Coming Into Compliance With the Drug Supply Chain Security Act (DSCSA)

In 2013, Congress enacted the Drug Supply Chain Security Act (DSCSA). The DSCSA applies to pharmaceutical manufacturers, distributors, repackagers and dispensers. Several of its requirements become mandatory in 2019 through 2023; however, it has become clear that many dispensers are currently not in compliance with the Act, and are not prepared to be compliant with the requirements that are soon-to-come. The FDA is currently working with the industry to determine exactly what the methods of compliance should be.

This course , presented by healthcare attorneys Melanie Bork Graham and Christopher Ezold, will address the requirements of the DSCSA, methods for compliance, the FDA’s guidance, and a discussion of how the FDA and the industry are working together to determine standards of compliance.

Learning Objectives:

1. Discuss the DSCSA and the requirements going into effect next year and beyond

2. Examine potential methods of compliance for the DSCSA

3. Explore the FDA’s guidance, and how the agency is working with the industry to determine compliance standards