Regulatory, Industry and Legal Perspectives on the Future of the DSCSA

This presentation will provide an update on the final stages of implementation of the DSCSA and anticipated future regulatory efforts. We will begin with a brief high level overview of the DSCSA, including a summary of recent regulatory developments, such as any new regulations or guidance documents issued by the FDA in 2024 with regard to the DSCSA. We will then pivot to address the end of the one-year FDA stabilization period, recent feedback from the pharmacy industry regarding DSCSA compliance concerns, and the readiness of the pharmacy industry to fully implement and obstacles to implementation of the interoperable electronic exchange of transaction data. We plan to include a discussion of the tools available to pharmacies to assist with compliance with DSCSA requirements as DSCSA implementation evolves. We will further discuss the challenges that state regulators face with regard to ensuring that dispensers, wholesalers and manufacturers comply with the DSCSA, particularly with regard to ensuring that stakeholders have robust processes for identifying, investigating and responding to suspect and illegitimate products. The presentation will also address emerging pharmacy trends that intersect with DSCSA implementation and require further assessment from a compliance perspective, such as new alternative 340B drug distribution arrangements. Additionally, we will provide an update on state and federal DSCSA enforcement and what pharmacies need to know and do to effectively address suspect and illegitimate products and challenges that they may face.