LSPediA Explains FDA Draft Guidance on DSCSA

On September 13^th, LSPediA CEO Riya Cao and Director of Compliance Guarantee Jami Vincent led a webinar aimed at breaking down the FDA’s final round of draft guidance on the Drug Supply Chain Security Act, covering interoperable data exchange and identifying trading partners under DSCSA as well as a proposed rule on standards for licensure of wholesale drug distributors (WDDs) and third-party logistics providers (3PLs).

If that sounds like a lot to cover, it is! – but simplifying DSCSA is what LSPediA does best.

EPCIS and the end of paper 3Ts

In July, the FDA revised its 2014 guidance with new standards for the information exchange necessary for product tracing. While there had been exceptions for paper records of the transaction information, transaction history, and transaction statement (3Ts), those will be phased out in favor of electronic methods.

Further, the guidance made the long-awaited recommendation that trading partners adopt Electronic Product Code Information Services (EPCIS), citing its ability to ensure DSCSA compliance, compatibility “with a range of technological approaches,” and broad global acceptance.

This change supports a uniform methodology that protects confidential information and trade secrets – and it recognizes that standardized electronic approaches are now more affordable and easier to access.

Do you know your partners?

Revising 2017 guidance, the FDA clarified the definitions of the various kinds of trading partners in the prescription drug supply chain, affecting which DSCSA requirements they need to follow and what it means for them to be authorized. The guidance also makes it easier to understand whether a business’ activities require licensing and annual reporting.

Notably, these definitions include:

• Salvager, which segregates out finished drug products to return those that can be distributed. They take possession of a product, but not ownership.
• Third-Party Logistics Provider (3PL), which provides or coordinates warehousing or other logistics services. They take possession of a product, but not ownership, and has no responsibility to direct its sale or disposition.
• Return Processor or Reverse Logistics Provider, which dispositions or processes products to be processed for credit to a trading partner or for disposal.

LSPediA also offered a clear breakdown of which registrations and licenses each kind of business must hold:

Proposed standards for WDDs and 3PLs

Finally, LSPediA walked attendees through a proposed rule that would set national standards for licensure of WDDs and 3PLs, toward minimizing supply chain threats. The FDA conducted a comprehensive review of existing state standards to establish a model that provides more certainty and clarity to the industry, and harmonizes requirements across state lines.

Once implemented, the new standards would cover licensure designation between the FDA and states, schedules for inspections, reporting requirements, application requirements, and rules for key personnel (such as not allowing a Facility Manager to manage more than one facility).

No looking back

An attendee asked that, since this is technically draft guidance, what should trading partners do: wait for it to be finalized, or take action?

Vincent answered that these changes should now be considered the standard, so trading partners can and should be working to meet them. Cao added that, regarding EPCIS, “there’s no looking back. The FDA has confirmed it, and the industry has conformed.” Both emphasized the benefits of taking action now – waiting too long to comply will be, at best, an expensive and stressful rush to the finish.

Do you have DSCSA questions? Write to QA@lspedia.com. Also, check out our Upcoming Events page for future webinars and training sessions!