Intended Use and Packaging Risks for Compounding Pharmacies (503Bs)

In 2015, the FDA shed light on a problematic practice within the healthcare industry involving improper, off-label use of syringes as closed container storage systems for compounded or repackaged drugs. The incidents cited revealed that interaction with rubber plungers in syringes that were not cleared for the purpose of closed container storage resulted in the loss of potency of several drugs when administration was delayed.¹