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State of Colifornio—Health and Welfare Agency ® Department of Health Services Page 5 of 6Poges RADIOACTIVE MATERIAL LICENSE License Number: 4097-39 Supplementary Sheet Amendment Number: 10 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, precalibrated 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 licensed as a radiopharmacy with the California Board of Pharmacy, and who guarantees the pharmaceutical quality of each product. 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 from a radiopharmacy licensed with 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 /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 procured in the form of kits which have been approved by the Department, may be administered to humans provided all instructions and recommendations contained in the manufacturer's package insert information are strictly followed, and provided the radioassay of the final product is determined with an overall error not exceeding ten percent. 24. counting equipment for radiometric assay of pharmaceuticals, body fluids, excreta, or in vitro assay samples shall be calibrated and tested sufficiently often to ensure the medical validity and reliability of data obtained. The stability of the equipment shall be checked at least once on each day of use, using appropriate standards or reference sources. For the State Department of Health Services February 3, 1994 Date: By: Radiologic Health Branch P.O. Box 942732 Sacramento, CA 94234-7320 RH 2551 (Int.) (1/91)