Minnesota Administrative Rules
Agency 144 - Health Department
Chapter 4731 - RADIATION SAFETY
SPECIFIC DOMESTIC LICENSING OF RADIOACTIVE MATERIAL
Part 4731.3390 - SPECIFIC LICENSE; MATERIAL FOR IN VITRO CLINICAL OR LABORATORY TESTING; MANUFACTURE AND DISTRIBUTION

A. the applicant satisfies the general requirements of part 4731.3070;

B. the radioactive material is prepared for distribution in prepackaged units of:

C. each prepackaged unit bears a durable, clearly visible label that:

D. 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

E. 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.