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4 i Stale of Ccli}Ornio—Heolih and Welford Agency Department of Health Services Page 4 of 4 Pages RADIOACTIVE MATERIAL LICENSE License Number: 5:766-39 Supplementary Sheet Amendment Number: 23. 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 f the California Board of Pharmacy. 24. Counting equipment for radiametric 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. 25. Production or processing of radiopharmaceuticals for the purpose of distribution to other licensees is not authorized by this license. 26. 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. 27. The licensee shall not routinely use doses exceeding those specified in the Department's "Routine Uses" listunless: (a) a nonroutine authorization for use Of a different dose range is included°in the license; or (b) a "Notice of Intent" has been filed with the Department. 28. 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 tids 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. 29• Treatment and management of patients receiving therapeutic quantities of unsealed radioactive materials shall be in accordance with guidance contained in Chapter 4, NCRP Report No. 37, "Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides" (NCRP Publications, 7910 Woodmont Avenue, Suite 1016, Bethesda, Maryland 20814). Release of patients containing 30 millicuries or more must be specifically approved by the Department. For the State Department of Health Servi 1-71S Date: July 22, 1992 By: 3 Radiologic Health Brari-cFT- P.O. Box 942732 Sacramento, CA 94234-73 RH 2551 (Int.) (1/91)