An application for a specific license to manufacture or distribute radioactive material for use under the general license under part 4731.3245 shall be approved if:
the radioactive material is prepared for distribution in prepackaged units of:
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; and
each prepackaged unit bears a durable, clearly visible label that:
the following statement, or a substantially similar statement that contains all the information called for, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package:
"The radioactive material may be 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 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 Minnesota commissioner of health, the Nuclear Regulatory Commission, or a state with which the Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority.
(Name of manufacturer)"; and
the label affixed to the unit, or the leaflet or brochure that accompanies the package, contains adequate information as to the precautions to be observed in handling and storing the radioactive material. In the case of a mock iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements under part 4731.2400.
29 SR 755; 33 SR 1440
March 12, 2009
Official Publication of the State of Minnesota
Revisor of Statutes