Current through Register Vol. 49, No. 13, September 23, 2024
Except as provided under part 4731.4414, a licensee must
require an authorized user for the oral administration of sodium iodide (I-131)
requiring a written directive in quantities less than or equal to 33
millicuries (1.22 GBq) to be a physician who:
A. is certified by a medical specialty board
whose certification process has been recognized by the NRC or an agreement
state and includes all of the requirements of item C, subitems (1) and (2). The
names of board certifications that have been recognized by the NRC or an
agreement state are posted on the NRCs Medical Use Licensee Toolkit web page;
B. is an authorized user under part
4731.4443, for oral administration of less than or equal to 33 millicuries
(1.22 GBq) of sodium iodide (I-131) for which a written directive is required
or oral administration of greater than 33 millicuries (1.22 GBq) of sodium
iodide (I-131) under part 4731.4443 or 4731.4445, or under equivalent
requirements of the NRC or an agreement state; or
C. has:
(1)
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 training must include:
(a) radiation physics and
instrumentation;
(b) radiation
protection;
(c) mathematics
pertaining to the use and measurement of radioactivity;
(d) chemistry of radioactive material for
medical use; and
(e) radiation
biology;
(2) work
experience under the supervision of an authorized user who meets the
requirements of this part, part 4731.4414, 4731.4443, or 4731.4445, or
equivalent requirements of the NRC or an agreement state. A supervising
authorized user who meets the requirements in part 4731.4443, subpart 1, item
B, must also have experience in oral administration of less than or equal to 33
millicuries (1.22 GBq) of sodium iodide (I-131) for which a written directive
is required or oral administration of greater than 33 millicuries (1.22 GBq) of
sodium iodide (I-131) as specified in part 4731.4443. The work experience must
involve:
(a) ordering, receiving, and
unpacking radioactive materials safely and performing the related radiation
surveys;
(b) performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for the proper operation of survey meters;
(c) calculating, measuring, and safely
preparing patient or human research subject dosages;
(d) using administrative controls to prevent
a medical event involving the use of radioactive materials;
(e) using procedures to safely contain
spilled radioactive material and using proper decontamination procedures;
and
(f) administering dosages to
patients or human research subjects that include at least three cases involving
the oral administration of less than or equal to 33 millicuries (1.22 GBq) of
sodium iodide I-131; and
(3) obtained written attestation that the
individual has satisfactorily completed the requirements of this item and is
able to independently fulfill the radiation safety-related duties as an
authorized user for oral administration of less than or equal to 33 millicuries
(1.22 GBq) of sodium iodide I-131 for medical uses authorized under part
4731.4440. The written attestation must be obtained from either:
(a) a preceptor authorized user who meets the
requirements of this part, part 4731.4414, 4731.4443, or 4731.4445, or
equivalent requirements of the NRC or an agreement state and has experience in
oral administration of less than or equal to 33 millicuries (1.22 GBq) of
sodium iodide (I-131) for which a written directive is required or oral
administration of greater than 33 millicuries (1.22 GBq) of sodium iodide
(I-131) as specified in part 4731.4443; or
(b) 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 of this part, part 4731.4414, 4731.4443, or 4731.4445,
or equivalent requirements of the NRC or an agreement state, has experience in
oral administration of less than or equal to 33 millicuries (1.22 GBq) of
sodium iodide (I-131) for which a written directive is required or oral
administration of greater than 33 millicuries (1.22 GBq) of sodium iodide
(I-131) as specified in part 4731.4443, subpart 1, item B, subitem (1), unit
(b), subunit vi, 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 subitems (1) and
(2).
