d. I have read and understand the provisions
of
410
IAC 5-3-7(i); and I understand that
compliance with those provisions is required as to all radioactive material
which is received, acquired, possessed, used, or transferred under the general
license for which this certificate is filed with the board.
Date: _____________ By: _____________________
(Signature of person filing form)
__________________________________________________
(Printed name and title of position of person filing
form)
CONDITIONS AND LIMITATIONS OF GENERAL LICENSE
410
IAC 5-3-7(i) 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
410
IAC 5-3-7(i)(2), (3), (4), (5), and
(6), the following radioactive materials in
prepackaged units 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:
(i) Carbon-14, in units not exceeding 10
microcuries each.
(ii) Cobalt-57,
in units not exceeding 10 microcuries each.
(iii) Hydrogen-3 (tritium), in units not
exceeding 50 microcuries each.
(iv)
Iodine-125, in units not exceeding 10 microcuries each.
(v) Mock Iodine-125 reference or calibration
sources, in units not exceeding 0.05 microcurie of iodine-129 and 0.005
microcurie of americium-241 each.
(vi) Iodine-131, in units not exceeding 10
microcuries each.
(vii) Iron-59, in
units not exceeding 20 microcuries each.
(viii) Selenium-75, in units not exceeding 10
microcuries each.
(2) No
person shall receive, acquire, possess, use, or transfer radioactive material
pursuant to the general license established by
410
IAC 5-3-7(i)(1) until he has filed
board form "V," "Certificate-In Vitro Testing with Radioactive Material Under
General License," with the board and received from the board a validated copy
of board form "V" with certification number assigned, or until he has been
authorized pursuant to
410
IAC 5-3-11(c)(3) to use radioactive
material under the general license in
410
IAC 5-3-7(i). The physician,
veterinarian, clinical laboratory, or hospital shall furnish on board form "V"
the following information and such other information as may be required by that
form:
(i) name and address of the physician,
veterinarian, clinical laboratory, or hospital;
(ii) the location of use; and
(iii) 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
410
IAC 5-3-7(i)(1) 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
410
IAC 5-3-7(i)(1) shall comply with
the following:
(i) The general licensee shall
not possess at any one time, pursuant to the general license in
410
IAC 5-3-7(i)(1), at any one location
of storage or use, a total amount of iodine-125, iodine-131, selenium-175,
iron-59, and/or cobalt-57 in excess of 200 microcuries.
(ii) The general licensee shall store the
radioactive material until used, in the original shipping container or in a
container providing equivalent radiation protection.
(iii) The general licensee shall use the
radioactive material only for the uses authorized by
410
IAC 5-3-7(i)(1).
(iv) 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 board, the U.S. 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.
(4) The general licensee shall not receive,
acquire, possess, or use radioactive material pursuant to
410
IAC 5-3-7(i)(1):
(i) Except as prepackaged units which are
labeled in accordance with the provisions of an applicable specific license
issued pursuant to
410
IAC 5-3-13(h) or in accordance with
the provisions of a specific license issued by the U.S. Nuclear Regulatory
Commission, 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
410
IAC 5-3-7(i) or its equivalent,
and
(ii) 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 the label affixed to each prepackaged unit or appears in a leaflet
or brochure which accompanies the package:
(A)
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 the U.S. 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 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 regulations and a general
license of a licensing state.
_____________________________________
Name of Manufacturer
(5) The physician, veterinarian, clinical
laboratory or hospital possessing or using radioactive material under the
general license of
410
IAC 5-3-7(i)(1) shall report in
writing to the board, any changes in the information furnished by him in the
"Certificate-In Vitro Testing with Radioactive Material Under General License,"
board form "V." The report shall be furnished within 30 days after the
effective date of such change.
(6)
Any person using radioactive material pursuant to the general license of
410
IAC 5-3-7(i)(1) is exempt from the
requirements of 410 IAC
5-4 and
410 IAC 5-10 with respect to radioactive
material covered by that general license, except that such persons using the
Mock Iodine-125 described in
410
IAC 5-3-7(i)(1)(viii) shall comply
with the provisions of
410 IAC
5-4-16,
410 IAC
5-4-22, and
410 IAC 5-4-23.
NOTE If larger quantities or other forms of radioactive
material than those specified in the general license of
410
IAC 5-3-7(i) are required, an
"Application for Radioactive Material License," should be filed to obtain a
specific radioactive material license. Copies of application and certification
forms may be obtained from the Medical Radiology Services Division, Indiana
department of health.
