Section 410IAC5-3-11. Specific licenses for human, medical and industrial uses

 

                                (a) Human Use of Radioactive Material in Institutions. In addition to the requirements set forth in 410 IAC 5-3-10, a specific license for human use of radioactive material in institutions will be issued if:

(1) The applicant has appointed a medical isotopes committee of at least three members to evaluate all proposals for research, diagnostic, and therapeutic use of radioactive material within that institution. Membership of the committee should include physicians expert in internal medicine, hematology, therapeutic radiology, and a person experienced, in assay of radioactive material and protection against radiation;

(2) The applicant possesses adequate facilities for the clinical care of patients;

(3) The physician designated on the application as the individual user has substantial experience in the handling and administration of radioactive material and, where applicable, the clinical management of radioactive patients; and

(4) The application is for a license to use unspecified quantities or multiple types of radioactive material, the applicant's staff has substantial experience in the use of a variety of radioactive materials for a variety of human uses.

                                (b) Licensing of Individual Physicians for Human Use of Radioactive Material.

(1) An application by an individual physician or group of physicians for a specific license for human use of radioactive material will be approved if:

(i) The applicant satisfies the general requirements specified in 410 IAC 5-3-10;

(ii) The application is for use in the applicant's practice in an office outside a medical institution;

(iii) The applicant has access to a hospital possessing adequate facilities to hospitalize and monitor the applicant's radioactive patients whenever it is advisable; and

(iv) The applicant has extensive experience in the proposed use, the handling and administration of radionuclides, and where applicable, the clinical management of radioactive patients.

(2) The board will not approve an application by an individual physician or group of physicians for a specific license to receive, possess, or use radioactive material on the premises of a medical institution unless:

(i) The use of radioactive material is limited to:

(A) The administration of radiopharmaceuticals for diagnostic or therapeutic purposes,

(B) The performance of diagnostic studies on patients to whom a radiopharmaceutical has been administered,

(C) The performance of in vitro diagnostic studies, or

(D) The calibration and quality control checks of radioactive assay instrumentation, radiation safety instrumentation, and diagnostic instrumentation;

(ii) The physician brings the radioactive material with him and removes the radioactive material when he departs (the institution cannot receive, possess, or store radioactive material other than the amount of material remaining in the patient); and

(iii) The medical institution does not hold a radioactive material license under 410 IAC 5-3-11(a).

                                (c) Specific Licenses for Certain Groups of Medical Uses of Radioactive Material.

(1) Subject to the provisions of 410 IAC 5-3-11(c)(2), (3), and (4) an application for a specific license pursuant to 410 IAC 5-3-11(a), (b) or (d) for any medical use or uses of radioactive material specified in one or more of Groups I to VI, inclusive, of Schedule C, 410 IAC 5-3-28, will be approved for all of the uses within the group or groups which include the use or uses specified in the application if:

(i) The applicant satisfies the requirements of 410 IAC 5-3-11(a), (b) and (d);

(ii) The applicant, or the physician designated in the application as the individual user, has adequate clinical experience in the types of uses included in the group or groups;

(iii) The applicant, or the physicians and all other personnel who will be involved in the preparation and use of the radioactive material, have adequate training and experience in the handling of radioactive material appropriate to their participation in the uses included in the group or groups;

(iv) The applicant's radiation detection and measuring instrumentation is adequate for conducting the procedures involved in the uses included in the group or groups; and

(v) The applicant's radiation safety operating procedures are adequate for handling and disposal of the radioactive material involved in the uses included in the group or groups.

(2) Any licensee or registrant who is authorized to use radioactive material pursuant to one or more groups in 410 IAC 5-3-11(c)(1) and Schedule C, 410 IAC 5-3-28, is subject to the following conditions:

(i) For Groups I, II, IV, and V, no licensee or registrant shall receive, possess or use radioactive material except as a radiopharmaceutical manufactured in the form to be administered to the patient, labeled, packaged and distributed in accordance with a specific license issued by the board pursuant to 410 IAC 5-3-13(j), a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.72 of 10 CFR Part 32, or a specific license issued by an agreement state or a licensing state pursuant to equivalent regulations.

(ii) For Group III, no licensee or registrant shall receive, possess or use generators or reagent kits containing radioactive material or shall use reagent kits that do not contain radioactive material to prepare radiopharmaceuticals containing radioactive material, except:

(A) Reagent kits not containing radioactive material that are approved by the board, the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state for use by persons licensed pursuant to 410 IAC 5-3-11(c) and Schedule C, 410 IAC 5-3-28, or equivalent regulations; or

(B) Generators or reagent kits containing radioactive material that are manufactured, labeled, packaged and distributed in accordance with a specific license issued by the board pursuant to 410 IAC 5-3-13(k) a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.73 of 10 CFR Part 32, or a specific license issued by an agreement state or a licensing state pursuant to equivalent regulations.

(iii) For Group VI, no licensee or registrant shall receive, possess, or use radioactive material except as contained in a source or device that has been manufactured, labeled, packaged and distributed in accordance with a specific license issued by the board pursuant to 410 IAC 5-3-13(l), a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.74 of 10 CFR Part 32, or a specific license issued to the manufacturer by an agreement state or a licensing state pursuant to equivalent regulations.

(iv) For Group III, any licensee or registrant who uses generators or reagent kits shall:

(A) Elute the generator, or process radioactive material with the reagent kit, in accordance with instructions approved by the U.S. Nuclear Regulatory Commission, an agreement state or licensing state and furnished by the manufacturer on the label attached to or in the leaflet or brochure that accompanies the generator or reagent kit;

(B) Before administration to patients, cause each elution or extraction of technetium-99m from a molybdenum-99/technetium-99m generator to be tested to determine either the total molybdenum-99 activity or the concentration of molybdenum-99. This testing shall be conducted according to written procedures and by personnel who have been specifically trained to perform the test;

(C) Prohibit the administration to patients of technetium-99m containing more than 1 microcurie of molybdenum-99 per millicurie of technetium-99m, or more than 5 microcuries of molybdenum-99 per administered dose, at the time of administration; and

(D) Maintain for 3 years for board inspection records of the molybdenum-99 test conducted on each elution from the generator.

(v) For Groups I, II, and III, any licensee using radioactive material for clinical procedures other than those specified in the product labeling (package insert) shall comply with the product labeling regarding:

(A) Chemical and physical form;

(B) Route of administration; and

(C) Dosage range.

(3) Any licensee who is licensed pursuant to 410 IAC 5-3-11 for one or more of the medical use groups in Schedule C, 410 IAC 5-3-28, also is authorized to use radioactive material under the general license in 410 IAC 5-3-7(i) for the specified in vitro uses without filing board form "V" as required by 410 IAC 5-3-7(i)(2); provided, that the licensee is subject to the other provisions of 410 IAC 5-3-7(i).

(4) Any licensee who is licensed pursuant to 410 IAC 5-3-11(c)(1) for one or more of the medical use groups in Schedule C, 410 IAC 5-3-28, also is authorized, subject to the provisions of 410 IAC 5-3-11(c)(4) and (5), to receive, possess and use for calibration and reference standards:

(i) Any radioactive material listed in Group I, Group II, or Group III of Schedule C, 410 IAC 5-3-28, with a half-life not longer than 100 days, in amounts not to exceed 15 millicuries total;

(ii) Any radioactive material listed in Group I, Group II, or Group III of Schedule C, 410 IAC 5-3-28, with half-life greater than 100 days in amounts not to exceed 200 microcuries total;

(iii) Technetium-99m in amounts not to exceed 30 millicuries; and

(iv) Any radioactive material, in amounts not to exceed 3 millicuries per source, contained in calibration or reference sources that have been manufactured, labeled, packaged and distributed in accordance with a specific license issued by the board pursuant to 410 IAC 5-3-13(l), a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.74 of 10 CFR Part 32, or a specific license issued to the manufacturer by an agreement state or a licensing state pursuant to equivalent regulations.

(5)(i) Any licensee or registrant who possesses sealed sources as calibration or reference sources pursuant to 410 IAC 5-3-11(c)(4) shall cause each sealed source containing radioactive material, other than hydrogen-3, with a half-life greater than 30 days in any form other than gas to be tested for leakage and/or contamination at intervals not to exceed 6 months. In the absence of a certificate from a transferor indicating that a test has been made within 6 months prior to the transfer, the sealed sources should not be used until tested, provided, however, that no leak tests are required when:

(A) The source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material, or

(B) The sealed source is stored and is not being used; such sources shall, however, be tested for leakage prior to any use or transfer unless they have been leak tested within 6 months prior to the date of use or transfer.

(ii) The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. The test sample shall be taken from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which contamination might be expected to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the board;

(iii) If the leak test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee or registrant shall immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with 410 IAC 5-3 and 410 IAC 5-4. A report shall be filed within 5 days of the test with the board describing the equipment involved, the test results, and the corrective action taken.

(6) Any licensee or registrant who possesses and uses calibration and reference sources pursuant to 410 IAC 5-3-11(c)(4)(iv) shall:

(i) Follow the radiation safety and handling instructions approved by the board, the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state and furnished by the manufacturer on the label attached to the source, or permanent container thereof, or in the leaflet or brochure that accompanies the source, and maintain such instruction in a legible and conveniently available form; and

(ii) Conduct a quarterly physical inventory to account for all sources received and possessed. Records of the inventories shall be maintained for inspection by the board and shall include the quantities and kinds of radioactive material, location of sources, and the date of the inventory.

                                (d) Human Use of Sealed Sources. In addition to the requirements set forth in 410 IAC 5-3-10, a specific license for human use of sealed sources will be issued only if the applicant or, if the application is made by an institution, the individual user:

(1) Has specialized training in the diagnostic or therapeutic use of the sealed source considered, or has experience equivalent to such training, and

(2) Is a physician.

                                (e) Use of Sealed Sources in Industrial Radiography. In addition to the requirements set forth in 410 IAC 5-3-10, a specific license for use of sealed sources in industrial radiography will be issued if:

(1) The applicant will have an adequate program for training radiographers and radiographer's assistants and submits to the board a schedule or description of such program which specifies the:

(i) Initial training,

(ii) Periodic training,

(iii) On-the-job training,

(iv) Means to be used by the licensee to determine the radiographer's knowledge and understanding of and ability to comply with board rules and licensing requirements, and the operating and emergency procedures of the applicant, and

(v) Means to be used by the licensee to determine the radiographer's assistant's knowledge and understanding of and ability to comply with the operating and emergency procedures of the applicant;

(2) The applicant has established and submits to the board satisfactory written operating and emergency procedures described in 410 IAC 5-5-13;

(3) The applicant will have an internal inspection system adequate to assure that these rules, license provisions, and the applicant's operating and emergency procedures are followed by radiographers and radiographer's assistants; the inspection system shall include the performance of internal inspections at intervals not to exceed 3 months and the retention of records of such inspections for 2 years;

(4) The applicant submits to the board a description of the overall organizational structure pertaining to the industrial radiography program, including specified delegations of authority and responsibility for operation of the program;

(5) The applicant who desires to conduct his own leak tests has established adequate procedures to be followed in testing sealed sources for possible leakage and contamination and submits to the board a description of such procedures including:

(i) instrumentation to be used,

(ii) method of performing tests, and

(iii) pertinent experience of the individual who will perform the test; and

(6) The licensee shall conduct a program for inspection and maintenance of radiographic exposure devices and storage containers to assure proper functioning of components important to safety.

(Indiana State Department of Health; Rule HRH-2,PT C,Sec C.26; filed May 26, 1978, 3:30 pm: 1 IR 148; filed Feb 29, 1984, 10:10 am: 7 IR 856; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA)