An application for a specific license to manufacture or
distribute radioactive material for use under the general license in rule
3701:1-46-11
of the Administrative Code will be approved if:
(A) The applicant satisfies the general
requirements specified in rule
3701:1-40-15
of the Administrative Code.
(B) The
radioactive material is to be prepared for distribution in prepackaged units
of:
(1) Iodine-125 in units not exceeding
0.37 megabecquerel (ten microcuries) each.
(2) Iodine-131 in units not exceeding 0.37
megabecquerel (ten microcuries) each.
(3) Carbon-14 in units not exceeding 0.37
megabecquerel (ten microcuries) each.
(4) Hydrogen-3 (tritium) in units not
exceeding 1.85 megabecquerels (fifty microcuries) each.
(5) Iron-59 in units not exceeding 0.74
megabecquerel (twenty microcuries) each.
(6) Selenium-75 in units not exceeding 0.37
megabecquerel (ten microcuries) each.
(7) Mock iodine-125 in units not exceeding
1.85 kilobecquerels (0.05 microcurie) of iodine-129 and 0.185 kilobecquerel
(0.005 microcurie) of americium-241 each.
(8) Cobalt-57 in units not exceeding 0.37
megabecquerel (ten microcuries) each.
(C) Each prepackaged unit bears a durable,
clearly visible label:
(1) Identifying the
radioactive contents as to chemical form and radionuclide, and indicating that
the amount of radioactivity does not exceed 0.37 megabecquerel (ten
microcuries) of iodine-131, iodine-125, selenium-75, cobalt-57, or carbon-14;
1.85 megabecquerels (fifty microcuries) of hydrogen-3 (tritium); or 0.74
megabecquerel (twenty microcuries) of iron-59; or mock iodine-125 in units not
exceeding 1.85 kilobecquerels (0.05 microcurie) of iodine-129 and 0.185
kilobecquerel (0.005 microcurie) of americium-241 each; and
(2) Displaying the radiation symbol described
in paragraph (A) of rule
3701:1-38-18
of the Administrative Code and the words, "Caution, Radioactive Material", and
"Not for Internal or External Use in Humans or Animals."
(D) The following statement, or a
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:
"The radioactive material may be 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 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
nuclear
Regulatory
regulatory
Commission
commission
or of a state with which the Commission
commission has entered into an agreement for the
exercise of regulatory authority.
(Name of manufacturer)"
(E) 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
paragraph (A) of rule
3701:1-38-19 of
the Administrative Code.
Notes
Ohio Admin. Code
3701:1-46-42
Effective:
5/23/2022
Five Year Review (FYR) Dates:
3/8/2022 and
05/23/2027
Promulgated
Under:
119.03
Statutory Authority:
3748.04
Rule Amplifies:
3748.04
Prior Effective Dates: 10/20/2002, 01/20/2008, 10/04/2010,
12/10/2012
