Section 410IAC5-3-31. Certification of in vitro testing under general license (form V)

 

                                Board Form "V"

(Date)

                                                                                                                                                          CERTIFICATE─IN VITRO TESTING WITH

                                                                                                                                                                      RADIOACTIVE MATERIAL UNDER

                                                                                                                                                                                     GENERAL LICENSE

                                410 IAC 5-3-7(i)(1) establishes a general license authorizing physicians, veterinarians, clinical laboratories, and hospitals to possess certain small quantities of radioactive material for in vitro clinical or laboratory tests not involving the internal or external administration of the radioactive material or the radiation therefrom to human beings or animals. Possession of radioactive material under 410 IAC 5-3-7(i) is not authorized until the physician, veterinarian, clinical laboratory, or hospital has filed board form V and received from the board a validated copy of board form V with certification number.

                                                                                                                                                                                        INSTRUCTIONS

                                Submit this form in triplicate to the Medical Radiology Services Division, Indiana State Department of Health. A certification number will be assigned and a validated copy of board form V will be returned.

____________________________________________________

1. Please print or type within the lines, below, the name and address (including ZIP Code) of the physician, veterinarian, clinical laboratory, or hospital for whom or for which this form is filed.

2. I hereby apply for a certification pursuant to 410 IAC 5-3-7(i) for use of radioactive material for (Please check one):

a. Myself, a duly licensed physician [authorized to dispense drugs] in the practice of medicine.

b. The above-named clinical laboratory.

c. The above-named hospital.

d. Myself, a duly licensed veterinarian.

3. To be completed by the board.

(Leave this space blank─number to be assigned by the board)

 

 

4. If place of use is different from address in item 1, please give complete address:

____________________________________________________

5. Certification:

I hereby certify that:

a. All information in this certification is true and complete.

b. Appropriate radiation measuring instruments are available to carry out the tests for which radioactive material will be used under the general license of 410 IAC 5-3-7(i). The tests will be performed only by personnel competent in the use of the instruments and in the handling of the radioactive material.

c. 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 effective date of such change.

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.

(v) The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in 410 IAC 5-3-7(i)(1)(viii) as required by 410 IAC 5-4-16.

(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 State Department of Health. (Indiana State Department of Health; 410 IAC 5-3-31; filed Feb 29, 1984, 10:10 am: 7 IR 893; 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)