410 IAC 5-3-11 - Specific licenses for human, medical and industrial uses
Authority: IC 16-41-35-26; IC 16-41-35-29
Affected: IC 16-41-35
Sec. 11.
(a) Human
Use of Radioactive Material in Institutions. In addition to the requirements
set forth in
410
IAC 5-3-10, a specific license for human use of
radioactive material in institutions will be issued if:
(1) The applicant has appointed a medical
isotopes committee of at least three members to evaluate all proposals for
research, diagnostic, and therapeutic use of radioactive material within that
institution. Membership of the committee should include physicians expert in
internal medicine, hematology, therapeutic radiology, and a person experienced,
in assay of radioactive material and protection against radiation;
(2) The applicant possesses adequate
facilities for the clinical care of patients;
(3) The physician designated on the
application as the individual user has substantial experience in the handling
and administration of radioactive material and, where applicable, the clinical
management of radioactive patients; and
(4) The application is for a license to use
unspecified quantities or multiple types of radioactive material, the
applicant's staff has substantial experience in the use of a variety of
radioactive materials for a variety of human uses.
(b) Licensing of Individual Physicians for
Human Use of Radioactive Material.
(1) An
application by an individual physician or group of physicians for a specific
license for human use of radioactive material will be approved if:
(i) The applicant satisfies the general
requirements specified in
410
IAC 5-3-10;
(ii) The application is for use in the
applicant's practice in an office outside a medical institution;
(iii) The applicant has access to a hospital
possessing adequate facilities to hospitalize and monitor the applicant's
radioactive patients whenever it is advisable; and
(iv) The applicant has extensive experience
in the proposed use, the handling and administration of radionuclides, and
where applicable, the clinical management of radioactive patients.
(2) The board will not approve an
application by an individual physician or group of physicians for a specific
license to receive, possess, or use radioactive material on the premises of a
medical institution unless:
(i) The use of
radioactive material is limited to:
(A) The
administration of radiopharmaceuticals for diagnostic or therapeutic
purposes,
(B) The performance of
diagnostic studies on patients to whom a radiopharmaceutical has been
administered,
(C) The performance
of in vitro diagnostic studies, or
(D) The calibration and quality control
checks of radioactive assay instrumentation, radiation safety instrumentation,
and diagnostic instrumentation;
(ii) The physician brings the radioactive
material with him and removes the radioactive material when he departs (the
institution cannot receive, possess, or store radioactive material other than
the amount of material remaining in the patient); and
(iii) The medical institution does not hold a
radioactive material license under 410 IAC 5-3-11(a).
(c) Specific Licenses for Certain
Groups of Medical Uses of Radioactive Material.
(1) Subject to the provisions of 410 IAC
5-3-11(c)(2), (3), and (4) an application for a specific license pursuant to
410 IAC 5-3-11(a), (b) or (d) for any medical use or uses of radioactive
material specified in one or more of Groups I to VI, inclusive, of Schedule C,
410 IAC
5-3-28, will be approved for all of the uses within
the group or groups which include the use or uses specified in the application
if:
(i) The applicant satisfies the
requirements of 410 IAC 5-3-11(a), (b) and (d);
(ii) The applicant, or the physician
designated in the application as the individual user, has adequate clinical
experience in the types of uses included in the group or groups;
(iii) The applicant, or the physicians and
all other personnel who will be involved in the preparation and use of the
radioactive material, have adequate training and experience in the handling of
radioactive material appropriate to their participation in the uses included in
the group or groups;
(iv) The
applicant's radiation detection and measuring instrumentation is adequate for
conducting the procedures involved in the uses included in the group or groups;
and
(v) The applicant's radiation
safety operating procedures are adequate for handling and disposal of the
radioactive material involved in the uses included in the group or
groups.
(2) Any licensee
or registrant who is authorized to use radioactive material pursuant to one or
more groups in 410 IAC 5-3-11(c)(1) and Schedule C,
410 IAC
5-3-28, is subject to the following conditions:
(i) For Groups I, II, IV, and V, no licensee
or registrant shall receive, possess or use radioactive material except as a
radiopharmaceutical manufactured in the form to be administered to the patient,
labeled, packaged and distributed in accordance with a specific license issued
by the board pursuant to
410
IAC 5-3-13(j), a specific license
issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.72 of
10 CFR Part 32, or a specific license issued by an agreement state or a
licensing state pursuant to equivalent regulations.
(ii) For Group III, no licensee or registrant
shall receive, possess or use generators or reagent kits containing radioactive
material or shall use reagent kits that do not contain radioactive material to
prepare radiopharmaceuticals containing radioactive material, except:
(A) Reagent kits not containing radioactive
material that are approved by the board, the U.S. Nuclear Regulatory
Commission, an agreement state or a licensing state for use by persons licensed
pursuant to 410 IAC 5-3-11(c) and Schedule C,
410 IAC
5-3-28, or equivalent regulations; or
(B) Generators or reagent kits containing
radioactive material that are manufactured, labeled, packaged and distributed
in accordance with a specific license issued by the board pursuant to
410
IAC 5-3-13(k) a specific license
issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.73 of
10 CFR Part 32, or a specific license issued by an agreement state or a
licensing state pursuant to equivalent regulations.
(iii) For Group VI, no licensee or registrant
shall receive, possess, or use radioactive material except as contained in a
source or device that has been manufactured, labeled, packaged and distributed
in accordance with a specific license issued by the board pursuant to
410
IAC 5-3-13(l), a specific license
issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.74 of
10 CFR Part 32, or a specific license issued to the manufacturer by an
agreement state or a licensing state pursuant to equivalent
regulations.
(iv) For Group III,
any licensee or registrant who uses generators or reagent kits shall:
(A) Elute the generator, or process
radioactive material with the reagent kit, in accordance with instructions
approved by the U.S. Nuclear Regulatory Commission, an agreement state or
licensing state and furnished by the manufacturer on the label attached to or
in the leaflet or brochure that accompanies the generator or reagent
kit;
(B) Before administration to
patients, cause each elution or extraction of technetium-99m from a
molybdenum-99/technetium-99m generator to be tested to determine either the
total molybdenum-99 activity or the concentration of molybdenum-99. This
testing shall be conducted according to written procedures and by personnel who
have been specifically trained to perform the test;
(C) Prohibit the administration to patients
of technetium-99m containing more than 1 microcurie of molybdenum-99 per
millicurie of technetium-99m, or more than 5 microcuries of molybdenum-99 per
administered dose, at the time of administration; and
(D) Maintain for 3 years for board inspection
records of the molybdenum-99 test conducted on each elution from the generator.
(v) For Groups I, II,
and III, any licensee using radioactive material for clinical procedures other
than those specified in the product labeling (package insert) shall comply with
the product labeling regarding:
(A) Chemical
and physical form;
(B) Route of
administration; and
(C) Dosage
range.
(3) Any
licensee who is licensed pursuant to 410 IAC 5-3-11 for one or more of the
medical use groups in Schedule C,
410 IAC
5-3-28, also is authorized to use radioactive material
under the general license in
410
IAC 5-3-7(i) for the specified in
vitro uses without filing board form "V" as required by
410
IAC 5-3-7(i)(2); provided, that the
licensee is subject to the other provisions of
410
IAC 5-3-7(i).
(4) Any licensee who is licensed pursuant to
410 IAC 5-3-11(c)(1) for one or more of the medical use groups in Schedule C,
410 IAC
5-3-28, also is authorized, subject to the provisions
of 410 IAC 5-3-11(c)(4) and (5), to receive, possess and use for calibration
and reference standards:
(i) Any radioactive
material listed in Group I, Group II, or Group III of Schedule C,
410 IAC
5-3-28, with a half-life not longer than 100 days, in
amounts not to exceed 15 millicuries total;
(ii) Any radioactive material listed in Group
I, Group II, or Group III of Schedule C,
410 IAC
5-3-28, with half-life greater than 100 days in
amounts not to exceed 200 microcuries total;
(iii) Technetium-99m in amounts not to exceed
30 millicuries; and
(iv) Any
radioactive material, in amounts not to exceed 3 millicuries per source,
contained in calibration or reference sources that have been manufactured,
labeled, packaged and distributed in accordance with a specific license issued
by the board pursuant to
410
IAC 5-3-13(l), a specific license
issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.74 of
10 CFR Part 32, or a specific license issued to the manufacturer by an
agreement state or a licensing state pursuant to equivalent
regulations.
(5)
(i) Any licensee or registrant who possesses
sealed sources as calibration or reference sources pursuant to 410 IAC
5-3-11(c)(4) shall cause each sealed source containing radioactive material,
other than hydrogen-3, with a half-life greater than 30 days in any form other
than gas to be tested for leakage and/or contamination at intervals not to
exceed 6 months. In the absence of a certificate from a transferor indicating
that a test has been made within 6 months prior to the transfer, the sealed
sources should not be used until tested, provided, however, that no leak tests
are required when:
(A) The source contains
100 microcuries or less of beta and/or gamma emitting material or 10
microcuries or less of alpha emitting material, or
(B) The sealed source is stored and is not
being used; such sources shall, however, be tested for leakage prior to any use
or transfer unless they have been leak tested within 6 months prior to the date
of use or transfer.
(ii)
The leak test shall be capable of detecting the presence of 0.005 microcurie of
radioactive material on the test sample. The test sample shall be taken from
the sealed source or from the surfaces of the device in which the sealed source
is mounted or stored on which contamination might be expected to accumulate.
Records of leak test results shall be kept in units of microcuries and
maintained for inspection by the board;
(iii) If the leak test reveals the presence
of 0.005 microcurie or more of removable contamination, the licensee or
registrant shall immediately withdraw the sealed source from use and shall
cause it to be decontaminated and repaired or to be disposed of in accordance
with 410 IAC 5-3 and 410 IAC 5-4. A report shall be filed within 5 days of the
test with the board describing the equipment involved, the test results, and
the corrective action taken.
(6) Any licensee or registrant who possesses
and uses calibration and reference sources pursuant to 410 IAC 5-3-11(c)(4)(iv)
shall:
(i) Follow the radiation safety and
handling instructions approved by the board, the U.S. Nuclear Regulatory
Commission, an agreement state or a licensing state and furnished by the
manufacturer on the label attached to the source, or permanent container
thereof, or in the leaflet or brochure that accompanies the source, and
maintain such instruction in a legible and conveniently available form; and
(ii) Conduct a quarterly physical
inventory to account for all sources received and possessed. Records of the
inventories shall be maintained for inspection by the board and shall include
the quantities and kinds of radioactive material, location of sources, and the
date of the inventory.
(d) Human Use of Sealed Sources. In addition
to the requirements set forth in
410
IAC 5-3-10, a specific license for human use of sealed
sources will be issued only if the applicant or, if the application is made by
an institution, the individual user:
(1) Has
specialized training in the diagnostic or therapeutic use of the sealed source
considered, or has experience equivalent to such training, and
(2) Is a physician.
(e) Use of Sealed Sources in Industrial
Radiography. In addition to the requirements set forth in
410
IAC 5-3-10, a specific license for use of sealed
sources in industrial radiography will be issued if:
(1) The applicant will have an adequate
program for training radiographers and radiographer's assistants and submits to
the board a schedule or description of such program which specifies the:
(i) Initial training,
(ii) Periodic training,
(iii) On-the-job training,
(iv) Means to be used by the licensee to
determine the radiographer's knowledge and understanding of and ability to
comply with board rules and licensing requirements, and the operating and
emergency procedures of the applicant, and
(v) Means to be used by the licensee to
determine the radiographer's assistant's knowledge and understanding of and
ability to comply with the operating and emergency procedures of the
applicant;
(2) The
applicant has established and submits to the board satisfactory written
operating and emergency procedures described in
410 IAC
5-5-13;
(3) The applicant will have an internal
inspection system adequate to assure that these rules, license provisions, and
the applicant's operating and emergency procedures are followed by
radiographers and radiographer's assistants; the inspection system shall
include the performance of internal inspections at intervals not to exceed 3
months and the retention of records of such inspections for 2 years;
(4) The applicant submits to the board a
description of the overall organizational structure pertaining to the
industrial radiography program, including specified delegations of authority
and responsibility for operation of the program;
(5) The applicant who desires to conduct his
own leak tests has established adequate procedures to be followed in testing
sealed sources for possible leakage and contamination and submits to the board
a description of such procedures including:
(i) instrumentation to be used,
(ii) method of performing tests,
and
(iii) pertinent experience of
the individual who will perform the test; and
(6) The licensee shall conduct a program for
inspection and maintenance of radiographic exposure devices and storage
containers to assure proper functioning of components important to
safety.
Notes
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