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i + state of California—Health and Welfare Agency Department of Health Services 0 Page 4 of 4 Pages RADIOACTIVE MATERIAL LICENSE License Number: 5790-39 Supplementary Sheet Amendment Number: 1 22. Radioactive materials prepared, processed, or modified by the licensee shall not be administered to humans except as specifically authorized by this license. 23. 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 fingers or hands of these individuals shall be monitored, using appropriate dosimeters. 24. 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. 25. Counting equipment for radiometric assay of pharmaceuticals, body fluids, excreta, or in vitro assay samples shall be calibrated and tested sufficiently often to ensure the medical validity and reliability of data obtained. The stability of the equipment shall be checked at least once on each day of use, using appropriate standards or reference sources. 26. Production or processing of radiopharmaceuticals for the purpose of distribution to other licensees is not authorized by this license. 27. The licensee shall not use radioactive material in the form of gas or aerosol in such a manner as to produce an airborne concentration exceeding the appropriate limit specified in Section 30266 or 30269 of the California Radiation Control Regulations. 28. The licensee shall not routinely use doses exceeding those specified in the Department's 01Routine Uses" list unless: (a) a nonroutine authorization for use of a different dose range is included in the license; or (b) a 01Notice of Intent1t has been filed with the Department. 29. 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(ies) authorized on this license. For the State-P99gr#ment of Health Services Date: April 23, 1993 BV.s( � t 3 / Radiologic Health Branch P.O. Box 942732 Sacramento, CA 94234-7320 RH 2551(Int.)(1/91)