The FDA DSCSA Pilot Program

The FDA DSCSA Pilot Program

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LSPediA Confirms Participation in FDA’s
DSCSA Pilot Project Program

LSPediA Inc. has announced today that FDA selected LSPediA to participate in the FDA DSCSA Pilot Project Program focusing on Verification, Notification, and Interoperability.

This pilot program is intended to assist the agency and members of the pharmaceutical distribution supply chain in the development of the interoperable electronic system to be established by LSPediA accepted into FDA DSCSA Pilot Project Program 2023.

LSPediA Pilot Background

The FDA is establishing the DSCSA Pilot Project Program to implement section 582(j) of the FD&C Act. This program is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the interoperable electronic system to be established by 2023.

The 2023 system has the potential to reduce diversion of drugs distributed domestically and help deter counterfeit drugs from entering the supply chain. The pilot program will be designed to explore issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, identifying the system attributes necessary to implement the DSCSA requirements, and any other issues identified by the FDA (see section 582(j)(2)(B) of the FD&C Act).

LSPediA Pilot Goals

LSPediA has developed an exceptionally cost-effective way to utilize the product identifier for verification that deters counterfeits through LSPediA’s Verification Router Service (VRS) solution. The Healthcare Distribution Alliance (HDA) already has piloted VRS technology with solution providers, wholesalers, and manufacturers. LSPediA is one of the first solution providers participating in the HDA pilot, performing more than 70,000 verifications to date.

Early on, LSPediA recognized that Verification Router Service, and more importantly, the technology that enables the router service, has the capacity to expand beyond verification and into product tracing and interoperability, LSPediA submits the request to participate in the FDA DSCSA pilot program for Verification/Notification and Interoperability. The results of the pilot will demonstrate that the Router Service is a viable path to full DSCSA compliance and can be put in place prior to 2023 by trading partners.

Pilot Design

LSPediA has designed a pilot program that involves both small and large companies.  LSPediA plans to start the pilot program on July 1, 2019 and complete it by Oct. 1. 9, 2019. We are committed to start the pilot project within four months or less of receiving the FDA’s acceptance letter.

LSPediA proposes using the Verification Router Service to meet the verification, notification, and interoperability obligations of companies operating under the DSCSA. The scope of the pilot project includes end-to-end testing with participating trading partners.

The goals of this pilot project are:

  1. Identify strategic points in the supply chain where product verifications could occur, building a chain of custody;
  2. Verify serial numbers on returned product, allowing it to be resold;
  3. Verify suspect products to deter counterfeiting;
  4. Notify the FDA and trading partners of suspect and illegitimate product with FDA reporting.

Pilot Outcome Reporting

LSPediA will manage the pilot project and report key performance data to the FDA. LSPediA also will provide VRS guidance and subject matter expertise to all functional areas as needed and will proactively identify risks and assist in risk mitigation.

Focus Area Verification Notification Interoperable
Product Tracing
KPIs Verification response time – wholesalers Time to prepare and send a 3911 notification Time to obtain product tracing information
Verification response time – dispensers Time to update a 3911 notification Time to gather product tracing information to support an investigation for a suspect or illegitimate product, or a recall
Percentage of items that are successfully verified vs. those that were targeted for verification Time to clear a 3911 notification Time to retrieve product tracing for a direct purchase
Number of connections/queries needed to gather product tracing information in response to a verification or notification request. Time to retrieve product tracing for an indirect purchase
Security Security
Trading Partner access Trading Partner access
Risk analysis Risk analysis Risk analysis

Value

The pilot will collect key performance data, identify challenges, and recommend best practices.

LSPediA’s pilot project is designed to identify the strategic points of the supply chain where a serialized drug product should be verified and traced to build a chain of custody. The pilot process includes end-to-end testing with participating trading partners performing verification and tracing transactions utilizing the unique product identifier as serialized products change ownership in the supply chain. The pilot will collect key performance data, identify challenges, and recommend best practices. Throughout the pilot project and upon completion, LSPediA will report findings and recommendations to the FDA.

History of the FDA DSCSA Pilot Project Program

The FDA announced the DSCSA Pilot Project Program in February, as a way to implement section 582(j) of the FD&C Act. This program is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the interoperable electronic system to be established by 2023.

Apply to Work in LSPediA’s FDA DSCSA Pilot Project Program

LSPediA encourages pharma companies large or small to join this pilot project and work collaboratively toward solutions that meet the requirements for sales returns, notification, and interoperability.

To apply for LSPediA’s FDA pilot project, please click here.

Customer Testimonials

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
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