DSCSA Dispenser Requirements
What you need to know
Are you worried about the DSCSA regulations? The Drug Supply Chain Security Act is complex and most people struggle to keep up with what's required to be compliant. If you are not compliant, you may risk financial penalties and time-consuming audits. Here's what you need to know to comply.
1) Confirm you are working with an Authorized Trading Partner (ATP)
2) Receive, validate, and store all track and trace documents
3) Quarantine suspect or illegitimate product
4) Notify FDA and trading partners if you receive suspect or illegitimate product
5) Respond to government authorities and trading partners within 48 hours
6) Only receive product with encoded product identifiers
7) Verify every product at package for lot number, expire date, serial number, NDC
8) Electronic tracking at individual level — Traceability information in EPCIS format*
9) Interoperability (electronic tracing of product) DSCSA compliant data exchange
*requires Global Location Number (GLN)
