DSCSA

FDA delays Product Identifier verification requirement for saleable returns

The Adents Team Written by The Adents Team
24-Sep-2019

FDA has just published a new guidance document to clarify requirements for wholesale distributors in the US who must verify the product identifier upon receipt of a returned product before further distribution as per DSCSA requirements.

Taking into account concerns expressed by pharma wholesale distributors and other trading partners and stakeholders, US FDA has published a new guidance document, delaying the enforcement of saleable returns Product Identifier verification.

Section 582(c)(4)(D) of the FD&C Act requires wholesale distributors to have systems in place that enable them to verify the product identifier on each sealed homogeneous case of saleable returned medicines. If product is not in a sealed homogeneous case, the product identifier on each package of saleable returned product needs to be verified. After November 27, 2019, he is not allowed to further distribute a saleable returned product until he has successfully verified its product identifier.

FDA delays saleable returns verification requirement for wholesalers

“Wholesale Distributor Verification Requirement for Saleable Returned Drug Product -Compliance Policy Guidance for Industry” now indicates that FDA “does not intend to take action before November 27, 2020, against wholesale distributors who do not verify a product identifier prior to resale or other further distribution of a package or sealed homogenous case of product as required by section 582(c)(4)(D) of the FD&C Act.”

This signifies a one-year delay in enforcement of the requirement for wholesale distributors to verify a product identifier of a saleable return before passing product on.

What the FDA guidance doc DOES NOT mean for wholesalers

This enforcement delay only refers to the requirements of UPID verification. However, it does not mean that wholesale distributors have another year to comply with DSCSA’s November 2019 requirements in general! Firstly, if a wholesale distributor passes on a saleable return without product identifier verification, he is still non-compliant with the law. Wholesalers are still required to be ready but simply won’t face any legal consequences before November 2020 if he is not. Secondly, all other November 2019 requirements for wholesalers and manufacturers remain unchanged. 

Thus, manufacturers are still required to respond to verification requests from distributors. Wholesale distributors, on the other hand, cannot pass on products that appear suspect, don’t have a product identifier (unless grandfathered) or do not come with correct transaction documentation from 27 November 2019, for example.

Reasons behind the enforcement delay for saleable returns verification

There are numerous challenges impacting the pharmaceutical industry’s readiness to comply with DSCSA’s November 2019 requirements. For instance, developing, testing and putting into service electronic systems with the capabilities to timely and efficiently verify product identifiers is complex. Refining and then testing verification systems during actual production in real-time using real-life quantities of saleable returned product rather than simply in pilots is challenging given the sheer volume of saleable returns to be verified.

Conclusion

Given above mentioned challenges, this grace period is not completely unexpected and welcomed by the industry to avoid disruption in drug distribution. Wholesale distributors, manufacturers and other stakeholders now need to make good use of this additional delay and work towards stabilizing their information exchange systems, onboard their stakeholders and ensure they are ready for saleable returns verification in a secure and timely manner by November 2020.

How Adents can help?

Adents’ VRS (Verification Router Service) solution, developed in accordance with all HDA Working Group guidelines and specification, is fully interoperable, agile and agnostic, making it compatible with any existing Level 4 enterprise level serialization solution to manage acceptance, formatting, and delivery of the verification requests and responses for saleable returned drug product in the US. 

The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.

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