This is the first part of a two-part series from Two Labs Director of Serialization, Michael Rowe.

I had the opportunity to attend the HDA Distribution Management Conference in Indianapolis a few weeks ago. There, I led a roundtable discussion around an important but often overlooked component of the coming DSCSA requirements: Tracing. 

While Tracing hasn’t gotten much airtime outside the tight circle of DSCSA experts – those of us who live and breathe this – the new Tracing requirement is a fundamental process that will be the norm in the pharmaceutical industry once the DSCSA requirements go into full effect. 

Here I want to dig into the basics: what is Tracing, and what is the impact on trading partners in the industry?

What is Tracing?

Within SEC. 203 of the Drug Supply Chain Security Act, titled Enhanced Drug Distribution Security, section 582 (D) and (E) spells out two distinct Tracing requirements, paraphrased below.

1

(D) During a suspect drug investigation or recall, all trading partners must promptly respond to the FDA or agency initiating the request.

This is pretty straightforward. If an agency reaches out and asks for transaction information, you respond with your data regarding the sale of the product, including the serial numbers. It is still unclear how the FDA or other agencies will submit these requests, whether it’s an automated system or via email or phone calls.

2

(E) There need to be systems in place to facilitate the gathering of transaction information that goes back to the manufacturer.

Within SEC. 203 of the Drug Supply Chain Security Act, titled Enhanced Drug Distribution Security, section 582 (D) and (E) spells out two distinct Tracing requirements, paraphrased below.

This applies if the investigation is conducted by the FDA, another agency, plus a trading partner in the supply chain. Even since DSCSA was first signed in 2013, there has been debate on what ‘facilitate the gathering’ means. Does the gathering fall on the entity making the request or the manufacturer?

Where the industry appears to be oriented towards (and based on unofficial comments from FDA) is that the initiating entity making the request would be responsible for doing the gathering. But it is up to the responding entity to help guide the requestor on where to go to get the next set of data. This was evidenced by diagrams that FDA showed at their public meeting in December 2022 and at the HDA DMC. See below an excerpt from FDA slides that demonstrates the “arrows” of data exchange that will likely occur during a Product Tracing.

The processes and industry best practices for facilitating a tracing request will undoubtedly evolve, especially after November 27, 2023, once the serialization data becomes more available in the supply chain.

Want to read more?

Check out the second part of this series, where I dive into how these tracing requirements are impacting company operations, as well as my opinion on what the industry is doing, what the FDA is telling us, credentialing, and more.

Next part: Are you ready for new DSCSA Tracing requirements?

About the Author

Michael Rowe is the Director of Serialization at Two Labs. He is well known for his DSCSA expertise and has spoken at several industry conferences and events, and he is a Lean Six Sigma Black Belt. Prior to Two Labs, he spent time with a large wholesale distributor as a manager of their Track & Trace program, advising all their divisions, suppliers, and customers on DSCSA requirements.