At LedgerDomain, we work on compliance with the Drug Supply Chain Security Act (DSCSA), which came into full effect in November with a one-year FDA stabilization period. To bring everyone up to speed with the latest changes, we hosted a December workshop and shared out example SOPs for manufacturers.

Under the DSCSA, trading partners are obligated to demonstrate their Authorized Trading Partner (ATP) status to their direct trading partners, and to ensure that their direct trading partners are indeed authorized. Until November, manual paperwork and processes fit this requirement, but with the “enhanced drug distribution security” requirements, ATPs must now prove their ATP status to each other electronically.

Thanks to everyone who took time from their holiday preparations to attend our third manufacturer workshop. We hope you learned as much as we did!

At the core, this is what we’ve heard from you:

  • Electronic Authorized Trading Partner (ATP) validation is a major priority moving forward through the stabilization period.
  • Manufacturers are largely wrapping up their EPCIS deployments, and are squaring up to handle exceptions, tracing, and 6-year auditability.
  • The XATP Address Book should be prepared to characterize, create and capture any trading partner relationship, whether the partner led with a credential or a trusted email address.
  • Fuzzy matching and third-party data should be used to validate the licensure and validity of that party’s ATP status.
  • Ship-to and bill-to ATP validation are both key to meeting federal and state compliance requirements.

We welcome everyone to access the example SOPs and resources below, or schedule an appointment to discuss your DSCSA compliance journey.

Download Example DSCSA SOPs for Manufacturers & Repackagers

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