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State of Califomia-Health and Welfare Agency M Department of Health Services Page 4 of 5 pages Amendment Number. 11 19. Except as otherwise specifically provided by this license, radiopharmaceuticals to be administered to humans shall be procured in prepackaged, precalibrated form from a supplier who is registered with the U. S. Food and Drug Administration, or prepared and compounded, from a prescription, in accordance with the regulations of the California Board of Pharmacy. 20. Except as otherwise specifically provided by this license, radioactive biologicals (including human serum albumin) to be administered to humans shall be procured in prepackaged, precalibrated form from a supplier who is licensed for the preparation and distribution of such products by the Division of Biologics Standards of the National Institutes of Health, or U. S. Food and Drug Administration; or prepared in accordance with the regulations of the California Board of Pharmacy. 21. Radioactive materials prepared, processed, or modified by the licensee shall not be administered to humans except as specifically authorized by this license. 22. The licensee shall elute generators and process radioactive material with reagent kits in -accordance with instructions fiarnished by the manufacturer on the label attached to or in the leaflet or brochure that accompanies the generator or reagent kit. 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 of the California Board of Pharmacy. 24. Equipment for radiometric assay of pharmaceuticals, body fluids, excreta, or m -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. 25. 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. 26. 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). 27. This license does not authorize commercial distribution of radioactive material. 28. Production or processing of radiopharmaceuticals for the purpose of distribution to other licensees is not authorized by this license.