| (3) A licensee providing mobile nuclear medicine services
shall maintain records, for inspection by the department, in accordance
with subsection (xxx) of this section including the letter required
in paragraph (1)(A) of this subsection and the record of each survey
required in paragraph (1)(F) of this subsection.
(ee) Decay-in-storage.
(1) The licensee may hold radioactive material with
a physical half-life of less than or equal to 120 days for decay-in-storage
and dispose of it without regard to its radioactivity if the licensee
does the following:
(A) monitors radioactive material at the surface before
disposal and determines that its radioactivity cannot be distinguished
from the background radiation level with an appropriate radiation
detection survey meter set on its most sensitive scale and with no
interposed shielding; and
(B) removes or obliterates all radiation labels, except
for radiation labels on materials that are within containers and that
will be handled as biomedical waste after it has been released from
the licensee.
(2) The licensee shall retain a record of each disposal
as required by paragraph (1) of this subsection in accordance with
subsection (xxx) of this section for inspection by the department.
The record shall include the following:
(A) date of the disposal;
(B) manufacturer's name, model number and serial number
of the survey instrument used;
(C) background radiation level;
(D) radiation level measured at the surface of each
waste container; and
(E) name of the individual who performed the survey.
(ff) Use of unsealed radioactive material for uptake,
dilution, and excretion studies that do not require a written directive.
Except for quantities that require a written directive in accordance
with subsection (t) of this section, a licensee may use any unsealed
radioactive material prepared for medical or veterinary use for uptake,
dilution, or excretion studies 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; or
(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
(B) a physician who is an authorized user and who meets
the requirements specified in subsections (jj) or (nn) and (jj)(3)(A)(ii)(VII)
of this section; or
(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.
(gg) Training for uptake, dilution, and excretion 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 (ff) 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 recognized, a specialty board shall require
all candidates for certification to:
(A) complete 60 hours of training and experience in
basic radionuclide handling techniques and radiation safety applicable
to the medical use of unsealed radioactive material for uptake, dilution,
and excretion studies as described in paragraph (3)(A) 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 subsections
(jj) or (nn) of this section or equivalent NRC or agreement state
requirements; or
(3) has completed 60 hours of training and experience,
including a minimum of eight hours of classroom and laboratory training,
in basic radionuclide handling techniques applicable to the medical
use of unsealed radioactive material for uptake, dilution, and excretion
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 of this subsection, subsections (l),
(jj), or (nn) of this section, or equivalent NRC or agreement state
requirements involving 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; and
(VI) administering dosages of radioactive drugs to
patients or human research subjects; and
(B) has obtained written attestation that the individual
has satisfactorily completed the requirements in subparagraph (A)
of this paragraph and is able to independently fulfill the radiation
safety-related duties as an authorized user for the medical uses authorized
under subsection (ff) 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 subsections
(jj) or (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), (gg), (jj), or (nn) of
this section, 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 subparagraph (A)
of this paragraph.
(hh) Use of unsealed radioactive material for imaging
and localization studies that do not require a written directive.
Except for quantities that require a written directive in accordance
with subsection (t) of this section, a licensee may use any unsealed
radioactive material prepared for medical or veterinary use for imaging
and localization studies 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; or
(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
(B) a physician who is an authorized user and who meets
the requirements specified in subsections (jj) or (nn) and (jj)(3)(A)(ii)(VII)
of this section; or
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