459.230 - Duties and restrictions regarding prepackaged units of radioactive material for in vitro testing

459.230. Duties and restrictions regarding prepackaged units of radioactive material for in vitro testing

1. A person may not receive, acquire, possess, use or transfer radioactive material pursuant to the general license established by NAC 459.228, until he or she has filed division form NRC-8, "Certificate - In Vitro Testing with Radioactive Material Under General License," with the Division and received from the Division a validated copy of division form NRC-8 with certification number assigned. The physician, clinical laboratory or hospital shall furnish on division form NRC-8 the following information and any other information required by that form:

(a) Name and address of the physician, clinical laboratory or hospital;

(b) The location of use; and

(c) A statement that the physician, 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 NAC 459.228, and that tests will be performed only by personnel competent in the use of the instruments and in the handling of the radioactive material.

2. A person who receives, acquires, possesses or uses radioactive material pursuant to the general license established by NAC 459.228, shall comply with the following:

(a) The general licensee shall not possess at any one time, pursuant to the general license in NAC 459.228, at any one location of storage or use a total amount of iodine 125, iodine 131, selenium 75, iron 59 or cobalt 57 in excess of 200 microcuries.

(b) The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.

(c) The general licensee shall use the radioactive material only for the uses authorized by NAC 459.228.

(d) 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 Division, the Nuclear Regulatory Commission 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.

(e) The general licensee must dispose of the mock iodine 125 reference or calibration sources described in subsection 4 of NAC 459.228, as required by NAC 459.3355 and 459.359 to 459.3615, inclusive.

3. The general licensee shall not receive, acquire, possess or use radioactive material pursuant to NAC 459.228:

(a) Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific license issued by the Nuclear Regulatory Commission or any agreement state which authorizes the manufacture and distribution of iodine 125, iodine 131, carbon 14, hydrogen 3 (tritium), selenium 75, iron 59, cobalt 57 or mock iodine 125 for distribution to persons generally licensed under NAC 459.228 or its equivalent; and

(b) Unless the following statement or a substantially similar statement, which contains the information 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 must be received, acquired, possessed and used only by physicians, 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 the Nuclear Regulatory Commission 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

4. The physician, clinical laboratory or hospital possessing or using radioactive material under the general license of NAC 459.228 shall report in writing to the Division any changes in the information furnished by him or her in the "Certificate - In Vitro Testing with Radioactive Material Under General License," division form NRC-8. The report must be furnished within 30 days after the effective date of such change.

5. Any person using radioactive material pursuant to the general license of NAC 459.228 is exempt from the requirements of NAC 459.320 to 459.374, inclusive, and 459.780 to 459.794, inclusive, with respect to radioactive material covered by that general license except that such persons using mock iodine 125 described in subsection 4 of NAC 459.228 shall comply with the provisions of NAC 459.3355, 459.359 to 459.3615, inclusive, 459.369 and 459.3695.

Bd. of Health, Radiation Control Reg. ยงยง 3.4.2.7.2-3.4.2.7.6, eff. 2-28-80-NAC A 1-18-94

NRS 459.201

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