[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: 21CFR640.56]

[Page 94]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                       Subpart F--Cryoprecipitate
 
Sec. 640.56  Quality control test for potency.

    (a) Quality control tests for potency of antihemophilic factor shall 
be conducted each month on at least four representative containers of 
Cryoprecipitated AHF.
    (b) The results of each test are received by the establishment 
licensed for Cryoprecipitated AHF within 30 days of the preparation of 
the cryoprecipitated antihemophilic factor and are maintained at that 
establishment so that they may be reviewed by an authorized 
representative of the Food and Drug Administration.
    (c) The quality control test for potency may be performed by a 
clinical laboratory which meets the standards of the Clinical 
Laboratories Improvement Amendments of 1988 (CLIA) (42 U.S.C. 263a) and 
is qualified to perform potency tests for antihemophilic factor. Such 
arrangements must be approved by the Director, Center for Biologics 
Evaluation and Research, Food and Drug Administration. Such testing 
shall not be considered as divided manufacturing, as described in 
Sec. 610.63 of this chapter, provided the following conditions are met:
    (1) The establishment licensed for Cryoprecipitated AHF has obtained 
a written agreement that the testing laboratory will permit an 
authorized representative of the Food and Drug Administration to inspect 
its testing procedures and facilities during reasonable business hours.
    (2) The testing laboratory will participate in any proficiency 
testing programs undertaken by the Center for Biologics Evaluation and 
Research, Food and Drug Administration.
    (d) If the average potency level of antihemophilic factor in the 
containers tested is less than 80 units of antihemophilic factor per 
container, immediate corrective actions shall be taken and a record 
maintained of such action.

[42 FR 21774, Apr. 29, 1977, as amended at 49 FR 23834, June 8, 1984; 50 
FR 4140, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 64 FR 45373, Aug. 
19, 1999; 66 FR 1837, Jan. 10, 2001]