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State Of California—Health and Welfare Agency D9DOrtment of Health Serv;ces <br />Page 3 of 4 Pages <br />RADIOACTIVE MATERIAL LICENSE License Number: -9:766-39 <br />Supplementary Sheet Amendment Number: <br />16. Analytical tests for leakage /or contamination of sealed sources shall be <br />performed only by persons specifically authorized to perform that service. <br />17. The following individuals are authorized to collect wipe test samples of sealed <br />sources possessed under this license using leak test kits acceptable to the <br />California Department of Health Services. <br />(a) The Radiation safety officer <br />(b) Qualified individuals designated by the Radiation Safety officer <br />18. Records of leak test results shall be kept in units of microcuries and maintained <br />for inspection. Records may be disposed of following Department inspection. Any <br />leak test revealing the presence of 0.005 microcuries or more of removable <br />radioactive material shall be reported to the Department of Health Services, <br />Radiologic Health Branch, 744 P Street, P. O. Box 942732, Sacramento, CA - <br />94234-7320, within five days of the test. This report shall include a description <br />of the defective source or device, the results of the test, and the corrective <br />action taken. <br />19. Except as otherwise specifically provided by this license, radioactive pharma- <br />ceuticals to be administered to humans shall be procured in prepackaged, precali- <br />brated form from a supplier who is registered with the U. S. Food and Drug <br />Administration in accordance With Section 510 of the Federal Food, Drug, and <br />Cosmetic Act, Or Prepared and compounded, from a prescription, in accordance with <br />the regulations of the California Board of Pharmacy. <br />20. Except as Otherwise specifically provided by this license, radioactive biologicals <br />(including human serum albumin) to be administered to humans shall be procured in <br />prepackaged, precalibrated form fram a supplier who is licensed for the <br />Preparation and distribution of such products by the Division of Biologics <br />Standards of the National Institutes of Health, Pursuant to Part 73 of the Public <br />Health Service Regulations, or by the Bureau of Biologics, U. S. Food and Drug <br />Administration; or prepared in accordance with the regulations of the California <br />Board of Pharmacy. <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. Where users or their assistants are engaged in elution of Technetium 99m <br />pertechnetate from generators /or preparation of labelled pharmaceuticals from <br />kits, the exposures to the fingers or hands of these individuals shall be <br />monitored, using appropriate dosimeters. <br />Date: —July 22, 1992 <br />RH 2551 (Int.) (1/91) <br />For the State Department of Health Services <br />By: 3 <br />Radiologic Health Branch <br />P.O. Box 942732 <br />Sacramento, CA 94234-7320 <br />