring instrumentation
is appropriate for performing surveys and procedures for the uses
involved;
(3) that the radiation safety operating procedures
are adequate for the handling and disposal of the radioactive material
involved in the uses; and
(4) that an RSC has been established in accordance
with subsection (i)(2) of this section, if applicable.
(o) License for medical and veterinary uses of radioactive
material with broad scope authorization. In addition to the requirements
of subsection (f) of this section, a license for medical use of radioactive
material with broad scope authorization will be issued if the agency
approves the following documentation submitted by the applicant:
(1) that the review of authorized user qualifications
by the RSC is in accordance with subsections (gg), (jj), (nn) - (qq),
(zz), (aaa), (ccc) and (ttt) of this section, as applicable;
(2) that the application is for a license authorizing
unspecified forms and/or multiple types of radioactive material for
medical research, diagnosis, and therapy;
(3) that the radiation detection and measuring instrumentation
is appropriate for performing surveys and procedures for the uses
involved;
(4) that the radiation safety operating procedures
are adequate for the handling and disposal of the radioactive material
involved in the uses;
(5) that staff has substantial experience in the use
of a variety of radioactive material for a variety of human and animal
uses;
(6) that the full-time RSO meets the requirements of
subsection (h) of this section; and
(7) that an RSC has been established in accordance
with subsection (i)(1) of this section.
(p) License for the use of remote control brachytherapy
units, teletherapy units, or gamma stereotactic radiosurgery units.
In addition to the requirements of subsection (f) of this section,
a license for the use of remote control brachytherapy (RCB) units,
teletherapy units, or gamma stereotactic radiosurgery units will be
issued if the agency approves the following documentation submitted
by the applicant:
(1) that the physician(s) designated on the application
as the authorized user(s) is qualified in accordance with subsection
(ttt) of this section;
(2) that the radiation detection and measuring instrumentation
is appropriate for performing surveys and procedures for the uses
involved;
(3) that the radiation safety operating procedures
are adequate for the handling and disposal of the radioactive material
involved in the uses;
(4) of the radioactive isotopes to be possessed;
(5) of the sealed source manufacturer(s) name(s) and
the model number(s) of the sealed source(s) to be installed;
(6) of the maximum number of sealed sources of each
isotope to be possessed, including the activity of each sealed source;
(7) of the manufacturer and model name and/or number
of the following units, as applicable:
(A) RCB unit;
(B) teletherapy unit; or
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