902 KAR 100:050.
General licenses.
RELATES TO: KRS
211.842-211.852, 211.990(4)
STATUTORY AUTHORITY:
KRS 194.050, 211.090, 211.844
NECESSITY, FUNCTION,
AND CONFORMITY: The Cabinet for Human Resources is empowered by KRS 211.844 to
provide by regulation for the registration and licensing of the possession or
use of any source of ionizing or electronic product radiation and the handling
and disposal of radioactive waste. The purpose of this administrative
regulation is to provide for the general licensing of certain uses of
radioactive material and specific devices containing radioactive material.
Section 1.
Applicability. The provisions of this administrative regulation apply to
persons who manufacture or use radioactive material under a general license as
provided under this administrative regulation.
Section 2. General
Licenses; Source Material. (1) A general license is hereby issued authorizing
commercial and industrial firms, research, educational and medical
institutions, and state and local government agencies to use and transfer not
more than fifteen (15) pounds of source material at any time for research,
development, educational, commercial, or operational purposes. A person
authorized to use or transfer source material pursuant to this general license
may not receive more than a total of 150 pounds of source material in any one
(1) calendar year:
(2) Persons who
receive, possess, use or transfer source material pursuant to the general
license issued in subsection (1) of this section are exempt from the provisions
of these administrative regulations to the extent that such receipt,
possession, use, or transfer is within the terms of such general license;
provided, however, that this exemption shall not be deemed to apply to any
person who is also in possession of source material under a specific license
issued pursuant to these administrative regulations.
(3) A general
license is hereby issued authorizing the receipt of title of source material
without regard to quantity. The general license under this subsection does not
authorize any person to receive, possess, use, or transfer source material.
(4) Depleted uranium
in industrial products and devices.
(a) A general
license is hereby issued to receive, acquire, possess, use, or transfer, in accordance
with the provisions of this subsection, depleted uranium contained in
industrial products or devices for the purpose of providing a concentrated mass
in a small volume of the product or device.
(b) The general
license applies only to industrial products or devices which have been
manufactured either in accordance with a specific license issued to the
manufacturer of the products or devices pursuant to 902 KAR 100:058 or in
accordance with a specific license issued to the manufacturer by the U.S. Nuclear
Regulatory Commission or an Agreement State which authorizes manufacture of the
products or devices for distribution to persons generally licensed by the U.S.
Nuclear Regulatory Commission or an Agreement State.
(c)1. Persons who
receive, acquire, possess, or use depleted uranium pursuant to this general
license shall notify the cabinet. The notification shall be submitted within
thirty (30) days after the first receipt or acquisition of such depleted
uranium. The general licensee shall furnish the following information and such
other information as may be required:
a. Name and address
of the general licensee;
b. A statement that
the general licensee has developed and will maintain procedures designed to
establish physical control over the depleted uranium and designed to prevent
transfer of such depleted uranium in any form, including metal scrap, to
persons not authorized to receive the depleted uranium; and
c. Name and/or
title, address, and telephone number of the individual duly authorized to act
for and on behalf of the general licensee in supervising the procedures.
2. The general
licensee possessing or using depleted uranium under this general license shall
report in writing to the cabinet any changes in information furnished by the
notification. The report shall be submitted within thirty (30) days after the
effective date of such change.
(d) A person who
receives, acquires, possesses, or uses depleted uranium pursuant to the general
license established by paragraph (a) of this subsection;
1. Shall not
introduce such depleted uranium, in any form, into a chemical, physical, or
metallurgical treatment or process except a treatment or process for repair or
restoration of any plating or other covering of the depleted uranium;
2. Shall not abandon
such depleted uranium;
3. Shall transfer or
dispose of such depleted uranium only by transfer in accordance with the
provisions of 902 KAR 100:040. In the case where the transferee receives the
depleted uranium pursuant to the general license established by this
subsection, the transferor shall furnish the transferee a copy of this
administrative regulation. In the case where the transferee receives the
depleted uranium pursuant to a general license contained in the U.S. Nuclear
Regulatory Commission's or Agreement State's regulation equivalent, the
transferor shall furnish the transferee a copy of this administrative
regulation accompanied by an note explaining that use of the product or device
is regulated by the U.S. Nuclear Regulatory Commission or Agreement State under
requirements substantially the same as those in this administrative regulation;
4. Within thirty
(30) days of any transfer, shall report in writing to the cabinet the name and
address of the person receiving the depleted uranium pursuant to such transfer;
and
5. Shall not export
such depleted uranium except in accordance with a license issued by the U.S.
Nuclear Regulatory Commission pursuant to 10 CFR Part 110.
(e) Any person
receiving, acquiring, possessing, using, or transferring depleted uranium
pursuant to the general license established by this subsection is exempt from
the requirements of 902 KAR 100:020 and 902 KAR 100:165 of these administrative
regulations with respect to the depleted uranium covered by that general license.
Section 3. General
Licenses; Radioactive Material Other than Source Material. (1) A general
license is hereby issued to transfer, receive, acquire, own, possess, and use
radioactive material incorporated in the following devices or equipment which
have been manufactured, tested and labeled by the manufacturer in accordance
with a specific license issued to the manufacturer by the U.S. Nuclear
Regulatory Commission for use pursuant to 10 CFR Part 31.3;
(a) Static
elimination device. Devices designed for use as static eliminators which
contain, as a sealed source or sources, radioactive material consisting of a
total of not more than 500 microcuries of polonium-210 per device; and
(b) Ion generating
tube. Devices designed for ionization of air which contain, as a sealed source
or sources, radioactive material consisting of a total of not more than 500
microcuries of polonium-210 per device or a total of not more than fifty (50)
millicuries of hydrogen-3 (tritium) per device.
(2) The general
license provided in subsection (1) of this section is subject to all applicable
provisions of these administrative regulations including provisions relating to
the labeling of containers.
(3) Certain
measuring, gauging or controlling devices.
(a) A general
license is hereby issued to commercial, and industrial firms and to research,
educational and medical institutions, individuals in the conduct of their
business, and state or local government agencies to own, receive, acquire,
possess, use or transfer in accordance with the provisions of this subsection,
radioactive material, excluding special nuclear material, contained in devices
designed and manufactured for the purpose of detecting, measuring, gauging or
controlling thickness, density, level, interface location, radiation, leakage,
or qualitative or quantitative chemical composition, or for producing light or
an ionized atmosphere.
(b) The general
license in this subsection applies only to radioactive material contained in
devices which have been manufactured and labeled in accordance with the
specifications contained in a specific license issued by the cabinet pursuant
to 902 KAR 100:058 or in accordance with the specifications contained in a
specific license issued by the U.S. Nuclear Regulatory Commission or an
Agreement State which authorizes distribution of devices to persons generally
licensed by the U.S. Nuclear Regulatory Commission or an Agreement State.
Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use
of radioactive control devices in food production require certain additional
labeling thereon which is found in 21 CFR Part 179.21.
(c) Any person who
owns, receive, acquires, possesses, uses, or transfers radioactive material in
a device pursuant to the general license in this subsection:
1. Shall assure that
all labels affixed to the device at the time of receipt, and bearing a
statement that removal of the label is prohibited, are maintained thereon and
shall comply with all instructions and precautions provided by such labels;
2. Shall assure that
the device is tested for leakage of radioactive material and proper operation
of the "on-off" mechanism and indicator, if any, at no longer than
six (6) month intervals or at such other intervals as are specified in the label;
however,
a. Devices
containing only krypton need not be tested for leakage of radioactive material,
and
b. Devices
containing only tritium or not more than 100 microcuries of other beta and/or
gamma-emitting material or ten (10) microcuries of alpha-emitting material and
devices held in storage in the original shipping container prior to initial
installation need not be tested for any purpose;
3. Shall assure that
other testing, installation, servicing, and removal from installation involving
the radioactive material, its shielding or containment, are performed:
a. In accordance
with the instructions provided by the labels; or
b. By a person
holding an applicable specific license from the cabinet, the U.S. Nuclear
Regulatory Commission or an Agreement State to perform such activities;
4. Shall maintain
records showing compliance with the requirements of this subsection. The
records shall show the results of tests. The records also shall show the names
of persons and dates of performance of testing, installation, servicing, and
removal from installation concerning the radioactive material, its shielding or
containment. Records of tests for leakage of radioactive material shall be
maintained for one (1) year after the next required leak test is performed or until
the sealed source is transferred or disposed. Records of tests of the
"on-off" mechanism and indicator shall be maintained for one (1) year
after the next required test of the "on-off" mechanism and indicator
is performed or until the sealed source is transferred or disposed. Records
which are required by subparagraph 3 of this paragraph shall be maintained for
a period of two (2) years from the date of the recorded event or until the
device is transferred or disposed;
5. Upon the
occurrence of a failure of or damage to, or any indication of a possible
failure of or damage to, the shielding of the radioactive material or the
"on-off" mechanism or indicator, or upon the detection of 0.005
microcurie or more removable radioactive material, shall immediately suspend
operation of the device until it has been repaired by the manufacturer or other
person holding an applicable specific license from the cabinet, the U.S.
Nuclear Regulatory Commission or an Agreement State to repair such devices, or
disposed of by transfer to a person authorized by an applicable specific
license to receive the radioactive material contained in the device and, within
thirty (30) days, furnish to the cabinet a report containing a brief
description of the event and the remedial action taken;
6. Shall not abandon
the device containing radioactive material;
7. Except as
provided in subparagraph 8 of this paragraph, shall transfer or dispose of the
device containing radioactive material only by transfer to a specific licensee
of the cabinet, the U.S. Nuclear Regulatory Commission or an Agreement State
whose specific license authorizes him to receive the device and within thirty
(30) days after transfer of a device to a specific licensee shall furnish to
the cabinet a report containing identification of the device by manufacturer's
name and model number and the name and address of the person receiving the
device. No report is required if the device is transferred to the specific
licensee in order to obtain a replacement device;
8. Shall transfer
the device to another general licensee only:
a. Where the device
remains in use at a particular location. In such case the transferor shall give
the transferee a copy of this administrative regulation and any safety
documents identified in the label on the device and within thirty (30) days of
the transfer, report to the cabinet the manufacturer's name and model number of
device transferred, the name and address of the transferee, and the name and/or
position of an individual who may constitute a point of contact between the
cabinet and the transferee; or
b. Where the device
is held in storage in the original shipping container at its intended location
of use prior to initial use by a general licensee; and
9. Shall comply with
the provisions of 902 KAR 100:020 for reporting radiation incidents, theft, or
loss of licensed material, but shall be exempt from the other requirements of
902 KAR 100:020 and 902 KAR 100:165.
(d) The general
license in this subsection does not authorize the manufacture of devices
containing radioactive material.
(e) The general
license provided in this subsection is subject to the provisions of 902 KAR
100:012, 902 KAR 100:015, 902 KAR 100:040, Sections 7, 13 and 14 and 902 KAR
100:070.
(f) A general
license is hereby issued to any person who holds a specific license issued by
the U.S. Nuclear Regulatory Commission or an Agreement State authorizing the
holder to manufacture, install, or service a device described in this
subsection to install and service such device provided:
1. The device has
been manufactured, labeled, installed, and serviced in accordance with
applicable provisions of the specific license issued to such person by the U.S.
Nuclear Regulatory Commission or an Agreement State; and
2. Such person
assures that any labels required to be affixed to the device under regulations
of U.S. Nuclear Regulatory Commission or an Agreement State which licensed
manufacture of the device bear a statement that removal of the label is
prohibited.
(4) Luminous safety
devices for aircraft.
(a) A general
license is hereby issued to own, receive, acquire, possess, and use tritium or
promethium-147 contained in luminous safety devices for use in aircraft,
provided:
1. Each device
contains not more than ten (10) curies of tritium or 300 millicuries of
promethium-147; and
2. Each device has
been manufactured, assembled, or imported in accordance with a specific license
issued by the U.S. Nuclear Regulatory Commission, or each device has been
manufactured or assembled in accordance with the specifications contained in a
specific license issued by the cabinet or any Agreement State to the
manufacturer or assembler of such device pursuant to licensing requirements
equivalent to those in Section 32.53 of 10 CFR, Part 32, of the regulations of
the U.S. Nuclear Regulatory Commission.
(b) Persons who own,
receive, acquire, possess, or use luminous safety devices pursuant to the
general license in paragraph (a) of this subsection are exempt from the
requirements of 902 KAR 100:020 and 902 KAR 100:165 except that they shall
comply with the provisions relating to reports of theft or loss of sources of
radiation and the provisions relating to notification of incidents.
(c) This general
license does not authorize the manufacture, assembly, or repair of luminous
safety devices containing tritium or promethium-147.
(d) This general
license does not authorize the ownership, receipt, acquisition, possession or
use of promethium-147 contained in instrument dials.
(e) This general
license is subject to the provisions of 902 KAR 100:015, 902 KAR 100:040,
Sections 7, 13, and 14 and 902 KAR 100:070.
(5) Calibration and
reference sources.
(a) A general
license is hereby issued to those persons listed below to own, receive,
acquire, possess, use, and transfer, in accordance with the provisions of
paragraphs (d) and (e) of this subsection, americium-241 in the form of
calibration or reference sources:
1. Any person who
holds a specific license issued by the cabinet which authorizes him to receive,
possess, use, and transfer radioactive material; and
2. Any person who
holds a specific license issued by the U.S. Nuclear Regulatory Commission which
authorizes him to receive, possess, use, and transfer special nuclear material.
(b) A general
license is hereby issued to receive, possess, use, and transfer plutonium in
the form of calibration or reference sources in accordance with the provisions
of paragraphs (d) and (e) of this subsection to any person who holds a specific
license issued by the cabinet which authorizes him to receive, possess, use,
and transfer radioactive material.
(c) A general
license is hereby issued to own, receive, possess, use, and transfer radium-226
in the form of calibration or reference sources in accordance with the provisions
of paragraphs (d) and (e) of this subsection to any person who holds a specific
license issued by the cabinet which authorizes him to receive, possess, use,
and transfer radioactive material.
(d) The general
license in paragraphs (a), (b) and (c) of this subsection apply only to
calibration or reference sources which have been manufactured in accordance
with the specifications contained in a specific license issued to the
manufacturer or importer of the sources by the U.S. Nuclear Regulatory
Commission pursuant to Section 32.57 of 10 CFR, Part 32, or Section 70.39 of 10
CFR, Part 70, or which may have been manufactured in accordance with the
specifications contained in a specific license issued to the manufacturer by
the cabinet or any Agreement State pursuant to licensing requirements
equivalent to those contained in 902 KAR 100:058.
(e) Persons who own,
receive, acquire, possess, use, and transfer one (1) or more calibration or
reference sources pursuant to these general licenses:
1. Shall not possess
at any one (1) time, at any one (1) location of storage or use, more than five
(5) microcuries of americium 241, five (5) microcuries of plutonium or five (5)
microcuries of radium-226 in such sources;
2. Shall not
receive, possess, use, or transfer such source unless the source, or the
storage container, bears a label which includes the following statement or a
substantially similar statement which contains the information called for in
the following statement:
"The
receipt, possession, use and transfer of this source, Model ______, Serial No.
_______, are subject to a general license and the regulations of the U.S.
Nuclear Regulatory Commission or of a state with which the Commission has
entered into an agreement for the exercise of regulatory authority. Do not
remove this label.
CAUTION
- RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS (AMERICIUM-241). (PLUTONIUM)
(RADIUM-226)*. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
Name
of Manufacturer or Importer"
*Showing
only the name of the appropriate material.
3. Shall not
transfer, abandon, or dispose of such source except by transfer to a person
authorized by a license from the cabinet, U.S. Nuclear Regulatory Commission,
or an Agreement State to receive the source;
4. Shall store such
source, except when the source is being used, in a closed container adequately
designed and constructed to contain americium-241, plutonium or radium-226
which might otherwise escape during storage; and
5. Shall not use
such source for any purpose other than the calibration of radiation detectors
or the standardization of other sources.
(f) The general
licenses provided in paragraphs (a), (b) and (c) of this subsection are subject
to the provisions of 902 KAR 100:015, 902 KAR 100:020, 902 KAR 100:040,
Sections 7, 13, and 14, 902 KAR 100:070, and 902 KAR 100:165.
(g) These general
licenses do not authorize the manufacture of calibration or reference sources
containing americium-241, plutonium, or radium-226.
(6) A general
license is hereby issued to own radioactive material without regard to
quantity. The general license under this subsection does not authorize the
licensee to manufacture, produce, transfer, receive, possess, or use
radioactive material.
(7) Ice detection
devices.
(a) A general
license is hereby issued to own, receive, acquire, possess, use, and transfer
strontium-90 contained in ice detection devices, provided each device contains
not more than fifty (50) microcuries of strontium-90 and each device has been
manufactured or imported in accordance with a specific license, issued by the
U.S. Nuclear Regulatory Commission or each device has been manufactured in
accordance with the specifications contained in a specific license issued by
the cabinet or any Agreement State to the manufacturer of such device pursuant
to licensing requirements equivalent to those in 902 KAR 100:058.
(b) Persons who own,
receive, acquire, possess, use, or transfer strontium-90 contained in ice
detection devices pursuant to the general license in paragraph (a) of this
subsection:
1. Shall, upon
occurrence of visually observable damage, such as a bend or crack or
discoloration from overheating to the device, discontinue use of the device
until it has been inspected, tested for leakage, and repaired by a person
holding a specific license from the cabinet, U.S. Nuclear Regulatory Commission
or an Agreement State to manufacture or service such devices; or shall dispose
of the device pursuant to the provisions of these administrative regulations;
2. Shall assure that
all labels affixed to the device at the time of receipt, and which bear a
statement which prohibits removal of the labels, are maintained thereon;
3. Are exempt from
the other requirements of these administrative regulations except that such
persons shall comply with 902 KAR 100:015, 902 KAR 100:020, Sections 16 and 17,
902 KAR 100:021, 902 KAR 100:040, Sections 7, 13, and 14 and 902 KAR 100:070.
(c) This general
license does not authorize the manufacture, assembly, disassembly or repair of
strontium-90 sources in ice detection devices.
Section 4. General
License for use of Radioactive Material for Certain In Vitro Clinical or
Laboratory Testing. (1) A general license is hereby issued to any physician,
veterinarian, clinical laboratory, or hospital to receive, acquire, possess,
transfer or use, for any of the following stated tests, in accordance with the
provisions of subsections (2), (3), (4), (5), and (6) of this section, the
following radioactive materials in prepackaged units for use in In Vitro
clinical or laboratory tests not involving internal or external administration
of radioactive material, or the radiation therefrom, to human beings or
animals:
(a) Iodine-125, in
units not exceeding ten (10) microcuries each.
(b) Iodine-131, in
units not exceeding ten (10) microcuries each.
(c) Carbon-14, in
units not exceeding ten (10) microcuries each.
(d) Hydrogen-3
(Tritium), in units not exceeding fifty (50) microcuries each.
(e) Iron-59, in
units not exceeding twenty (20) microcuries each.
(f) Cobalt-57, in
units not exceeding ten (10) microcuries each.
(g) Mock iodine-125
reference or calibration sources, in units not exceeding 0.05 microcurie of
iodine-29 and 0.005 microcurie of americium-241 each.
(h) Selenium-75, in
units not exceeding ten (10) microcuries each.
(2) No person shall
receive, acquire, possess, use or transfer radioactive material pursuant to the
general license established by subsection (1) of this section until he has
filed form KR-251, "Registration Certificate - In Vitro Testing" with
the cabinet and received from the cabinet a validated copy of form KR-251 with
certification number assigned. The physician, veterinarian, clinical
laboratory, or hospital shall furnish on form KR-251, the following information
and such other information as may be required by that form:
(a) Name and address
of the physician, veterinarian, clinical laboratory, or hospital;
(b) The location of
use; and
(c) A statement that
the physician, veterinarian, clinical laboratory, or hospital has appropriate
radiation measuring instruments to carry out in vitro clinical or laboratory
tests with radioactive materials as authorized under the general license in
subsection (1) of this section and that such tests will be performed only by
personnel competent in the use of such instruments and in the handling of the
radioactive material.
(3) A person who
receives, acquires, possesses or uses radioactive material pursuant to the
general license established by subsection (1) of this section shall comply with
the following:
(a) The general
licensee shall not possess at any one (1) time, pursuant to the general license
in subsection (1) of this section, at any one (1) location of storage or use, a
total amount of iodine-125, iodine-131, selenium-75, cobalt-57 and/or iron-59
in excess of 200 microcuries.
(b) The general
licensee shall store the radioactive material, until used, in the original
shipping container or in a container providing equivalent radiation protection.
(c) The general
licensee shall use the radioactive material only for the uses authorized by
subsection (1) of this section.
(d) The general
licensee shall not transfer the radioactive material to a person who is not
authorized to receive it pursuant to a license issued by the cabinet, the U.S.
Nuclear Regulatory Commission, or any Agreement State, nor transfer the
radioactive material in any manner other than in the unopened, labeled shipping
container as received from the supplier.
(e) The general
licensee shall dispose of the Mock iodine-125 reference or calibration sources
as required by 902 KAR 100:021, Section 2.
(4) The general
licensee shall not receive, acquire, possess, or use radioactive material
pursuant to subsection (1) of this section:
(a) Except as
prepackaged units which are labeled in accordance with the provisions of a
specific license issued under these administrative regulations or in accordance
with the provisions of an applicable specific license issued pursuant to 902
KAR 100:058 or in accordance with the provisions of a specific license issued
by the U.S. Nuclear Regulatory Commission, or any Agreement State which
authorizes the manufacture and distribution of iodine-125, iodine-131,
carbon-14, hydrogen-3 (tritium), selenium-75, cobalt-57, Mock iodine-125 or
iron-59 to persons generally licensed under subsection (1) of this section or
its equivalent;
(b) Unless the
following statement, or a substantially similar statement which contains the
information called for in the following statement, appears on a label affixed
to each prepackaged unit or appears in a leaflet or brochure which accompanies
the package:
"This
radioactive material may be received, acquired, possessed, and used only by
physicians, veterinarians, clinical laboratories or hospitals and only for in
vitro clinical or laboratory tests not involving internal or external
administration of the material, or the radiation therefrom, to human beings or
animals. Its receipt, acquisition, possession, use and transfer are subject to
the regulations and a general license of the U.S. Nuclear Regulatory Commission
or of a state with which the commission has entered into an agreement for the
exercise of regulatory authority.
Name
of Manufacturer
(5) The physician,
veterinarian, clinical laboratory, or hospital possessing or using radioactive
material under the general license of subsection (1) of this section shall
report in writing to the cabinet, any changes in the information furnished by
him in the "Registration Certificate - In Vitro Testing," form
KR-251. The report shall be furnished within thirty (30) days after the
effective date of such change.
(6) Any person using
radioactive material pursuant to the general license of subsection (1) of this
section is exempt from the requirements 902 KAR 100:020, 902 KAR 100:021, and
902 KAR 100:165, except that such person using the Mock-iodine 125 shall comply
with the provisions of 902 KAR 100:020, Sections 16 and 17 and 902 KAR 100:021.
(7) Any licensee who
is licensed pursuant to 902 KAR 100:073 for medical use of radioactive material
also is authorized to use radioactive material under the general license in
this section for the specified in vitro uses without filing form KR-251 as
required; provided, that the licensee is subject to the other provisions of
this section.
Section 5. General
License for Medical Diagnostic Uses. (1) A general license is hereby issued to
any physician to receive, possess, transfer, or use radioactive material set
forth below for the stated diagnostic uses, provided, however, that the use is
in accordance with the provisions of subsections (2), (3), and (4) of this
section, the radioactive material is in the form of capsules, disposable
syringes, or other prepackaged individual doses; and the radioactive material
has been manufactured in accordance with a specific license issued by the
cabinet pursuant to 902 KAR 100:058, or by the U.S. Nuclear Regulatory
Commission or any Agreement State pursuant to equivalent regulations
authorizing distribution to persons generally licensed pursuant to this
subsection or its equivalent:
(a) Iodine-131 as
sodium iodide for measurement of thyroid uptake;
(b) Iodine-131 as
iodinated human serum albumin (IHSA) for determinations of blood and blood
plasma volume;
(c) Iodine-125 as
iodinated human serum albumin (IHSA) for determinations of blood and blood
plasma volume;
(d) Cobalt-57 for
the measurement of intestinal absorption of cyanocobalamin;
(e) Cobalt-58 for
the measurement of intestinal absorption of cyanocobalamin;
(f) Cobalt-60 for
the measurement of intestinal absorption of cyanocobalamin;
(g) Chromium-51 as
sodium radiochromate for determination of red blood cell volumes and studies of
red blood cell survival time.
(2) Manufacturers of
radiopharmaceuticals which are under a general license shall affix a certain
identifying label to the container or in the leaflet or brochure which
accompanies the radiopharmaceutical as otherwise provided in these
administrative regulations.
(3) No physician
shall receive, possess, use, or transfer radioactive material pursuant to the
general license established by subsection (1) of this section until he has
filed form KR-252, "Registration Certificate - Medical Use of Radioactive
Material" with the cabinet and received from the cabinet a validated copy
of the form KR-252 with certification number assigned. The generally licensed
physician shall furnish on form KR-252 the following information and such other
information as may be required by that form:
(a) Name and address
of the generally licensed physician;
(b) A statement that
the generally licensed physician is a duly licensed physician authorized to
dispense drugs in the practice of medicine in the state of Kentucky and
specifying the license number; and
(c) A statement that
the generally licensed physician has appropriate radiation measuring
instruments to carry out the diagnostic procedures for which he proposes to use
the radioactive material under the general license of this section and that he
is competent in the use of such instruments.
(4) A physician who
receives, possesses or uses a pharmaceutical containing radioactive material
pursuant to the general license established by subsection (1) of this section
shall comply with the following:
(a) He shall not
possess at any one time pursuant to the general license in subsection (1) of
this section more than:
1. 200 microcuries
of iodine-131;
2. 200 microcuries
of iodine-125;
3. Five (5)
microcuries of cobalt-57;
4. Five (5)
microcuries of cobalt-60;
5. Five (5)
microcuries of cobalt-58; and
6. 200 microcuries
of chromium-51.
(b) He shall store
the pharmaceutical, until administered, in the original shipping container or a
container providing the equivalent radiation protection.
(c) He shall use the
pharmaceutical only for the uses authorized by subsection (1) of this section.
(d) He shall not
administer the pharmaceutical to a woman with confirmed pregnancy or to a
person under eighteen (18) years of age.
(e) He shall not
transfer the radioactive material to a person who is not authorized to receive
it pursuant to a license issued by the cabinet, the U.S. Nuclear Regulatory
Commission or any Agreement State, or in any manner other than in the unopened,
labeled shipping container as received from the supplier, except by
administering it to a patient.
(5) The generally licensed
physician possessing or using radioactive material under the general license of
subsection (1) of this section shall report to the cabinet, any changes in the
information furnished by him in the "Registration Certificate - Medical
Use of Radioactive Material," form KR-252. The report shall be submitted
within thirty (30) days after the effective date of change.
(6) Any person using
radioactive material pursuant to the general license of subsection (1) of this
section is exempt from the requirements of 902 KAR 100:020, 902 KAR 100:021 and
902 KAR 100:165. (1 Ky.R. 397; eff. 2-5-75; Am. 12 Ky.R. 1023; eff. 1-3-86; 16
Ky.R. 2546; eff. 6-27-90.)
