[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: 21CFR640.3]

[Page 85-86]
 
                        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 A--Whole Blood
 
Sec. 640.3  Suitability of donor.

    (a) Method of determining. The suitability of a donor as a source of 
Whole Blood shall be determined by a qualified physician or by persons 
under his supervision and trained in determining suitability. Such 
determination shall be made on the day of collection from the donor by 
means of medical history, a test for hemoglobin level, and such physical 
examination as appears necessary to a physician who shall be present on 
the premises when examinations are made, except that the suitability of 
donors may be determined when a physician is not present on the 
premises, provided the establishment (1) maintains on the premises, and 
files with the Center for Biologics Evaluation and Research, a manual of 
standard procedures and methods, approved by the Director of the Center 
for Biologics Evaluation and Research, that shall be followed by 
employees who determine suitability of donors, and (2) maintains records 
indicating the name and qualifications of the person immediately in 
charge of the employees who determine the suitability of donors when a 
physician is not present on the premises.
    (b) Qualifications of donor; general. Except as provided in 
paragraph (f) of this section and for autologous donations, a person may 
not serve as a source of Whole Blood more than once in 8 weeks. In 
addition, donors shall be in good health, as indicated in part by:
    (1) Normal temperature;
    (2) Demonstration that systolic and diastolic blood pressures are 
within normal limits, unless the examining physician is satisfied that 
an individual with blood pressures outside these limits is an otherwise 
qualified donor under the provisions of this section;
     (3) For allogeneic donors, a blood hemoglobin level which shall be 
demonstrated to be no less than 12.5 grams (g) of hemoglobin per 100 
milliliters (mL) of blood; or a hematocrit value of 38 percent, and for 
autologous donors, a blood hemoglobin level which shall be demonstrated 
to be no less than 11.0 g of hemoglobin per 100 mL of blood or a 
hematocrit value of 33 percent.
    (4) Freedom from acute respiratory diseases;
    (5) Freedom from any infectious skin disease at the site of 
phlebotomy and from any such disease generalized to such an extent as to 
create a risk of contamination of the blood;
    (6) Freedom from any disease transmissible by blood transfusion, 
insofar as can be determined by history and examinations indicated 
above; and
    (7) Freedom of the arms and forearms from skin punctures or scars 
indicative of addiction to self-injected narcotics.
    (c) Additional qualifications of donor; viral hepatitis. No 
individual shall be used as a source of Whole Blood if he has--
    (1) A history of viral hepatitis;
    (2) A history of close contact within 12 months of donation with an 
individual having viral hepatitis;
    (3) A history of having received within 12 months of donation, human 
blood or any derivative of human blood which the Food and Drug 
Administration has advised the blood establishment is a possible source 
of viral hepatitis.
    (d) Therapeutic bleedings. Blood withdrawn in order to promote the 
health of a donor otherwise qualified under the provisions of this 
section, shall not be used as a source of Whole Blood unless the 
container label conspicuously indicates the donor's disease that 
necessitated withdrawal of blood.
    (e) [Reserved]
    (f) Qualifications; donations within less than 8 weeks. A person may 
serve as a source of Whole Blood more than once in 8 weeks only if at 
the time of donation the person is examined and certified by a physician 
to be in good

[[Page 86]]

health, as indicated in part in paragraph (b) of this section.

[38 FR 32089, Nov. 20, 1973, as amended at 49 FR 23834, June 8, 1984; 50 
FR 4138, Jan. 29, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11013, Mar. 
26, 1990; 64 FR 45371, Aug. 19, 1999; 66 FR 1836, Jan. 10, 2001]