21 Must-know Questions On Serialization & Dscsa Compliance

Navigating the complexities of pharmaceutical serialization and DSCSA (Drug Supply Chain Security Act) compliance can be overwhelming—especially with evolving regulations, tight deadlines, and multiple systems involved. That’s why we’ve compiled 21 Must-Know Questions to help you gain clarity and take actionable steps toward full compliance.

This comprehensive FAQ guide addresses everything from the basics of serialization and aggregation to the role of EPCIS, handling returns, verifying serialized products, integrating with ERP/WMS systems, and future-proofing your compliance strategy. Whether you’re a manufacturer, repackager, wholesaler, or pharmacy, this resource provides clear answers to common challenges and regulatory expectations.

💡 What you’ll learn:

  • What needs to be serialized under DSCSA

  • Key differences between serialization and aggregation

  • How to verify products using EPCIS and VRS

  • Compliance obligations when outsourcing packaging

  • Risk management and cybersecurity for serialized data

  • And much more…

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