Current through Register Vol. 24-18, September 15, 2024
(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 material 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 kilobecquer-els (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 kilobecquer-els (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 Ameri-cium-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 annual
resubmittal of revised department Form RHF-15 and submit-tal 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, or Cobalt-57 in excess of 7.4 megabecquerels
(200 microcu-ries).
(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 NRC, or an 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 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 NRC, or an 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 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:
This radioactive material shall 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 rules and a general license of
an agreement state or the NRC.
.............................
Name of manufacturer
This radioactive material shall 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 rules and a general license of
an agreement state or the NRC.
.............................
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 department, any changes in the information previously furnished in the
"Certificatein-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
rules.
Statutory Authority:
RCW
70.98.050 and
70.98.080. 09-06-003, §
246-233-040, filed 2/18/09, effective 3/21/09. Statutory Authority:
RCW
70.98.050. 04-04-055, § 246-233-040,
filed 1/30/04, effective 3/1/04.
