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y .. <br /> State of Call to rola—Health and Welfare Agency Department of Health Services <br /> 5 7 <br /> Page Of pages <br /> RADIOACTIVE MATERIAL LICENSE License Number 1276-39 <br /> Supplementary Sheet 42 <br /> Amendment Number <br /> 21. 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 Drug <br /> Administration in accordance with Section 510 of the Federal Food, Drug, and <br /> Cosmetic Act, or licensed as a radiopharmacy with the California Board of <br /> Pharmacy, and who guarantees the pharmaceutical quality of each product. <br /> 22. 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 from a radiopharmacy licensed with the California <br /> Board of Pharmacy. <br /> 23. Radioactive materials prepared, processed, or modified by the licensee shall not <br /> be administered to humans except as specifically authorized by this license. <br /> 24. Where users or their assistants are engaged in elution of pertechnetate 99m from <br /> generators and/or preparation of labelled pharmaceuticals from kits, the <br /> exposures to the fingers or hands of these individuals shall be monitored, using <br /> appropriate dosimeters. <br /> 25. Technetium-99m labelled pharmaceuticals prepared by the licensee by aseptic <br /> addition of pertechnetate to sterile, pyrogen-free reagents procured in the form <br /> of kits which have been approved by the Department, may be administered to <br /> humans provided all instructions and recommendations contained in the <br /> manufacturer's package insert information are strictly followed, and provided <br /> the radioassay of the final product is determined with an overall error not <br /> exceeding ten percent. <br /> 26. Counting equipment for radiometric assay of pharmaceuticals, body fluids, <br /> excreta, or in vitro assay samples shall be calibrated and tested sufficiently <br /> often to ensure the medical validity and reliability of data obtained. The <br /> stability of the equipment shall be checked at least once on each day of use, <br /> using appropriate standards or reference sources. <br /> 27. Production or processing of radiopharmaceuticals for the purpose of distribution <br /> to other licensees is not authorized by this license. <br /> 28. The licensee shall not use radioactive material in the form of gas or aerosol in <br /> such a manner as to produce an airborne concentration exceeding the appropriate <br /> limit specified in Section 30266 or 30269 of the California Radiation Control <br /> Regulations. <br /> For the State Department of Health Services <br /> August 8, 1989 3 <br /> Date by <br /> - Radiologic Health Branch <br /> RH 2551(2182) 714 P StrPPt Sarramentn CA QFR1d <br />