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 (
0.05
µCi) of iodine-129 and
1.85 Bq (
0.005
µCi) 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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