Amy Kim

Sr. Specialist, Scientific Communications, SA & TS

July 10, 2019

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

Daikyo CZ IN Syringe

So how are these compounded syringes any different from FDA-approved pre-filled syringes on the market today? The difference is in the lack of proper evaluation by compounding pharmacies of the syringe systems for intended use/storage that the FDA requires for approval of pre-filled syringes. With subpotent drugs and further adverse consequences an all-too-real risk to patient safety, compounding pharmacies need to consider the risks of their packaging choices. Given the changing regulations affecting compounding pharmacies, it is no longer safe to assume past practices and previous component selections will continue to meet FDA requirements.

To mitigate risk and ensure future compliance with the changing regulations, the following packaging considerations should be addressed:

  • Qualification of delivery systems for intended use/storage
  • Suitability of container systems/components regarding storage, shelf-life, and in-use conditions relative to drug product stability (fit-for-purpose)
  • Possible drug interactions with components/container systems
  • Container closure integrity (CCI)
  • Delivery system performance requirements
  • Distributor or third-party reliability (sufficient product choices, supply shortages, lack of change notifications or transparency)

West can help achieve compliance by offering:

  • Fit-for-use component recommendations
  • Beyond-use dating (BUD) stability testing
  • CCI evaluations
  • Rigorous change control procedures (West provides customer notification of changes impacting components/stability information updates)

West is committed to the safe and efficient delivery of drug products. An element of this commitment is staying abreast of regulations and offering customers the information and testing services they need through the Integrated Solutions platform. For more information, contact an Account Manager or Technical Customer Support (TCS) representative.