Current through Register Vol. 46, No. 39, September 25, 2024
(a) Purpose and
scope. This section contains requirements for the medical uses of byproduct
materials that are subject to specific licenses. These requirements are in
addition to, and not a substitute for, other requirements in this Part. Any
license issued prior to the effective date of this regulation that references
subdivision (b) of this section shall be deemed to reference subdivision (d) of
this section.
(b) Definitions.
Whenever used in this section, or in Federal regulations incorporated herein,
the following terms shall have the following meanings:
(1) Authorized medical physicist means an
individual who is authorized to practice medical physics pursuant to article
166 of the Education Law and:
(i) meets the
definition and the training requirements for an authorized medical physicist
set forth in 10 CFR sections
35.2,
35.51 and 35.57; or
(ii) is named
as a radiation therapy physicist on a medical use radioactive materials license
issued by the department and meets the requirements set forth in
10 CFR section
35.59.
(2) Authorized nuclear pharmacist means an
individual who is authorized to practice pharmacy pursuant to article 137 of
the Education Law and:
(i) meets the
requirements for an authorized nuclear pharmacist in
10 CFR sections
35.55(a) and
35.59;
or
(ii) is identified as an
authorized nuclear pharmacist on:
(a) a
specific license issued by the Nuclear Regulatory Commission or agreement state
that authorizes medical use or the practice of nuclear pharmacy;
(b) a permit issued by a Nuclear Regulatory
Commission master material licensee that authorizes medical use or the practice
of nuclear pharmacy;
(c) a permit
issued by a Nuclear Regulatory Commission or agreement state broad scope
medical use licensee that authorizes medical use or the practice of nuclear
pharmacy; or
(d) a permit issued by
a Nuclear Regulatory Commission master material license broad scope medical use
permittee that authorizes medical use or the practice of nuclear pharmacy;
or
(iii) is identified
as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has
been authorized to identify authorized nuclear pharmacists; or
(iv) was a nuclear pharmacist preparing only
radioactive drugs containing accelerator-produced radioactive material, and the
individual practiced at a pharmacy at a Federal government agency or federally
recognized Indian tribe before November 30, 2007 or at all other pharmacies
before August 8, 2009, or an earlier date as noticed by the Nuclear Regulatory
Commission.
(3)
Authorized user means an individual who is authorized to practice medicine
pursuant to article 131 of the Education Law and:
(i) meets the applicable requirements in
10 CFR sections
35.59 and
35.190(a),
35.290(a),
35.390(a),
35.392(a),
35.394(a),
35.490(a),
35.590(a)
or
35.690(a);
or
(ii) is identified as an
authorized user on:
(a) a Nuclear Regulatory
Commission or agreement state license that authorizes the medical use of
byproduct material;
(b) a permit
issued by a Nuclear Regulatory Commission master material licensee that is
authorized to permit the medical use of byproduct material;
(c) a permit issued by a commission or
agreement state specific licensee of broad scope that is authorized to permit
the medical use of byproduct material; or
(d) a permit issued by a commission master
material license broad scope permittee that is authorized to permit the medical
use of byproduct material.
(4) Medical use means the intentional
internal or external administration of byproduct material or the radiation from
byproduct material to patients or human research subjects under the supervision
of an authorized user.
(5) Positron
emission tomography facility is a facility operating a cyclotron or accelerator
for the purpose of producing PET radionuclides.
(6) Prescribed dosage means the specified
activity or range of activity of unsealed byproduct material as documented in a
written directive, or in accordance with the directions of the authorized user
for procedures performed pursuant to
10
CFR sections 35.100 and
35.200.
Further details concerning this referenced code are contained in subdivision
(c) of this section.
(7) Prescribed
dose means:
(i) for gamma stereotactic
radiosurgery, the total dose as documented in the written directive;
(ii) for teletherapy, the total dose and dose
per fraction as documented in the written directive;
(iii) for manual brachytherapy, either the
total source strength and exposure time or the total dose, as documented in the
written directive; or
(iv) for
remote brachytherapy afterloaders, the total dose and dose per fraction as
documented in the written directive.
(8) Radiation safety officer means an
individual who:
(i) meets the requirements
set forth in
10 CFR sections
35.50(a) or (c)(1) and
35.59;
or
(ii) is identified as a
radiation safety officer on a specific medical use license issued by the
Nuclear Regulatory Commission or agreement state or a medical use permit issued
by a Nuclear Regulatory Commission master material licensee.
(9) Sealed source means any
byproduct material that is encased in a capsule designed to prevent leakage or
escape of the byproduct material.
(10) Treatment site means the anatomical
description of the tissue intended to receive a radiation dose, as described in
a written directive.
(c)
Approved medical uses of byproduct materials. A licensee may use byproduct
materials on human beings for the particular uses set forth below, provided
that the licensee meets all applicable requirements of this Part:
(1) use of unsealed byproduct material for
uptake, dilution and excretion studies;
(2) use of unsealed byproduct material for
imaging and localization studies;
(3) use of unsealed byproduct material for
which a written directive is required;
(4) use of sources for manual
brachytherapy;
(5) use of sealed
sources for diagnosis;
(6) use of
sealed source in a remote afterloader unit, teletherapy unit or gamma
stereotactic radiosurgery unit; or
(7) other specific medical uses of byproduct
material or radiation from byproduct material, as licensed by the
department.
(d) Federal
standards. All licensees shall comply with the provisions of the following
Federal regulations, which are hereby incorporated by reference, with the same
force and effect as if fully set forth at length herein: title 10 of the Code
of Federal Regulations, part 35, Medical Use of Byproduct Material. This code
is published by the Office of the Federal Register National Archives and
Records Administration. Copies may be obtained from the Superintendent of
Documents, United States Government Printing Office, Washington, DC 20402. This
code is available for copying and inspection at the Regulatory Affairs Unit,
New York State Department of Health, Corning Tower, Empire State Plaza, Albany,
NY 12237. Notwithstanding any provision herein to the contrary, if a conflict
occurs between the above referenced CFR and other provisions in this Part,
compliance with the more restrictive regulation is required.
(e) General requirements applicable to all
licensees authorized to use byproduct materials for medical purposes.
(1) Recordkeeping requirements. A licensee
shall comply with all recordkeeping requirements set forth in subpart L
(Records) of part 35 of 10 CFR. Further details concerning this referenced code
are contained in subdivision (c) of this section.
(2) Reporting requirements. A licensee shall
comply with all reporting requirements set forth in subpart M (Reports) of part
35 of 10 CFR as revised herein as follows:
(i)
in sections 35.3045(c) and 35.3047(c), replace phrase "NRC Operations Center"
with "Department";
(ii) in sections
35.3045(d) and 35.3047(d), replace "By an appropriate method listed in section
§30.6(a) of this chapter, the licensee shall submit a written report to the
appropriate NRC Regional Office listed in section 30.6 of this chapter" with
"shall submit a written report to the Department";
(iii) in sections 35.3045(g)(1) and
35.3047(f)(1), replace the term "NRC" with "Department"; and
(iv) in section 35.3067, replace "The report
must be filed with the appropriate NRC Regional Office listed in section 30.6
of this chapter, by an appropriate method listed in section 30.6(a) of this
Chapter, with a copy to the Director, Office of Federal and State Materials and
Environmental Management Programs." with "The report shall be filed with the
Department".
(3)
Training and experience requirements. A licensee shall ensure that all staff
who are involved in the use of byproduct material pursuant to a specific
license have the training and experience required by this Part.
(4) Other general requirements. A licensee
shall comply with requirements set forth in 10 CFR sections
35.5,
35.6,
35.11(a) and (b), 35.24(b), (e), (f) and (g), 35.27, 35.40, 35.41, 35.49,
35.60, 35.61, 35.63, 36.67, 35.69, 35.70, 35.75, 35.80, 35.92 as modified
herein as follows: in section 35.27(a)(1) and (b)(1), replace "19.12 of this
chapter" with "16.13(c) of this Part".
(f) Requirements for the use of unsealed
byproduct material for uptake, dilution and excretion studies. A licensee shall
use unsealed byproduct material for uptake dilution and excretion studies only
if authorized to do so by a specific license issued by the department and
provided that the licensee complies with
10
CFR sections 35.100 and
35.190
and all applicable provisions of this Part.
(g) Requirements for the use of unsealed
byproduct material for imaging and localization studies. A licensee shall use
unsealed byproduct material for imaging and localization studies only if
authorized to do so by a specific license issued by the department and provided
that the licensee complies with
10
CFR sections 35.200,
35.204
and
35.290
and other applicable provisions of this Part.
(h) Requirements for the use of unsealed
byproduct material for which a written directive is required. A licensee shall
use unsealed byproduct material for which a written directive is required only
if authorized to do so by a specific license issued by the department and
provided that the licensee complies with subpart E (Unsealed Byproduct
Material-Written Directive Required) of part 35 of 10 CFR and other applicable
provisions of this Part.
(i)
Requirements for the use of sources for manual brachytherapy. A licensee may
use sources for manual brachytherapy only if authorized to so by a specific
license issued by the department and provided that the licensee complies with
subpart F (Manual Brachytherapy) of part 35 of 10 CFR.
(j) Requirements for the use of sealed
sources for diagnosis. A licensee may use sealed sources for diagnosis only if
authorized to do so by a specific license issued by the department and provided
that the licensee complies with subpart G (Sealed Sources for Diagnosis) of
part 35 of 10 CFR and other applicable provision of this Part.
(k) Use of sealed source in a remote
afterloader unit, teletherapy unit or gamma stereotactic radiosurgery unit. A
licensee may use a sealed source in a remote afterloader unit, teletherapy unit
or gamma stereotactic radiosurgery unit only if authorized to so by a specific
license issued by the department and provided that the licensee complies with
subpart H (Photon Emitting Remote Afterloader Units, Teletherapy Units and
Gamma Stereotactic Radiosurgery Units) of part 35 of 10 CFR and other
applicable provisions of this Part.
(l) Other medical uses of byproduct material
or radiation from byproduct material. A licensee may use byproduct material or
a radiation source approved for medical use which is not specifically addressed
in paragraphs (b)(1) through (6) of this section if the licensee submits to the
department information required by
10 CFR section
35.12(b) through (d) and the
licensee has received written approval from the department in a specific
license or license amendment and uses the material in accordance with specific
conditions that the department deems necessary or desirable for the safest
medical use of the material.
(m)
General use license. Any licensee who is licensed for one or more of the types
of medical uses specified in paragraphs (b)(1) through (6) of this section also
is authorized to use radioactive material under the general license in Appendix
16-A, table 6, item (i) infra, for the specified "in vitro" uses without filing
Form GEN 373 as required by Appendix 16-A, table 6, item (i), subdivision (2),
infra, provided, however, that the licensee is subject to the other provisions
of Appendix 16-A, table 6, item (i), infra.
