An application for a specific license to manufacture or distribute byproduct material for use under the general license of He-P 4031.06 shall be approved if:

1. (a) The applicant satisfies the general requirements specified in He-P 4030.09;

2. (b) The radioactive material is to be prepared for distribution in prepackaged units of:

   1. (1) Carbon-14 in units not exceeding 370 kilobecquerel (10 microcurie) each;
   2. (2) Cobalt-57 in units not exceeding 370 kilobecquerel (10 microcurie) each;
   3. (3) Hydrogen-3 (tritium) in units not exceeding 1.85 megabecquerel (50 microcurie) each;
   4. (4) Iodine-125 in units not exceeding 370 kilobecquerel (10 microcurie) each;
   5. (5) Mock Iodine-125 in units not exceeding 1.85 kilobecquerel (0.05 microcurie) of iodine-129 and 185 becquerel (0.005 microcurie) of americium-241 each;
   6. (6) Iodine-131 in units not exceeding 370 kilobecquerel (10 microcurie) each;
   7. (7) Iron-59 in units not exceeding 740 kilobecquerel (20 microcurie) each; and
   8. (8) Selenium-75 in units not exceeding 370 kilobecquerel (10 microcurie) each.

3. (c) Each prepackaged unit bears a durable, clearly visible label:

   1. (1) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 370 kilobecquerel (10 microcurie) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 megabecquerel (50 microcurie) of hydrogen-3 (tritium); 740 kilobecquerel (20 microcurie) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kilobecquerel (0.05 microcurie) of iodine-129 and 185 becquerel (0.005 microcurie) of americium-241 each; and
   2. (2) Displaying the radiation caution symbol described in He-P 4022.11(c). and the words, "CAUTION, RADIOACTIVE MATERIAL", and "Not for Internal or External Use in Humans or Animals".

4. (d) The following statement or information shall appear on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

   “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 therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the DHHS/RHS or the NRC or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority. (Name of Manufacturer).”

5. (e) 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 byproduct material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source shall also contain directions to the licensee regarding the waste disposal requirements set out in He-P 4023.01 of these rules.

Source. #10983, eff 11-24-15