A colleague in Texas reports that her facility’s transfusion service performs therapeutic phlebotomies, which are discarded as biohazard waste. Her hospital transfusion service is not registered with the FDA for this procedure. The hospital nursing service has no involvement with therapeutic phlebotomies. The inquiring colleague recently inspected another hospital where therapeutic phlebotomy was performed by the nursing service, but not by the transfusion service (which is the exact opposite of the inquiring colleague’s local experience). When inquiring as to why therapeutic phlebotomies were done by nursing services and not by the transfusion service, she was led to believe that the Code of Federal Regulations (CFR) requires transfusion services to register with the FDA if they perform therapeutic phlebotomies. This information was of concern to the inquiring colleague since her hospital transfusion service is not registered with the FDA. She wonders if other hospitals provide therapeutic phlebotomies through their nursing or transfusion services, and if so, are they registered with FDA because they provide therapeutic phlebotomy services.

Editor's note: According to a colleague at the FDA, "registration exemptions are outlined in the 2003 21 CFR 600-799 on page 62, section 607.65. Section (f) states that therapeutic collection of blood or plasma is not by itself a requirement for a transfusion service to register."

The following responses have been received.

ADDENDA June 26, 2003

1. The editor suggests that the following previous e-network discussions might be of interest:

• Documenting disposal of blood removed by therapeutic phlebotomy
• Procedure for Documenting Physician Orders for Autologous Donation

2. A colleague at an academic center in Maryland agrees that if the hospital is DISCARDING units of blood that are collected during therapeutic phlebotomy that this activity would not require FDA registration. However, he cautions that in his experience, if an institution is planning to use a therapeutic phlebotomy unit for human transfusion, then there are additional considerations, including but not limited to FDA registration, variance from FDA to issue the units, additional labeling requirements, notation form the primary physician as to the reason for the phlebotomy (such as for treatment of hereditary hemochromatosis) and a policy that ensures that there is no charge for the collection of the unit. There must be careful consideration of the FDA position before implementing such a cross-over plan. The responding colleague suggests that interested individuals might read the FDA guidance document, "Variances for Blood Collection from Individuals with Hereditary Hemochromatosis" which was issued in August of 2001.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator