DSCSA 101 | Resources for DSCSA Compliance
The Drug Supply Chain Security Act (DSCSA), enacted on November 27, 2013 aims to help combat the threat of pharmaceutical diversion by enhancing the traceability of prescription pharmaceutical products in the U.S. This letter communicates trading partners’ DSCSA implementation plan using LSPediA as their DSCSA solution provider for EPCIS and VRS.
The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety of this LSPediA article.
LSPediA partnered with the FDA in order to conduct a pilot that tracks end-to-end supply chain transactions utilizing the product identifier, specifically the 2D data matrix barcode, for drug product verification and tracing.
The DSCSA requirement for manufacturers is now more important than ever. With an ever-evolving timeline, the enforcement dates from the FDA aren’t always clear. LSPediA breaks down exactly what manufacturers are required to do to be compliant and when those regulations are enforced.
Since DSCSA was enacted in 2013, several DSCSA requirements are now in enforcement by the FDA. A wholesale distributor must meet all the past requirements while prepare for the upcoming new ones. We break down exactly what is required of wholesale distributors and when enforcement dates go into effect.
The Drug Supply Chain Security Act (DSCSA) sets out multiple phases of compliance that started Nov. 27, 2013 and finish rolling out Nov. 27, 2023. This includes Serialization and Product Tracing. Understanding the DSCSA Requirement for Dispensers is vital in today’s market.
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