The goals of legislation are to allow for greater trust and transparency while standardizing data exchange and providing a way to recognize suspect and illegitimate products through serialization.
However, it will also bring new rules and regulations to drug companies, creating an increased opportunity for potential mistakes and pitfalls. Mistakes that can cost you time and money by preventing the distribution of products and incurring fines/penalties (even jail time).
The DSCSA has several provisions, allowing the FDA the authority to draft additional requirements and enforcement criteria, which can suddenly put your drug out of compliance. We will remain vigilant, watching for any changes and adjusting plans to make sure you remain DSCSA compliant.