Q:  We sometimes send tissue to another healthcare organization.  Does this make us a source facility?

A:  Yes.  The FDA would consider a routine policy or practice of shipping tissue to another facility the activity of a manufacturer, even if it is infrequent.  Such facilities are required to register with the FDA within 5 days of beginning operations and to update their registration every December.  Registered facilities must comply with those federal regulations  applicable to the operations that they perform.   This is a free registration, available at the following website: http://www.fda.gov/cber/tissue/tisreg.htm

Note: Returning unused tissue back to the source facility is not considered distribution and does not require FDA registration.  Also, FDA registration would not be required in the rare and well documented urgent situation.  However, such urgent situations should be the exception to the rule.  If there is a routine pattern of distribution, the FDA would require registration.