Trace the package, not just the case
Each saleable package has a unique serial number along with its lot and expiration date. You need to know which packages you received, held, shipped, or dispensed — and be able to produce that history later.
The law, without the jargon
What DSCSA expects of you.
The Drug Supply Chain Security Act is U.S. law for prescription drugs moving through the supply chain. It applies to manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers (including pharmacies).
Exchange electronic transaction information
When product changes hands, the seller sends an electronic notice describing what was shipped. The buyer uses that notice when receiving. Paper pedigrees and “we will email a spreadsheet” do not meet the interoperable system the law describes.
Trade only with authorized partners
You may buy from and sell to authorized trading partners — counterparties with the right licenses or registrations. Keeping that evidence next to the partner record is part of staying in bounds.
Keep records for six years
Transaction information must be retained and produced on request. If you receive an official tracing request, the expected response window is typically 48 hours. That only works if the history is already in a system, not in a retired employee’s inbox.
Verify returns and suspect product
Certain saleable returns and suspect packages must be checked with the manufacturer. Illegitimate or recalled product should be held, investigated, and dispositioned — not sold through.
This page is an orientation, not legal advice. Your counsel and quality team own the interpretation for your licenses. TraceGard is the system of record that makes those obligations operational.
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