Christopher Smith, Senior Counsel, co-presents "Regulatory, Industry, and Legal Perspectives on the Future of the DSCSA" at the American Society of Pharmacy Law Developments in Pharmacy Law Seminar, which runs from November 7 to 10.

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. Speakers plan to include a discussion of the tools available to pharmacies to assist with compliance with DSCSA requirements as DSCSA implementation evolves. The panel 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, panelists 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.

Learning Objectives

  • Describe the key compliance requirements imposed upon pharmacies with regard to identifying and investigating suspect and illegitimate products.
  • Identify some of the tools available to pharmacies to engage with and respond to regulator DSCSA requests for information and investigations.
  • List some of the challenges and obstacles that pharmacies face in implementing the interoperable exchange of transaction data.
  • Discover what regulators may be looking for when they come to inspect or investigate.

For more information, visit ASPL.org.

Event Detail

3:55 p.m. - 4:55 p.m.

Phoenix, NV

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