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State of California-Health and Welfare Agency Department of Health Services Page 6 of 7 pages RADIOACTIVE MATERIAL LICENSE License Number: 1276-39 Supplementary Sheet Amendment Number: 62 27. Radioactive materials prepared, processed, or modified by the licensee shall not be administered to humans except as specifically authorized by this license. 28. The licensee shall elute generators and process radioactive material with reagent kits in accordance with instructions furnished by the manufacturer on the label attached to or in the leaflet or brochure that accompanies the generator or reagent kit. 29. 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 recommendations 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. 30. For a period not to exceed 60 days in any calendar year, a visiting physician is authorized to use licensed materials for human use under the terms of this license, provided the visiting physician: (a) Has the prior written permission of the hospital's Administrator and its Radiation Safety Committee. (b) Is specifically named as a user on an Nuclear Regulatory Commission(NRC) or Agreement State license authorizing human use. (c) Performs only those procedures for which the physician is specifically authorized by the Nuclear Regulatory Commission(NRC) or Agreement State license. The licensee shall maintain for inspection copies of the written permission specified in (a) above and the license(s) specified in (b) and (c) above. These records shall be maintained for five years from the time the licensee grants its permission under (a) above. 31. Equipment for radiometric assay of pharmaceuticals, body fluids, excreta, or in-vitro assay samples shall be calibrated to ensure reliability of data obtained. The stability of the equipment shall be checked at least once each day of use, using appropriate standards. 32. Nuclear medicine technology procedures shall be performed by nuclear medicine technologists pursuant to the California Code of Regulations, Title 17, Subchapter 4.6. Such procedures shall be performed under the supervision of individuals listed as authorized users on this license who meet the criteria specified in Section 30510. Certificates or special permits issued pursuant to Subchapter 4.6 shall be prominently displayed at the facility authorized on this license. 33. This license does not authorize commercial distribution of radioactive material. 34. Production or processing of radiopharmaceuticals for the purpose of distribution to other licensees is not authorized by this license.