Specific Label Statements

How to Subscribe
MLS & MLT Comprehensive CE Package
Includes 182 CE courses, most popular
$109Add to cart
Pick Your Courses
Up to 8 CE hours
$55Add to cart
Individual course$25Add to cart
Need multiple seats for your university or lab? Get a quote
The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about Current Good Manufacturing Practices for Transfusion Services (online CE course)
Specific Label Statements

These specific statements must be on the label:18
  • For Whole Blood, Plasma, Platelets, and partial units of Red Blood Cells, the volume of the product which is accurate to within ± 10 percent; or optionally for Platelets, the volume range within reasonable limits.
  • Recommended storage temperature (in degrees Celsius)
  • If the product is intended for transfusion, the statements:
    • "Rx only"
    • "See circular of information for indications, contraindications, cautions, and methods of infusion"
    • "Properly identify intended recipient"
  • If the product is intended for transfusion, the ABO and Rh groups of the donor must be designated conspicuously. Note: For cryoprecipitated AHF, the Rh group may be omitted.
  • The statement, "This product may transmit infectious agents."
The Circular of Information is the information provided to the end user of a blood component that cannot be squeezed onto the label. The instruction provides infusion details, indications, warnings, description of products, and possible reactions. This can be obtained from the blood supplier and should be made available to anyone in the transfusion service who transfuses blood components.
18. Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart G, Section 606.122 "Circular of information." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-G/section-606.122.