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OW oepohtnenl or Heaun services <br /> Stole of C9,lornle—Hea10 end Wellare Agency <br /> Page 5 of 7 Pages <br /> RADIOACTIVE MATERIAL LICENSE License Number. <br /> 1276-39 <br /> Supplementary Sheet Amendment Number: <br /> 58 <br /> 21. Radioactive materials prepared, processed, or modified by the licensee shall not <br /> be administered to humans except as specifically authorized by this license. <br /> 22. Techinetium 991111 labelled pharmac'elticals pxWared by the lig by ascetic <br /> administered <br /> addition of pertechnetate to sterile, pyrogen-frce ren is determined with an <br /> to humans provided the radioassay of the final. product <br /> overall error not exceeding rig ten percent- VMen the pharmaceutical is prepared <br /> from reagents procured in the form of approved kits, the lig must strictly <br /> follow all instructions and recommendations contained in the package insert <br /> information; otherwise the pharmaceutical must be prepared and compounded from a <br /> prescription in accordance with the regulations of the California Hoard of <br /> Pharmacy- <br /> 23. F33uip[nent for radiometric assay of Pharmaceuticals' body <br /> fluids, exareta or in <br /> vitro assay samples shall be calibrated to ensure the reliability of data <br /> obtained. The stability of the equipment shall be checked at least once an each <br /> day of use, using appropriate ^tar3da ..'ds- <br /> 24. production or processing of radiopharnaceuticals for the purpose of distribution <br /> to other licensees is not authorized by this license. <br /> 25. For a period not to exceed 60 days in any calendar year, a visiting physician <br /> is authorized to use licensed materials for human use under the terms of this <br /> lig, provided the visiting physician_ <br /> (a) Has the prior written permission of the hospital's Administrator and its <br /> Radiation Safety O mmittee. <br /> (b) Is specifically named as a user on an Nuclear Regulatory Cotmmssion (NRC) <br /> or Agreement State license authorizing human use. <br /> (c) Performs only those procedures for which the physician is specifically <br /> authorized by the Nuclear Regulatory (bamission (NRC) or Agreement State <br /> license. <br /> The licensee shall maintain for inspection copies of the written <br /> permission specified in (a) above and the license(s) specified in <br /> (b) and (c) above. These records shall be maintainer) for five years <br /> from the time the licensee grants its permission under (a) above. <br /> 26. Treatment and management of patients receiving therapeutic quantities of <br /> unsealed radioactive materials shall be in accordance with guidance contained in <br /> Chapter 4, "Release from Hospital of Patients Containing Radioactive Materials", <br /> National Cbunci l on Radiation Protection and Measurements (NCRP) Report No. 37, <br /> " of Patients Plho Have Received `tjerTneutic Anoints <br /> Precautions de the CRp publications, <br /> D.C. 20014) . <br /> of Radionuclides (NCRP Publications, P.O. Hrnc 30175, Washington, <br /> For the State Department of Health Services <br /> Date: October 11, 1994 By: 3 <br /> Radiologic Health Branch <br /> P.O. Box 942732 <br /> Sacramento,CA 94234-7320 <br /> "H 2561 QW.)(1191) <br />