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4 <br />State of Califomia-Health and Welfare Agency <br />Department of Health Services <br />Page 4 of 5 pages <br />License Number: 4097-39 <br />Amendment Number: 13 <br />21. Radioactive materials prepared, processed, or modified by the licensee shall not be administered to humans <br />except as specifically authorized by this license. <br />22. The licensee shall elute generators and process radioactive material with reagent kits in accordance with <br />instructions furnished by the manufacturer on the label attached to or in the leaflet or brochure that <br />accompanies the generator or reagent kit. <br />23. Technetium 99m labelled pharmaceuticals prepared by the licensee by aseptic addition of pertechnetate to <br />sterile, pyrogen free reagents may be administered to humans provided the radioassay of the final product is <br />determined with an overall error not exceeding ten percent. When the pharmaceutical is prepared from reagents <br />procured in the form of approved kits, the licensee must strictly follow all instructions and recommendations <br />contained in the package insert information; otherwise the pharmaceutical must be prepared and compounded <br />from a prescription in accordance with the regulations of the California Board of Pharmacy. <br />24. Equipment for radiometric assay of pharmaceuticals, body fluids, excreta, or in -vitro assay samples shall be <br />calibrated to ensure reliability of data obtained. The stability of the equipment shall be checked at least once <br />each day of use, using appropriate standards. <br />25. Nuclear medicine technology procedures shall be performed by nuclear medicine technologists pursuant to the <br />Title 17, California Code of Regulations, Subchapter 4.6. Such procedures shall be performed under the <br />supervision of individuals listed as authorized users on this license who meet the criteria specified in Section <br />30510. Certificates or special permits issued pursuant to Subchapter 4.6 shall be prominently displayed at the <br />facility(ies) authorized on this license. <br />26. Treatment and management of patients receiving therapeutic quantities of unsealed radioactive materials shall <br />be in accordance with guidance contained in Chapter 4, "Release from Hospital of Patients Containing <br />Radioactive Material' National Council on Radiation Protection and Measurements (NCRP) Report No. 37, <br />"Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides" <br />(NCRP Publications, P. O. Box 30175, Washington, D. C., 20014). <br />27. This license does not authorize commercial distribution of radioactive material. <br />28. Production or processing of radiopharmaceuticals for the purpose of distribution to other licensees is not <br />authorized by this license. <br />29. Radioactive materials shall be used by occupational workers in such a manner that the dose limits specified <br />in Title 10, Code of Federal Regulations, Part 20, Subpart C (Sections 20.1201 through 20.1208) are not <br />exceeded. <br />30. The licensee shall monitor occupational exposures to radiation and shall supply and require the use of <br />individual monitoring devices by personnel as required by Title 10, Code of Federal Regulations, Part 20, <br />Section 20.1502 (a). <br />31. The licensee shall monitor occupational intakes of radioactive material by, and assess the committed effective <br />dose equivalent to, individuals who may have exceeded or are likely to exceed, the limits specified in Title 10, <br />Code of Federal Regulations, Part 20, Section 20.1502 (b). Suitable and timely measurements used for <br />determination of such internal exposures shall be performed as specified by Section 20.1204. <br />r <br />