§ 606.122 Circular of information. A circular of information must be available for distribution if the product is intended for transfusion. The circular of information must 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 ) A statement that the product was prepared from blood that was found negative when tested for relevant transfusion-transmitted infections, as required under § 610.40 of this chapter (include each test that was performed).
( f ) The statement: “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 circular of information must 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 circular of information must 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 circular of information must 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 appropriate for the product.
( 3 ) When applicable, instructions to begin administration of the product within a specified time after thawing.
( 4 ) Instructions to administer to ABO-group-compatible recipients.
( 5 ) A statement that this product has the same risk of transmitting infectious agents as Whole Blood; other plasma volume expanders without this risk are available for treating hypovolemia.
( n ) For Cryoprecipitated AHF, the circular of information must 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 °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; 77 FR 18, Jan. 3, 2012; 80 FR 29895, May 22, 2015]