With the FDA's final enforcement deadline for DSCSA set for November 27, 2023, all pharmaceutical trading partners must be able to send and receive EPCIS files for every product transaction, track shipments at the individual package level, and use interoperable connections that enable full traceability from manufacturing to dispensing.
Six months isn't a lot of time when it comes to compliance (particularly given the demands of interoperability), but it can be more than enough if you're working with quality solutions. Here are main points you'll need to consider, and how you can cut the time needed to accomplish them.
DSCSA requires trading partners to form interoperable point-to-point connections to conduct transactions, using systems that can import and process one another’s data. After this requirement goes into effect, dispensers can only receive shipments with serialized and properly aggregated data. The industry is adopting GS1’s EPCIS standard for interoperable data.
Under this requirement, dispensers must exchange serial data in a secure, interoperable, electronic manner. As well, they must implement systems and process that can:
Connections must be formed between each individual pair of trading partners; if your business has 50 partners, you need to form 50 connections. These can take weeks or even months to complete and test, making this requirement a significant time commitment.
However, in 2022, LSPedia sought a way to speed up the process of creating, testing, and qualifying DSCSA interoperable connections, which resulted in our partnership with SAP to offer fully pre-configured connections.
Our teams collaborated on the computer system qualification for AS2 network connections necessary to send DSCSA EPCIS data files. The publication of the Operational Qualification Report last August showed that LSPediA and SAP had deployed reliable infrastructure and connections for a Third Party Integrator.
For customers using SAP’s ATTP, the time needed to connect with LSPedia trading partners for EPCIS data exchanges can now be reduced by half or more. LSPedia and SAP also provide compliant qualification documents to support pharma companies’ audit and retention policies.
Pharmaceutical trading partners can only buy or sell prescription drug products that are encoded with serial numbers in the 2D data matrix barcode and the human-readable text format, with exceptions for certain grandfathered products.
You'll need systems and processes in place to handle suspect or illegitimate products:
Product tracing relies on electronically delivered 3Ts data: Transaction History, Transaction Information, and Transaction Statement. (Note that Phase II of DSCSA eliminates the requirement for Transaction History.)
Trading partners must:
LSPedia's OneScan Suite is the industry's leading solution for serialization and EPCIS data interoperability, enabling serial generation, encoding, commissioning, reworking, and decommissioning. EPCIS is where serialized events are created, updated, and stored.
As well, LSPedia's Verifier® Verification Router Service functions as a platform, a network, and a cloud application, enabling companies to verify serialized products with a single scan of any 2D barcode. Verifier routes verification requests to the manufacturer’s EPCIS serial repository for an immediate query and response. The solution operates 24/7, with sub-second response time for each transaction.
The FDA defines and provides requirements for pharmaceutical trading partners to do business as Authorized Trading Partners.
Businesses may only trade with other Authorized Trading Partners; lacking this status restricts their ability to operate. Pharmaceutical trading partners must register with the FDA and hold valid licenses for their business type where stated in the Food, Drug, and Cosmetic Act, comply with reporting requirements as applicable, and follow any state licensing laws.
In addition to maintaining the federal and state licenses of suppliers and customers, businesses should keep their trading partners updated on their own licenses.
The OneScan ATP database of more than 31,000 authorized trading partners enables you to quickly find, add, verify, and manage anyone you're doing business with, saving you valuable time in record-keeping by building tracking into the day-to-day flow of business.
Exceptions are transaction errors that prevent an order from being received into inventory. These can be caused by data problems, mismatches between the EPCIS data and the physical product as received, or even damage to packaging that prevents the label from being read.
They can have serious consequences, as missing transaction data, or any mismatches with the product they describe, must be resolved before a shipment can be received. This can result in temporary quarantine, return to the sender, or even destruction of the product. At the dispenser level, these can directly prevent medications from reaching patients, or cause staff to go to great lengths to source a needed medication on short notice.
The difficulty of resolving exceptions can vary wildly, though they're always more difficult if you don't have a robust solution for exceptions management. It's not possible for any company in the pharmaceutical supply chain to say they're invulnerable to a given error, or even a category of them. Don't get caught off-guard by writing off exceptions as minor or one-off concerns; rather, they should be a core part of your supply chain planning.
With an advanced solution like LSPedia's OneScan Investigator, exceptions management can be automated, helping companies proactively defend against exceptions; this, in turn, protects their partners, patients, and stress levels.
Investigator cuts the resolution time for an exception from days to minutes by alerting users to errors and guiding them through the resolution process. This enables a company to locate a problem before it can stop business, sending notifications with live hyperlinks that allow the point of contact to quickly view the issue and take the next step.
If you haven’t yet begun to prepare your data management resources and coordinate with your trading partners, it's not too late! You can start now, guided by experts at DSCSA implementation, and still reach November 2023 with no compliance worries. Contact LSPedia today, or write to us at DSCSA@lspedia.com.