Physician Substitutes (12/14/84)

December 14, 1984

FROM:     Acting Director, Office of Biologics Research and
          Review

SUBJECT:  Physician Substitutes

TO:       All Manufacturers of Source Plasma (Human)


Under the provisions of 21 CFR 640.75, the Office of Biologics
Research and Review is now approving adequately trained
physician substitutes to perform some of the routine functions of
a physician, provided the following requirements are met:

1.   The physician substitute must have appropriate basic
     education in the health care profession and must have
     formal on-the-job training in plasmapheresis.  The physician
     who is responsible for the training must evaluate the
     individual's performance of assigned duties in the plasma
     center at the conclusion of a training period of at least 5
     weeks duration. A description of the training program must
     be submitted along with the curricula vitae for the
     physician substitute and for the physician responsible for
     the training program.

2.   Submit a copy of the physician substitute job description
     or statement of responsibilities.  The description of
     duties must clearly define the limits of his or her
     authority and must provide specific instructions concerning
     the accessing of medical care and/or consulting a physician
     in case of emergencies.

3.   The substitute's functions must be limited to manual
     pheresis procedures on healthy donors.  The use of
     physician substitutes for matters related to automated
     pheresis, therapeutic plasma exchange or "disease state
     donors" is not approved.

4.   Of a physician substitute will be responsible for the
     administration of tetanus toxoid, a 6 week training period
     which includes a specific component dealing with the
     procedures and hazards related to immunization of donors
     with tetanus toxoid is required.  The physician should
     evaluate and review all immunization records at least
     weekly.

At the present time, substitutes for physicians are not
acceptable in any immunization program except tetanus.  All
procedures related to donor immunization are under review, and
future changes are anticipated.  To facilitate evaluation of
specific programs, we recommend keeping records of all adverse
reactions related to immunization in a format that permits easy
retrieval and analysis.




     Elaine C. Esber, M.D.