DSCSA Requirement for Wholesalers
The Drug Supply Chain Security Act (DSCSA) was enacted on November 27, 2013 to help combat the threat of pharmaceutical diversion by enhancing the traceability of prescription pharmaceutical products in the U.S. It set multiple phases of compliance requirements for 10 years through November 27, 2023 for Drug Wholesale Distributors (WDD). FDA summarizes the compliance requirements in four areas.
1. Authorized Trading Partner (January 1, 2015)
DSCSA requires that the trading partners of a WDD may only be authorized trading partners. This means maintaining various federal and state licenses from suppliers and customers, as well as keep trading partners update on one’s own licenses.
This requirement can be implemented using OneScan ATP module.
2. Product Tracing Requirement (November 27, 2017 & November 27, 2023)
2.1. Lot Tracing (November 27, 2017)
Started on November 27, 2017, WDD cannot receive lot level product tracing data, including transaction information, t history and transaction statement (3Ts), in an electronic format when purchasing from manufacturers. A WDD cannot accept the ownership of the products without the electronic lot tracing document from the manufacturers. Shipments without electronic 3Ts will be returned to the manufacturers. The pharmaceutical industry has adopted EDI 856 Advanced Shipping Notice (ASN) as the standard lot level product tracing requirement.
This requirement can be implemented by receiving inbound ASN data from manufacturers.
2.2. Serial Tracing (November 27, 2023)
WDDs are required to receive serial level product tracing data, including transaction information, transaction statement, and the unique product identifier data, in an electronic format when purchasing from manufacturers effective November 27, 2023. A WDD cannot accept the ownership of the products without the electronic serial tracing document from the manufacturers. Shipments without electronic serial tracing will be returned to the manufacturers. The pharmaceutical industry has adopted GS1’s EPCIS as the standard serial product tracing requirement. The EPCIS data contains commission aggregation and shipment event, transaction information, and transaction statement meeting DSCSA requirement.
This requirement can be implemented by receiving inbound EPICS data from manufacturers.
- Solution – OneScan EPCIS
- Implementation timeline – now to December 2022*
- Action – Contact LSPeidA Sales
* Timeline adjusted to buffer time requirement for turning on outbound serial shipping.
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In addition to the inbound serial tracing, FDA requires WDDs provide outbound serial tracing to their dispenser customers starting in November 2023. WDDs must send serial level product tracing data of the corresponding shipment in an electronic format to their dispenser customers. Finally, WDDs must capture outbound serialized shipment and send serial level product tracing data to their dispenser customers.
This requirement can be implemented by enabling outbound serialized shipping, generating outbound EPCIS data, sending the EPCIS to customers or hosting it in the customer portal.
- FDA enforcement – November 27, 2023
- Solution – OneScan EPCIS, OneScan Edge, OneScan Customer Portal
- Implementation timeline – now to June 2023*
- Action – Contact LSPediA Sales
* Timeline adjusted to allow user training, SOP development, and on-boarding customers.
3. Serialization (November 27, 2018)
WDDs cannot accept drug products that are not serialized except for grandfathered products, effective November 27, 2018. The 3Ts in lot tracing attest that the inbound shipment from the manufacturer meets DSCSA requirement for serialization and grandfathered product rules.
This requirement is already implemented through lot level tracing capabilities.
4. Verification (November 27, 2019)
WDDs must verify the product identifier on each unit (or sealed homogenous case) before restocking returned resaleable drug products, effective November 27, 2023 While this facet of compliance was delayed from 2019 to 2023, the enforcement requires the identification and investigation of suspect products. The industry has created a Verification Router Services (VRS) network to enable industry wide connectivity and interoperability for product verification on the serial level.
This DSCSA requirement can be implemented using a VRS solution.
- FDA enforcement – November 27,2023
- Solution – OneScan VRS Connector, OneScan Verifier, OneScan Investigator
- Implementation timeline – now to June 2023*
- Action – Contact LSPediA Sales
* Timeline adjusted to allow integration to ERP, Investigator supplier on-boarding, and SOP development.
The DSCSA highlights a 10-year supply chain vision from the FDA. Its specific requirement directly impacts the way that pharmaceuticals are made, sold, and distributed. Any disruption in the supply chain means lost revenue for all parties involved. A reliable DSCSA solution provider is essential to support a WDD’s operations and related FDA compliance initiatives. If you are looking for a software solution provider to help your supply chain performance stay on time and on budget, contact LSPediA for your free DSCSA audit report. It can be the first step in streamlining your processes, automating your operations, and supporting your compliance success.
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The LSPediA OneScan Investigator product allows us to work smarter, manage technical issues and negative verifications better, and not find it necessary to hire FTEs and throw other resources at the problem.Matt Sample, VP Manufacturer Operations, AmerisourceBergen
Partnering with LSPediA to provide a VRS solution has been invaluable. They have been a great partner not only in integrating our software but also in helping us to optimize its performance.Claudio Gallina, VP Pharmaceutical Division, VAI
We wanted to be compliant with DSCSA on day one. We looked at several different solutions for VRS and LSPediA's OneScan stood out to us the most. We're looking forward to utilizing LSPediA's software to streamline our returns process and reduce the amount of returns we receive overall.Frank Rivera, VP Operations & Distribution, Drogueria Betances
We tested LSPediA's OneScan VRS and I’m impressed with the speed of the scans. In my previous role I managed a packaging department and had to aggregate cartons into cases and the process was slow (1-3 seconds per scan) while using other competitive solutions.Joshua Young, Senior Manager & Head of Operations, Komtur Pharmaceuticals
Implementing RxChain has improved our accuracy drastically. In past years it was common to have one shipping discrepancy a month, sometimes more. After partnering with LSPediA, we went two years without a single shipping discrepancy. That's huge.Bryan Brassell, Warehouse and Facilities Manager, Kowa Pharmaceuticals
Everybody at LSPediA is very knowledgeable with their products. When we ask a question they just know the answer. Everybody on staff has the knowledge and experience and that's exactly what we've been looking for.Mark Rumble, VP Operations, Auburn Pharmaceutical
Since partnering with LSPediA we've become more efficient in our packing and shipping of products. RxChain is simple to use and anyone on our staff is able to utilize it to run the reports they need.Roy Paul, Senior Systems Engineer, Kowa Pharmaceuticals
Before implementing LSPediA's OneScan VRS Solution and Investigator module, our entire investigation process was done via paperwork. The VRS changes all of that. We'll know whether or not product is counterfeit and that's going to help us on both the efficiency side and the quality side.Leonardo Gil, Supervisor Returns and Inventory, Drogueria Betances
OneScan Investigator is the only solution that solves the management of anticipated volumes of negative verifications. In addition, it gives us the ability to manage suspect/illegitimate products and file FDA 3911 notifications in one place and do trading partner notifications when required.Matt Sample, VP Manufacturer Operations, AmerisourceBergen
OneScan Investigator resolves the exceptions from the saleable returns process, keeps the products moving, and prevents negative impact to the supply chain.Kelly Lacy, Product Owner, Manufacturer Operations, AmerisourceBergen
LSPediA had by far the best Verification Router Service out of everyone that we looked at. That's why we chose to utilize their lookup directory. We especially enjoy the automated approach to creating 3911 reports for the FDA.Jim Toland, PreSales Engineer, Axway Healthcare
LSPediA's OneScan VRS Solution and Investigator Module improved a lot of my daily work. Rather than manually entering each individual product as they come in, I'm now able to go straight from the scanner to the system.Beverly Wyles, Supply Chain Operations Analyst, Attain Med
With our previous provider, there was no communication and not a lot of responsibility taken for things not working. We had the interview with LSPediA and quickly realized these were the people we wanted to work with. Not just for the functionality of their software, but also for their customer service.Mike Smith, Systems Network Administrator, Auburn Pharmaceutical
We invested a lot of time and effort looking into other software solutions for VRS. When we spoke to other companies that had partnered with LSPediA, it confirmed they had what we were looking for: personalized attention for individual companies and quick responses to inquiries.Petra Huegel, Traffic Coordinator & Certified Quality Inspector, Drugs Unlimited
Choosing LSPediA over competing companies really came down to their knowledge. They answered all of questions confidently and had solutions for whatever we threw at them.Terrie Stonerock, VP Information Technology, Auburn Pharmaceutical
LSPediA's OneScan VRS and Investigator module provides us with an automated, elegantly designed approach and response to Serialization.Jessica Beaver, VP Regulatory and Business Operations, Kowa Pharmaceuticals
I would seriously recommend LSPediA. Their leadership has been awesome. Their project management skills have been terrific. The expertise and knowledge around Manufacturing, regulations, serialization, integrating systems has been incredibly valuable to us.Ken Riester, VP Supply Chain, Kowa Pharmaceuticals
We consider LSPediA to be experts when it comes to the DSCSA and Serialization. They know and understand the ever changing regulations are are proactive on putting things in place to get us ready to go live with serialization.Brad King, Business Operations, Kowa Pharmaceuticals
LSPediA has been a very valuable partner for Blue Link. By utilizing LSPediA's VRS our customers are able to scan 2D barcodes on returned product and get a response instantaneously. It's amazing how fast it works.Darren Myher, CTO, Blue Link