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Will FDA Delay Enforcement on Saleable Returns Verification?

By June 18, 2019September 5th, 2019DSCSA, News, Verification Router Service, VRS

Lately, I’ve been asked the same question by pharmaceutical manufacturers and wholesalers:

“Will the FDA postpone enforcement of the Nov. 27 DSCSA deadline of saleable returns?”

It’s easy to see why: The saleable returns market totals 60 million units a year and is valued at $11 billion, a big exposure that must be managed.

2017 Serialization Delay

Distributors and manufacturers would love the FDA to hand them a “Get Out of Jail Free” card by delaying enforcement. After all, the agency pushed back the enforcement of unique product identifiers from November 2017 to November 2018. Can that happen again for salable returns?

The 2017 enforcement delay was widely supported by manufacturers, solution providers, and the regulator. The reason for the break was because package line and vision solution providers had a backlog and couldn’t install or produce enough equipment by the compliance deadline. Each piece of equipment was engineered and made to order, a process that doesn’t scale.

2019 Verification Enforcement

The same problem isn’t here this time. Verifications can be done via phone, email, EPCIS data exchange, and most effectively, utilizing a Verification Router Service (VRS) solution. All these options exist on the market, with the sub-second response rate of VRS makes that verification highly scalable.

A problem with a lack of solutions or inability to scale them doesn’t exist when it comes to verification. My experience with the FDA tells me that there is just not enough of a problem to warrant a significant enforcement delay from the FDA this time around. That’s why LSPediA recommends doing everything necessary now to show good faith and good intent to regulators to be ready by the November 2019 deadline.

Despite lots of wishful thinking, and whatever noise we might now be hearing, counting on an enforcement delay is simply too risky for your business.

Mitigate Risks

With five months left to the November deadline, selecting the right VRS software is your best bet to meet compliance. LSPediA released a nimble and robust VRS solution, called OneScan®, last November after participating in the Healthcare Distribution Alliance’s VRS pilot and GS1-US workgroup.  OneScan® is live and in production with nearly 10,000 GTIN’s and 100,000 successful sub-second verifications.

A VRS solution built on proven technology, OneScan® goes beyond verification with full DSCSA functionalities including:

  1. Verification history
  2. Negative exceptions management
  3. Suspect product investigation
  4. Illegitimate product notification
  5. Interoperability

Turnkey Solution

Building a workflow in addition to selecting, installing, and implementing a complete verification process in the next 23 weeks sounds daunting. A better option is to leverage LSPediA’s software with its robust verification engine, built-in workflow, and automated FDA reporting.

To learn more, please call (248) 973-2008, email [email protected], or visit LSPediA VRS Page.