DSCSA FDA product serialization

Our Take on the FDA’s Guidance for Pharma

Last Friday, June 30, the FDA announced that it will push back enforcement of the Drug Supply Chain Security Act (DSCSA) product identification mandate to November 2018. You can download the FDA’s guidance for the pharmaceutical industry here; meanwhile, we have a few key points we’d like to share with you now, with a more in-depth analysis coming later.

Importantly, we’d like to remind you that this guidance impacts the DSCSA from an enforcement standpoint. The FDA’s 12-month enforcement discretion for product serialization (from November 2017 to November 2018) is a delay in enforcement discretion, NOT a delay in the law going live. The main takeaway here is that existing parts of DSCSA are still in effect, as well as requirements other than product serialization, and are set to begin in November 2017. Most notably, the electronic exchange of T3 data lot-level data with customers is still required by November 2017.

A historical footnote to be aware of is that the FDA delayed its first DSCSA milestone that required lot-level exchange in 2015. At that time, the enforcement delay was for four months, and the FDA strictly enforced the law following the four-month postponement. With that in mind, Verify Brand expects that the FDA will NOT push back the product serialization enforcement deadline beyond November 2018. We have every reason to believe that the moratorium will be a one-time 12-month delay, and the product identification enforcement piece of the DSCSA will go into effect as announced.

Interestingly, the FDA included this in its announcement: “A limited number of vendors have the expertise to provide solutions related to information technology systems for data management or specific equipment for packaging or manufacturing lines.”

Because many serialization and traceability providers have been unable to meet the needs of the pharma industry, Verify Brand thinks the FDA is encouraging the industry to use this extended time to carefully evaluate vendor capabilities and select an experienced vendor like Verify Brand, or replace vendors that have not met customer needs to mitigate the risk of missing FDA deadlines.

As we have said in blog posts, webinars, and presentations at industry events, you should quickly and prudently evaluate the systems, partners and technologies that will help you achieve compliance. That way, you’ll be knowledgeable, compliant, and will have a solid foundation for your serialized workflow that will provide benefits for many years to come.

Want to learn how our deep expertise and SWIFT implementation framework can help you cross the DSCSA finish line? Schedule a demo today.



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