COMPLIANCE INFO_1983-2005 - Laserfiche WebLink

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State of California44ealth and Welfare Agency :1 Department of Health Services SLVpbTeritary Sheet Amendment Nmter51 22. The licensee shall elute generators and process radioactive material with reagent kits in accordance with instructions furnished 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. The licensee is authorized to hold radioactive materials with a physical half life of less than 65 days for decay in storage before disposal in ordinary trash provided: (a) Radioactive waste to be disposed of in this manner shall be held for decay in storage for no less than 10 half lives. (b) Before disposal as normal waste, radioactive waste shall be surveyed to determine that its radioactivity cannot be distinguished from background All radiation labels shall be removed or obliterated 25. 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. 26. Nuclear medicine technology procedures shall be performedby 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. 27. Treatment and management of patients receiving therapeutic quantities of unsealed radioactive materials shall be in accordance with guidance contained in Chapta 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 ve Received Therapeutic Amounts of Radionuclides" (NCRP Publications, P. O. Box 30175, Washington, D. C., 20014). 28. This license does not authorize distribution to persons licensed pursuant to Section 30195 (a) and (b) of the California Radiation Control Regulations or equivalent provisions of the NRC or Agreement States. 29. This license does not authorize commercial distribution of radioactive material. 30. Production or processing of radiopharmaceuticals for the purpose of distribution to other licensees is not authorized by this license. 31. Radioactive materials shall be used by occupational workers in such a mariner that the dose limits specified in Title 10, Code of Federal Regulations, Part 20, Subpart C (Sections 20.1201 through 20.1208) are not exceeded