Where does my FDA registration number and US license number need to appear on the ISBT 128 label?
For collection facilities, the US license number can appear in either the upper left quadrant or the lower left quadrant, but not both. This information can be found in the examples section of the US Consensus Standard (section 5). The FDA registration number should appear below the collection facility name in the upper left quadrant. For modifying facilities, the FDA registration number and US license number (if applicable) should appear below the modifying facility’s name in the lower right quadrant. If both the collection facility and the modifying facility have a US license for that product, then both US licenses would appear on the label only if they have a written joint manufacturing agreement on file with the FDA. To find out whether or not you must register with FDA, please refer to FDA Registration Form 2830. Click on the link to download the form. The instructions on the second page for completing the form specify which facilities it applies to.
