Ohio Admin. Code 3701:1-46-11 - General license for use of radioactive material for certain in-vitro clinical or laboratory testing
(A) A general license is hereby 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, in accordance with the provisions of paragraphs
(B) to (F) of this rule, the following byproduct or
accelerator produced
radioactive
materials in prepackaged units:
(1)
Iodine-125, in units not exceeding three hundred seventy kilobecquerels (ten
microcuries) each for use in in-vitro clinical or laboratory tests not
involving internal or external administration of byproduct or accelerator produced
radioactive material, or the radiation therefrom, to
human beings or animals.
(2)
Iodine-131, in units not exceeding three hundred seventy kilobecquerels (ten
microcuries) each for use in in-vitro clinical or laboratory tests not
involving internal or external administration of byproduct
radioactive
material, or the radiation therefrom, to human beings or animals.
(3) Carbon-14, in units not exceeding three
hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro
clinical or laboratory tests not involving internal or external administration
of byproduct
radioactive material, or the radiation therefrom, to
human beings or animals.
(4)
Hydrogen-3 (tritium), in units not exceeding 1.85 megabecquerels (fifty
microcuries) each for use in in-vitro clinical or laboratory tests not
involving internal or external administration of byproduct
radioactive
material, or the radiation therefrom, to human beings or animals.
(5) Iron-59, in units not exceeding seven
hundred forty kilobecquerels (twenty microcuries) each for use in in-vitro
clinical or laboratory tests not involving internal or external administration
of byproduct
radioactive material, or the radiation therefrom, to
human beings, or animals.
(6)
Selenium-75, in units not exceeding three hundred seventy kilobecquerels (ten
microcuries) each for use in in-vitro clinical or laboratory tests not
involving internal or external administration of byproduct
radioactive
material, or the radiation therefrom, to human beings or animals.
(7) Mock iodine-125 reference or calibration
sources, in units not exceeding 1.85 kilobecquerels ( 0.05 microcurie) of
iodine-129 and one hundred eighty-five becquerels ( 0.005 microcurie) of
americium-241 each for use in in-vitro clinical or laboratory tests not
involving internal or external administration of byproduct
radioactive
material, or the radiation therefrom, to human beings or animals.
(8) Cobalt-57, in units not exceeding three
hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro
clinical or laboratory tests not involving internal or external administration
of accelerator produced
radioactive material, or the radiation therefrom, to
human beings or animals.
(B) A person shall not receive, acquire,
possess, use, or transfer byproduct or
accelerator
produced
radioactive material under the general license
established by paragraph (A) of this rule unless that person:
(1) Has filed the radioactive materials
in-vitro testing form with the director; or
(2) Has a license that authorizes the medical
use of byproduct or accelerator
produced
radioactive material that was issued under rules for
medical uses of radioactive material.
(C) A person who receives, acquires,
possesses, or uses byproduct or accelerator
produced
radioactive material pursuant to the general license
established by paragraph (A) of this rule shall comply with the following:
(1) The general licensee shall not possess at
any one time, pursuant to the general license in paragraph (A) of this rule, 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 (two
hundred microcuries).
(2) The
general licensee shall store the byproduct or
accelerator produced
radioactive
material, until used, in the original shipping container or in a container
providing equivalent radiation protection.
(3) The general licensee shall use the
byproduct or accelerator produced
radioactive material only for the uses authorized
by paragraph (A) of this rule.
(4)
The general licensee shall not transfer the byproduct or accelerator produced
radioactive material except by transfer to a
person authorized to receive it by a license pursuant to this chapter, from the
United States nuclear regulatory commission, or from an agreement state or
transfer the byproduct or accelerator
produced
radioactive material in any
manner other than in the unopened, labeled shipping container as received from
the supplier.
(5) The general
licensee shall dispose of the mock iodine-125 reference or calibration sources
described in paragraph (A)(7) of this rule as required by rule
3701:1-38-19 of
the Administrative Code.
(D) The general licensee shall not receive,
acquire, possess or use byproduct or
accelerator produced
radioactive material pursuant to paragraph (A) of
this rule:
(1) Except as prepackaged units
which are labeled in accordance with the provisions of a specific license
issued under the provisions of rule
3701:1-46-42
of the Administrative Code or in accordance with the provisions of a specific
license issued by the United States nuclear regulatory commission or an
agreement state that authorizes manufacture and distribution of iodine-125,
iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, iron-59, mock
iodine-125, or cobalt-57 for distribution to persons generally licensed by the
United States nuclear regulatory commission or an agreement state.
(2) Unless 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: This
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 regulatory commission or of a state with
which the commission has entered into an agreement for the exercise of
regulatory authority ________________________ (name of manufacturer)
(E) The licensee possessing or
using byproduct or accelerator produced
radioactive materials under the general license
of paragraph (A) of this rule shall report in writing to the director any
changes in the information furnished by the licensee in department form
HEA-5518, "In-Vitro Testing With Radioactive Material Form." The report shall
be furnished within thirty days after the effective date of such change.
(F) Any person using
byproduct or accelerator produced
radioactive material pursuant to the general
license of paragraph (A) of this rule is exempt from the requirements of
Chapter 3701:1-38 of the Administrative Code with respect to
byproduct or accelerator produced
radioactive materials covered by that general
license, except that such persons using the mock iodine-125 described in
paragraph (A)(7) of this rule shall comply with the provisions of paragraph (A)
of rule
3701:1-38-19 of
the Administrative Code and paragraphs (A) and (B) of rule
3701:1-38-21 of the
Administrative Code.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/10/2002, 01/20/2008, 10/04/2010
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 10/4/10
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