Code of Federal Regulations Title 10. Energy § 10.32.71 Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter.

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

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

(d) 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 a leaflet or brochure which accompanies the package:   1

¹ Labels authorized by the regulations in effect on September 26, 1979, may be used until one year from September 27, 1979.

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 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)

(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 must also contain directions to the licensee regarding the waste disposal requirements set out in § 20.2001.