IE Circular No. 79-01, Administration of Unauthorized Byproduct Material to Humans

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.