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n State of Calitornla—Health and Welfare Agency Supplementary Sheet Page 4 Deportment of Health Services of 5 Pages License Number: 5766-39 Amendment Number: 3 19. E sept as otherwise specifically provided by this license, radicphanriac eut-i cols to be administered to hm ans sball be procured in prepackaged, precalibrated form, from a supplier 410 is registered with the U. S. Food. and Drug Adni stration, Or prepared and campounded, f m a PresaY1pticn, in aCCXJ7I ance with the regulations of the California Board of Pbalmacy. 20. Except as Otherwise specifically Provided by this license, radioactive biologicals (including human serum albumin) to be administered to humans shall be procured in ted farm from a supplier wbo is licensed for the preparatim and djStrA=tjLcn of such products by the Dbvision of Biologics Standards Of the Nati Institutes of Health, or U. S. Food and Drug nd mi r i st-,ation; or prepared in accardance 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. 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) . 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 recomTendations 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 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. For the State Department of Health Services Date: September 15, 1994 By: 3 Radlologlc Health Branch P.O. Box 942732 Sacramento, CA 94234-7320 RH 2551 (Int.) (1/91)