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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.