Home Products Most Popular Contact
No items in your cart.
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) »
How to Subscribe
MLS & MLT Comprehensive CE Package
Includes 123 CE courses, most popular
$95 Add to cart
Pick Your Courses
Up to 8 CE hours
$50 Add to cart
Individual course$20 Add to cart

Additional Container Labeling Requirements

Section 606.121 covers the specific requirements for labeling blood components. Section 610.60, which applies to general biological products, also discusses container labeling requirements. Here, it is stated that the container label must include:
  • The proper name of the product
  • The name, address, and license number (or registration number for registered facilities) of manufacturer.
  • The lot number or other lot identification
  • The expiration date
  • The statement, "Rx only"
  • The preservative used and its concentration
  • Amount of product in the container
  • Recommended storage temperature
There is also a requirement in this section that a sufficient area of the container remain uncovered by the label to permit inspection of the contents.
When there is divided manufacturing (such as irradiation of a Red Blood Cell unit at a facility other than the collection facility), the name, address, and license number (or registration number for unlicensed facilities) of each must appear on the label.
This section also defines the location of the product name on the label, the font size, and color. There is an exception for units labeled in ISBT 128 as the label color may be all black and white.