WAC 246-235-097
Manufacture and distribution of
radioactive material for certain in vitro clinical or
laboratory testing under general license. An application for
a specific license to manufacture or distribute radioactive
material for use under the general license of WAC 246-233-040
will be approved if:
(1) The applicant satisfies the general requirements
specified in WAC 246-235-020;
(2) The radioactive material is to be prepared for
distribution in prepackaged units of:
(a) Iodine-125 in units not exceeding 370 kilobecquerels
(10 microcuries) each;
(b) Iodine-131 in units not exceeding 370 kilobecquerels
(10 microcuries) each;
(c) Carbon-14 in units not exceeding 370 kilobecquerels
(10 microcuries) each;
(d) Hydrogen-3 (tritium) in units not exceeding 1.85
megabecquerels (50 microcuries) each;
(e) Iron-59 in units not exceeding 740 kilobecquerels (20
microcuries) each;
(f) Cobalt-57 in units not exceeding 370 kilobecquerels
(10 microcuries) each;
(g) Selenium-75 in units not exceeding 370 kilobecquerels
(10 microcuries) each;
(h) Mock Iodine-125 in units not exceeding 1.85
kilobecquerels (0.05 microcurie) of iodine-129 and 185
becquerels (0.005 microcurie) of americium-241 each.
(3) Each prepackaged unit bears a durable, clearly
visible label:
(a) Identifying the radioactive contents as to chemical
form and radionuclide, and indicating that the amount of
radioactivity does not exceed 370 kilobecquerels (10
microcuries) of iodine-125, iodine-131, carbon-14, cobalt-57,
or selenium-75; 1850 kilobecquerels (50 microcuries) of
hydrogen-3 (tritium); 740 kilobecquerels (20 microcuries) of
iron-59; or Mock Iodine-125 in units not exceeding 1.85
kilobecquerels (0.05 microcurie) of iodine-129 and 185
becquerels (0.005 microcurie) of americium-241 each; and
(b) Displaying the radiation caution symbol described in
WAC 246-221-120 (1)(a) and the words, "CAUTION, RADIOACTIVE
MATERIAL," and "Not for internal or external use in humans or
animals."
(4) 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:
(a) 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 United States 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
(b) 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 a licensing state.
. . . . . . . . . . . .
Name of manufacturer
(5) The label affixed to the unit, or the leaflet or
brochure which accompanies the package, contains adequate
information as to the precautions to be observed in handling
and storing such radioactive material. In the case of the
Mock Iodine-125 reference or calibration source, the
information accompanying the source must also contain
directions to the licensee regarding the waste disposal
requirements set out in WAC 246-221-170 of these regulations.