Criteria for Exemption of Lot Release (8/26/88)


Date:     August 26, 1988

From:     Director, Center for Biologics Evaluation and Research

Subject:  Criteria for Exemption of Lot Release

To:       Licensed Manufacturers of Blood Grouping Reagents


This is to notify you that effective immediately, the Center for
Biologics Evaluation and Research (CBER) will consider requests
for exemption from official product lot release of Blood Grouping
Reagent specificities:  Anti-A; Anti-B; and Anti-D (slide and
modified tube high protein) produced from human blood.

The following information must be provided for each specificity
for which the exemption is requested:

     1.   A summary of all lots manufactured for each
          specificity identifying the total number of lots
          processed and the number of lots prepared initially
          for licensure but not submitted for release.

     2.   A summary of the disposition of those lots
          manufactured and not submitted for release.

     3.   A detailed summary of all valid complaints to include
          labeling errors, presence of contaminating
          antibodies, decreased potency and presence of
          particulate matter; and the actions taken by the
          manufacturer for each product not identified.

     4.   Annual summary report of all lots manufactured,
          released, and distributed.

The above documentation should cover a period of three years of
manufacturing prior to the date of the request.

Subsequent to an acceptance of an exemption, each manufacturer
will be required to submit one lot of each specificity annually
for surveillance purposes.

Additionally, there must be a history of satisfactory
establishment inspection by the FDA during the immediate
proceeding three years.

Acceptance of this exemption does not exempt the manufacturer
from appropriate   ongoing in-house stability studies of
representative lots of each specificity for review at periodic
inspections. (21 CFR 660.21)


                              Paul D. Parkman, M.D.