| (C) an individual under the supervision, as specified
in subsection (s) of this section, of the authorized nuclear pharmacist
in subparagraph (A) of this paragraph, or the physician who is an
authorized user in subparagraph (B) of this paragraph; or
(3) is obtained from and prepared by an NRC or agreement
state licensee for use in research in accordance with a Radioactive
Drug Research Committee-approved protocol or an IND protocol accepted
by the FDA; or
(4) is prepared by the licensee for use in research
in accordance with a Radioactive Drug Research Committee-approved
application or an IND protocol accepted by the FDA.
(ii) Permissible molybdenum-99, strontium-82, and strontium-85
concentrations.
(1) The licensee may not administer to humans a radiopharmaceutical
that contains:
(A) more than 0.15 µCi of molybdenum-99 per mCi
of technetium-99m (0.15 kilobecquerel (kBq) of molybdenum-99 per MBq
of technetium-99m); or
(B) more than 0.02 µCi of strontium-82 per mCi
of rubidium-82 chloride (0.02 kBq of strontium-82 per MBq of rubidium-82
chloride) injection; or
(C) more than 0.2 µCi of strontium-85 per mCi
of rubidium-82 (0.2 kBq of strontium-85 per MBq of rubidium-82 chloride)
injection.
(2) The licensee who uses molybdenum-99/technetium-99m
generators for preparing a technetium-99m radiopharmaceutical shall
measure the molybdenum-99 concentration in each eluate from a generator
to demonstrate compliance with paragraph (1) of this subsection.
(3) The licensee who uses a strontium-82/rubidium-82
generator for preparing a rubidium-82 radiopharmaceutical shall, before
the first patient use of the day, measure the concentration of radionuclides
strontium-82 and strontium-85 to demonstrate compliance with paragraph
(1) of this subsection.
(4) If the licensee is required to measure the molybdenum-99
or strontium-82 and strontium-85 concentrations, the licensee shall
retain a record of each measurement in accordance with subsection
(www) of this section for inspection by the department. The record
shall include the following:
(A) for each measured elution of technetium-99m:
(i) the ratio of the measures expressed as µCi
of molybdenum-99 per mCi of technetium-99m (kBq of molybdenum-99 per
MBq of technetium-99m);
(ii) time and date of the measurement; and
(iii) name of the individual who made the measurement.
(B) for each measured elution of rubidium-82:
(i) the ratio of the measures expressed as µCi
of strontium-82 per mCi of rubidium (kBq of strontium-82 per MBq of
rubidium-82);
(ii) the ratio of the measures expressed as µCi
of strontium-85 per mCi of rubidium (kBq of strontium-85 per MBq of
rubidium-82);
(iii) time and date of the measurement; and
(iv) name of the individual who made the measurement.
(5) The licensee shall report any measurement that
exceeds the limits in paragraph (1) of this subsection at the time
of generator elution, in accordance with subsection (xxx) of this
section.
(jj) Training for imaging and localization studies.
Except as provided in subsection (l) of this section, the licensee
shall require an authorized user of unsealed radioactive material
for the uses authorized in subsection (hh) of this section to be a
physician who:
(1) is certified by a medical specialty board whose
certification process has been recognized by the department, the NRC
or an agreement state. The names of board certifications that have
been recognized by the department, the NRC, or an agreement state
are posted on the NRC's Medical Uses Licensee Toolkit web page. To
have its certification process recognized, a specialty board shall
require all candidates for certification to:
(A) complete 700 hours of training and experience in
basic radionuclide handling techniques and radiation safety applicable
to the medical use of unsealed radioactive material for imaging and
localization studies as described in paragraph (3) of this subsection;
and
(B) pass an examination, administered by diplomates
of the specialty board, that assesses knowledge and competence in
radiation safety, radionuclide handling, and quality control; or
(2) is an authorized user in accordance with subsection
(nn) of this section and meets the requirements of paragraph (3)(A)(ii)(VII)
of this subsection or equivalent NRC or agreement state requirements;
or
(3) has completed 700 hours of training and experience,
including a minimum of 80 hours of classroom and laboratory training,
in basic radionuclide handling techniques applicable to the medical
use of unsealed radioactive material for imaging and localization
studies.
(A) The training and experience shall include the following:
(i) 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
(ii) work experience under the supervision of an authorized
user who meets the requirements in subsection (l) of this section,
this subsection, or paragraph (3)(A)(ii)(VII) of this section, and
subsection (nn) of this section, or equivalent NRC or agreement state
requirements. An authorized nuclear pharmacist who meets the requirements
in subsections (k) or (l) of this section may provide the supervised
work experience for subclause (VII) of this clause. Work experience
must involve the following:
(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 radioactive material;
(V) using procedures to contain spilled radioactive
material safely and using proper decontamination procedures;
(VI) administering dosages of radioactive drugs to
patients or human research subjects; and
(VII) eluting generator systems appropriate for preparation
of radioactive drugs for imaging and localization studies, measuring
and testing the eluate for radionuclide purity, and processing the
eluate with reagent kits to prepare labeled radioactive drugs; and
(B) has obtained written attestation that the individual
has satisfactorily completed the requirements in this paragraph and
is able to independently fulfill the radiation safety-related duties
as an authorized user for the medical uses authorized under subsections
(ff) and (hh) of this section. The attestation must be obtained from
either:
(i) a preceptor authorized user who meets the requirements
of subsection (l) of this section, this subsection or paragraph (3)(A)(ii)(VII)
of this subsection and subsection (nn) of this section or equivalent
NRC or agreement state requirements; or
(ii) a residency program director 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 subsections (l), or (jj), or (nn) of this
section and paragraph (3)(A)(ii)(VII) of this subsection, or equivalent
NRC or agreement state requirements, and concurs with the attestation
provided by the residency program director. The residency training
program must be approved by the Residency Review Committee of the
Accreditation Council for Graduate Medical Education or the Royal
College of Physicians and Surgeons of Canada or the Council on Postdoctoral
Training of the American Osteopathic Association and must include
training and experience specified in this paragraph.
(kk) Use of unsealed radioactive material that requires
a written directive. A licensee may use any unsealed radioactive material
identified in subsection (nn)(2)(A)(ii)(VI) of this section prepared
for medical use that requires a written directive that meets the following:
(1) is obtained from:
(A) a manufacturer or preparer licensed in accordance
with §289.252(r) of this title or equivalent NRC or agreement
state requirements;
(B) a PET radioactive drug producer licensed in accordance
with §289.252(kk) of this title or equivalent NRC or agreement
state requirements; or
(2) excluding production of PET radionuclides, prepared
by:
(A) an authorized nuclear pharmacist; or
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