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The Hidden 2017 Requirement for Wholesale Distributors

By January 31, 2017March 8th, 2021DSCSA, Track and Trace

We know wholesale drug distributors (WDDs) are working feverishly to prepare for the 2019 DSCSA requirement – trading only serialized products and verifying returned saleable products.  When I ask my WDD clients how they’re preparing for the 2017 requirement, they respond with, “What requirement?”—and a puzzled look.

Please be warned: WDDs do have a DSCSA requirement for 2017, but it’s somewhat “hidden.” Let me explain.

Direct Requirement vs. Implicit Requirement

In the DSCSA, there are direct requirements and implicit requirements. Direct requirements are clearly spelled out in DSCSA, like this one:

‘‘(D) VERIFICATION OF SALEABLE RETURNED PRODUCT.—Beginning 6 years after the date of enactment of the Drug Supply Chain Security Act, upon receipt of a returned product that the wholesale distributor intends to further distribute, before further distributing such product, the wholesale distributor shall verify the product identifier, including the standardized numerical identifier, for each sealed homogeneous case of such product or, if such product is not in a sealed homogeneous case, verify the product identifier, including the standardized numerical identifier, on each package.”

Very clear, right? WDDs need to verify saleable returns starting 2019 as described above.

Then there are implicit requirements. An implicit requirement is not directly laid out in the DSCSA by the FDA, but is implied based on other requirements—sort of a sub-requirement. In the pharmaceutical supply chain, an upstream requirement, given the nature of the business, becomes a downstream requirement. What’s impacting manufacturers may also impact WDDs and vice versa. Because it is not spelled out in the DSCSA, an implicit requirement is easily overlooked. Some WDDs—as I related above—have no idea that they have work to do right now and that it’s due this year, in 2017. It’s the ability to receive electronic product tracing, and it came about due to a direct DSCSA requirement for manufacturers:

  ‘‘(C) ELECTRONIC FORMAT. —‘‘(i) IN GENERAL.—Beginning not later than 4 years after the date of enactment of the Drug Supply Chain Security Act, except as provided under clause (ii), a manufacturer shall provide the transaction information, transaction history, and transaction statement required under subparagraph (A)(i) in electronic format.

Very clear—for manufacturers. They must send electronic product tracing starting in 2017. Implicitly, this means WDDs must receive electronic product tracing—Transaction History, Transaction Information, and Transaction Statement, or the three Ts.

WDDs Must Receive Electronic Product Tracing Starting in 2017

Many leading WDDs have already met this requirement, some as early as 2015. But many more, especially the small- and medium-size businesses, still receive product tracing in paper form, such as invoices or packing slips from their suppliers.

Don’t get blindsided. WDDs—and all pharmaceutical supply chain partners—are responsible for both direct and implicit requirements.

Complexity Ahead

To summarize, WDDs have a lot on their plates. This timetable lays out the entire set of DSCSA requirements.

It’s not only the big three who need to take control of their businesses and their destinies. All distributors need to make critical decisions about their futures – and they need to do it now. When you trade with hundreds of manufacturers and handle thousands of SKUs, there is no simple, one-size-fits-all solution. Bringing the serialized products in and getting the serialized products out – without interrupting the business, and while meeting FDA compliance requirements – is a big job. It requires proper planning, a complex solution architecture, and resources to execute the implementation. That may sound overwhelming, but it doesn’t have to be.

Partner with LSPediA for Complete DSCSA Compliance

Working with LSPediA means you have a partner with deep experience and a complete understanding of the entire DSCSA compliance process. Plus, the benefits you gain by partnering with us go beyond the regulatory compliance, extending across your organization to:

  • Lower overall spending
  • Mitigate compliance risks
  • Shorten your project timeline

Contact us today and we’ll create a DSCSA compliance strategy that’s right for your business and tailored to your specific needs.

About LSPediA – Life Sciences Solutions
LSPediA is a leading provider of services and solutions that secure supply chains, protect against product counterfeiting, and help businesses comply with FDA regulations. Our customers are partners in the pharmaceutical supply chain, including manufacturers, wholesale distributors, dispensers, and reverse logistics providers. LSPediA helps customers define needs and implement best-of-breed supply chain and enterprise solutions that improve efficiency and comply with FDA and global standards.

We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals. Our expertise, experience, and technical know-how help customers derive maximum value from their investments, both now and well into the future.

For more information about LSPediA, call +1 (248) 973-2008, email [email protected], or visit our website at www.lspedia.com.

For additional information, contact: Julianne Jahn [email protected]