IE Circular No. 79-14 - Unauthorized Procurement and Distribution of Xenon-133
UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT WASHINGTON, D.C. 20555 July 13, 1979 IE Circular No. 79-14 UNAUTHORIZED PROCUREMENT AND DISTRIBUTION OF XENON-133 Description of Circumstances: Recently the U.S. Nuclear Regulatory Commission (NRC) and the State of Texas have investigated several incidents in which a nuclear pharmacy procured bulk shipments of Xenon-133 gas labeled "Not For Human Use"; partitioned the material into unit doses, relabeled and packaged the material, and distributed it as a prepared radiopharmaceutical for human use. Some bulk shipments of Xenon-133 were procured by the nuclear pharmacy and transferred to medical institutions not authorized to receive the material. The above actions by the nuclear pharmacy are contrary to both NRC and the Food and Drug Administration (FDA) regulatory requirements. The nuclear Pharmacy procured the Xenon-133 gas from a supplier whose product was not intended for human use. This was in noncompliance with the nuclear pharmacy's NRC license which requires that "radioactive gases as free gas or in solution, to be administered to humans, shall be procured from a supplier who distributes the product indicated for human use in accordance with the Federal Food, Drug and Cosmetic Act." Also, contrary to NRC regulations (10 CFR 30.41 (b)(5) and 10 CFR 30.41(c)), the nuclear pharmacy transferred Xenon-133 "Not For Human Use" to medical institutions who were only authorized to receive Xenon-133 in a form suitable for human use. The NRC only licenses nuclear pharmacies to distribute radioactive drugs that have been approved or accepted by FDA. This includes those radioactive drugs: (a) subject to an FDA-approved "New Drug Application" (NDA) or (b) for which FDA has accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND). The nuclear pharmacy in this case violated FDA regulations since it did not possess an NDA or IND which is required to process "chemical grade" radioactive material into "pharmaceutical grade" radioactive drugs. As part of its approval of NDAs and INDs, FDA requires that certain tests (i.e., total activity, radionuclide purity, etc.) be performed to ensure that the material is safe and effective for human use. The nuclear pharmacy in this case also did not test either the unit doses or the bulk shipments of Xenon-133. Notice to Licensee Who Procure, Distribute, and Use Radiopharmaceuticals: All licensees who procure, process, and distribute radiopharmaceuticals for human use or who administer radiopharmaceuticals to humans should be aware of NRC's and FDA's regulations. Licensees who receive Xenon-133 and other radio- pharmaceuticals for human use should review the labels, leaflets, and brochures 7907180135.IE Circular No. 79-14 July 13, 1979 Page 2 of 2 enclosed in radiopharmaceutical packages to verify that the radioactive material is a radiopharmaceutical intended for human use. Chemical grade radioactive materials are typically labelled as follows: "Caution: For Manu- facturing, Processing, or Repacking. Pharmaceutically Unrefined. Not Tested for Sterility or Freedom From Pyrogens. Not for Human Use in Present Form." Most NRC licensees who distribute and use radioactive materials for human use have a license condition, as stated in the Description of Circumstances part of this Circular, which requires that radioactive gases for human use be procured only from a supplier who distributes the product indicated for human use in accordance with the Federal Food, Drug and Cosmetic Act. Distributors and users should review their NRC licenses and procedures to ensure against the use of unauthorized radioactive material. The contents of this Circular should be brought to the attention of all personnel in your organization who procure, prepare and use radiopharmaceu- ticals for human use. Appropriate instructions should be included in your procedures for procurement, receipt, preparation and use of radiopharmaceu- ticals. 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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