[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR606.170]

[Page 53]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS--Table of Contents
 
                     Subpart I--Records and Reports
 
Sec. 606.170  Adverse reaction file.

    (a) Records shall be maintained of any reports of complaints of 
adverse reactions regarding each unit of blood or blood product arising 
as a result of blood collection or transfusion. A thorough investigation 
of each reported adverse reaction shall be made. A written report of the 
investigation of adverse reactions, including conclusions and followup, 
shall be prepared and maintained as part of the record for that lot or 
unit of final product by the collecting or transfusing facility. When it 
is determined that the product was at fault in causing a transfusion 
reaction, copies of all such written reports shall be forwarded to and 
maintained by the manufacturer or collecting facility.
    (b) When a complication of blood collection or transfusion is 
confirmed to be fatal, the Director, Office of Compliance and Biologics 
Quality, Center for Biologics Evaluation and Research, shall be notified 
by telephone, facsimile, express mail, or electronically transmitted 
mail as soon as possible; a written report of the investigation shall be 
submitted to the Director, Office of Compliance and Biologics Quality, 
Center for Biologics Evaluation and Research, within 7 days after the 
fatality by the collecting facility in the event of a donor reaction, or 
by the facility that performed the compatibility tests in the event of a 
transfusion reaction.

(Information collection requirements approved by the Office of 
Management and Budget under control number 0910-0116)

[40 FR 53532, Nov. 18, 1975, as amended at 49 FR 23833, June 8, 1984; 50 
FR 35471, Aug. 30, 1985; 55 FR 11014, Mar. 26, 1990; 64 FR 45371, Aug. 
19, 1999]