| (E) adding or changing the areas in which radioactive
material is used or stored and are identified in the application or
on the license, including areas used in accordance with subsection
(ff) or (hh) of this section if the change includes addition or relocation
of either an area where positron emission tomography (PET) radionuclides
are produced or a PET radioactive drug delivery line from the PET
radionuclide/PET radioactive drug production area, and other areas
of use where radioactive material is used only in accordance with
either subsection (ff) or (hh) of this section are exempt;
(F) changing the address(es) of use identified in the
application or on the license;
(G) changing operating, safety, and emergency procedures;
(H) before permitting anyone to work as an ARSO, or
before the RSO assigns duties and tasks to an ARSO that differ from
those for which this individual is authorized on the license; and
(I) before receiving a sealed source from a different
manufacturer or of a different model number than authorized by its
license unless the sealed source is used for manual brachytherapy,
is listed in the Sealed Source and Device Registry, and is in a quantity
and for an isotope authorized by the license.
(3) A licensee possessing a Type A specific license
of broad scope for medical use, issued under §289.252(h)(2) of
this title, is exempt from:
(A) the provisions of subsection (q)(1) of this section
regarding the need to file an amendment to the license for medical
use of radioactive material;
(B) the provisions of paragraph (2)(B) of this subsection;
(C) the provisions of paragraph (2)(E) of this subsection
regarding additions to or changes in the areas of use at the addresses
identified in the application or on the license;
(D) the provisions of paragraph (4) of this subsection;
(E) the provisions of paragraph (5)(A) of this subsection
for an authorized user, an authorized nuclear pharmacist, an authorized
medical physicist, or an ophthalmic physicist;
(F) the provisions of paragraph (5)(C) of this subsection;
and
(G) the provisions of subsection (u)(1) of this section.
(4) A licensee shall notify the department in the form
of a license amendment request, no later than 30 days after the date
that the licensee permits an individual to work under the provisions
of §289.256(r) as an authorized user, authorized medical physicist,
ophthalmic physicist, or authorized nuclear pharmacist providing that
the individual is authorized on a license for the same use. A licensee
includes with the notification documentation:
(A) a copy of the department, NRC, or agreement state
license;
(B) the permit issued by an NRC master material licensee;
(C) the permit issued by the department, the NRC, or
an agreement state licensee of broad scope; or
(D) the permit issued by an NRC master material license
broad scope permittee.
(5) A licensee shall notify the department in the form
of a license amendment request no later than 30 days after:
(A) an authorized user, an authorized nuclear pharmacist,
an RSO, an ARSO, an authorized medical physicist, or ophthalmic physicist
permanently discontinues performance of duties under the license or
has a name change;
(B) the licensee permits an individual qualified to
be an RSO under subsections (h) and (m) of this section to function
as a temporary RSO and to perform the functions of an RSO in accordance
with subsection (g)(6) of this section;
(C) the licensee has added to or changed the areas
of use identified in the application or on the license where byproduct
material is used in accordance with either subsection (ff) or (hh)
of this section, if the change does not include addition or relocation
of either an area where PET radionuclides are produced or a PET radioactive
drug delivery line from the PET radionuclide/PET radioactive drug
production area; or
(D) the licensee obtains a sealed source for use in
manual brachytherapy from a different manufacturer or with a different
model number than authorized by its license for which it did not require
a license amendment as provided in paragraph (1) of this subsection.
The notification must include the manufacturer and model number of
the sealed source, the isotope, and the quantity per sealed source.
(s) Supervision. A licensee may permit the receipt,
possession, use, or transfer of radioactive material by an individual
under the supervision of an authorized user, unless prohibited by
license condition.
(1) A licensee who permits the receipt, possession,
use, or transfer of radioactive material by an individual under the
supervision of an authorized user shall do the following:
(A) instruct the supervised individual in the licensee's
written operating, safety, and emergency procedures, written directive
procedures, requirements of this chapter, and license conditions with
respect to the use of radioactive material; and
(B) require the supervised individual to follow the
instructions of the supervising authorized user for medical uses of
radioactive material, written operating, safety, and emergency procedures
established by the licensee, written directive procedures, requirements
of this chapter, and license conditions with respect to the medical
use of radioactive material.
(2) A licensee who permits the preparation of radioactive
material for medical use by an individual under the supervision of
an authorized nuclear pharmacist or authorized user, shall do the
following:
(A) instruct the supervised individual in the preparation
of radioactive material for medical use, as appropriate to that individual's
involvement with radioactive material; and
(B) require the supervised individual to follow the
instructions of the supervising authorized user or authorized nuclear
pharmacist regarding the preparation of radioactive material for medical
use, the written operating, safety, and emergency procedures established
by the licensee, the requirements of this chapter, and license conditions.
(3) A licensee who permits supervised activities in
accordance with paragraphs (1) and (2) of this subsection is responsible
for the acts and omissions of the supervised individual.
(4) Only an authorized user may authorize the medical
use of radioactive material.
(t) Written directives.
(1) A written directive shall be dated and signed by
an authorized user before any administration of sodium iodide I-131
greater than 30 microcuries (µCi) (1.11 megabequerels (MBq)),
administration of any therapeutic dosage of unsealed radioactive material,
or administration of any therapeutic dose of radiation from radioactive
material. If, because of the emergent nature of the patient's condition,
a delay in order to provide a written directive would jeopardize the
patient's health, an oral directive is acceptable. The information
contained in the oral directive shall be documented in writing as
soon as possible in the patient's record. A written directive shall
be prepared and signed by the authorized user within 48 hours of the
oral directive.
(2) The written directive shall contain the patient
or human research subject's name and the following information for
each application.
(A) For any administration of quantities greater than
30 µCi (1.11 MBq) of sodium iodide I-131: the dosage.
(B) For an administration of a therapeutic dosage of
a radiopharmaceutical other than sodium iodide I-131: the radiopharmaceutical,
the dosage, and the route of administration.
(C) For gamma stereotactic radiosurgery: the total
dose, the treatment site, and the values for the target coordinate
settings per treatment for each anatomically distinct treatment site.
(D) For teletherapy: the total dose, the dose per fraction,
the number of fractions, and the treatment site.
(E) For high-dose rate remote afterloading brachytherapy:
the radionuclide, the treatment site, the dose per fraction, the number
of fractions, and the total dose.
(F) For permanent implant brachytherapy:
(i) before implantation: the treatment site, the radionuclide,
and the total source strength; and
(ii) after implantation but before the patient leaves
the post-treatment recovery area: the treatment site, the number of
sources implanted, the total source strength implanted, and the date.
(G) For all other brachytherapy, including low, medium,
and pulsed rate afterloaders:
(i) before implantation: the treatment site, the radionuclide,
and the dose;
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