Date:     August 8, 1995     

From:     Director, Center for Biologics Evaluation and Research

Subject:  Recommendations for Labeling and Use of Units of Whole
          Blood, Blood Components, Source Plasma, Recovered
          Plasma or Source Leukocytes Obtained from Donors with
          Elevated Levels of Alanine Aminotransferase (ALT)

To:       All Registered Blood Establishments


Introduction

In a public meeting on December 3, 1993, FDA's Blood Products
Advisory Committee (BPAC) recommended that if donors are
voluntarily screened for ALT, and units with elevated ALT are
inadvertently collected, FDA should recommend that such units be
either a) quarantined and destroyed or, b) labeled to indicate
that ALT is elevated and that the contents are for in vitro use
only.

The usefulness of the ALT assay for screening blood donors was
discussed and examined in detail at the Consensus Development
Conference on Infectious Disease Testing for Blood Transfusions
sponsored by the National Institutes of Health in January, 1995. 
The Consensus Statement included a recommendation that žALT
testing of volunteer blood donors should be discontinuedž.

Subsequently, on March 23, 1995, BPAC concluded that the
continuation of ALT testing of Whole Blood and Source Plasma
donors is not scientifically justified.

This memorandum is not intended to address the utility of
screening donors for serum/plasma ALT values in relation to the
safety of blood.  FDA does not recommend either for or against
ALT testing.  However, if a blood establishment elects to perform
the ALT test, units with an ALT level greater than twice the
upper limit of the normal range (based either on the ALT test kit
package insert definition of the upper limit of normal or the
results of a community sample sizeable and diverse enough to 

validate an alternative upper limit of normal) should not be
transfused, and should be labeled either:

1.  to indicate that ALT is elevated and that the contents may be
used for the manufacture of in vitro diagnostic reagents only, or

2.  to indicate that ALT is elevated and that the contents may be
used for laboratory research only.


LABELING OF BLOOD AND BLOOD COMPONENTS WITH ELEVATED ALT VALUES

Therefore, FDA is recommending that, if units of Whole Blood,
blood components, Source Plasma, Recovered Plasma or Source
Leukocytes intended for further manufacturing are tested for ALT,
products of those units which have ALT levels greater than twice
the upper limit of the normal range (based either on the ALT test
kit package insert definition of the upper limit of normal or the
results of a community sample sizeable and diverse enough to
validate an alternative upper limit of normal), and which are not
destroyed, should be labeled with the following statements as
appropriate:

1.             "ALT ELEVATED"

                     and

2.   "Caution:  For Use in Manufacturing Noninjectable Products
     Only" or, "Caution: For Laboratory Research Only"


Technical questions, information, and comments may be directed to
the:
     Division of Blood Applications (HFM-375) 
     1401 Rockville Pike, Suite 200N
     Rockville, MD 20852-1448 
     Phone: (301)-594-2012    FAX: (301) 594-6431




                                      __________________________
                                      Kathryn C. Zoon, Ph.D.