ACD Whole Blood.
CPD Whole Blood.
CPDA-1Whole Blood.
Heparin Whole Blood.

Packaging and storage— Collect into an approved container (see Transfusion and Infusion Assemblies and Similar Medical Devices á161ñ)containing a sterile,pyrogen-free approved anticoagulant (see USPmonographs Anticoagulant Citrate Dextrose Solution,Anticoagulant Citrate Phosphate Dextrose Solution,or Anticoagulant Citrate Phosphate Dextrose Adenine Solution).Store Whole Blood in the original container,or transfer to an equivalent one using a technique that does not compromise sterility.Whole Blood is stored at a temperature between 1and 6unless platelets are to be prepared,in which case the blood is stored for no longer than 8hours following collection at room temperature.(See General Notices and Requirements.)USP28

Expiration date— Whole Blood collected in Anticoagulant Citrate Dextrose Solution,Anticoagulant Citrate Phosphate Dextrose Solution,or in Anticoagulant Citrate Phosphate Dextrose–Dextrose Solutionmay be stored for up to 21days at 1to 6after the blood has been drawn.Whole Blood collected in Anticoagulant Citrate Phosphate Dextrose Adenine Solutionmay be stored for up to 35days at 1to 6.If the hermetic seal of the container is broken during collection,preparation,or further processing,the expiration date is not later than 24hours after the seal is broken (when blood is stored at 1to 6),but not to exceed the original expiration date of the unit.USP28

Labeling— Label the container to indicate the volume of the Whole Blood collected from the donor,the collection date,the donation number or other coding means to uniquely identify the unit and to provide traceability to the donor,the storage temperature,and the expiration date (see below).Label it to indicate the type of anticoagulant or other preservative solution used to collect it.Label it also to identify donor status (i.e.,volunteer or paid).Label it also with the following statements:“See Circular of Information for indications,contraindications,cautions,and methods of infusion.”;“Properly identify recipient.”;and “Caution:Rx only.”Label it to indicate the ABOgroup and Rh type,as indicated in Table 1.[NOTE—Each Whole Blood product must have a determination made as to its ABOgroup and Rh type and specificity of unexpected red cell antibodies,if any.] If an ABOblood group color scheme is used,use the following labeling color:Group A(yellow),Group B(pink),Group O(blue),and Group AB(white).Label Whole Blood with the type and results of tests for adventitious agents.If it has been issued prior to determination of the test results,label it also with the warning “Donor Untested”and to further specify “Uncrossmatched Blood,”when appropriate.If the unit of Whole Blood was filtered to reduce leukocytes,label it as “Whole Blood,Leukocytes Reduced.”USP28

USP Reference standards á11ñ— USP Hemoglobin RS.USP28

Identification— USP28

Visual inspection— Inspect visually during storage and immediately prior to use.If the color or physical appearance is abnormal or there is any indication or suspicion of microbial contamination,the unit is unsuitable for transfusion.USP28

Hemoglobin content— Proceed as directed under Red Blood Cells,except to use 20µLof Whole Blood (without dilution)as the Test solution.Calculate the hemoglobin concentration in Whole Blood from the calibration curve as directed under Red Blood Cells,except do not multiply by 2.USP28

Leukocyte count (for units labeled as Whole Blood,Leukocytes Reduced)— Proceed as directed under Red Blood Cells,except to use 100µLof Whole Blood.USP28

Expert Committee:(BBP)Blood and Blood Products

USP28–NF23Page 274

Phone Number:1-301-816-8339