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t a <br /> State of Callfornlo—Health and Welfare Agency ® Department of Health Services <br /> Page 3 of 4 Pages <br /> RADIOACTIVE MATERIAL LICENSE License Number: 5790-39 <br /> Supplementary Sheet Amendment Number: 1 <br /> 16. Analytical tests for leakage and/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 <br /> maintained for inspection. Records may be disposed of following Department <br /> inspection. Any leak test revealing the presence of 0.005 microcuries or more <br /> of removable radioactive material shall be reported to the Department of Health <br /> Services, Radiologic Health Branch, 744 P Street, P. O. Box 942732, Sacramento, <br /> CA 94234-7320, within five days of the test. This report shall include a <br /> description of the defective source or device, the results of the test, and the <br /> corrective action taken. <br /> 19. Notwithstanding the periodic leak test required by Section 30275 (c) , any <br /> licensed sealed source is exempt from such leak tests when the source contains <br /> 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries <br /> or less of alpha emitting material. <br /> 20. Except as otherwise specifically provided by this license, radioactive pharma- <br /> ceuticals to be administered to humans shall be procured in prepackaged, <br /> precalibrated form from a supplier who is registered with the U. S. Food and <br /> Drug Acb-inistration in accordance with Section 510 of the Federal Food, Drug, <br /> and Cosmetic Act, or prepared and compounded, from a prescription, in accordance <br /> with the regulations of the California Board of Pharmacy. <br /> 21. Except as otherwise specifically provided by this license, radioactive <br /> biologicals (including human serum albumin) to be administered to humans shall <br /> be procured in prepackaged, precalibrated form from a supplier who is licensed <br /> for the preparation and distribution of such products by the Division of <br /> Biologics Standards of the National Institutes of Health, Pursuant to Part 73 of <br /> the Public Health Service Regulations, or by the Bureau of Biologics, U. S. Food <br /> and Drug Administration; or prepared in accordance with the regulations of the <br /> California Board of Pharmacy. <br /> For the State Department of Health Services <br /> Date: April 23, 1993 By: 3 <br /> Radiologic Health Branch <br /> P.O. Box 942732 <br /> Sacramento, CA 94234-7320 <br /> PH 2551(Int.)(1191) <br />