The industry continues to hold its breath in preparation for the implementation of the latter phases of the Drug Supply Chain Security Act (DSCSA).
November 2017 marks the second phase of the DSCSA (where manufacturers have to serialize their products), and many companies are only now getting preparations underway for the first phase.
“We’re seeing what we call the ‘long tail,’” said Peter Sturtevant, Sr. Director, Industry Engagement, Pharmaceuticals, GS1 US. “Smaller manufacturers who are just starting down the journey of serialization understand the requirements of the legislation, but some are waiting to understand implementation best practices in the next phase of DSCSA before they roll it out.”
“You have the many who have been engaged in this for years and have departments that are managing their process,” he continued. “You have others who are still sorting out the best way to implement [the DSCSA regulations] for their organizations.”
Some of the requirements for dispensers, for example, is still so far out in the future that they are just skimming the surface now as it relates to what they may have to build for infrastructure to meet those requirements.
“Don’t wait. Get engaged, get involved now,” said Sturtevant. “Learn from your customers, peers, and industry trading partners.”
One question has been circulating among small and large pharmaceutical companies alike, and that is: is there going to be a delay in implementation deadlines?
“Some in the industry have questioned if there’s going to be delays or if there will be enforcement initially,” said Sturtevant. “I also think that the complexity and the enormity as it relates to implementing DSCSA is challenging. As an industry, we’re learning a lot, but I don’t think anyone could have anticipated fully what it’s going to take to implement.”
Moreover, the FDA hasn’t provided guidance for over a year. There have been multiple meetings with representatives from the FDA in attendance who continue to say they are working on additional guidance.
Thus far, there’s been no communicated or known enforcement for what occurred in phase one. There may have been some enforcement behind the scenes, but it hasn’t been publically communicated.
What Implementing the DSCSA is Really Going to Take
“There’s no quick fix,” said Sturtevant. “The whole industry is going to have to engage and come together to implement this.
“I think the industry does believe that there will be great benefit beyond compliance. But my experience is that, today, compliance is the big driver and everyone is so myopic looking at the compliance side. We know that it can generate value beyond compliance in terms of patient safety, business efficiencies, and more. Those benefits will be leveraged and realized in time.”
Depending on where a company is in the supply chain, there are different compliance timelines and milestones:
- November 2017: Manufacturers serialize products
- November 2018: Repackagers serialize products
- November 2019: Distributors serialize products
“And that is where this ‘grandfathering’ piece comes in,” said Sturtevant. “The industry is questioning if, for those two years, they’ll still be able to trade lot-based inventory even though it’s not serialized.”
The industry is still waiting on guidance from the FDA on how to handle products manufactured prior to November 27, 2017 with only lot numbers.
As of November 2019, distributors may only receive and ship serialized product with the identifier and maintain TH, TI, TS electronically. This means any lot-based items may not be received or shipped by a wholesale distributor. As a result, the industry wants to know if these lot-based items will be grandfathered under the DSCSA.
“I firmly believe that the FDA wants to respect and support what can and can’t be done by the industry to meet those requirements,” said Sturtevant.
Many pharmaceutical products have shelf lives or expiration dating in a 24-month timeframe. Some experts have suggested that the FDA may approach grandfathering between 2017 and 2019 with that 24-month period in mind.
GS1 Standards: Utilizing EPCIS for the DSCSA
To help pharmaceutical industry professionals prepare for the DSCSA, GS1 US has published a new release of the guideline, Applying GS1 Standards for DSCSA and Traceability (R1.2). This is intended to assist with serialization efforts and item-level traceability requirements in 2017 and 2023, respectively.
Essentially, it is an implementation guideline for applying GS1 standards, which utilizes EPCIS for the DSCSA.
“When the last version was published in the fall of 2014, the first milestone of the DSCSA hadn’t even been reached. There were assumptions—waiting to see what the industry was going to do in this area. There were many open questions,” said Sturtevant, adding that the GS1 US Guideline Release 1.2 has endeavored to address these questions.
There are still other open questions, he added, saying that they intend to start working on 1.3.
“This is a journey, and we’ll have to come together to determine how we’re going to go down that path,” said Sturtevant. “We know what the end game is and what’s been defined and required, but how do we get there? What’s the best practice? What the most effective, the most efficient way that I as a trading partner can comply with the requirements?”
Sturtevant explained that there are four different phases for resolution of serialized exceptions in the new GS1 US Implementation Guideline Release 1.2: from business process, to ‘narrative tables,’ to process flow maps (or diagrams), to the XML examples.
It is also important to note that the DSCSA is only for when there is a sale or change in ownership. Transferring products from one warehouse to another within the same company, for example, isn’t within DSCSA transactions.
“Now, I may use EPCIS to facilitate and accommodate that, but it’s not a DSCSA transaction,” said Sturtevant. “EPCIS tracks movement within a company from one place to another.”
In short, the EPCIS is all about events and activities.
Advice to the Industry
When asked what advice he has for industry professionals preparing for the DSCSA regulations, Sturtevant’s answer was twofold: education and pilot testing.
“Education—understand the requirements of the legislation of the law and how it relates to you as a trading partner,” said Sturtevant.
“Pilot. Test. Test. Test,” he added. “Start practicing with your trading partners and start sharing data, information, shipments. It’s not feasible to be done without extensive testing. I don’t think I can express how important that is.”
Furthermore, despite how expansive the DSCSA may seem, it is only scratching the surface.
“Currently, the ‘patient’ isn’t defined in the legislation,” said Sturtevant. “The last milestone for the DSCSA is the receipt at the dispenser’s receiving dock. So, the dispenser is either a retail pharmacy, a hospital chain, etc.
“Not that people are asking to increase the scope of the requirements, but there are some struggles with implementing best practices in each organization.”
As the next phase of the DSCSA nears, it’s important to remember, that these changes—although expensive and time-consuming ones—are only the beginning of a completely renovated pharmaceutical supply chain.
“I don’t think 2023 is the end,” said Sturtevant. “It is the final known milestone.”