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11 State of California-I-leaith and Welfare Agency C Deparbmnt of Health Services Page 6 of 7 pages License Num 1812-39 EV I CA I L# .- , 25. 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. 26. Where users or their assistants are engaged in elution of pertechnetate 99m from generators, the exposure to the fingers or hands shall be monitored as required by Title 10, Code of Federal Regulations, Part 20, Section 20.1502(a). 27. Mo -99 break through may not exceed 0.15 uCi per mCi of Tc-99m, and less than 2.5 uCi Mo -99 per administered dose. 28. 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. 29. Nuclear medicine technology procedures shall be performed by nuclear medicine technologists pursuant to the Title 17, California Code of Regulations, 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(ies) authorized on this license. 30. Treatment and management of patients receiving therapeutic quantities of unsealed radioactive materials shall be in accordance with guidance contained in Chapter 4, "Release from Hospital of Patients Containing Radioactive Material" National Council on Radiation Protection and Measurements (NCRP) Report No. 37, "Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides" (NCRP Publications, P. O. Box 30175, Washington, D. C., 20014). 31. Treatment and management of patients undergoing brachytherapy shall be in accordance with guidance contained in Chapter 5, "Safety Precautions in Clinical Application", National Council on Radiation Protection and Measurements (NCRP) Report No. 40, Protection Against Radiation From Brachytherapy Sources (NCRP Publications, P. O. Box 30175, Washington, D.C., 20014). 32. Notwithstanding the six-month test interval requirement of Section 30275 of the California Radiation Control Regulations, medical cesium 137 sources (3M Company Models 6500 - 6507 or old Model 6D6C, and Isotope Products Model 67-800 or 67-820 series) possessed under this license may be tested for leakage and/or contamination at three-year intervals. 33. This license does not authorize distribution to persons licensed pursuant to Title 17, California Code of Regulations, Section 30195 (a) and (b) or equivalent provisions of the U.S. Nuclear Regulatory Commission or Agreement States.