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NRC PROPOSAL WOULD ALLOW NUCLEAR PHARMACISTS TO COMPOUND

Executive Summary

NRC PROPOSAL WOULD ALLOW NUCLEAR PHARMACISTS TO COMPOUND radiopharmaceuticals, a June 17 Federal Register announcement states. The Nuclear Regulatory Commission proposed rule, covering the preparation, use and commercial distribution of by-product material for medical applications, would "permit physician authorized users and authorized nuclear pharmacists who meet certain training and experience criteria to prepare (including compound) radioactive drugs," the notice reports. In addition, commercial nuclear pharmacies and medical use licensees would be allowed to depart from the manufacturer's instructions for the use of radionuclide generators and reagent kits for the preparation of radiopharmaceuticals. The proposal "is intended to provide greater flexibility by allowing properly qualified nuclear pharmacists and authorized users who are physicians greater discretion to prepare radioactive drugs containing by-product material for medical use," the notice explains. The proposed rule would also allow authorized physicians to use radiopharmaceuticals for indications not listed in the package insert, and to use radioactive drugs for research "provided that human subjects are protected," the Federal Register continues. Authorized physicians are also allowed under the proposed rule to use radiolabeled biologics, "provided that dosages of alpha- or beta-emitting radionuclides are measured." An interim final rule published August 23, 1990 allowed departure at the written direction of an authorized pharmacist from approved labeling for radiopharmaceuticals and from manufacturer's instructions for the use of radionuclide generators and reagent kits in the preparation of radioactive drugs. However, the interim rule did not allow for the "pharmacist-directed departures" described in the proposed rule. The comment period for the proposed rule ends Oct. 15.
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