US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials

05 Mar 2021

• By Joanne S. Eglovitch

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.

Covid vaccine manufacture — FDA Downgrades Container Closure Changes In Response To COVID-19 Supply Chain Crunch • Source: Shutterstock

The US Food & Drug Administration will downgrade some post-approval change classifications for manufacturers seeking to alter the materials used in container closure systems (CCS) for COVID-19 vaccines as well as other sterile injectables that are in shortage.

The action responds to constraints in the supply of CCS components prompted by the public health emergency, said the FDA...