Commercial distribution
Commercial distribution means any distribution of a blood product except under the investigational use provisions of part 312 of this chapter, but does not include internal or interplant transfer of a bulk product substance between registered establishments within the same parent, subsidiary, and/or affiliate company. For foreign establishments, the term commercial distribution shall have the same meaning except that the term shall not include distribution of any blood or blood product that is neither imported nor offered for import into the United States.