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 wholesalers and 3PLs.
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 DSCSA wholesaler 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.
- The XATP Address Book should be prepared to characterize, create and capture any trading partner relationship – both upstream and downstream.
- Ship-to and bill-to ATP validation are both key to meeting federal and state compliance requirements.
- Instant onboarding to new customers is desired.
We welcome everyone to access the example SOPs and resources below, or schedule an appointment to discuss your DSCSA compliance journey.
