Attachment 180-3-3 - CERTIFICATE - IN VITRO TESTING WITH RADIOACTIVE MATERIAL UNDER GENERAL LICENSE180 NAC 3-008.09 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 180 NAC 3-008.09 is not authorized until the physician, veterinarian, clinical laboratory, or hospital has filed Form NRH-17 and received from the Department a validated copy of Form NRH-17 with a certification number.
CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 180 NAC 3-008.09
008.09GENERAL LICENSE FOR USE OF RADIOACTIVE MATERIAL FOR CERTAIN IN VITRO CLINICAL OR LABORATORY TESTING.The following applies to the general license for use of radioactive material for certain in vitro clinical or laboratory testing:
(A) A general license is issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, according to the provisions of 180 NAC 3-008.09(B) through (F), 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 resulting radiation, to human beings or animals: (i) Iodine-125, iodine-131, selenium-75, cobalt-57, and carbon-14 in units not exceeding 370 kBq (10 µCi) each;(ii) Hydrogen-3 (tritium), in units not exceeding 1.85 MBq (50 µCi) each;(iii) Iron-59, in units not exceeding 740 kBq (20 µCi) each; or(iv) Mock Iodine-125 reference or calibration sources, in units not exceeding 1.85 kBq ( 0.05µCi) of iodine-129 and 1.85 Bq ( 0.005µCi) of americium-241 each.(v) Colbalt-57, in units not exceeding 0.37 MBq (01 µCi) each;(B) No person receives, acquires, possesses, uses or transfers radioactive material according to the general license established by 180 NAC 3-008.09(A) until they file Department Form NRH-17, "Certificate - In Vitro Testing with Radioactive Material Under General License", with the Department and received from the Department a validated copy of Department Form NRH-17 with certification number assigned. The physician, veterinarian, clinical laboratory or hospital must furnish on Department Form NRH-17 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 in the practice of veterinary medicine, 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 180 NAC 3-008.09(A) 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;(C) A person who receives, acquires, possesses or uses radioactive material according to the general license established by 180 NAC 3-008.09(A) must comply with the following: (i) The general licensee must not possess at any one time, according to the general license in 180 NAC 3-008.09(A) at any one location of storage or use a total amount of iodine-125, iodine-131, iron-59, cobalt-57 and selenium-75 in excess of 7.4 MBq (200 mCi);(ii) The general licensee must store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection;(iii) The general licensee must use the radioactive material only for the uses authorized by 180 NAC 3-008.09(A);(iv) The general licensee must not transfer the radioactive material to a person who is not authorized to receive it according to a license issued by the Department, the U.S. Nuclear Regulatory Commission (NRC), or any Agreement State, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier; and(v) The general licensee must dispose of the Mock Iodine-125 reference or calibration sources described in 180 NAC 3-008.09(A)(iv) as required by 180 NAC 4-039 and 4-044.(D) The general licensee must not receive, acquire, possess, or use radioactive material according to 180 NAC 3-008.09(A): (i) Other than as prepackaged units which are labeled according to the provisions of an applicable specific license issued according to 180 NAC 3-014.08 or according to the provisions of a specific license issued by the U.S. Nuclear Regulatory Commission (NRC), or any Agreement 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 180 NAC 3-008.09 or its' equivalent, and(ii) Unless the following statement, or substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: This radioactive material is received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the resulting radiation, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission (NRC) or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.
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Name of Manufacturer
(E) The physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital possessing or using radioactive material under the general license of 180 NAC 3-008.09(A) must report in writing to the Department, any changes in the information furnished by him or her in the "Certificate - In Vitro Testing with Radioactive Material Under General License", Department Form NRH-17. The report must be furnished within 30 days after the effective date of such change; and(F) Any person using radioactive material according to the general license of 180 NAC 3-008.09(A) is exempt from the requirements of 180 NAC 4 and 10 with respect to radioactive material covered by that general license, other than such persons using the Mock Iodine-125 described in 180 NAC 3-008.09(A)(iv) must comply with the provisions of 180 NAC 4-039, 4-057, and 4-058.Click here to view image
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180 Neb. Admin. Code, ch. 3, Attachment 3
Adopted effective 6/15/2021