The FDA and the DSCSA – Fighting the Good Fight

November 5, 2019

Following the FDA’s lead, LSPediA Tools Help Companies Meet Verification Mandates

Despite the discretion, wholesale distributors are choosing to stay the course with the original DSCSA enforcement date for saleable returns

Keep DSCSA On Track

The DSCSA lays out a 10-year serialization journey for the pharmaceutical industry. Dr. Connie Jung, Acting Associate Director for Policy and Communications in the new Office of Drug Security, Integrity, and Recalls in FDA’s Center for Drug Evaluation and Research, Office of Compliance, recently spoke at the 2019 HDA Traceability Seminar about the progress of DSCSA. In her speech, she discussed the FDA’s role towards protecting public health and ensuring patient safety. She also spoke about the industry’s role in keeping the DSCSA on track. If the industry isn’t ready to facilitate the process, there’s a big potential for supply chain disruption—with subsequent negative patient safety impacts.

Keeping DSCSA on track this November means the wholesalers must implement verification requirements under the DSCSA section 582(c)(4)(A)-(C); and manufacturers must respond to live verifications compliant to DSCSA section 582(b)(4)(A)-(E). LSPediA published our advisory on 10/15/2019 detailing the specific requirements for both wholesalers and manufacturers.

Solution Providers Play an Important Role

Another significant partner to keep both wholesalers and manufacturers on track for DSCSA compliance are solution providers. One cannot underestimate the importance of solution providers in this initiative. For the verification requirement, wholesalers rely on solutions to initiate the verification request with a single scan of the 2D barcode, and manufacturers rely on solutions to respond to the verification request. This automation and interoperability amongst solutions is key towards successful processing of what is estimated to be 59 million serial verifications per year in the US. A Verification Router Service network was formed with collaborative solution providers including LSPediA, Axway, SAP, Chronicled, rfxcel, Adents, TraceLink, and others to enable industry to meet this requirement.

Can Solutions Manage Negative Verifications?

As a leading solution provider in serialization with millions of 2D barcodes scanned by the LSPediA Edge Solution for receiving, picking, packing, and shipping; LSPediA recognized earlier on that the quality of industry barcodes were improving, but nowhere near 100% for product serial verifications. The DSCSA relies on verification to authenticate a drug product, but up to 30% of the barcodes currently in the U.S. Rx pharmaceutical supply chain are still failing.

A good product with a faulty barcode will receive a negative verification response. The regulatory interpretation of a negative verification puts the product into a suspect or illegitimate product category until proven otherwise. This leaves many products in that situation, roughly 20 million negative verifications a year. Without a DSCSA compliant solution to manage and clear the negative verifications; wholesalers will run out of floor space to hold them, run out of resources to sort and process them, and reduce the ability to identify and capture the real counterfeit products. At the same time; manufacturers will be impacted with product loss and its disruptive ripple effect in the supply chain causing lost sales, backorders, and the need for increasing production to fill the void.

In the eyes of FDA regulators, there are even greater risks. These include the inability to properly respond to negative verifications, the challenge of identifying similar at-risk products, and problems associated with quarantine, investigating, and reporting of suspect or illegitimate products to the FDA. The DSCSA regulations were enacted to avoid these risks, so regulators have high expectations for the process that was supposed to improve how these suspect products are identified.

LSPediA Automates Negative Verification Management

Recognizing that a solution that goes beyond basic VRS capabilities is critical to the industry for keeping up with the verification compliance process, LSPediA released the Investigator® module in April 2019 to enable investigation and negative verification management in order to identify true illegitimate products and clear good products in a timely and pragmatic manner.

The Investigator® is system agnostic and can “bolt-on” to any VRS and WMS solution. It categorically identifies negative verifications and alerts the corresponding manufacturer in real time. This then allows the manufacturer to resolve the faulty barcode issue or confirm a need to quarantine suspect products. Once a scan identifies a suspect product, or a distributor is notified that a product in their possession is suspect, the DSCSA requires the following:

  • Quarantine the suspect product
  • Retain suspect product samples
  • Conduct investigations with trading partners
  • File an FDA 3911 notice
  • Maintain a complete history of the investigation for six years.

Supply Chain Companies Join to Help Fight the Good Fight

These remaining DSCSA verification mandates were deliberately kept on track by the FDA regulators. Given the ability to verify serialized products, the pharmaceutical supply chain continues its progress towards ensuring suspect and illegitimate products are removed from the supply chain and patients are protected from dangerous drugs.

Joined by leading wholesale distributor and manufacturing customers; LSPediA’s Investigator® module enables functional and regulatory success for the full verification requirement and improves supply chain operations at-large.

  • Uses algorithmic technology enabling both the requestor and the responder to clearly identify suspect and/or illegitimate products in need of investigation
  • Provides a collaborative workspace – for all parties involved to capture pictures, emails, file attachments, actions, and the disposition of investigated products in a fully automated environment complete with an audit trail identifying all actions – and the identities of the individuals who took those actions

Looking Forward and Staying Diligent

The FDA will continue driving the industry towards a safer, more efficient pharmaceutical supply chain—and LSPediA is ready to partner with manufacturers and wholesale distributors to help your businesses succeed. Take the next step and:

  • Learn all about how LSPediA’s Investigator® solution can provide you with turnkey compliance for section 582 (c)(4)(A), 582 (c)(4)(B), and 582 (c)(4)(C)
  • Contact us to see how we can help you overcome specific challenges in your quest for DSCSA compliance, supply chain improvement, or other organizational goals

Everyone in the Rx serialization space has a responsibility to work with the FDA to be a champion towards protecting those unable to protect themselves…and LSPediA seeks to enable your success.