What are the DQSA and DSCSA?

The Drug Quality and Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA) came into effect for dispensers and manufacturers more than 5 years ago.

The DQSA, came into effect for manufacturers, distributors and repackagers on January 1, 2015. For dispensers (those administering drugs) the DQSA was effective as of July 1, 2015. Title II of DQSA, the DSCSA, outlines critical steps to build an electronic system to identify and trace certain prescription drugs as they are distributed in the United States.

What you need to know

The DSCSA places reporting requirements on dispensers of prescription drugs, including controlled pharmaceuticals. Within 48 hours of a request by the FDA or Board of Pharmacy (BOP), tracing, verification and serialization information for all drug products across all changes of ownership from manufacturer to dispenser must be supplied.

For more information, please refer to the FDA site regarding drug supply chain security.