Pre-Licensing Inspection for Immunization (7/7/88)


Date:     7 July 1988

From:     Director, Center for Biologics Evaluation and Research

Subject:  Discontinuance of Pre-Licensing Inspection for
          Immunization Using Licensed Tetanus Toxoid and
          Hepatitis B and Rabies Vaccines.

To:       All Licensed Source Plasma Manufacturers

Pre-license inspections will no longer be required prior to
approval of product license amendments for Source Plasma
collected from donors immunized with licensed tetanus, rabies and
hepatitis B vaccines according to the approved immunization
schedules provided in the manufacturer's package insert.  Product
license amendments must be submitted for each antigen and the
following documentation should be submitted in addition to the
requirements under Section Y, Immunization of Donors, Form FDA
2600:

     1.   Complete donor records for at least 5 donors
          including:

          a.   Records for titers at 2 months or more post
               initial immunization.

          b.   What determines whether booster immunizations
               are administered?

          c.   Volume, route and amount of antigen
               administered.

          d.   Criteria for evaluation of donor response.

          e.   Copy of informed consent.

     2.   Summary of any adverse reactions encountered during
          the immunization schedule to date.

In addition, we recommend keeping records in a format that
permits easy retrieval and analysis of all adverse reactions
related to immunization.

Immunization procedures should not begin until a reference number
has been assigned. Units of Source Plasma collected from
immunized donors may not be shipped until the amendment has been
approved.

For further information or clarification, contact Blood Bank
Practices Laboratory, Division of Blood and Blood Products, CBER
at (301) 496-0952.

                                                              
                      Elaine C. Esber, M.D.