Current through Register Vol. 48, No. 12, March 22, 2024
Except as provided in Section
335.9160,
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 who meets the
requirements of Section
335.9050
for a use identified in subsection
335.9050(b)(2)(F)(iii)
or equivalent U.S. Nuclear Regulatory Commission or Agreement State
requirements; or
b) Is an
authorized user under Section
335.9100
or
335.9140
or equivalent U.S. Nuclear Regulatory Commission or Agreement State
requirements and who meets the requirements in subsection (d); or
c) Is certified by a medical specialty board
whose certification process has been recognized by the Agency under Section
335.9100
or
335.9140
or by the U.S. Nuclear Regulatory Commission or an Agreement State and who
meets the requirements in subsection (d).
d) The physician shall have:
1) Successfully completed 80 hours of
classroom and laboratory training applicable to parenteral administrations
listed in subsection
335.9050(b)(2)(F)(iii).
The training shall 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 in this Section, Section 335.9050, 335.9160 or equivalent U.S.
Nuclear Regulatory Commission or Agreement State requirements in the parenteral
administrations listed in subsection
335.9050(b)(2)(F)(iii).
A supervising authorized user who meets the requirements in this Section,
Section 335.9050, or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements shall have experience in administering dosages in the same
category or categories as the individual requesting authorized user status. The
work experience shall 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 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 unsealed radioactive material;
E) Using procedures to contain spilled
radioactive material safely and using proper decontamination procedures;
and
F) Administering dosages to
patients or human research subjects that include at least 3 cases of the
parenteral administrations as specified in subsection
335.9050(b)(2)(F)(iii);
and
3) Obtained written
attestation that the individual has satisfactorily completed the requirements
in subsections (d)(1) and (d)(2) and is able to independently fulfill the
radiation safety-related duties as an authorized user for the parenteral
administration of unsealed radioactive material requiring a written directive.
The attestation shall be obtained from either:
A) A preceptor authorized user who meets the
requirements in this Section, Section 335.9050, 335.9160, or equivalent U.S.
Nuclear Regulatory Commission or Agreement State requirements. A preceptor
authorized user who meets the requirements in this Section or Section 335.9050,
or equivalent U.S. Nuclear Regulatory Commission or Agreement State
requirements, shall have experience in administering dosages in the same
category or categories as the individual requesting authorized user status;
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 in this Section, Section 335.9050, 335.9160, or
equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements,
has experience in administering dosages in the same dosage category or
categories as the individual requesting authorized user status, and concurs
with the attestation provided by the residency program director. The residency
training program shall be approved by the Residency Review Committee of the
Accreditation Council for Graduate Medical Education, the Royal College of
Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of
the American Osteopathic Association and shall include training and experience
specified in subsection (d)(1) and (d)(2).
AGENCY NOTE: Specialty boards whose certification processes
have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or
an Agreement State will be posted on the NRC's
website.