This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG and will be included in the next printing of the Compliance Policy Guides Manual. It is intended for FDA personnel and is available electronically to the public. This guidance document represents the agency's current thinking on the deferral of donors due to red blood cell loss during collection of Source Plasma by automated plasmapheresis. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulation, or both.

BACKGROUND:

The Center for Biologics Evaluation and Research (CBER) issued a memorandum to all registered blood and Source Plasma establishments on December 4, 1995, addressing the temporary deferral of Source Plasma donors who have lost red blood cells due to technical difficulties during an automated plasmapheresis procedure. The issue of red blood cell loss during automated plasmapheresis previously had been presented by the Food and Drug Administration to the Blood Products Advisory Committee on June 21, 1994. The Committee concurred with the policy articulated in the December 4 memorandum that the volume of red blood cell loss during automated plasmapheresis procedures for the collection of Source Plasma stated in the memorandum would not compromise donor safety.

POLICY:

Firms should review Source Plasma donor records prior to collection to determine if any red cell loss has occurred during the past eight weeks. If a red cell loss has occurred during an automated plasmapheresis procedure, the volume of loss recorded should be the total extracorporeal red blood cell volume calculated as described by the manufacturer of the apheresis equipment. No attempt should be made to open the system in order to measure the red blood cell loss; to do so could lead to unnecessary exposure to biohazardous agents.

If a donor loses more than 200 ml of red blood cells during a plasmapheresis procedure, the donor should be deferred for eight weeks. It is not necessary to defer a donor for any single incident as long as the red blood cell loss does not exceed 200 ml.

During the eight-week period following the first observable red blood cell loss of less than 200 ml, a second observable red blood cell loss should result in an eight-week deferral from the date of the most recent red blood cell loss.

REGULATORY ACTION GUIDANCE:

Under 21 CFR 640.63(e), any person who has donated one unit or more of whole blood (450 ml) or who has lost the equivalent amount of red blood cells should not serve as a donor of Source Plasma for eight weeks.

Source Plasma establishments should have standard operating procedures (SOPs) in place to defer donors in accordance with the above stated policy. Appropriate regulatory action will be considered for significant deviations from the policy or the firm's SOPs. CBER's Office of Compliance and Biologics Quality, Division of Case Management (HFM-610) may be consulted for further guidance.

Issued: 12/21/98