These products are not intended for use in humans. The Food Drug and Cosmetic Act also permits licensed medical practitioners and pharmacists to prepare drugs for use in the course of their specific practice, independent of the above types of investigational studies. A physician or pharmacist administering or preparing a radioactive substance for human use bears all responsibility for its safety, efficacy and pharmaceutical quality, including its sterility and non-pyrogenicity. Prior to shipment of radioactive material for potential human use, NEN requires acknowledgement of the circumstances described above. EU Regulation No.
National regulations exist to control their possession, use and distribution.
Please review the Safety Data Sheet which is mailed to you with or before the first delivery of such a product.