Handling of Human Blood Source Materials (12/23/87)



DATE   :  December 23, 1987

FROM   :  Director, Office of Biologics Research and Review

SUBJECT:  Handling of Human Blood Source Materials

TO     :  Licensed in-vitro diagnostic manufacturers


On December 6, 1985, FDA's Center for Devices and Radiological
Health (CDRH) issued guidelines for labeling human blood derived
in-vitro diagnostic devices concerning HIV testing status. The
Office of Biologics Research and Review (OBRR) also issued
recommendations for labeling and shipping HIV-antibody positive
blood products on December 9, 1985 (copies attached).

It has recently come to the attention of the OBRR that the labels
for some licensed and unlicensed reagents intended for blood bank
use have failed to provide the HIV testing status of the source
material (blood, plasma or serum) as well as appropriate
precautionary statements. Therefore, in order to minimize any
risk of transmission of HIV to laboratory workers and others who
cone in contact with these materials, we are recommending the
following:

     1) All source material used in the manufacture of
     licensed and unlicensed in-vitro diagnostic reagents
     for blood bank use should be tested for the presence
     of antibody to HIV;

     2) No source material positive for antibody to HIV
     should be utilized in the manufacture of such
     reagents unless there is no alternate source
     material; and

     3) The labeling (container, package and circular) of
     the final product should bear additional labeling
     statements as provided in CDRH letter of December 6,
     1985.

With regard to the acquisition (in accordance with 2lCFR 601.22)
of unlicensed human source biological products for further
manufacturing, e.g.,cord blood samples, the OBRR recommends that
the final product manufacturer assure that the following are
maintained by the source supplier:

     1. Detailed procedures implemented by the source
     supplier related to the handling and preparation of
     the product for shipment, including tests performed
     for infectious agents, e.g., HBsAg and Anti-HIV.

     2. Explicit information regarding informed consent
     from the donor for the required HBsAg and Anti-HIV
     tests.

     3. Procedures for follow-up of any positive results.

Questions concerning labeling requirements on this matter may be
addressed to the Division of Blood and Blood Products
(301-496-4396) or the Division of Product Certification
(301-443-5433).



                           Elaine C. Esber, M.D.