CR79001 Jan 5 1979 MEMORANDUM FOR: B. H. Grier, Director, Region I J. P. O'Reilly, Director, Region II J. G. Keppler, Director, Region III K. V. Seyfrit, Director, Region IV R. H. Engelken, Director, Region V FROM: James H. Sniezek, Director, Division of Resident and Regional Reactor Inspection, IE SUBJECT: IE CIRCULAR NO 79-01, ADMINISTRATION OF UNAUTHORIZED BYPRODUCT MATERIAL TO HUMANS The subject circular is transmitted of issuance on January 12, 1979. The circular should be issued to all medical licensees except teletherapy medical licensees and to all radiopharmaceutical suppliers in your Region. Enclosed is a draft copy of the transmittal letter and two removable labels for each licensee who is to receive this circular. One label is for the draft transmittal letter and the other label is for the envelope. James H. Sniezek, Director Division of Fuel Facilities and Materials Safety Inspection Office of Inspection and Enforcement Enclosures: 1. Draft transmittal letter 2. IE Circular No. 79-01 3. Removable Addressee Labels CONTACT: E. D. Flack, IE 49-28188 . (Transmittal letter for IE Circular 79-01, to each medical licensee except teletherapy licensees and each radiopharmaceutical supplier) IE Circular No. 79-01 Addressee: The enclosed IE Circular 79-01, is forwarded to you for information. If there are any questions related to your understanding of the suggested actions, please contact this office. Signature (Regional Director) Enclosures: 1. IE Circular No. 79-01 2. List of IE Circulars Issued in 1978 . NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT WASHINGTON, D. C. 20555 January 12, 1979 IE Circular No. 79-01 ADMINISTRATION OF UNAUTHORIZED BYPRODUCT MATERIAL TO HUMANS Description of Circumstances: Recently the U. S. Nuclear Regulatory Commission (NRC) has investigated two incidents in which reagent grade compounds containing byproduct material were administered as intravenous radiopharmaceutical to humans. These compounds had neither been manufactured for use as radiopharmaceutical nor undergone testing for human use. In these incidents the byproduct materials were in chemical forms other that the forms used in diagnostic studies and should not have been shipped by the supplier. In one case Selenium-75 labeled selenious acid was shipped instead of Selenium-75 labeled selenomethionine. In the other case Ytterbium-169 labeled chloride was shipped instead of Ytterbium-169 labeled diethylenetriaminepentaacetic acid (DTPA). The hospitals which received these materials should not have accepted them since they were not authorized to possess them by their NRC license. In addition, the hospital personnel preparing the patient doses should not have prepared these materials for administration to a patient since the labels, leaflets, and brochures in each case identified the radioisotope and chemical form and included a warning that the radioactive material was not for use in humans of clinical diagnosis. Notice to Medical License Medical licensees should have procedures to be followed by persons preparing radiopharmaceutical for administration to humans. The procedures should include the following steps: a. confirmation that the compound is a radiopharmaceutical intended for human use, b. Verification that the type, chemical form and quantity of byproduct material is the correct one for the particular patient and the medical procedure being used, and c. verification that the radiopharmaceutical was manufactured and distributed under a license issued by the NRC or and Agreement State . IE Circular No.79-01 January 12, 1979 These confirmations and verifications can be accomplished by reviewing the label, leaflets, and brochures enclosed int he package. Medical licensees should instruct and require personnel to follow these procedures in preparing and administering radiopharmaceutical to patients. The contents of this Circular should be brought to the attention of all personnel who prepare and administer licensed radiopharmaceutical to human patients. No written response to this Circular is required. If you require additional information regarding this subject, please contact the Director of the appropriate NRC Regional Office.
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