Sec. 30. Board Form "U"
CERTIFICATE-MEDICAL USE OF RADIOACTIVE MATERIAL UNDER GENERAL
LICENSE
410
IAC 5-3-7(h) establishes a general
license authorizing physicians to possess certain small quantities of I-125,
I-131, Co-57, Co-58, Co-60, and Cr-51 for specified diagnostic uses. Possession
of radioactive material under
410
IAC 5-3-7(h) is not authorized until
the physician has filed board form U and received from the board a validated
copy of board form U with certification number assigned.
Submit this form in triplicate to the Medical Radiology
Services Division, Indiana department of health. A certification number will be
assigned and a validated copy of board form U will be returned. Please print or
type your name and address (including ZIP Code), within the lines below:
I am a duly licensed physician [authorized to dispense drugs]
in the practice of medicine. My Indiana license number is:__.
4. I have read
and understand the provisions of
410
IAC 5-3-7(h) of the Indiana Rule for
Radiation Control [410 IAC
5]; and I understand that I am required to comply
with those provisions as to all radioactive material which I receive, possess,
use, or transfer under the general license for which this certificate is filed
with the board:
Date:_By:__
(Signature of person filing form)
CONDITIONS AND LIMITATIONS OF
GENERAL LICENSE
410
IAC 5-3-7(h)
Medical Diagnostic Uses
(1) A general license is hereby issued to any
physician to receive, possess, transfer, or use radioactive material set forth
below for the stated diagnostic uses, provided, however, that the use is in
accordance with the provisions of
410
IAC 5-3-7(h)(2), (3), and (4), the
radioactive material is in the form of capsules, disposable syringes, or other
prepackaged individual doses; and the radioactive material has been
manufactured in accordance with the specific license issued by the board
pursuant to
410
IAC 5-3-13(g) or by the U.S. Nuclear
Regulatory Commission, any agreement state, or a licensing state pursuant to
equivalent regulations authorizing distribution to persons generally licensed
pursuant to
410
IAC 5-3-7(h) or its equivalent:
(i) chromium-51 as sodium radiochromate for
determination of red blood cell volumes and studies of red blood cell survival
time;
(ii) cobalt-57 for the
measurement of intestinal absorption of cyanocobalamin;
(iii) cobalt-58 for the measurement of
intestinal absorption of cyanocobalamin;
(iv) cobalt-60 for the measurement of
intestinal absorption of cyanocobalamin;
(v) iodine-125 as iodinated human serum
albumin (IHSA) for determinations of blood and blood plasma volume;
(vi) iodine-131 as sodium iodide for
measurement of thyroid uptake; and
(vii) iodine-131 as iodinated human serum
albumin (IHSA) for determinations of blood and blood plasma
volume.
(2) No physician
shall receive, possess, use or transfer radioactive material pursuant to the
general license established by
410
IAC 5-3-7(h)(1) until he has filed
board form "U," "Certificate-Medical Use of Radioactive Material Under General
License" with the board and received from the board a validated copy of the
board form "U" with certification number assigned. The generally licensed
physician shall furnish on board form "U" the following information and such
other information as may be required by that form:
(i) name and address of the generally
licensed physician;
(ii) a
statement that the generally licensed physician is a duly licensed physician
[authorized to dispense drugs] in the practice of medicine in this state; and
(iii) a statement that the
generally licensed physician has appropriate radiation measuring instruments to
carry out the diagnostic procedures for which he proposes to use radioactive
material under the general license of
410
IAC 5-3-7(h) and that he is
competent in the use of such instruments.
(3) A physician who receives, possesses or
uses a pharmaceutical containing radioactive material pursuant to the general
license established by
410
IAC 5-3-7(h)(1) shall comply with
the following:
(i) he shall not possess at
any one time, pursuant to the general license in
410
IAC 5-3-7(h)(1) more than
(A) 200 microcuries of iodine-131,
(B) 200 microcuries of iodine-125,
(C) 5 microcuries of cobalt-57,
(D) 5 microcuries of cobalt-58,
(E) 5 microcuries of cobalt-60, and
(F) 200 microcuries of chromium-51;
(ii) he shall store the
pharmaceutical until administered in the original shipping container, or a
container providing equivalent radiation protection;
(iv) he shall not administer the
pharmaceutical to a woman with confirmed pregnancy or to a person under 18
years of age; and
(v) he 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, or in any manner other than
in the unopened, labeled shipping container as received from the supplier,
except by administering it to a patient.
(4) The generally licensed physician
possessing or using radioactive material under the general license of
410
IAC 5-3-7(h)(1) shall report in
duplicate to the board, any changes in the information furnished by him in the
"Certificate-Medical Use of Radioactive Material Under General License," board
form "U." The report shall be submitted within 30 days after the effective date
of such change.
(5) Any person
using radioactive material pursuant to the general license of
410
IAC 5-3-7(h)(1) is exempt from the
requirements of 410 IAC
5-4 and
410 IAC 5-10 with respect to the radioactive
material covered by the general license. NOTE:
410
IAC 5-3-13(g) requires manufacturers
of radiopharmaceuticals which are under the general license in this
paragraph to include one of the following statements in the
label affixed to the container or in the leaflet or brochure which accompanies
the radiopharmaceutical:
This radioactive drug may be received, possessed, and used
only by physicians licensed [to dispense drugs] in the practice of medicine.
Its receipt, possession, use, and transfer are subject to the regulations and a
general license or its equivalent 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)
This radioactive drug may be received, possessed, and used
only by physicians licensed [to dispense drugs] in the practice of medicine.
Its receipt, possession, use, and transfer are subject to the rules and a
general license or its equivalent of a licensing state.
____________
(Name of Manufacturer)
NOTE
If larger quantities or other forms of radioactive material
than those specified in the general license of
410
IAC 5-3-7(h) are required, the
physician should file an "Application for Radioactive Material License," and
obtain a specific radioactive material license. Copies of application and
certification forms may be obtained from the Medical Radiology Services
Division, Indiana State Department of Health.
