Drug Supply Chain Security Act (DSCSA) Implementation Timeline

The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013.  Title II of the DQSA is the Drug Supply Chain Security Act (DSCSA).  The enactment of the DSCSA started the clock on a 10 year implementation plan to track pharmaceuticals as they make their way from the manufacturer to the pharmacy.

There are many activities described in the law that need to happen during the long implementation process that FDA will oversee.  Everything from guidance and assessments to regulations will be issued from FDA on a staggered basis between now and approximately the year 2024.  The DSCSA also requires many public meetings where stakeholders will be able to give their input on what will become the final regulations.  Below is an overview of the timeframes for the DSCSA.

from FDA