459.296 - Specific licenses: Manufacture or distribution of radioactive material for in vitro clinical or laboratory testing
459.296. Specific licenses: Manufacture or distribution of radioactive material for in vitro clinical or laboratory testing
An application for a specific license to manufacture or distribute radioactive material for use under the general license of NAC 459.228 will be approved if:
1. The applicant satisfies the general requirements specified in NAC 459.238.
2. The radioactive material is to be prepared for distribution in prepackaged units of:
(a) Iodine-125 in units not exceeding 10 microcuries each.
(b) Iodine-131 in units not exceeding 10 microcuries each.
(c) Carbon-14 in units not exceeding 10 microcuries each.
(d) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each.
(e) Iron-59 in units not exceeding 20 microcuries each.
(f) Cobalt-57 in units not exceeding 10 microcuries each.
(g) Selenium-75 in units not exceeding 10 microcuries each.
(h) Mock iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each.
3. Each prepackaged unit bears a durable, clearly visible label:
(a) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed:
(1) Ten microcuries (0.37 megabecquerel) of iodine-125, iodine-131, selenium-75, cobalt-57 or carbon-14;
(2) Fifty microcuries (1.85 megabecquerels) of hydrogen-3 (tritium);
(3) Twenty microcuries (0.74 megabecquerel) of iron-59; or
(4) For mock iodine-125, 0.05 microcurie (1.85 kilobecquerels) of iodine-129 and 0.005 microcurie (0.185 kilobecquerel) of americium-241 each.
(b) Displaying the radiation caution symbol described in NAC 459.355 and the words, "CAUTION - RADIOACTIVE MATERIAL," and "Not for Internal or External Use in Humans or Animals."
4. The following statement, or a 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 leaflet or brochure which accompanies the package:
This radioactive material may 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.
Name of Manufacturer
5. The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information regarding the precautions to be observed in handling and storing such radioactive material. In the case of the mock iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements of NAC 459.3355 and 459.359 to 459.3615, inclusive.
Bd. of Health, Radiation Control Reg. §§ 220.127.116.11-18.104.22.168.5, eff. 2-28-80-NAC A 1-18-94; R185-08, 5-7-2010
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