333-102-0250 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under a General License An application for a specific license to manufacture or distribute radioactive material for use under the general license specified in OAR 333-102-0130 or equivalent may be approved if: (1) The applicant satisfies the general requirements specified in OAR 333-102-0200. (2) The radioactive material is to be prepared for distribution in prepackaged units of: (a) Carbon-14 in units not exceeding ten microcuries (370 kBq) each; (b) Cobalt-57 in units not exceeding ten microcuries (370 kBq) each; (c) Hydrogen-3 (tritium) in units not exceeding 50 microcuries (1.85 MBq) each; (d) Iodine-125 in units not exceeding ten microcuries (370 kBq) each; (e) Mock iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each; (f) Iodine-131 in units not exceeding ten microcuries (370 kBq) each; (g) Iron-59 in units not exceeding 20 microcuries (740 kBq) each; (h) Selenium-75 in units not exceeding ten microcuries (370 kBq) each; (i) Cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries) 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 ten microcuries (370 kBq) of iodine-125, iodine-131, carbon-14, cobalt-57 or selenium-75; 50 microcuries (1.85 MBq) of hydrogen-3 (tritium); 20 microcuries (740 kBq) of iron-59; or mock iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each or colbalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries); and (b) Displaying the radiation caution symbol described in OAR 333-120-0400 and the words, CAUTION, RADIOACTIVE MATERIAL and Not for Internal or External Use in Humans or Animals. (4) 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 a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: (a) This radioactive material may 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 there from, 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 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 may 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 there from, 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 label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to 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 in OAR 333-120-0500. Statutory/Other Authority: ORS 453.635 & 453.665 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 20-2010, f. & cert. ef. 9-1-10 PH 4-2007, f. & cert. ef. 3-1-07 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 15-1994, f. & cert. ef. 5-6-94 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85