EPCIS for DSCSA: Why and When it Matters, and How to Prepare

Dozens of countries are implementing life sciences supply chain regulatory requirements over the next several years. Most have a government reporting requirement, but the US is one of only two countries – the other is Brazil – that mandates the exchange of compliance data between trading partners. Rather than dictating the data formats and mechanism for this, the FDA has left it up to industry to decide.

The Electronic Product Code Information System (EPCIS) is one of the top contenders for serialized data exchange. What is EPCIS, what are the key considerations and timing, and how can you best prepare while you await the decision?

What is EPCIS?

EPCIS was originally developed as an efficient means for sharing huge volumes of serialized data within any industry. It gives trade partners a standardized way to share information about the movement and status of product throughout the supply chain. It is a GS1 global standard.

What are the considerations for DSCSA?

Lot-level data

EPCIS has not emerged as a factor in exchanging lot-level compliance data. Most of the wholesale distributors have not agreed to accept it, preferring instead to receive ASNs, which deliver logistical information in addition to compliance data.

Companies started implementing the HDMA ASN 856 Guideline to meet lot based DSCSA requirements in mid-2014 and this became the de facto industry standard. As pharmacy chains and hospitals are now coming on board, the adoption of the ASN has continued.

Serialization data

While EPCIS is currently favored to handle serialized data exchange, the industry has yet to make an official decision. Serialized ASNs are another possibility.

As noted above, EPCIS was expressly designed to exchange large volumes of serialized data. If EPCIS is selected, there will be an additional decision to make: would it only carry compliance data and be sent in tandem with ASNs, or would it assume logistical data as well, eliminating the need for an ASN? Many within the industry feel that the two should co-exist, with EPCIS serving purely a compliance purpose and ASNs managing logistical data, which was their original intent.

If serialized ASNs are adopted, they would carry both compliance and logistical data. One concern within the industry is that while ASNs do include fields for serial numbers, they are not structurally built to manage a high volume of serialization data. Data exchange via serialized ASN could potentially become a cumbersome process when shipment volumes are high.

How will a decision be made?

Both HDMA and key supply chain companies will shape the decision. Pilot projects set to begin this year run by HDMA, Rx360, and PDSA will ultimately drive the final outcome.

Technology-wise, the FDA does not have a preference; they will accept the industry recommendation and then hold businesses accountable for implementing the chosen interoperable format.

Timing

As pilots begin, the data format dialogue is accelerating. At the same time, there is conversation around when manufacturers will begin sending serialized data. Because they must start serializing in 2017, and because there are verification requirements for the entire supply chain in regards to returns, some manufacturers have begun to express that they would like to send serialized data prior to 2023, when they are required to do so. That raises the question of whether the rest of the supply chain might be forced to upgrade sooner than anticipated so they can receive whatever format is selected.

How can you prepare for EPCIS or another chosen data exchange format?

There is no set timeframe for the data exchange format decision, and you need to select your serialization architecture now. How can you be confident that a solution partner will be able to handle EPCIS, if that is the chosen format?

Do certifications matter?

GS1 offers a general purpose EPCIS certification process, agnostic of industry or specific compliance requirements, and solution providers can choose to pursue whichever certifications they deem relevant to their business.

If EPCIS is selected by the US, an in-country work group will dictate how it should be specifically applied to DSCSA. At this point, with the decision still pending, there are no certifications that apply to DSCSA implementation that would help solution providers better serve customers.

How about experience and industry involvement?

Even though EPCIS is not yet the official format for serialization data exchange in the US, supply chain partners may still choose to exchange data in this format. As you evaluate the EPCIS experience and knowledge level of solution providers, ask them:

• Do you currently support data exchange between trade partners in EPCIS format?
• Do you have customers who are actively using that functionality?
• How long has it been live in production?

And from a preparedness standpoint, your solution provider should be involved in ongoing dialogue and preparing for multiple outcomes. Ask them:

• Do you participate in GS1, HDMA, or other industry groups that are discussing the selection of EPCIS?
• How are you currently working with customers to understand their data exchange business requirements?
• What product adaptations will you need to make to support EPCIS or serialized ASNs, and when would you be ready?

Ultimately your solution provider should be a partner who helps you understand the ongoing debate, makes sure your business needs will be addressed by the chosen data format and proves that they can implement whatever mechanism that US industry groups select.