180 NAC 3-008.09 establishes a general license authorizing
physicians, veterinarians, clinical laboratories, and hospitals to possess
certain small quantities of radioactive material for In Vitro clinical or
laboratory tests not involving the internal or external administration of the
radioactive material or the radiation therefrom to human beings or animals.
Possession of radioactive material under 180 NAC 3-008.09 is not authorized
until the physician, veterinarian, clinical laboratory, or hospital has filed
Form NRH-17 and received from the Department a validated copy of Form NRH-17
with a certification number.
008.09
GENERAL
LICENSE FOR USE OF RADIOACTIVE MATERIAL FOR CERTAIN IN VITRO CLINICAL OR
LABORATORY TESTING.
The following applies to the general license for use of
radioactive material for certain in vitro clinical or laboratory
testing:
(A) A general license is
issued to any physician, veterinarian in the practice of veterinary medicine,
clinical laboratory or hospital to receive, acquire, possess, transfer or use,
for any of the following stated tests, according to the provisions of 180 NAC
3-008.09(B) through (F), 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 resulting radiation,
to human beings or animals:
(i) Iodine-125,
iodine-131, selenium-75, cobalt-57, and carbon-14 in units not exceeding 370
kBq (10 µCi) each;
(ii)
Hydrogen-3 (tritium), in units not exceeding 1.85 MBq (50 µCi)
each;
(iii) Iron-59, in units not
exceeding 740 kBq (20 µCi) each; or
(iv) Mock Iodine-125 reference or calibration
sources, in units not exceeding 1.85 kBq ( 0.05µCi) of iodine-129 and
1.85 Bq ( 0.005µCi) of americium-241 each.
(v) Colbalt-57, in units not exceeding 0.37
MBq (01 µCi) each;
(B) No person receives, acquires, possesses,
uses or transfers radioactive material according to the general license
established by 180 NAC 3-008.09(A) until they file Department Form NRH-17,
"Certificate - In Vitro Testing with Radioactive Material Under General
License", with the Department and received from the Department a validated copy
of Department Form NRH-17 with certification number assigned. The physician,
veterinarian, clinical laboratory or hospital must furnish on Department Form
NRH-17 the following information and such other information as may be required
by that form:
(i) Name and address of the
physician, veterinarian, clinical laboratory or hospital;
(ii) The location of use; and
(iii) A statement that the physician,
veterinarian in the practice of veterinary medicine, clinical laboratory or
hospital has appropriate radiation measuring instruments to carry out in vitro
clinical or laboratory tests with radioactive material as authorized under the
general license in 180 NAC 3-008.09(A) 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;
(C) A person who receives, acquires,
possesses or uses radioactive material according to the general license
established by 180 NAC 3-008.09(A) must comply with the following:
(i) The general licensee must not possess at
any one time, according to the general license in 180 NAC 3-008.09(A) at any
one location of storage or use a total amount of iodine-125, iodine-131,
iron-59, cobalt-57 and selenium-75 in excess of 7.4 MBq (200 mCi);
(ii) The general licensee must store the
radioactive material, until used, in the original shipping container or in a
container providing equivalent radiation protection;
(iii) The general licensee must use the
radioactive material only for the uses authorized by 180 NAC
3-008.09(A);
(iv) The general
licensee must not transfer the radioactive material to a person who is not
authorized to receive it according to a license issued by the Department, the
U.S. Nuclear Regulatory Commission (NRC), 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; and
(v) The general licensee must dispose of the
Mock Iodine-125 reference or calibration sources described in 180 NAC
3-008.09(A)(iv) as required by 180 NAC
4-039 and
4-044.
(D) The general licensee must not receive,
acquire, possess, or use radioactive material according to 180 NAC 3-008.09(A):
(i) Other than as prepackaged units which are
labeled according to the provisions of an applicable specific license issued
according to 180 NAC 3-014.08 or according to the provisions of a specific
license issued by the U.S. Nuclear Regulatory Commission (NRC), or any
Agreement State which authorizes the manufacture and distribution of
iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75,
cobalt-57, or Mock Iodine-125 to persons generally licensed under 180 NAC
3-008.09 or its' equivalent, and
(ii) Unless the following statement, or
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 is received, acquired, possessed,
and used only by physicians, veterinarians in the practice of veterinary
medicine, clinical laboratories or hospitals and only for in vitro clinical or
laboratory tests not involving internal or external administration of the
material, or the resulting radiation, 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 (NRC) or of a State
with which the Commission has entered into an agreement for the exercise of
regulatory authority.
____________________________
Name of Manufacturer
(E) The physician, veterinarian in the
practice of veterinary medicine, clinical laboratory or hospital possessing or
using radioactive material under the general license of 180 NAC 3-008.09(A)
must report in writing to the Department, any changes in the information
furnished by him or her in the "Certificate - In Vitro Testing with Radioactive
Material Under General License", Department Form NRH-17. The report must be
furnished within 30 days after the effective date of such change; and
(F) Any person using radioactive material
according to the general license of 180 NAC 3-008.09(A) is exempt from the
requirements of 180 NAC 4 and 10 with respect to radioactive material covered
by that general license, other than such persons using the Mock Iodine-125
described in 180 NAC 3-008.09(A)(iv) must comply with the provisions of 180 NAC
4-039,
4-057, and
4-058.
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