United States Nuclear Regulatory Commission - Protecting People and the Environment

                                 UNITED STATES
                         NUCLEAR REGULATORY COMMISSION
                            WASHINGTON, D.C.  20555

                                 July 13, 1979
                                                                                                                                                                                                                                                                            IE Circular No. 79-14


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
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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-

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.

Page Last Reviewed/Updated Thursday, March 29, 2012