Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use

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The Nuclear Regulatory Commission (NRC) is amending regulatory text and the response to a public comment contained in a final rule published in the Federal Register on Friday, December 2, 1994, entitled "Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use." This action is necessary following reconsideration by the NRC regarding the requirements for the information to be included on labels for radioactive drugs to be transferred for commercial distribution. The effect of this action is to reduce regulatory burden and uncertainty for licensees that manufacture and distribute radiopharmaceuticals that contain byproduct material for medical use.