Just two days of DSCSA preparation can save you months of stress

May 30, 2023

Who is your DSCSA expert?

There's just a precious handful of months left before November 27, 2023, when the Drug Supply Chain Security Act goes into enforcement. After that day -- which will mark the completion the FDA’s 10-year transformation of the pharmaceutical supply chain -- companies who aren't exchanging serialized data will be at risk of regulatory penalties. Further, incomplete adoption of the law's new rules for transaction data will make businesses vulnerable to lost or stopped product, hurting the flow of business and damaging partner relationships.

November may seem far away, but there's a lot to do -- and it all gets easier if someone at your company is an expert at both DSCSA requirements and your own operations.

You may be familiar with the basic components of DSCSA compliance:

  • Accept (and only accept) serialized products, meaning that incoming drugs must carry a unique product identifier, and that each product is traceable at the individual package level
  • Receive or transfer EPCIS data for any incoming product before or at the time of a transaction
  • Maintain individual interoperable connections to each trading partner, enabling you to securely transmit and receive transaction data
  • Set processes to investigate suspect or illegitimate products
  • Set processes to verify serialized products and process saleable returns
  • Report illegitimate products to the FDA and immediate trading partners

Though all trading partners must comply with DSCSA, each company’s operations, history, and compliance journey are unique. Understanding the measures broadly isn’t the same as being able to navigate your organization through it on a strategic and operational level.

A crucial year demands crucial knowledge

Without a base of knowledge to draw from, the new problems that will inevitably occur amid the industry’s transition to DSCSA can be overwhelming. And it's clear that there will be more problems, given the explosion of data associated with the move to EPCIS.

While the new system will be more secure, the onset of tracking for so many products at the package level, combined with the complexity of EPCIS files themselves (as they record every event in a single item's history), means there's more, and more complex, data in the pharmaceutical supply chain than ever before.

The crucial changes needed for DSCSA take time, and your results will reflect whether you’ve had it or not. For example, if you wait until October of this year, you can probably expect months during which your supply chain operations are more expensive, more confusing, and much slower, with the constant risk of lost product and damaged business relationships.

Two days of training can save you months of stress

Our methodology combines DSCSA background with interactive tools to ensure that attendees come away with firsthand knowledge of EPCIS, VRS, product tracing, exceptions management, 3911 FDA reporting, interoperability, master data, and more.

The sessions also involve insight into structuring an organization’s DSCSA implementation, integrating DSCSA solutions with business systems, and how the process fits into all trading partner operations.

Sign up now!

Next classes:

Wednesday, June 7

Thursday, June 8