[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: 21CFR606.122]

[Page 50-51]
 
                        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 G--Finished Product Control
 
Sec. 606.122  Instruction circular.

    An instruction circular shall be available for distribution if the 
product is intended for transfusion. The instruction circular shall 
provide adequate directions for use, including the following 
information:
    (a) Instructions to mix the product before use.
    (b) Instructions to use a filter in the administration equipment.
    (c) The statement ``Do Not Add Medications'' or an explanation 
concerning allowable additives.
    (d) A description of the product, its source, and preparation, 
including the name and proportion of the anticoagulant used in 
collecting the Whole Blood from each product is prepared.
    (e) Statements that the product was prepared from blood that was 
negative when tested for antibody to Human Immunodeficiency Virus (HIV) 
and nonreactive for hepatitis B surface antigen by FDA required tests 
and nonreactive when tested for syphilis by a serologic test for 
syphilis (STS).
     (f) The statements: ``Warning. The risk of transmitting infectious 
agents is present. Careful donor selection and available laboratory 
tests do not eliminate the hazard.''
    (g) The names of cryoprotective agents and other additives that may 
still be present in the product.
    (h) The names and results of all tests performed when necessary for 
safe and effective use.
    (i) The use of the product, indications, contradications, side 
effects and hazards, dosage and administration recommendations.
    (j) [Reserved]
    (k) For Red Blood Cells, the instruction circular shall contain:
    (1) Instructions to administer a suitable plasma volume expander if 
Red Blood Cells are substituted when Whole Blood is the indicated 
product.
    (2) A warning not to add Lactated Ringer's Injection U.S.P. solution 
to Red Blood Cell products.
    (l) For Platelets, the instruction circular shall contain:
    (1) The approximate volume of plasma from which a sample unit of 
Platelets is prepared.
    (2) Instructions to begin administration as soon as possible, but 
not more than 4 hours after entering the container.
    (m) For Plasma, the instruction circular shall contain:
    (1) A warning against further processing of the frozen product if 
there is evidence of breakage or thawing.
    (2) Instructions to thaw the frozen product at a temperature between 
30 and 37  deg.C.
    (3) When applicable, instructions to begin administration of the 
product within 6 hours after thawing.
    (4) Instructions to administer to ABO-group-compatible recipients.
    (5) A statement that this product has the same hepatitis risk as 
Whole Blood;

[[Page 51]]

other plasma volume expanders without this risk are available for 
treating hypovolemia.
    (n) For Cryoprecipitated AHF, the instruction circular shall 
contain:
    (1) A statement that the average potency is 80 or more International 
Units of antihemophilic factor.
    (2) The statement: ``Usually contains at least 150 milligrams of 
fibrinogen''; or, alternatively, the average fibrinogen level determined 
by assay of representative units.
    (3) A warning against further processing of the product if there is 
evidence of breakage or thawing.
    (4) Instructions to thaw the product for no more than 15 minutes at 
a temperature of between 30 and 37  deg.C.
    (5) Instructions to store at room temperature after thawing and to 
begin administration as soon as possible but no more than 4 hours after 
entering the container or after pooling and within 6 hours after 
thawing.
    (6) A statement that 0.9 percent Sodium Chloride Injection U.S.P. is 
the preferred diluent.
    (7) Adequate instructions for pooling to ensure complete removal of 
all concentrated material from each container.
    (8) The statement: ``Good patient management requires monitoring 
treatment responses to Cryoprecipitated AHF transfusions with periodic 
plasma factor VIII or fibrinogen assays in hemophilia A and 
hypofibrinogenemic recipients, respectively.''

[50 FR 35470, Aug. 30, 1985, as amended at 53 FR 116, Jan. 5, 1988; 64 
FR 45371, Aug. 19, 1999]

    Effective Date Note:  The information collection requirements 
contained in Sec. 606.122 will not become effective until OMB approval 
has been obtained. FDA will publish a notice of OMB approval in the 
Federal Register.