COMPLIANCE INFO_1983-2005 - Laserfiche WebLink

Home Browse Search

State of CoNfomlo—Health and Welfare Agency Department of Health ServiceS Page 4 of 5 Pages RADIOACTIVE MATERIAL LICENSE license Number: 1294-39 Supplementary Sheet Amendment Number: 48 19. The licensee is authorized to hold radioactive materials with a physical half-life of less than 65 days fordecay-in-storage before disposal in ordinary trash provided: (a) Radioactive waste to be disposed of in this manner shall be held for decay a minimum of ten half-lives. (b) Before disposal as normal waste, radioactive waste shall be surveyed to determine that its radioactivity cannot be distinguished from background. All radiation labels shall be removed or obliterated. 20. Iodine 131 shall not be used in sudi a manner that the thyroid uptake exceeds 1.0 microcurie in any calendar quarter. 21. 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 radiogmmacy with the California Board of Pharmacy, and who guarantees the pharmaceutical quality of each product. 22. 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 radicpharmacy licensed with the California Board of Pharmacy. 23. Radioactive materials prepared, processed, or modified by the licensee shall not be administered to humans except as specifically authorized by this license. 24. 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 f'ingers or hands of these individuals shall be monitored, using appropriate dosimeters. 25. Technetium -99m labelled pharmaceuticals prepared by the licensee by aseptic addition of pertechnetate to sterile, ogee -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. For the State Department of Health Services Date: December 28, 1993 By {2 3 adioioglc Health Branch P.O. Box 942732 Sacramento, CA 94234-7320 RH2551 (Int.)(1/91)