Our first DSCSA 2023 webinar is today, June 15, at noon Eastern Time! Registration is still open, so sign up now!
For the next three days, our Executive Global Advisor Brian Files, an expert on U.S. and international pharmaceutical compliance, will present key aspects of the DSCSA and answer your questions.
- TODAY, JUNE 15: The Verification Router Service: Aligning to the Standard
- Wednesday, June 16: ASN to EPCIS: Industry Change, Your Challenge
- Thursday, June 17: Authorized Trading Partners: The OCI Solution
We’ve already done sneak peeks about today’s Verification Router Service webinar and Thursday’s presentation about authorized trading partners. Here’s our last sneak peek about “ASN to EPCIS.” Enjoy! And remember to sign up for the series. All registrants can download the webinars starting next week.
What is the DSCSA?
The DSCSA went into effect on November 27, 2013. It calls for product tracing, product identifiers (PIs), authorized trading partners, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies). Full serialization will begin on November 27, 2023.
DSCSA requirements for electronic data exchange
Trading partners must provide transaction information (TI) and a transaction statement (TS) to the subsequent owner of a product “prior to, or at the time of, each transaction.” This information must “be exchanged in a secure, interoperable, electronic manner in accordance with the standards established [through FDA guidance].”
In 2023, TI must include product identifiers (PIs), which include serial numbers and expiration dates. This is part of the full serialization of the U.S. pharmaceutical supply chain.
The FDA puts a premium on these requirements, saying, “electronic, interoperable exchange of TI is … foundational to achieving electronic interoperable tracing and verification … .”
What is ASN?
An advanced shipping notice (ASN) tells what’s being shipped (e.g., number of items, shipment date, number of boxes, shipment weight, description of packaging) and how it’s being shipped (e.g., land, sea, air).
Why are people talking about ASN? Because it does not currently support DSCSA 2023 requirements for including PIs. What are the ramifications?
What is EPCIS?
The Electronic Product Code Information Service (EPCIS) is a global GS1 standard for exchanging Electronic Product Code (EPC) information and enables automatic communication and exchange of authenticated data.
Right now, it seems to be the pharma industry’s preference for meeting DSCSA requirements — but will it remain the frontrunner, or will another standard gain favor?
Final thoughts
Again, head over to our registration page so you can join Brian today, tomorrow, and Thursday. All the webinars begin at noon Eastern Time and will last up to 45 minutes (depending on how long our Q&A goes).
See you at the webinars!
