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.
If you’re a wholesaler or a manufacturer rushing to meet the November 2019 deadline, this guidance is significant. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety this LSPediA article.
DSCSA’s verification requirement for wholesaler distributors has four sections. The compliance policy specifies that the delayed requirement is section 582 (c)(4)(D). However, the compliance policy also identifies requirements that will be enforced without delay. These no-delay requirements are sections 582 (c)(4)(A), 582 (c)(4)(B), and 582 (c)(4)(C). The four sections and their enforcement status are summarized in the table below.
Table 1 DSCSA Verification Requirement
|582 (c)(4)(A)||Wholesale Distributor Requirement for Verification of Suspect Product||No Delay||11/27/2019|
|582 (c)(4)(B)||Wholesale Distributor Requirement for Verification of Illegitimate Product||No Delay||11/27/2019|
|582 (c)(4)(C)||Wholesale Distributor Requirement for Verification Electronic Database||No Delay||11/27/2019|
|582 (c)(4)(D)||Wholesale Distributor Requirement for Verification of Saleable Returned Product||Delayed||11/27/2020|
Focus on Enforcement
While most companies are knee-deep in VRS implementation for the requirement of saleable returns, they need to refocus quickly on the implementation of 582 (c)(4)(A), (B), and (C). The specific infrastructure necessary for said implementation are as follows:
- Systems and processes to manage and handle suspect product
- Systems and processes to manage and handle illegitimate product
- The electronic database with the capability to respond to request and share data access with trading partners as appropriate
Furthermore, with the publication of the final guidance document, the FDA has called manufacturers to action regarding compliance policy, announcing that they “[do] not relieve a manufacturer of its verification obligations pursuant to section 582(b)(4)(C) of the FD&C Act upon receiving a request for verification from a wholesale distributor.”
Contrary to taking a breather, wholesale distributors and manufacturers need to utilize every available day from now until November 27 to focus on implementing 582 (c)(4)(A), (B), and (C).
Delay on Section D – Verification of Saleable Returned Products
Regulators have made a thoughtful decision not to enforce, at least not until industry gets to the level of preparedness necessary to prevent supply chain disruptions stemming from an inability to meet the requirement. The FDA recognizes a number of factors that have contributed to the industry’s readiness, or lack of it.
- The very large volume of saleable returned product requiring verification;
- The need to refine and test verification systems during actual production using real-time volumes of saleable returned product rather than simply in pilots
- The complexities of building an interoperable, electronic system with the capabilities to timely and efficiently verify the large volume of saleable returned products amid immature technologies.
FDA also acknowledged that “several pilot participants are in the early stages of developing and testing interoperable, electronic systems to enable verification and achieve interoperability between networks.”
Worthy of mention is that LSPediA’s FDA DSCSA Pilot project and our participants have performed thousands of live verifications and provided invaluable reports to the FDA. These reports contain key performance indicators of successful verifications, GS1 compliance, barcode exceptions and more.
Takeaways – Invest in Critical Enforcement Items
We urge all to focus on the enforcement requirement and stay the course of forward momentum. Our call to action goes to both manufacturers and wholesale distributors.
LSPediA’s Investigator® solution provides turnkey compliance for section 582 (c)(4)(A), 582 (c)(4)(B), and 582 (c)(4)(C). It provides both system capability and automated workflow to manage suspect product investigation and illegitimate drug product notification. Upon receiving a suspect/illegitimate notification, Investigator® has the capabilities to:
- Shelf-check and document all items in procession
- Respond to requests in real time
- Conduct suspect/illegitimate product investigation with in-app email and camera
- Document 3911 initialization, updates, and termination
- Maintain complete investigation history and 3911 reporting history information for six years
- Share data with trading partners as appropriate
LSPediA engages the process of not only preparedness, but the innovative nature of serialization at-hand. LSPediA’s Investigator® fills the system and process gap that was called out by the FDA in this compliance policy. With Investigator®, you can demonstrate clearly to the FDA with confidence that your company took proper steps to perform DSCSA activities in full compliance to the FDA’s requirement.
The compliance policy document spoke clearly, stating that our industry must keeping moving forward. The compliance requirement for verification of saleable returns, 582 (c)(4)(D), is not going anywhere. A 12 months delay is a great opportunity for wholesalers and manufacturers to select and deploy the best of breed solution in a planned and systematic manner without any rush.
Most manufacturers considered the saleable returns verification as a purely wholesaler focused requirement, and many came to the realization of their own compliance liability and risk to their product viability too late. As the compliance date has crept closer into this November, many wholesalers that have been driving towards readiness have noted a lack of urgency from manufacturers, creating an overarching level of risk that is seriously in need of management.
The ability to meet DSCSA compliance, and just as notably to innovate on the Rx supply chain is never a one-sided initiative. Holistically, it is akin to a team rowing event. This enforcement discretion needs to be recognized for what it truly is – a demand for mobilization. Manufacturers, wholesale distributors, solution providers, and all partnering entities in-between need to keep constant the momentum that has only just engaged itself over the last month.
LSPediA’s OneScan has been designed since the beginning to address all sections of the verification requirement. Our solution offers a smarter way of working to identify, quarantine, investigate, report, and facilitate the investigation of suspect products. Our OneScan solution is just one of the many ways you can ensure your serializations investments are focused on creating business value and/or risk mitigation quality.
Use the discretion period to be thoughtful, innovative, and prepared – not to rest in a manner that finds industry in the same precarious state of unreadiness next year. Your goals should be to work smarter, reduce waste, and generate profitability; choose solution partners that share the same vision. Reach out to us today.