410 Ind. Admin. Code 5-3-30

Current through January 8, 2025

Section 410 IAC 5-3-30 - Certification of medical use under general license (form U)

Authority: IC 16-41-35-26; IC 16-41-35-29

Affected: IC 16-41-35

Sec. 30. Board Form "U"

(Date)

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.

INSTRUCTIONS

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:

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I am a duly licensed physician [authorized to dispense drugs] in the practice of medicine. My Indiana license number is:__.

CERTIFICATE

I hereby certify that:

1. All information in this certificate is true and complete.

2. I have appropriate radiation measuring instruments to carry out the diagnostic procedures for which I will use radioactive material under the general license of 410 IAC 5-3-7(h) and I am competent in the use of such instruments.

3. I understand that board rules require that any change in the information furnished on this certificate be reported to the board within 30 days from the date of such change.

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;

(iii) he shall use the pharmaceutical only for the uses authorized by 410 IAC 5-3-7(h)(1);

(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)

____________

(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.

410 IAC 5-3-30

Indiana State Department of Health; 410 IAC 5-3-30; filed Feb 29, 1984, 10:10 am: 7 IR 891; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; errata filed Feb 3, 2010, 2:21 p.m.: 20100224-IR-410100062ACA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA

Readopted filed 11/13/2019, 3:14 p.m.: 20191211-IR-410190391RFA

Errata filed 7/28/2021, 8:26 a.m.: 20210811-IR-410210309ACA