• FDA Delay

As of October 2020, the FDA has announced an extension of the delay of enforcement around the verification of saleable returns verification for Pharmaceutical Wholesale Distributors. This delay is an extension of the original delay detailed in the 2019 Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy guidance put forth by the FDA. If your company accepts returns from your customers, the FDA requires that those returns must be verified with the manufacturer as being valid before they can be resold to other customers. Enforcement of this requirement has now been delayed for a second time for an additional 3 years, until November 27th, 2023.

Background

The original requirement for wholesale distributors to verify saleable returned products before redistribution went into effect on November 27, 2019. This requirement dictates that wholesale distributors must have systems in place that enable them to verify the product identifier, including the standardized numerical identifier, on each package of saleable returned product. Until the product identifier can be successfully verified, the product should be handled as suspect (quarantined and investigated) and only once verified, can the product be further distributed.

Delay

After publishing the 2019 Compliance Policy, in which wholesale distributors were supposed to comply by November 27, 2020, the FDA received comments and feedback from a variety of wholesale distributors, trading partners and stakeholders, expressing their concern around being able to implement the proper processes and systems to meet these requirements. According to stakeholders, the primary factors that influenced the initial delay still exist and have not been properly addressed. These include:

  • The very large volume of saleable returned products 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; and
  • 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

Because of these concerns, the FDA has determined that some wholesale distributors may need additional time beyond the original delay outlined in the 2019 Compliance Policy. Furthermore, according to the latest release from the FDA, “to minimize possible disruptions in the distribution of certain prescription drugs in the United States, the FDA does not intend to take action before November 27, 2023, against wholesale distributors who do not verify a product identifier prior to resale or other further distribution.”

Existing Technology

After the initial requirement set forth by the FDA, several technology companies went to work on building the proper tools to manage these requirements. And although the law did not stipulate how the verification requests would be fulfilled, the use of a Verification Router Service (VRS) began to emerge as the industry leader. According to the law in its current form, manufacturers will be required to respond to requests for verification within 24 hours to comply. As a wholesale distributor, there are three parts to the VRS that you should understand:

  • Requesters are companies like yours who are “requesting” validation of a given serialized product.
  • Responders are the manufacturers or repackagers who must respond to the request with a Valid/Invalid type of response.
  • VRS Providers are the technology companies that provide the software services to which requesters and responders connect that make the system work.  LSPediA, rfXcel, Adents, TraceLink, SAP and others are VRS providers.

“Although there appear to be legitimate reasons why there is another delay in the enforcement of saleable returns verification, I’m disappointed that the industry as a whole has taken so long to solve these issues. With this new enforcement delay, the industry will continue to be vulnerable to illegitimate product entering the supply chain for at least another 3 years. As always, Blue Link will continue to work with industry professionals to provide the capabilities required by the DSCSA. Looking to the future, my question is what additional delays should we expect to see as we grow closer to the 2023 deadline?”

Michael Benedick

Michael Benedick, Pharmaceutical Software Expert

In response to these initial requirements of Nov. 2019, Blue Link has already developed a solution in partnership with LSPediA, which includes support for calling 3rd party provided Verification Router Services from within the Blue Link software. Blue Link will continue to monitor the industry for any additional changes as we work towards the new deadline in 2023.

Blue Link Pharma Software