WAC 246-233-040
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:
(a) Iodine-125, in units not exceeding 370 kilobecquerels
(10 microcuries) each 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.
(b) Iodine-131, in units not exceeding 370 kilobecquerels
(10 microcuries) each 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.
(c) Carbon-14, in units not exceeding 370 kilobecquerels
(10 microcuries) each 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.
(d) Hydrogen-3 (tritium), in units not exceeding 1.85
megabecquerels (50 microcuries) each 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.
(e) Iron-59, in units not exceeding 740 kilobecquerels
(20 microcuries) each 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.
(f) Cobalt-57, in units not exceeding 370 kilobecquerels
(10 microcuries) each 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.
(g) Selenium-75, in units not to exceed 370
kilobecquerels (10 microcuries) each 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.
(h) Mock Iodine-125 reference or calibration sources, in
units not exceeding 1.85 kilobecquerels (0.05 microcurie) of
Iodine-129 and 185 becquerels (0.005 microcurie) of
Americium-241 each 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.
*Note:
The new drug provisions of the Federal Food, Drug and Cosmetic Act also govern the availability and use of any
specific diagnostic drugs in interstate commerce.
(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 that
person has received a validated copy of department Form RHF-15
"Certificate - in vitro testing with radioactive material
under general license." Annual validation requires
resubmittal of revised department Form RHF-15 and submittal of
the annual fee to the department. The physician,
veterinarian, clinical laboratory or hospital shall furnish on
department Form RHF-15 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 material 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
time, pursuant to the general license in subsection (1) of
this section at any one location of storage or use, a total
amount of Iodine-125, Iodine-131, Selenium-75, Iron-59, and/or
Cobalt-57 in excess of 7.4 megabecquerels (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 department, the
United States Nuclear Regulatory Commission, any agreement
state or licensing 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 described in
subsection (1)(h) of this section as required by WAC 246-221-170.
(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 provision of an applicable specific
license issued pursuant to WAC 246-235-097 or in accordance
with the provisions of a specific license issued by the United
States Nuclear Regulatory Commission, or any agreement state
or licensing 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 this subsection or its
equivalent; and
(b) Unless one of the following statements, as
appropriate, or a substantially similar statement which
contains the information called for in one of the following
statements, appears on a label affixed to each prepackaged
unit or appears in a leaflet or brochure which accompanies the
package:
(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 department, any changes in the information
previously furnished in the "Certificate - in vitro testing
with radioactive material under general license," department
Form RHF-15. The report shall be furnished within thirty days
after the effective date of such change.
(6) This general license is subject to the provisions of
WAC 246-220-020, 246-220-030, 246-220-040, 246-220-060,
246-220-070, 246-220-090 and 246-220-100. In addition, any
person using radioactive material pursuant to the general
license of subsection (1) of this section is exempt from the
requirements of chapters 246-221 and 246-222 WAC with respect
to radioactive material covered by that general license,
except that such persons using the Mock Iodine-125 described
in subsection (1)(h) of this section shall comply with the
provisions of WAC 246-221-170, 246-221-240, and 246-221-250
and of these regulations.