Exemptions to Permit Persons with a History of Viral
(4/23/92)

Date:     April 23, 1992

From:     Director, Center for Biologics Evaluation and
          Research

Subject:  Exemptions to Permit Persons with a History of Viral
          Hepatitis Before the Age of Eleven Years to Serve as
          Donors of Whole Blood and Plasma: Alternative
          Procedures, 21 CFR 640.120

  To:     All Registered Blood Establishments

This Memorandum responds to inquiries that the FDA has received
for exceptions from certain donor suitability requirements set
forth in 21 CFR 640.3(c)(1) and 640.63(c)(11). These two
regulations preclude persons with a history of viral hepatitis,
occurring at any age, from donating Whole Blood or Source Plasma.

On September 27, 1991, after discussion in a public meeting, the
Blood Products Advisory Committee to the FDA recommended that the
regulations referenced above be amended because they exclude a
large number of suitable donors. The Committee further
recommended that persons with a history of viral hepatitis, prior
to 11 years of age, not be excluded from donating Whole Blood and
Source Plasma.

In accordance with the recommendation of the Committee, FDA
intends to propose amendments to the regulations referred to
above. Until the regulations are amended, the FDA will consider
procedures acceptable that permit a person with a history of
viral hepatitis before the age of eleven years to serve as a
donor of Whole Blood and Source Plasma. This exception to 21 CFR
640.3(c)(1) and 640.63(c)(11) is in conformance with 21 CFR
640.120, Alternative Procedures.