Standard operating procedures for DSCSA workflows
Example SOPs for trading partners who need clear, adaptable procedures for ATP confirmation, electronic verification requests, and interoperable tracing.
Operational language your team can adapt
These example SOPs outline practical steps and protocols aligned with the Drug Supply Chain Security Act. They are informational starting points, designed to be adapted to each trading partner’s systems, responsibilities, and internal review process.
Reviewed in 2026 for the post-stabilization enforcement environment. FDA’s phased exemptions have expired for manufacturers, repackagers, wholesalers, and larger dispensers; the small dispenser exemption ends November 27, 2026.
Select your kit
Manufacturers & Repackagers
Procedures for teams responding to verification and tracing workflows while maintaining authorized trading partner evidence.Wholesalers & Dispensers
Procedures for trading partner confirmation, electronic request handling, investigation support, and record readiness.These example SOPs are intended solely for informational purposes. Trading partners should adapt them to their own workflows and compliance obligations. Copyright LedgerDomain 2026.
Pair SOPs with credentialed DSCSA workflows
LedgerDomain can help connect your procedures to ATP credentials, address books, enhanced verification, and tracing tools.
