902 Kar 100:050. General Licenses

Link to law: http://www.lrc.ky.gov/kar/902/100/050.htm
Published: 2015

      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.)
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