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State of C.;;llfornlo—Health and Welfare Agency 0 • Supplementary Sheet Department of Health Services 5 6 Page of Pages 5766-39 License Number: 2 Amendment Number: 18. Records of leak test results shall be kept in units of microcuries and maintained for inspection. Records may be disposed of following Department inspection. Any leak test revealing the presence of 0.005 microcuries or more of removable radioactive material shall be reported to the Department of Health Services, Radiologic Health Branch, 744 P Street, P. O. Box 942732, Sacramento, CA 94234-7320, within five days of the test. This report shall include a description of the defective source or device, the results of the test, and the corrective action taken. 19. Except as otherwise specifically provided by this license, radioactive pharma- ceuticals to be administered to humans shall be procured in prepackaged, precali- brated form from a supplier who is registered with the U. S. Food and Drug Administration in accordance with Section 510 of the Federal Food, Drug, and Cosmetic Act, or prepared and cortpounded, from a prescription, in accordance with the regulations of the California Board of Pharmacy. 20. Except as otherwise specifically provided by this license, radioactive biologicals (including human serum albumin) to be administered to humans shall be procured in prepackaged, precalibrated form from a supplier who is licensed for the preparation and distribution of such products by the Division of Biologics Standards of the National Institutes of Health, Pursuant to Part 73 of the Public Health Service Regulations, or by the Bureau of Biologics, U. S. Food and Drug Administration; or prepared in accordance with the regulations of the California Board of Pharmacy. 21. Radioactive materials prepared, processed, or modified by the licensee shall not be administered to humans except as specifically authorized by this license. 22. Where users or their assistants are engaged in elution of Technetium 99m pertechnetate from generators and/or preparation of labelled pharmaceuticals from kits, the exposures to the fingers or hands of these individuals shall be monitored, using appropriate dosimeters. 23. Technetium 99m labelled pharmaceuticals prepared by the licensee by aseptic addition of pertechnetate to sterile, pyrogen -free reagents may be administered to humans provided the radioassay of the final product is determined with an overall error not exceeding ten percent. When the pharmaceutical is prepared from reagents procured in the form of approved kits, the licensee must strictly follow all instructions and reconm►endations contained in the package insert information; otherwise the pharmaceutical must be prepared and compounded from a prescription in accordance with the regulations of the California Board of Pharmacy. For the State Department of Health Services February 4, 1994 3 By: R 2551 (Int.) (1/91) Radiologic Health Branch P.O. Box 942732 Sacramento, CA 94234-7320